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Use of combined oral contraceptives and risk of venous thromboembolism

Description

Combined hormonal contraceptives (CHCs) 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 CHCs associated with etonogestrel and norelgestromin was higher at 6–12 VTE per 10,000 women per year, and the risk for CHCs 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.
CHCs are reimbursable in Germany up to the 20th birthday (since April 2020 up to the 22nd birthday). Thus, German health insurance data can be used to estimate the VTE risk of individual CHCs in girls and young women under 20 years of age.
The aim of this project, funded by the German Federal Institute for Drugs and Medical Devices (BfArM), is to use data from the German Pharmacoepidemiological Research Database GePaRD to estimate the VTE risk of various CHCs, including progestogens with an as of yet unclear risk of VTE such as chlormadinone and nomegestrol.

Funding period

Begin:   February 2019
End:   October 2020

Sponsor

  • Federal Institute for Drugs and Medical Devices

Contact

Dr. rer. medic. Tania Schink

Selected project-related publications