The safety of a drospirenone-containing oral contraceptive: final results from the European Active Surveillance Study on oral contraceptives based on 142,475 women-years of observation.

OBJECTIVES: The study was conducted to compare risks of adverse cardiovascular and other events associated with the use of drospirenone (DRSP)-containing oral contraceptives (OCs) and other OCs. METHODS AND MATERIALS: The European Active Surveillance study (EURAS) was a multinational, prospective, noninterventional cohort study of new users of DRSP, levonorgestrel (LNG) and other progestin-containing OCs. Semiannual follow-up was based on mailed questionnaires, with additional follow-up procedures when needed. RESULTS: Overall, 58,674 women were followed for 142,475 women-years of observation. Loss to follow-up was 2.4%. Serious adverse and fatal events were rare, and rate ratios were close to unity (1.0). Cox regression analysis of cardiovascular outcomes yielded hazard ratios for DRSP-containing vs. LNG-containing and other OCs of 1.0 and 0.8 (upper 95% confidence limits, 1.8 and 1.3) for venous, and 0.3 and 0.3 (upper 95% confidence limits, 1.2 and 1.5) for arterial thromboembolism, respectively. CONCLUSIONS: Risks of adverse cardiovascular and other serious events in users of a DRSP-containing OC are similar to those associated with the use of other OCs.

Benign gynecological tumors: estimated incidence. Results of the German Cohort Study on Women's Health.

OBJECTIVE: To analyze the lifetime incidence of benign gynecological tumors. STUDY DESIGN: The German Cohort Study on Women's Health was launched in 1998 as historic cohort study with prospective follow up. The study ascertained self-reported information on tumors by calendar time. The incidence of benign gynecological tumors was calculated from the data of the first cohort period. RESULTS: The cohort comprised 396000 women-years of observation and 1676 benign tumors were observed. This lead to incidence estimates of 27.0, 18.6, and 23.3 per 100000 women-years of observation for all benign tumors of the uterus, ovary, and breast respectively. CONCLUSION: In absence of other data, it is reasonable to use incidence rates generated by a large cohort of German women as a best estimate for the population up to 65 years of age.