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Objectives: The previously reported initial results of the International Active Surveillance study “Safety of Contraceptives: Role of Estrogens” (INAS-SCORE) suggested that the risks of venous and arterial thromboembolism (VTE/ATE) of ethinylestradiol-containing combined oral contraceptives (COCs) might be higher compared to preparations containing dienogest and estradiol valerate (DNG/EV). Follow-up of study participants was extended to substantiate these findings. Study design: Prospective, non-interventional cohort study conducted in the United States and seven European countries with two main exposure groups and one exposure subgroup: new users of DNG/EV and other COC (oCOC), particularly levonorgestrel-containing COCs (LNG/EE). All self-reported clinical outcomes of interest were validated via attending physicians and relevant source documents. The extension phase of the study focused on VTE and ATE. Comprehensive follow-up procedures were implemented. Statistical analyses were based on Cox regression models. Results: A total of 50,203 COC users were followed up for 2 to 7 years. Overall, 20.3% and 79.7% of these women used DNG/EV and oCOC (including 11.5% LNG/EE users), respectively. A low loss to follow-up of 3.3% was achieved. Based on 68 VTE and 32 ATE the primary analyses (European dataset) yielded the following adjusted hazard ratios and 95% confidence intervals: DNG/EV versus oCOC, 0.4 (0.2-0.9) and 0.1 (0.0-0.5), respectively; DNG/EV versus LNG/EE, 0.4 (0.2-1.1) and 0.1 (0.0-1.0), respectively. Conclusion: Results showed a lower risk of VTE and ATE for DNG/EV versus oCOC, and a similar or lower risk for DNG/EV versus LNG/EE. *Correspondence to: Jürgen Dinger, ZEG-Berlin Center for Epidemiology and Health Research, Invalidenstrasse 115, 10115 Berlin, Germany, Tel: 1719745433; E-mail: j.dinger@zeg-berlin.de

frontiers in women's health

Combined oral contraceptives containing dienogest and estradiol valerate may carry a lower risk of venous and arterial thromboembolism compared to conventional preparations: Results from the extended INAS-SCORE study