Use of combined oral contraceptives and risk of venous thromboembolism
- Combined hormonal contraceptives (CHC) are the most widely used method of birth control in Germany. In 2018, an estimated 210 million daily doses covered by statutory health insurance providers were dispensed in Germany.
CHC use has long been known to increase the risk of venous thromboembolism (VTE), and several studies have shown that, among other things, the risk depends on the type of progestogen. After a critical review of the available evidence, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded in 2014 that CHCs with the progestogens levonorgestrel, norethisterone, and norgestimate have the lowest risk of VTE (5–7 cases of VTE per 10,000 women per year). The risk for CHC associated with etonogestrel and norelgestromin was higher at 6–12 VTE per 10,000 women per year, and the risk for CHC with drospirenone, gestodene, and desogestrel was the highest (9–12 VTE per 10,000 women per year). With the data available at the time of the review, however, it was not possible to estimate the risk of VTE for CHCs with other progestogens.
The aim of this project, funded by the German Federal Institute for Drugs and Medical Devices (BfArM), was to use data from the German Pharmacoepidemiological Research Database GePaRD to estimate the VTE risk of various CHC, including progestogens with an as of yet unclear risk of VTE such as chlormadinone, dienogest, and nomegestrol.
Based on a cohort of 677,331 girls and young women between 10 and 19 years of age, who started use of CHC, we confirmed that levonorgestrel with low ethinylestradiol (< 50µg) is the COC with the lowest risk of VTE and showed that for chlormadinone and dienogest, the risk of VTE is two times higher and thus in the same range as for desogestrel and drospirenone.
- Begin: February 2019
End: October 2020
- Federal Institute for Drugs and Medical Devices
- Dr. rer. medic. Tania Schink
Selected project-related publications
Articles with peer-review
- Schink T, Princk C, Braitmaier M, Haug U. Use of combined oral contraceptives and risk of venous thromboembolism in young women: A nested case-control analysis using German claims data. BJOG: An International Journal of Obstetrics & Gynaecology. 2022;129(13):2107-2116.
Articles without peer-review
- Schink T, Princk C, Haug U. Risiko venöser Thromboembolien bei Einnahme von kombinierten hormonalen Kontrazeptiva. Bulletin zur Arzneimittelsicherheit - Informationen aus BfArM und PEI. 2021;2:13-16.
Presentations at scientific meetings/conferences
- Schink T, Princk C, Braitmaier M, Haug U. Use of combined oral contraceptives and risk of venous thromboembolism: A nested case-control analysis in German claims data. 17. Jahrestagung der Deutschen Gesellschaft für Epidemiologie (DGEpi), 26.-29. September 2022, Greifswald.
- Schink T, Princk C, Braitmaier M, Haug U. Use of combined oral contraceptives and risk of venous thromboembolism: A nested case-control analysis in German claims data. 38th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), 24-28 August 2022, Copenhagen, Denmark. (Abstract published in: Pharmacoepidemiology & Drug Safety. 2022;31(Suppl.2):66)