Selección de Resúmenes de Menopausia

Octubre de 2008

Juan Enrique Blümel. Departamento Medicina Sur. Universidad de Chile

 

Semana del 22 al 28 de Octubre 2008

 

Stroke. 2008 Oct 23. [Epub ahead of print

Effect of Raloxifene on Stroke and Venous Thromboembolism According to Subgroups in Postmenopausal Women at Increased Risk of Coronary Heart Disease.

Mosca L, Grady D, Barrett-Connor E, Collins P, Wenger N, Abramson BL, Paganini-Hill A, Geiger MJ, Dowsett SA, Amewou-Atisso M, Kornitzer M

From Columbia University, New York, NY; the University of California, San Francisco, San Francisco, Calif; the University of California-San Diego, La Jolla, Calif; Royal Brompton Hospital and Imperial College, London, UK; Emory University, Atlanta, Ga; the University of Toronto, Toronto, Ontario, Canada; Keck School of Medicine, University of Southern California, Los Angeles, Calif; Eli Lilly and Company, Indianapolis, Ind; and Brussels Free University, Brussels, Belgium.

BACKGROUND AND PURPOSE: Raloxifene, a selective estrogen receptor modulator, reduces risk of invasive breast cancer and osteoporosis, but the effect on risk for stroke and venous thromboembolism in different patient subgroups is not established. The purpose of this analysis was to evaluate the effect of raloxifene on the incidence of all strokes, stroke deaths, and venous thromboembolic events according to participant subgroups. METHODS: This was a secondary end point analysis of an international, randomized, placebo-controlled clinical trial of 10 101 postmenopausal women with or at increased risk of coronary heart disease followed a median of 5.6 years. Strokes, venous thromboembolic events, and deaths were adjudicated by expert centralized committees. Strokes were categorized as ischemic, hemorrhagic, or undetermined and venous thromboembolic events were subclassified. RESULTS: The incidences of all strokes did not differ between raloxifene (incidence rate per 100 woman-years=0.95) and placebo (incidence rate=0.86) treatment groups (P=0.30). In women assigned raloxifene versus placebo, there was a higher incidence of fatal strokes (incidence rates=0.22 and 0.15, respectively, P=0.0499) and venous thromboembolic events (incidence rates=0.39 and 0.27, respectively, P=0.02). No significant subgroup interactions were found except that there was a higher incidence of stroke associated with raloxifene use among current smokers. CONCLUSIONS: In postmenopausal women at increased risk for coronary events, the incidences of venous thromboembolism and fatal stroke but not all strokes were higher in those assigned raloxifene versus placebo. Raloxifene's effect did not differ across subgroups, except that the risk of stroke differed by smoking status. Treatment decisions about raloxifene should be based on a balance of projected absolute risks and benefits.

 

Calcif Tissue Int. 2008 Oct 23. [Epub ahead of print]

Intramuscular Neridronate in Postmenopausal Women with Low Bone Mineral Density.

Adami S, Gatti D, Bertoldo F, Sartori L, Di Munno O, Filipponi P, Marcocci C, Frediani B, Palummeri E, Fiore CE, Costi D, Rossini M

Rheumatology Unit, Ospedale di Valeggio, University of Verona, 37067, Valeggio, Verona, Italy, silvano.adami@univr.it.

Compliance to osteoporosis treatment with oral bisphosphonates is very poor. Intermittent intravenous bisphosphonate is a useful alternative, but this route is not readily available. Neridronate, a nitrogen-containing bisphosphonate that can be given intramuscularly (IM), was tested in a phase 2 clinical trial in 188 postmenopausal osteoporotic women randomized to IM treatment with 25 mg neridronate every 2 weeks, neridronate 12.5 or 25 mg every 4 weeks, or placebo. All patients received calcium and vitamin D supplements. The patients were treated over 12 months with 2-year posttreatment follow-up. After 12-month treatment, all three doses were associated with significant bone mineral density (BMD) increases at both the total hip and spine. A significant dose-response relationship over the three doses was observed for the BMD changes at the total hip but not at the spine. Bone alkaline phosphatase decreased significantly by 40-55% in neridronate-treated patients, with an insignificant dose-response relationship. Serum type I collagen C-telopeptide decreased by 58-79%, with a significant dose-response relationship (P < 0.05). Two years after treatment discontinuation, BMD declined by 1-2% in each dose group, with values still significantly higher than baseline at both the spine and the total hip. Bone turnover markers progressively increased after treatment discontinuation, and on the second year of follow-up the values were significantly higher than pretreatment baseline. The results of this study indicate that IM neridronate might be of value for patients intolerant to oral bisphosphonates and unwilling or unable to undergo intravenous infusion of bisphosphonates.

 

Metabolism 2008 Nov;57(11):1509-15.

Estrogen replacement therapy decreases plasma adiponectin but not resistin in postmenopausal women.

Kunnari A, Santaniemi M, Jokela M, Karjalainen AH, Heikkinen J, Ukkola O, Kesäniemi YA.

Department of Internal Medicine, Biocenter Oulu, University of Oulu, Clinical Research Center, Oulu University Hospital, 90220 Oulu, Finland.

The effects of estrogen replacement therapy (ERT) to cardiovascular disease risk are still unclear. Low adiponectin and high resistin plasma concentrations are reported to be associated with atherosclerosis. However, it is not known how ERT affects plasma adiponectin and resistin concentrations. Seventy-three hysterectomized, nondiabetic, postmenopausal women were randomized in a double-blind, double-dummy study to receive either peroral estradiol valerate or transdermal 17beta-estradiol gel for 6 months. Biochemical measurements were determined from samples taken before and after the therapy. Peroral estradiol valerate therapy decreased adiponectin concentrations from 13.6 to 11.6 mg/L (P = .008), whereas transdermal 17beta-estradiol gel had no effect (12.7 vs 12.2 mg/L). Neither treatment changed the resistin concentrations significantly. Plasma concentrations of estradiol and estrone did not correlate with adiponectin or resistin concentrations before or after therapy. The change in adiponectin concentration correlated significantly with the changes in waist-hip ratio, very low-density lipoprotein triglycerides, and insulin-like growth factor 1 in the peroral estradiol valerate group. The changes in these variables and the change in estradiol concentration explained 43.1% (P = .001) of the variability in the change of plasma adiponectin, the change in very low-density lipoprotein triglycerides being the strongest determinant (beta = -.407, P = .011). The results show that peroral ERT can decrease plasma adiponectin levels. However, ERT does not seem to influence plasma resistin concentrations.

 

J Endocrinol Invest 2008 Jul;31(7 Suppl):2-6.

Epidemiology of glucocorticoid-induced osteoporosis.

Civitelli R, Ziambaras K.

Division of Bone and Mineral Diseases, Department of Internal Medicine, Washington University School of Medicine, Saint Louis MO 63110, USA. rcivitel@im.wustl.edu

Glucocorticoid-induced osteoporosis is the leading cause of medication-induced osteoporosis. The incidence of new fractures after one year of glucocorticoid therapy can be as high as 17%, and observational studies suggest that fractures, which are often asymptomatic, occur in 30-50% of chronic glucocorticoid-treated patients. Fractures can occur within 3 months of initiation of steroid therapy and with daily doses as low as 2.5 mg of prednisone, indicating that there is no "safe dose" of glucocorticoid therapy in terms of skeletal safety. Even inhaled steroids can lead to bone loss, if used for prolonged periods of time. Importantly in glucocorticoid- treated patients, fractures tend to occur at bone mineral density levels that usually carry lower risk in women with post-menopausal osteoporosis, thus implying effects independent of bone mass. Glucocorticoids seem to affect skeletal sites that are mostly composed of trabecular bone, although fractures can occur at cortical sites as well. The combination of high dose, long duration of treatment, and a continuous pattern of administration significantly increase the relative risk of fractures. The rapid and profound bone loss that occurs after initiation of glucocorticoid therapy has some very practical implications with regards to the site and the timing of bone mineral density measurements and fracture prevention strategies.

 

Cochrane Database Syst Rev. 2008 Oct 8;(4):CD001690

Oestrogens and progestins for preventing and treating postpartum depression.

Dennis CL, Ross LE, Herxheimer A

Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 155 College Street, Toronto, Ontario, Canada, M5T 1P8.

BACKGROUND: Postpartum depression is a common complication of childbirth, affecting approximately 13% of women. A hormonal aetiology has long been hypothesised due to the sudden and substantial fluctuations in concentrations of steroid hormones associated with pregnancy and the immediate postpartum period. There is also convincing evidence that oestrogens, progestins, and related compounds have important central nervous system activity at physiological concentrations. OBJECTIVES: The primary objective of this review was to assess the effects of oestrogens and progestins, including natural progesterone and synthetic progestogens, compared with placebo or usual antepartum, intrapartum, or postpartum care in the prevention and treatment of postpartum depression. SEARCH STRATEGY: We searched The Cochrane Pregnancy and Childbirth Group trials register (June 2004), the Cochrane Depression Anxiety and Neurosis Group trials register (July 2004), the Cochrane Central Register of Controlled Trials (July 2004), MEDLINE (1966 to 2004), EMBASE (1980 to 2004), and CINAHL (1982 to 2004). We scanned secondary references and contacted experts in the field. SELECTION CRITERIA: All published and unpublished randomised controlled trials comparing an oestrogen and progestin intervention with a placebo or usual antepartum, intrapartum, or postpartum care among pregnant women or new mothers recruited within the first year postpartum. DATA COLLECTION AND ANALYSIS: Two review authors participated in the evaluation of methodological quality, data extraction, and data analysis. Results are presented using relative risk for categorical data and weighted mean difference for continuous data. MAIN RESULTS: Two trials, involving 229 women, met the selection criteria. Norethisterone enanthate, a synthetic progestogen, administered within 48 hours of delivery was associated with a significantly higher risk of developing postpartum depression. Oestrogen therapy was associated with a greater improvement in depression scores than placebo among women with severe depression. AUTHORS' CONCLUSIONS: Synthetic progestogens should be used with significant caution in the postpartum period. The role of natural progesterone in the prevention and treatment of postpartum depression has yet to be evaluated in a randomised, placebo-controlled trial. Oestrogen therapy may be of modest value for the treatment of severe postpartum depression. Its role in the prevention of recurrent postpartum depression has not been rigorously evaluated.

 

Arch Physiol Biochem. 2008 Oct;114(4):211-23

Does obesity play a major role in the pathogenesis of sleep apnoea and its associated manifestations via inflammation, visceral adiposity, and insulin resistance?

Vgontzas AN.

Department of Psychiatry, Sleep Research and Treatment Center, Hershey, PA, USA.

Despite the early recognition of the strong association between obstructive sleep apnoea (OSA) and obesity, and OSA and cardiovascular problems, sleep apnoea has been treated as a "local abnormality" of the respiratory track rather than as a "systemic illness". In 1997, we first reported that the pro-inflammatory cytokines interleukin-6 (IL-6) and tumour necrosis factor-alpha (TNFalpha) were elevated in patients with disorders of excessive daytime sleepiness (EDS) and proposed that these cytokines were mediators of daytime sleepiness. In subsequent studies, it was shown that IL-6, TNFalpha, and insulin levels were elevated in sleep apnoea independently of obesity and that visceral fat was the primary parameter linked with sleep apnoea. Further studies showed that women with the polycystic ovary syndrome (PCOS) were much more likely than controls to have sleep-disordered breathing (SDB) and daytime sleepiness, suggesting a pathogenetic role of insulin resistance in OSA. Additional accumulated evidence that supports the role of obesity and the associated metabolic aberrations in the pathogenesis of sleep apnoea and related symptoms include: obesity without sleep apnoea is associated with daytime sleepiness; the protective role of gonadal hormones as suggested by the increased prevalence of sleep apnoea in post-menopausal women and the significantly reduced risk for OSA in women on hormonal therapy; partial effects of continuous positive airway pressure (CPAP) in obese patients with apnoea on hypercytokinemia, insulin resistance indices, and visceral fat; and that the prevalence of the metabolic syndrome in the U.S. population from the Third National Health and Nutrition Examination Survey (1988-1994) parallels the prevalence of symptomatic sleep apnoea in general random samples. Furthermore, the beneficial effect of a cytokine antagonist on EDS and apnoea in obese, male apnoeics and that of exercise and weight loss on SDB and EDS in general random or clinical samples, supports the hypothesis that cytokines and insulin resistance are mediators of EDS and sleep apnoea in humans. Finally, our recent finding that in obese, hypothalamic CRH neuron is hypoactive, provides additional evidence on the potential central neural mechanisms for depressed ventilation and consequent development of sleep apnoea in obese individuals. In conclusion, accumulating evidence provides support to our thesis that obesity via inflammation, insulin resistance, visceral adiposity, and central neural mechanisms, e.g. hypofunctioning hypothalamic CRH, play a major role in the pathogenesis of sleep apnoea, sleepiness, and the associated cardiovascular co-morb

 

 

Semana del 15 al 21 de Octubre 2008

 

Gynecol Endocrinol. 2008 Aug;24(8):470-4

Impact of diabetes mellitus on the sexuality of Peruvian postmenopausal.

Mezones-Holguin E, Blümel JE, Huezo M, Vargas R, Castro J, Córdova W, Valenzuela G, Castelo-Branco C

Faculty of Human Medicine, National University of Piura, Piura, Peru.

AIM: To evaluate sexual function among postmenopausal diabetic women. PATIENTS AND METHODS: A total of 72 postmenopausal women, 36 diabetic, with a stable partner were included in this study. Sexual functioning was assessed using the Female Sexual Functioning Index (FSFI) and depression using the Beck Depression Inventory scale. RESULTS: There was no difference between diabetic and control women regarding age, years of schooling, number of children, age at menarche, age at first sexual experience, years postmenopausal or body mass index. Diabetics had a worse score for depression (11.5 +/- 5.6 vs. 8.9 +/- 4.7, p < 0.03), a lower frequency of sexual intercourse per month (2.7 +/- 2.8 vs. 4.4 +/- 2.9, p < 0.01) and a more deteriorated marital relationship (scale of 0-20: 13.4 +/- 2.9 vs. 15.1 +/- 1.9, p < 0.009). Diabetics demonstrated worse scores globally (19.3 +/- 8.1 vs. 26.8 +/- 4.5, p < 0.0001) and in all domains of the FSFI: desire (2.6 +/- 1.4 vs. 3.8 +/- 1.1, p < 0.0001), arousal (3.5 +/- 1.9 vs. 4.7 +/- 0.8, p < 0.002), lubrication (3.2 +/- 1.9 vs. 4.5 +/- 1.3, p < 0.003), orgasm (3.2 +/- 1.8 vs. 4.5 +/- 1.1, p < 0.002), satisfaction (3.8 +/- 1.3 vs. 4.8 +/- 0.9, p < 0.0005) and pain (3.1 +/- 1.7 vs. 4.6 +/- 1.3, p < 0.0001) (values all mean +/- standard deviation). Considering sexual dysfunction as a score higher than 26.55, the prevalence of sexual dysfunction among diabetics was 75.0% vs. 30.6% in the control group (p < 0.001). After adjusting for depression, years of schooling, hysterectomy, marital relationship and age, diabetes mellitus remained an important risk factor for sexual dysfunction (odds ratio 6.2, 95% confidence interval 2.0-19.6, p < 0.02). CONCLUSION: Diabetes mellitus affects all areas of female sexuality and this condition is independent of depression.

 

Menopause. 2008 Oct 8. [Epub ahead of print

A population-based study of dyspareunia in a cohort of middle-aged Brazilian women.

Valadares AL, Pinto-Neto AM, Conde DM, Sousa MH, Osis MJ, Costa-Paiva L.

From the 1Department of Gynecology and Obstetrics, Universidade Estadual de Campinas, Campinas, Brazil; and 2Department of Gynecology and Obstetrics, Universidade Federal de Goiás, Goiânia, Brazil.

OBJECTIVE:: To investigate the prevalence of dyspareunia and its associated factors in a cohort of middle-aged women. DESIGN:: A cross-sectional, population-based study was carried out using an anonymous, self-report questionnaire completed by 200 Brazilian-born women, 40 to 65 years of age, with 11 years or more of formal education. The evaluation instrument was based on the Short Personal Experiences Questionnaire. Sociodemographic, clinical, behavioral, reproductive, and partner-related factors were assessed. Poisson multiple regression analysis was performed, and prevalence ratios (PRs) with their 95% CIs were calculated. RESULTS:: The prevalence of dyspareunia was 39.5%. Multiple analysis showed that dyspareunia was more common in women who reported nervousness (PR = 1.73, 95% CI: 1.14-2.63) and depression (PR = 1.69, 95% CI: 1.09-2.61). A score of more than 3 for frequency of sexual activity (PR = 0.20, 95% CI: 0.05-0.84) and having had more than two pregnancies (PR = 0.62, 95% CI: 0.48-0.81) were factors indicative of a protective effect against dyspareunia. CONCLUSIONS:: Dyspareunia was common in this cohort of middle-aged women. Nervousness and depression increased the likelihood of experiencing dyspareunia. These findings suggest that psychological symptoms should be taken into consideration in the management of the middle-aged woman with dyspareunia, and measures should be adopted to minimize the repercussions of these factors on sexuality.

 

Atherosclerosis. 2008 Sep 6. [Epub ahead of print

Sex hormone levels and subclinical atherosclerosis in postmenopausal women: The Multi-Ethnic Study of Atherosclerosis.

Ouyang P, Vaidya D, Dobs A, Golden SH, Szklo M, Heckbert SR, Kopp P, Gapstur SM.

Johns Hopkins University, Baltimore, MD, United States.

We examined cross-sectional associations between sex hormones and carotid artery intimal-medial thickness (cIMT) and coronary artery calcium in women in the Multi-Ethnic Study of Atherosclerosis. Serum testosterone, estradiol, sex hormone binding globulin (SHBG), and dehydroepiandrosterone levels were measured in 1947 postmenopausal women aged 45-84 years (30% White, 14% Chinese-American, 31% Black, and 25% Hispanic) and not on hormone therapy. Using multiple linear regression we evaluated associations between log(sex hormone) levels and log(cIMT) adjusted for age, ethnicity, body mass index (BMI) and cardiac risk factors. Associations between sex hormone levels and the presence and extent of coronary calcium were evaluated. Total and bioavailable testosterone were positively associated with common cIMT independent of age, BMI, hypertension, smoking, HDL-cholesterol, LDL-cholesterol and insulin sensitivity (p=0.009 and p=0.002, respectively). SHBG was negatively associated with common cIMT (p=0.001) but further adjustment for BMI, cardiovascular risk factors, and LDL- and HDL-cholesterol removed significance. Estradiol and dehydroepiandrosterone were not associated with common cIMT. Sex hormones were not associated with presence of coronary calcium. Among women with measurable coronary calcium, higher SHBG (p=0.012) and lower bioavailable testosterone (p=0.007) were associated with greater coronary calcium score. No heterogeneity by ethnicity was found. In postmenopausal women, testosterone is independently associated with greater common cIMT. SHBG is negatively associated and this may be mediated by LDL- and HDL-cholesterol. In contrast, SHBG and testosterone were associated with extent of coronary calcium but in the opposite direction compared to carotid intimal-medial thickness. These differences warrant further evaluation.

 

J Bone Miner Res. 2008 Oct 10. [Epub ahead of print]

Activation of Renin-Angiotensin System Induces Osteoporosis Independently of Hypertension.

Asaba Y, Ito M, Fumoto T, Watanabe K, Fukuhara R, Takeshita S, Nimura Y, Ishida J, Fukamizu A, et al.

Abstract Hypertension and osteoporosis are two major age-related disorders; however, the underlying molecular mechanism for this co-morbidity is not known. The renin-angiotensin system (RAS) plays a central role in the control of blood pressure, and has been an important target of anti-hypertensive drugs. Using a chimeric RAS model of transgenic THM (Tsukuba Hypertension Mouse) expressing both the human renin and human angiotensinogen genes, we have demonstrated in the present study that activation of RAS induces high turnover osteoporosis with accelerated bone resorption. Transgenic mice that express only the human renin gene were normotensive and yet exhibited a low bone mass, suggesting that osteoporosis occurs independently of the development of hypertension per se. Ex vivo cultures revealed that angiotensin II (AngII) acted on osteoblasts, not directly on osteoclast precursor cells, and increased osteoclastogenesis-supporting cytokines, RANKL and VEGF, thereby stimulating the formation of osteoclasts. Knockdown of AT2 receptor inhibited the AngII activity, while silencing of the AT1 receptor paradoxically enhanced it, suggesting a functional interaction between the 2 AngII receptors on the osteoblastic cell surface. Finally, treatment of THM mice with an ACE inhibitor, enalapril, improved osteoporosis as well as hypertension, whereas treatment with losartan, an ARB specific for AT1, resulted in exacerbation of the low bone mass phenotype. Thus, blocking the synthesis of AngII may be an effective treatment of osteoporosis as well as hypertension, especially for those afflicted with both conditions.

 

Panminerva Med. 2008 Sep;50(3):247-54.

Is there a place for postmenopausal hormone therapy use in women with lupus?

Gompel A, Piette JC.

Unit of Endocrinological Gynecology, Paris Descartes University, Hôtel Dieu de Paris, APHP, Paris, France

The Women Health Initiative (WHI) randomized trials have reported increase in cardiovascular and breast cancer risks from the use of post-menopausal hormone therapy (HT). A striking decrease of HT use has been observed worldwide despite the fact that other regimens in younger post-menopausal women could be safer. Systemic lupus erythematosis (SLE) is considered as estrogen sensitive. HT is generally considered as contraindicated in these women who are especially at risk for cardiovascular diseases and osteoporosis. However, recent randomized trials have raised the question of a lack of deleterious effects of estrogen containing oral contraceptives. In view of the recent knowledge and understanding in the field of menopause the authors were interested to examine the HT effects in women with SLE by analysis the published cases control, observational studies and randomized trials. The randomized trials and large observational studies showed a mild increase risk in flares and thrombotic events, whereas retrospective studies did not show increase in these risks but suggesting selection bias. A better profile on the blood clotting parameters and surrogate markers of the arterial risk can be obtained by transdermal estrogen and natural progesterone in non SLE women. Less venous thrombotic events are observed in women at risk for thrombosis with the transdermal estradiol administration in a case control study. However no randomized trial is still available and no epidemiological data are reassuring on the arterial risk. Prescription of HT has to remain especially prudent in women with SLE. If a decision of treatment is taken transdermal estradiol and progesterone or close pregnane derivatives should be probably most valuable but also used at the minimal dose.

 

Br J Sports Med. 2008 Oct 16. [Epub ahead of print

When Will We Treat Physical Activity as a Legitimate Medical Therapy......even though it does not come in a pill?

Church T, Blair SN.

Pennington Biomedical Research Center, United States.

A recent highly publicized report claimed that an exercise pill as been discovered. (1) A mystical substance was found to increase endurance in mice without exercise training. By the way, this is not the first time such an observation has been made. None the less it was widely reported that this may be the end of the need to get off the couch and soon all the benefits of exercise will be delivered via a pill. Sound too good to be true? It likely is, as mimicking the multiple health benefits of exercise with a pill would be the equivalent of creating a cancer free cigarette. If exercise could be put in a pill form, the world as we know it would be radically changed forever with healthcare and financial implications too large to quantify. We would have a new powerful therapeutic option for the prevention and treatment of cardiovascular disease, diabetes, dementia, osteoporosis, depression, old age, certain types of cancer and many other ailments some of which are not typically considered "exercise related". (2) In 2007 the Milken Institute, estimated that the top 7 chronic diseases which include CVD, cancer, diabetes, mental disorders and lung disease are estimated to cost the US 1.3 billion dollars annually; with the shift in age of the population this cost is expected to increase dramatically in coming years. (3) If exercise came in a pill we could dramatically reduce the prevalence as well as the morbidity and mortality associated of these conditions creating a much healthier, happier and more productive world. Many doctors would be out of work and hospitals would have to be downsized. But creating an exercise pill is no easy task; and as indicated by the list above, the pill would have to simultaneously benefit numerous complex physiological systems, not just improve exercise capacity as documented in the recent report. It is somewhat audacious to suggest that we can mimic the health benefits of exercise with a pill and while maybe some day in the far future this may be possible it is not likely anytime soon. However, this topic is not likely to go away soon as we know of at least 4 other substances that are currently understudy that claim to increase fitness in animals.

 

Cardiovasc Diabetol. 2008 Oct 15;7(1):30. [Epub ahead of print

Are the adverse effects of glitazones linked to induced testosterone deficiency?

Carruthers M, Trinick TR, Jankowska E, Traish AM.

ABSTRACT: BACKGROUND: Adverse side-effects of the glitazones have been frequently reported in both clinical and animal studies, especially with rosiglitazone (RGZ) and pioglitazone (PGZ), including congestive heart failure, osteoporosis, weight gain, oedema and anaemia. These led to consideration of an evidence-based hypothesis which would explain these diverse effects, and further suggested novel approaches by which this hypothesis could be tested. Presentation of hypothesis: The literature on the clinical, metabolic and endocrine effects of glitazones in relation to the reported actions of testosterone in diabetes, metabolic syndrome, and cardiovascular disease is reviewed, and the following unifying hypothesis advanced: "Glitazones induce androgen deficiency in patients with Type 2 Diabetes Mellitus resulting in pathophysiological changes in multiple tissues and organs which may explain their observed clinical adverse effects." This also provides further evidence for the lipocentric concept of diabetes and its clinical implications. Testing of the hypothesis: Clinical studies to investigate the endocrine profiles, including measurements of TT, DHT, SHBG, FT and estradiol, together with LH and FSH, in both men and women with T2DM before and after RGZ and PGZ treatment in placebo controlled groups, are necessary to provide data to substantiate this hypothesis. Also, studies on T treatment in diabetic men would further establish if the adverse effects of glitazones could be reversed or ameliorated by androgen therapy. Basic sciences investigations on the inhibition of androgen biosynthesis by glitazones are also warranted. IMPLICATIONS OF THE HYPOTHESIS: Glitazones reduce androgen biosynthesis, increase their binding to SHBG, and attenuate androgen receptor activation, thus reducing the physiological actions of testosterone, causing relative and absolute androgen deficiency. This hypothesis explains the adverse effects of glitazones on the heart and other organs resulting from reversal of the action of androgens in directing the maturation of stem cells towards muscle, vascular endothelium, erythroid stem cells and osteoblasts, and away from adipocyte differentiation. The higher incidence of side-effects with RGZ than PGZ, may be explained by a detailed study of the mechanism by which glitazones down-regulate androgen biosynthesis and action, resulting in a state of androgen deficiency.

 

Epidemiology. 2008 Nov;19(6):766-79.

Observational studies analyzed like randomized experiments: an application to postmenopausal hormone therapy and coronary heart disease.

Hernán MA, Alonso A, Logan R, Grodstein F, Michels KB, Willett WC, Manson JE, Robins JM.

Department of Epidemiology, Harvard School of Public Health, Boston, Massachusetts, USA.

BACKGROUND: The Women's Health Initiative randomized trial found greater coronary heart disease (CHD) risk in women assigned to estrogen/progestin therapy than in those assigned to placebo. Observational studies had previously suggested reduced CHD risk in hormone users. METHODS: Using data from the observational Nurses' Health Study, we emulated the design and intention-to-treat (ITT) analysis of the randomized trial. The observational study was conceptualized as a sequence of "trials," in which eligible women were classified as initiators or noninitiators of estrogen/progestin therapy. RESULTS: The ITT hazard ratios (HRs) (95% confidence intervals) of CHD for initiators versus noninitiators were 1.42 (0.92-2.20) for the first 2 years, and 0.96 (0.78-1.18) for the entire follow-up. The ITT HRs were 0.84 (0.61-1.14) in women within 10 years of menopause, and 1.12 (0.84-1.48) in the others (P value for interaction = 0.08). These ITT estimates are similar to those from the Women's Health Initiative. Because the ITT approach causes severe treatment misclassification, we also estimated adherence-adjusted effects by inverse probability weighting. The HRs were 1.61 (0.97-2.66) for the first 2 years, and 0.98 (0.66-1.49) for the entire follow-up. The HRs were 0.54 (0.19-1.51) in women within 10 years after menopause, and 1.20 (0.78-1.84) in others (P value for interaction = 0.01). We also present comparisons between these estimates and previously reported Nurses' Health Study estimates. CONCLUSIONS: Our findings suggest that the discrepancies between the Women's Health Initiative and Nurses' Health Study ITT estimates could be largely explained by differences in the distribution of time since menopause and length of follow-up.

 

Sleep. 2008 Oct 1;31(10):1339-49.

Sex steroid hormone profiles are related to sleep measures from polysomnography and the Pittsburgh Sleep Quality Index.

Sowers MF, Zheng H, Kravitz HM, Matthews K, Bromberger JT, Gold EB, Owens J, Consens F, Hall M.

Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, Michigan, USA. STUDY OBJECTIVES: To relate reproductive hormones (and the preceding 7-year rates of their change) to objectively and subjectively assessed sleep measures, independent of age, vasomotor symptom frequency, depressive symptoms, and body size. DESIGN: A cross-sectional sleep substudy nested in the Study of Women's Health Across the Nation (SWAN), a longitudinal study of the menopausal transition. SETTING: Community-based. PARTICIPANTS: 365 Caucasian, African American, and Chinese women. MEASUREMENTS AND RESULTS: Sleep duration, continuity, and architecture were measured during two nights of in-home polysomnography (PSG) studies. Participants completed the Pittsburgh Sleep Quality Index (PSQI) for sleep quality, sleep diaries for medication, vasomotor symptoms, lifestyle information and questionnaires for depressive symptoms. Blood collected annually in the years prior to sleep study was assayed for follicle stimulating hormone (FSH), estradiol (E2), and total testosterone (T). More rapid rate of FSH change was significantly associated with higher delta sleep percent, longer total sleep time (TST), but less favorable self-reported sleep quality (PSQI). Baseline E2 was modestly and negatively associated with sleep quality. Women in the lowest total testosterone quartile at baseline had more wake time after sleep onset (WASO) than women in the highest quartile. Lower E2/T ratio, an index reflecting the increasing androgenic environment with the menopause transition, was associated with less WASO. CONCLUSIONS: More rapid rate of FSH change was associated with longer sleep duration but poor sleep quality. Women with higher T or who were closer to the completion of the transition process (as indexed by a lower E2/T) had less sleep discontinuity (less WASO).

 

 

Semana del 8 al 14 de Octubre 2008

 

J Am Coll Nutr. 2008 Oct;27(5):519-27.

Calcium supplementation and incident kidney stone risk: a systematic review.

Heaney RP.

Creighton University, Omaha, NE 68131, USA. rheaney@creighton.edu

BACKGROUND: A report of a small increase in kidney stone risk in the calcium treatment arm of the Women's Health Initiative (WHI) led to a reduction in U.S. calcium supplement sales. OBJECTIVE: To reassess kidney stone risk in postmenopausal women using data accumulated in calcium supplement trials, bone active agent registration trials, and in unpublished WHI data available online; and to compare these estimates with formal published epidemiological studies of stone risk. METHODS: Literature review of published studies relating calcium intake to stone risk; adverse event report data from pharmaceutical industrial trials designed to evaluate bone active agents. RESULTS: Stone risk in postmenopausal women has increased substantially in the past 40 years, but absolute population incidence estimates vary widely from a low of about 70 incidents/100,000/yr for Olmsted County, MN, today, to a concurrent high of approximately 190/100,000/yr for the Nurses' Health Study II. Reported WHI incidence rates are higher still, with values around 300/100,000/yr for various WHI subgroupings. The reasons for these discordances are unclear. Despite this uncertainty about background rate, most of the studies show no increase in stone risk with high calcium intake (from either diet or supplements). Contrariwise there is a substantial body of evidence, both from controlled trials and from observational studies, indicating that there is an inverse relationship between calcium intake and stone risk.

 

Mol Endocrinol. 2008 Oct 9. [Epub ahead of print

Update of Estrogen plus Progestin Therapy for Menopausal Hormone Replacement Implicating Stem Cells in the Increased Breast Cancer Risk.

Horwitz KB.

Department of Medicine, Division of Endocrinology, University of Colorado at Denver, Aurora, CO.

This transcript is based on my "The Year in Hormones & Cancer" lecture at ENDO 08 that reviewed current data surrounding hormone replacement therapy (HRT); the relationship between systemic estrogen plus progestin (E+P) treatment and increased breast cancer risk; and explored the hypothesis that women who "develop" breast cancer while on E+P had occult, undiagnosed disease before they started therapy. Beginning with recent HRT data focusing on E+P and its association with breast cancer to set the stage, the lecture then reviewed our newly published data that progestins expand breast cancer stem cells. Finally, the issues of occult or undiagnosed breast cancer in presumably healthy women, and of tumor dormancy in breast cancer survivors, were brought to bear on the discussion. Taken together, these apparently disparate themes allowed me to suggest the idea that systemic progestins have the ability to reawaken cancers that were presumed to be either nonexistent or cured. To avoid this potentially devastating outcome while retaining the benefits of E+P, I advocated the use of local progestin delivery methods, rather than the currently popular systemic routes.

 

Maturitas. 2008 Oct 7. [Epub ahead of print

Estrogen therapy influence on periurethral vessels in postmenopausal incontinent women using Dopplervelocimetry analysis.

Kobata SA, Girão MJ, Baracat EC, Kajikawa M, Di Bella V Jr, Sartori MG, Jármy-Di Bella ZI.

UNIFESP - são paulo federal university, São Paulo, Brazil.

Lack of estrogen affects the urinary tract mainly by diminishing vascular, muscular and epithelial trophism, resulting in negative effects on continence in postmenopausal women. Therefore, the use of estrogens in these patients may revert these alterations and lead to an expressive improvement of the urinary symptoms. OBJECTIVE: Study the effect of topical estrogen therapy (conjugated equine estrogens, estriol or promestriene) in periurethral vessels detected by Dopplervelocimetric analysis using, as parameters: the number of vessels, resistance and pulsatility indexes, as well as the minimum diastolic value. METHODS: Forty-one postmenopausal women with stress urinary incontinence were randomized into three groups according to different types of topical estrogen received during 3 months. Group 1 received conjugated equine estrogens, group 2 received estriol and group 3 received promestriene. Periurethral Dopplervelocimetry analysis was done before estrogen administration and during treatment in all groups. RESULTS: We observed an increase in the number of the periurethral vessels in group 1 and group 2, being higher in group 1 than in group 2. The pulsatility index remained unchanged in all three groups. The resistance index at the periurethral vessels reduced only at the conjugated estrogen group (group 1). In this same group we noticed an increase in the mean minimal diastolic value, meaning a better periurethral vascularization. CONCLUSION: Topical conjugated equine estrogens and estriol were effective in increasing the number of periurethral vessels in postmenopausal women with urinary stress incontinence, with the conjugated equine estrogens being the most effective intervention studied.

 

J Laryngol Otol. 2008 Oct 10:1-5.

Impact of total versus subtotal thyroidectomy on calcium metabolism and bone mineral density in premenopausal women.

Tunca F, Senyurek YG, Terzioglu T, Tanakol R, Tezelman S.

Department of General Surgery, Istanbul Medical Faculty, Istanbul University, Turkey.

Objective:This study aimed to compare the impact of total versus subtotal thyroidectomy on calcium metabolism and bone mineral density in euthyroid, premenopausal women.Subjects:The study included 24 premenopausal women who had undergone total (n = 10) or subtotal (n = 14) thyroidectomy and who were receiving nonsuppressive doses of thyroxine. The median post-operative period was four years. We determined, in all patients, the following parameters associated with calcium metabolism: total serum calcium, inorganic phosphate, intact parathormone, calcitonin and alkaline phosphatase. The bone mineral density of the spine and hip were measured using a Hologic QDR 4500C bone densitometer and were compared with controls matched for age and peak bone mineral density (using the t-test).Results:The measured calcium metabolism parameters were normal in all patients, and none had osteoporosis. There was no significant difference in the bone mineral density measurements for the spine and hip, comparing patients who had undergone total versus subtotal thyroidectomy (using the t-test).Conclusion:The impact of total thyroidectomy on bone mineral metabolism is not significantly different from that of subtotal thyroidectomy, in premenopausal women with normal thyroid-stimulating hormone values.

 

Drugs. 2008;68(15):2131-62.

New Drugs for Type 2 Diabetes Mellitus : What is their Place in Therapy?

Krentz AJ, Patel MB, Bailey CJ.

Department of Diabetes and Endocrinology, Southampton University Hospitals and University of Southampton, Southampton, UK.

Oral therapy for type 2 diabetes mellitus, when used appropriately, can safely assist patients to achieve glycaemic targets in the short to medium term. However, the progressive nature of type 2 diabetes usually requires a combination of two or more oral agents in the longer term, often as a prelude to insulin therapy. Issues of safety and tolerability, notably weight gain, often limit the optimal application of anti-diabetic drugs such as sulfonylureas and thiazolidinediones. Moreover, the impact of different drugs, even within a single class, on the risk of long-term vascular complications has come under scrutiny. For example, recent publication of evidence suggesting potential detrimental effects of rosiglitazone on myocardial events generated a heated debate and led to a reduction in use of this drug. In contrast, current evidence supports the view that pioglitazone has vasculoprotective properties. Both drugs are contraindicated in patients who are at risk of heart failure. An additional recently identified safety concern is an increased risk of fractures, especially in postmenopausal women.Several new drugs with glucose-lowering efficacy that may offer certain advantages have recently become available. These include (i) injectable glucagon-like peptide-1 (GLP-1) receptor agonists and oral dipeptidyl peptidase-4 (DPP-4) inhibitors; (ii) the amylin analogue pramlintide; and (iii) selective cannabinoid receptor-1 (CB1) antagonists. GLP-1 receptor agonists, such as exenatide, stimulate nutrient-induced insulin secretion and reduce inappropriate glucagon secretion while delaying gastric emptying and reducing appetite. These agents offer a low risk of hypoglycaemia combined with sustained weight loss. The DPP-4 inhibitors sitagliptin and vildagliptin are generally weight neutral, with less marked gastrointestinal adverse effects than the GLP-1 receptor agonists. Potential benefits of GLP-1 receptor stimulation on beta cell neogenesis are under investigation. Pancreatitis has been reported in exenatide-treated patients. Pramlintide, an injected peptide used in combination with insulin, can reduce insulin dose and bodyweight. The CB1 receptor antagonist rimonabant promotes weight loss and has favourable effects on aspects of the metabolic syndrome, including the hyperglycaemia of type 2 diabetes. However, in 2007 the US FDA declined approval of rimonabant, requiring more data on adverse effects, notably depression. The future of dual peroxisome proliferator-activated receptor-alpha/gamma agonists, or glitazars, is presently uncertain following concerns about their safety.In conclusion, several new classes of drugs have recently become available in some countries that offer new options for treating type 2 diabetes. Beneficial or neutral effects on bodyweight are an attractive feature of the new drugs. However, the higher cost of these agents, coupled with an absence of long-term safety and clinical outcome data, need to be taken into consideration by clinicians and healthcare organizations.

 

Osteoporos Int. 2008 Oct 9. [Epub ahead of print]

The relation between bisphosphonate use and non-union of fractures of the humerus in older adults.

Solomon DH, Hochberg MC, Mogun H, Schneeweiss S.

Division of Pharmacoepidemiology, Harvard Medical School, Boston, MA, USA, dsolomon@partners.org.

While nitrogen-containing bisphosphonates have been shown to reduce fracture risk in postmenopausal women and men, their safety in the period after a fracture is unclear. In fully adjusted multivariable regression models, bisphosphonate use in the post-fracture period was associated with an increased probability of non-union [odds ratio (OR) 2.37, 95% confidence interval (CI) 1.13-4.96]. Clinicians might consider waiting for several months before introduction of a bisphosphonate after a fracture. INTRODUCTION: While nitrogen-containing bisphosphonates have been shown to reduce fracture risk in postmenopausal women and men, their safety in the period after a fracture is unclear. We examined the risk of non-union associated with post-fracture bisphosphonate use among a group of older adults who had experienced a humerus fracture. METHODS: We conducted a nested case-control study among subjects who had experienced a humerus fracture. From this cohort, cases of non-union were defined as those with an orthopedic procedure related to non-union 91-365 days after the initial humerus fracture. Bisphosphonate exposure was assessed during the 365 days prior to the non-union among cases or the matched date for controls. Multivariable logistic regression models were examined to calculate the OR and 95% CI for the association of post-fracture bisphosphonate use with non-union. RESULTS: From the cohort of 19,731 patients with humerus fractures, 81 (0.4%) experienced a non-union. Among the 81 cases, 13 (16.0%) were exposed to bisphosphonates post-fracture, while 69 of the 810 controls (8.5%) were exposed in the post-fracture interval. In fully adjusted multivariable regression models, bisphosphonate use in the post-fracture period was associated with an increased odds of non-union (OR 2.37, 95% CI 1.13-4.96). Albeit limited by small sample sizes, the increased risk associated with bisphosphonate use persisted in the subgroup of patients without a history of osteoporosis or prior fractures (OR 1.91, 95% CI 0.75-4.83). CONCLUSIONS: In this study of older adults, non-union after a humerus fracture was rare. Bisphosphonate use after the fracture was associated with an approximate doubling of the risk of non-union.

 

Int J Cancer. 2008 Oct 6. [Epub ahead of print]

Plasma 25-hydroxyvitamin D and premenopausal breast cancer risk in a German case-control study.

Abbas S, Chang-Claude J, Linseisen J.

Division of Cancer Epidemiology, German Cancer Research Center, Heidelberg, Germany.

Laboratory and epidemiological data have linked vitamin D to breast cancer prevention. Beside dietary intake, endogenous production of vitamin D substantially contributes to a subject's vitamin D status. Most studies, however, have assessed dietary intake only. Although differential effects of vitamin D on premenopausal and postmenopausal breast cancer have been discussed, this is the first study to investigate the association of plasma 25-hydroxyvitamin D [25(OH)D], as indicator of the overall vitamin D status, with breast cancer risk with restriction to premenopausal women only. We used data of a population-based case-control study comprising 289 cases and 595 matched controls. Information on sociodemographic and breast cancer risk factors was collected by questionnaire and plasma 25(OH)D was measured by enzyme immunoassay. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated using conditional logistic regression. We observed a significant inverse association between breast cancer risk and plasma 25(OH)D concentrations. Compared with the lowest category (<30 nmol/L), the ORs (95% CI) for the upper categories (30-45, 45-60, >/=60 nmol/L) were 0.68 (0.43-1.07), 0.59 (0.37-0.94) and 0.45 (0.29-0.70), respectively (p(trend) = 0.0006). The association was shown to be nonlinear (p(nonlinearity) = 0.06) in fractional polynomial analysis with a stronger effect in women at low plasma 25(OH)D levels, providing some evidence of a threshold effect (at circa 50 nmol/L). The association was stronger in progesterone receptor negative tumors, with suggestive evidence of effect heterogeneity (p(heterogeneity) = 0.05, case-only model). Our findings support a protective effect of vitamin D for premenopausal breast cancer.

 

Acta Reumatol Port. 2008 Jul-Sep;33(3):314-328.

Performance of decision algorithms for the identification of low bone mineral density in portuguese postmenopausal women.

Machado P, Silva JA.

Servico de Reumatologia dos Hospitais da Universidade de Coimbra Coimbra Portugal.

Objectives Although several algorithms have been proposed to select postmenopausal women PMW for dual-energy x-ray absorptiometry DEXA measurements information on their utility in clinical practice is scarce. Our aim was to assess the utility and the economic repercussion of the use of five of these algorithms in Portuguese postmenopausal women. Methods We included 588 PMW and selected five simple algorithms ORAI ABONE Body Weight Criterion (BWC) OSTA and a modified version of OSTA OST . Sensitivities specificities predictive values areas under the receiver operating characteristic curve AUROC and economic estimates were computed. Results Sensitivities ranged between 71.2 -80.8 and AUROC between 0.611-0.674. In PMW aged > 65 years the use of any of the algorithms would cause extra costs or a residual saving. In PMW aged > 55 and <65Y considering total savings ABONE had the best performance but considering savings per preventable fracture ORAI assumed the lead followed by BWC. In the age group > 40 and < 55Y the most profitable option considering total savings would be not doing DEXA to anyone considering savings per preventable fracture BWC figures as the most useful. Conclusions This study provides evidence for the validity of all the selected tools as useful algorithms to select PMW for DEXA. On the basis of our results and considering the importance of simplicity in the applicability of an algorithm we would suggest the following strategy in Portuguese PMW 1 Aged > 65Y perform DEXA irrespective of other risk factors. 2 Aged <65Y perform DEXA if body weight < 70Kg.

 

 

Semana del 1 al 7 de Octubre 2008

 

Vasc Health Risk Manag. 2008;4(3):515-24

Relaxin as a natural agent for vascular health.

Bani D.

Department of Anatomy, Histology and Forensic Medicine, Sect. Histology, University of Florence Italy.

Hypertension, atherothrombosis, myocardial infarction, stroke, peripheral vascular disease, and renal failure are the main manifestations of cardiovascular disease (CVD), the leading cause of death and disability in developed countries. Continuing insight into the pathophysiology of CVD can allow identification of effective therapeutic strategies to reduce the occurrence of death and/or severe disabilities. In this context, a healthy endothelium is deemed crucial to proper functioning and maintenance of anatomical integrity of the vascular system in many organs. Of note, epidemiologic studies indicate that the incidence of CVD in women is very low until menopause and increases sharply thereafter. The loss of protection against CVD in post-menopausal women has been chiefly attributed to ovarian steroid deficiency. However, besides steroids, the ovary also produces the peptide hormone relaxin (RLX), which provides potent vasoactive effects which render it the most likely candidate as the elusive physiological shield against CVD in fertile women. In particular, RLX has a specific relaxant effect on peripheral and coronary vasculature, exerted by the stimulation of endogenous nitric oxide (NO) generation by cells of the vascular wall, and can induce angiogenesis. Moreover, RLX inhibits the activation of inflammatory leukocytes and platelets, which play a key role in CVD. Experimental studies performed in vascular and blood cell in vitro and in animal models of vascular dysfunction, as well as pioneer clinical observations, have provided evidence that RLX can prevent and/or improve CVD, thus offering background to clinical trials aimed at exploring the broad therapeutic potential of human recombinant RLX as a new cardiovascular drug.

 

Osteoporos Int. 2008 Oct 2. [Epub ahead of print

DXA-based hip structural analysis of once-weekly bisphosphonate-treated postmenopausal women with low bone mass.

Bonnick SL, Beck TJ, Cosman F, Hochberg MC, Wang H, de Papp AE.

Clinical Research Center of North Texas, Denton, TX, 76210, USA, sbonnickcrcnt@verizon.net.

DXA-based hip structural analysis from 947 individuals completing two large osteoporosis clinical trials was pooled and analyzed. Treatment with once-weekly (OW) ALN or OW RIS resulted in significant improvements from baseline in geometric parameters at all three HSA ROIs. Improvements were generally greater with OW ALN than OW RIS. INTRODUCTION: BMD can be altered by changes in distribution and quantity of bone and changes in mineralization. These effects cannot be distinguished with conventional measurements of BMD. Currently, tissue composition is evaluated only by invasive means. Structural geometry of the proximal femur, however, can be measured in vivo by several methods, including dual energy X-ray absorptiometry (DXA) using specialized hip structure analysis (HSA) software. METHODS: DXA-based HSA was obtained and analyzed in a subset of 947 subjects participating in the Fosamax Actonel Comparison Trials. Data were pooled to evaluate treatment effects on the structural geometry of the proximal femur by once-weekly alendronate (ALN) 70 mg and risedronate (RIS) 35 mg in postmenopausal women with low bone mass. RESULTS: Both ALN and RIS treatment over 2 years resulted in improvements in HSA-derived geometry at all three HSA regions of interest (ROI). The largest treatment effects were seen at the intertrochanteric ROI. Consistently greater treatment effects were seen with ALN compared with RIS at all three HSA-ROIs. CONCLUSIONS: HSA offers insight into the potential mechanisms of fracture risk reduction from pharmacologic intervention. In the current study, treatment with once-weekly bisphosphonates resulted in significant improvements in hip geometric parameters.

 

Cancer Epidemiol Biomarkers Prev. 2008 Sep 30. [Epub ahead of print]

Conjugated Equine Estrogens and Colorectal Cancer Incidence and Survival: The Women's Health Initiative Randomized Clinical Trial.

Ritenbaugh C, Stanford JL, Wu L, Shikany JM, Schoen RE, Stefanick ML, Taylor V, Garland C, et al.

For the Women's Health Initiative Investigators.

BACKGROUND: In separate Women's Health Initiative randomized trials, combined hormone therapy with estrogen plus progestin reduced colorectal cancer incidence but estrogen alone in women with hysterectomy did not. We now analyze features of the colorectal cancers that developed and examine the survival of women following colorectal cancer diagnosis in the latter trial.Participants and METHODS: 10,739 postmenopausal women who were 50 to 79 years of age and had undergone hysterectomy were randomized to conjugated equine estrogens (0.625 mg/d) or matching placebo. Colorectal cancer incidence was a component of the monitoring global index of the study but was not a primary study endpoint. Colorectal cancers were verified by central medical record and pathology report review. Bowel exam frequency was not protocol defined, but information on their use was collected.RESULTS: After a median 7.1 years, there were 58 invasive colorectal cancers in the hormone group and 53 in the placebo group [hazard ratio, 1.12; 95% confidence interval (95% CI), 0.77-1.63]. Tumor size, stage, and grade were comparable in the two randomization groups. Bowel exam frequency was also comparable in the two groups. The cumulative mortality following colorectal cancer diagnosis among women in the conjugated equine estrogen group was 34% compared with 30% in the placebo group (hazard ratio, 1.34; 95% CI, 0.58-3.19).CONCLUSIONS: In contrast to the preponderance of observational studies, conjugated equine estrogens in a randomized clinical trial did not reduce colorectal cancer incidence nor improve survival after diagnosis.

 

BMC Cancer. 2008 Sep 30;8(1):279. [Epub ahead of print

The effect of menopause and hysterectomy on systemic vascular endothelial growth factor in women undergoing surgery for breast cancer.

Lowery AJ, Sweeney KJ, Molloy AP, Hennessy E, Curran C, Kerin MJ.

ABSTRACT: BACKGROUND: Vascular endothelial growth factor (VEGF) is a potent angiogenic cytokine produced physiologically by the uterus. Pathological secretion by tumours promotes growth and metastasis. High circulating VEGF levels potentially have a deleterious effect on breast cancer by promoting disease progression. The aims of this study were to investigate circulating VEGF levels in breast cancer patients and assess the effect of menopause or hysterectomy on systemic VEGF. METHODS: Patients undergoing primary surgery for breast cancer and controls matched for age, menopausal and hysterectomy status were prospectively recruited. Serum VEGF, FSH, LH, Estrogen and Progesterone and platelet levels were measured. Serum VEGF was corrected for platelet load (sVEGFp) to provide a biologically relevant measurement of circulating VEGF. SVEGFp levels were analysed with respect to tumour characteristics, menopausal status and hysterectomy status. RESULTS: Two hundred women were included in the study; 89 breast cancer patients and 111 controls. SVEGFp levels were significantly higher in breast cancer patients compared to controls (p=0.0001), but were not associated with clinico-pathological tumor characteristics. Systemic VEGF levels reduced significantly in the breast cancer patients following tumor excision (p=0.018). The highest systemic VEGF levels were observed in postmenopausal breast cancer patients. Postmenopausal women who had had a previous hysterectomy had significantly higher VEGF levels than those with an intact postmenopausal uterus (p=0.001). CONCLUSION: This study identifies an intact postmenopausal uterus as a potential means of reducing circulating levels of VEGF which could confer a protective effect against breast cancer metastatic potential.

 

BMC Cancer. 2008 Sep 30;8(1):278. Epub ahead of print

Weight, height, body mass index and risk of breast cancer in postmenopausal women: a case-control study.

Montazeri A, Sadighi J, Farzadi F, Maftoon F, Vahdaninia M, Ansari M, Sajadian A, Ebrahimi M, et al

BACKGROUND: Many women in Iran have a relatively high body mass index. To investigate whether the condition contributes to excess breast cancer cases, a case-control study was conducted to assess the relationships between anthropometric variables and breast cancer risk in Tehran, Iran. Methods: All incident cases of breast cancer in the Iranian Centre for Breast Cancer (ICBC) were identified through the case records. Eligible cases were all postmenopausal women with histological confirmed diagnosis of breast cancer during 1996 to year 2000. Controls were randomly selected postmenopausal women attending the ICBC for clinical breast examination during the same period. The body mass index (BMI) was calculated based on weights and heights as measured by the ICBC nursing staff. Both tests for trend and logistic regression analysis were performed to calculate odds ratios and 95% confidence intervals as measures of relative risk. Results: In all, 116 breast cancer cases and 116 controls were studied. There were no significant differences between cases and control with regard to most independent variables studied. However, a significant difference was observed between cases and controls indicating that the mean BMI was higher in cases as compared to controls (P = 0.004). Performing logistic regression analysis while controlling for age, age at menopause, family history of breast cancer and parity, the results showed that women with a BMI in the obese range had a three fold increased risk of breast cancer [odds ratio (OR) = 3.21, 95% confidence interval (CI): 1.15-8.47]. CONCLUSION: The results suggest that obesity in postmenopausal women could increase risk of breast cancer and it merits further investigation in populations such as Iran where it seems that many women are short in height, and have a relatively high body mass index.

 

J Cell Biochem. 2008 Sep 26. [Epub ahead of print]

Leptin signaling in breast cancer: An overview.

Cirillo D, Rachiglio AM, la Montagna R, Giordano A, Normanno N.

Protein Chemistry Laboratory, Centro di Ricerche Oncologiche di Mercogliano, Mercogliano (AV), Italy.

The adipocyte-derived peptide leptin acts through binding to specific membrane receptors, of which six isoforms (obRa-f) have been identified up to now. Binding of leptin to its receptor induces activation of different signaling pathways, including the JAK/STAT, MAPK, IRS1, and SOCS3 signaling pathways. Since the circulating levels of leptin are elevated in obese individuals, and excess body weight has been shown to increase breast cancer risk in postmenopausal women, several studies addressed the role of leptin in breast cancer. Expression of leptin and its receptors has been demonstrated to occur in breast cancer cell lines and in human primary breast carcinoma. Leptin is able to induce the growth of breast cancer cells through activation of the Jak/STAT3, ERK1/2, and/or PI3K pathways, and can mediate angiogenesis by inducing the expression of vascular endothelial growth factor (VEGF). In addition, leptin induces transactivation of ErbB-2, and interacts in triple negative breast cancer cells with insulin like growth factor-1 (IGF-1) to transactivate the epidermal growth factor receptor (EGFR), thus promoting invasion and migration. Leptin can also affect the growth of estrogen receptor (ER)-positive breast cancer cells, by stimulating aromatase expression and thereby increasing estrogen levels through the aromatization of androgens, and by inducing MAPK-dependent activation of ER. Taken together, these findings suggest that the leptin system might play an important role in breast cancer pathogenesis and progression, and that it might represent a novel target for therapeutic intervention in breast cancer.

 

Menopause. 2008 Sep 26. [Epub ahead of print]

Effect of one-week treatment with vaginal estrogen preparations on serum estrogen levels in postmenopausal women.

Labrie F, Cusan L, Gomez JL, Côté I, Bérubé R, Bélanger P, Martel C, Labrie C.

Oncology and Molecular Endocrinology Research Center, Laval University Hospital Research Center (CRCHUL) and Laval University, Quebec, Canada.

OBJECTIVE: Approximately 50% of postmenopausal women suffer from vaginal atrophy, and a large proportion of them choose intravaginal estrogen preparations administered for local action to avoid systemic exposure to estrogens and its associated risk of breast and uterine cancer. The primary objective of this study was the evaluation of the systematic bioavailability of estradiol and estrone and the pharmacokinetics of two of the most frequently used intravaginal estrogen preparations, namely Vagifem and Premarin cream. DESIGN: While immunobased assays could not previously provide accurate measurement of serum estrogen concentrations in postmenopausal women, we have used validated mass spectrometry assays to measure the pharmacokinetics of serum estradiol and estrone during the 24 hours following the seventh daily application of 25 microg estradiol (Vagifem) and 1 g (0.625 mg) conjugated estrogens (Premarin) cream in 10 postmenopausal women in each group. RESULTS: Serum estradiol was increased on average by 5.4-fold from 3 to 17 pg/mL during the 24-hour period after daily administration of 25 mug estradiol or 1 g (0.625 mg) conjugated estrogens cream. Serum estrone, conversely, increased 150% with Vagifem and 500% with Premarin cream. CONCLUSIONS: The present data using validated, accurate, and sensitive mass spectrometry assays of estrogens show that the Vagifem pill and Premarin cream, after 1 week of daily treatment, cause an approximately fivefold increase in serum estradiol in postmenopausal women, thus indicating that the effects are unlikely to be limited to the vagina and that systemic actions are expected after application of these intravaginal estrogen preparations.

 

J Bone Joint Surg Am. 2008 Oct;90(10):2142-8

Low incidence of anti-osteoporosis treatment after hip fracture.

Rabenda V, Vanoverloop J, Fabri V, Mertens R, Sumkay F, Vannecke C, Deswaef A, Verpooten GA, Reginster JY.

Department of Public Health, Epidemiology and Health Economics, Liège, Belgium.

BACKGROUND: Following hip fracture, pharmacologic treatment can reduce the rate of subsequent fragility fractures. The objective of the present study was to assess the proportion of patients who are managed with bisphosphonates or selective estrogen-receptor modulators after hip fracture and to evaluate, among those managed with alendronate, the twelve-month compliance and persistence with treatment. METHODS: Data were gathered from health insurance companies and were collected by AIM (Agence Intermutualiste) for the Belgian National Social Security Institute (INAMI). We selected all postmenopausal women who had been hospitalized for a hip fracture between April 2001 and June 2004 and had not been previously managed with bisphosphonates. Patients who had received alendronate treatment after the hip fracture were categorized according to their formulation use during the follow-up study (daily, weekly, daily followed by weekly, or weekly followed by weekly). Compliance at twelve months was quantified with use of the medication possession ratio (i.e., the number of days of alendronate supplied during the first year of treatment, divided by 365). Persistence with prescribed treatment was calculated as the number of days from the initial prescription to a lapse of more than five weeks after completion of the previous prescription refill. The cumulative treatment persistence rate was determined with use of Kaplan-Meier survival curves. RESULTS: A total of 23,146 patients who had sustained a hip fracture were identified. Of these patients, 6% received treatment during the study period: 4.6% received alendronate, 0.7% received risedronate, and 0.7% received raloxifene. Bisphosphonate treatment was dispensed to 2.6% and 3.6% of the patients within six months and one year after the occurrence of the hip fracture, respectively. Among women who received alendronate daily (n = 124) or weekly (n = 182) and were followed for at least one year after the hip fracture, the twelve-month mean medication possession ratio was 67% (65.9% in the daily group and 67.7% in the weekly group). The analysis of persistence with treatment included a total of 726 patients (142 in the daily group, 261 in the weekly group, and 323 in the switch group). At twelve months, the rate of persistence was 41% and the median duration of persistence was 40.3 weeks. CONCLUSIONS: The vast majority of patients who experience a hip fracture do not take anti-osteoporotic therapy after the fracture. Furthermore, among patients who begin alendronate treatment after the fracture, the adherence to treatment decreases over time and remains suboptimal.

 

Clin Cancer Res. 2008 Oct 1;14(19):6336-42

Prevention of Anastrozole-Induced Bone Loss with Monthly Oral Ibandronate during Adjuvant Aromatase Inhibitor Therapy for Breast Cancer.

Lester JE, Dodwell D, Purohit OP, Gutcher SA, Ellis SP, Thorpe R, Horsman JM, Brown JE, et al

Academic Unit of Clinical Oncology, University of Sheffield, Sheffield, United Kingdom.

PURPOSE: The aromatase inhibitor anastrozole is a highly effective well-tolerated treatment for postmenopausal endocrine-responsive breast cancer. However, its use is associated with accelerated bone loss and an increase in fracture risk. The ARIBON trial is a double-blind, randomized, placebo-controlled study designed to evaluate the impact of bisphosphonate treatment on bone mineral density (BMD) in women taking anastrozole. EXPERIMENTAL DESIGN: BMD was assessed in 131 postmenopausal, surgically treated women with early breast cancer at two U.K. centers. Of these, 50 patients had osteopenia (T score -1.0 to -2.5) at either the hip or lumbar spine. All patients were treated with anastrozole 1 mg once a day and calcium and vitamin D supplementation. In addition, osteopenic patients were randomized to receive either treatment with ibandronate 150 mg orally every month or placebo. RESULTS: After 2 years, osteopenic patients treated with ibandronate gained +2.98% (range -8.9, +19.9) and +0.60% (range -9.0, +6.9) at the lumbar spine and hip, respectively. Patients treated with placebo, however, lost -3.22% (range -16.0, +4.3) at the lumbar spine and -3.90% (range -12.3, +7.2) at the hip. The differences between the two treatment arms were statistically significant at both sites (P < 0.01). At 12 months, urinary n-telopeptide, serum c-telopeptide, and serum bone-specific alkaline phosphatase levels declined in patients receiving ibandronate (30.9%, 26.3%, and 22.8%, respectively) and increased in those taking placebo (40.3%, 34.9%, and 37.0%, respectively). CONCLUSIONS: Monthly oral ibandronate improves bone density and normalizes bone turnover in patients treated with anastrozole.