Medscape Medical News 2006.
Ortho Evra Patch Linked to Risk for Venous Thromboembolism
Yael Waknine
September 21, 2006 - The US Food and Drug Administration (FDA) and Ortho-McNeil Pharmaceutical (a Johnson & Johnson company) have notified healthcare professionals regarding changes to the safety labeling for a weekly norelgestromin/ethinyl estradiol transdermal system (Ortho Evra). The label has been updated to reflect new data from 2 US epidemiologic studies that evaluated the relative risk for developing nonfatal venous thromboembolism (VTE) in women using the contraceptive patch vs oral contraceptives containing 35 µg of ethinyl estradiol, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program. Both studies were conducted using electronic healthcare claims data, and the second study also included patient chart reviews. Although findings from the first study revealed no significant difference in VTE risk for patch users compared with those taking oral contraceptives containing 35 µg of ethinyl estradiol (odds ratio [OR] = 0.9; 95% confidence interval [CI], 0.5 - 1.6), the second study linked the patch to more than double the risk for the event (OR = 2.4; 95% CI, 1.1 - 5.5). The FDA notes that the latter finding supports the agency's concerns regarding the risk for VTE in women using the contraceptive patch. Healthcare professionals are advised to balance the higher estrogen exposure and the possible increased risk of VTE against the chance of pregnancy if the patch is not used; contraceptive options other than the patch should be considered for women with risk factors for thromboembolic disease.
Arch Intern Med. 2006 Apr 10;166(7):772-80
Venous thrombosis and conjugated equine estrogen in women without a uterus.
Curb JD, Prentice RL, Bray PF, Langer RD, Van Horn L, Barnabei VM, Bloch MJ, Cyr MG, Gass M, Lepine L, Rodabough RJ, Sidney S, Uwaifo GI, Rosendaal FR.
University of Hawaii and Pacific Health Research Institute, Honolulu.
BACKGROUND: Postmenopausal hormone therapy has been associated with a 2- to 3-fold increased risk of venous thromboembolism (VT) (including deep vein thrombosis and pulmonary embolism) in observational studies and secondary prevention clinical trials. Clinical trial data on the effects of estrogen alone on VT are limited. METHODS: The Women's Health Initiative estrogen trial enrolled 10 739 women aged 50 to 79 years without a uterus. Participants were randomly assigned to receive conjugated equine estrogen (0.625 mg/d) or placebo. RESULTS: During a mean of 7.1 years, VT occurred in 111 women randomly assigned to receive estrogen (3.0 per 1000 person-years) and 86 randomly assigned to receive placebo (2.2 per 1000 person-years; hazard ratio, 1.32; 95% confidence interval, 0.99-1.75). Deep venous thrombosis was reported in 85 women randomly assigned to receive estrogen (2.3 per 1000 person-years) and 59 randomly assigned to receive placebo (1.5 per 1000 person-years; hazard ratio, 1.47; 95% confidence interval, 1.06-2.06). The VT risk was highest in the first 2 years. There were no significant interactions between estrogen use and age, body mass index, or most other VT risk factors. Comparison of Women's Health Initiative VT findings for estrogen and previous Women's Health Initiative findings for estrogen plus progestin showed that the hazard ratios for estrogen plus progestin were significantly higher than those for estrogen alone (P = .03), even after adjusting for VT risk factors. CONCLUSION: An early increased VT risk is associated with use of estrogen, especially within the first 2 years, but this risk increase is less than that for estrogen plus progestin.
J Obstet Gynaecol. 2006 Jul;26(5):448-51
The effects of parity, oral contraceptive use and hormone replacement therapy on the incidence of varicose veins.
Jukkola TM, Makivaara LA, Luukkaala T, Hakama M, Laurikka J.
Tampere School of Public Health, Tampere University.
Three population-based age cohorts (40-, 50- and 60-years old) of women (n = 3,590) were followed up to find out if pregnancies, use of oral contraceptives (OCs) or hormone replacement therapy (HRT) affect the appearance of varicose veins. Results were presented as odds ratios (OR) of prevalences at entry (POR) and as incidence odds ratios (IOR) during the 5-year follow-up. Parity with three or more births was an independent risk factor for varicose veins IOR 2.0 (95% confidence interval (CI), 1.0 - 3.9). OC use showed a small and not significant protective effect for varicose veins, both POR and IOR equal to 0.9. HRT use indicated an increased risk of varicose veins, with POR 1.3 (1.0 - 1.7), but in the follow-up, the effect disappeared, IOR 1.0 (0.5 - 1.9). As a conclusion, higher age and high parity are characteristic for varicose veins. The use of HRT or OCs do not increase the risk.
Maturitas. 2006 Jul 14; [Epub ahead of print]
Depressive symptoms, physical activity, and weight gain in premenopausal Latina and White women.
Juarbe TC, Gutierrez Y, Gilliss C, Lee KA.
Department of Family Health Care Nursing, School Nursing, University of California, San Francisco, USA.
OBJECTIVES: Describe changes and examine the association between depressive symptoms, physical activity, body mass index (BMI), and perceived health among Latina (n=81) and White (n=151) women in the first year of the late-premenopausal stage. METHODS: Longitudinal study focused on the biopsychosocial health of midlife women (ages 40-50 years) with regular menstrual cycles and not taking hormones. Frequency of depressive symptoms, BMI, waist to hip ratios, and self-reported physical activity levels were obtained at 6-month intervals and perceived health at 12 months. Results are reported here for 232 women who remained premenopausal (low FSH/regular cycles) for the first 12 months. RESULTS: Depressive symptoms were similar for Latinas (11.1+/-9.8) and Whites (11.1+/-8.2) and increased by 2.3 points over time for all women. Latinas had higher BMI (28+/-5.7, p<0.01) than Whites (26+/-5.7). Body weight increased an average of 1.2lbs over 12 months for both groups. Both groups reported sub-optimal levels of physical activity that did not change over time, but Latinas reported higher levels at all 3 time points. Controlling for age and ethnicity, women in service or agricultural occupations reported higher activity levels than women in other roles. Better perceived health at 12 months was predicted by lower baseline BMI (r=0.43, p<0.01) and fewer depressive symptoms (r=0.38, p<0.01). CONCLUSIONS: Depressive symptoms, weight gain and physical inactivity among women in the late-premenopausal stage point to the need for interventions focused on causal factors other than hormonal changes and menopause.
