Amir Sarayani, Pharm.D., M.P.H., a Ph.D. candidate in the department of pharmaceutical outcomes and policy in the University of Florida College of Pharmacy, was one of 10 students nationally selected to receive an American College of Clinical Pharmacology, or ACCP, Student and Trainee Abstract Award. Sarayani and the other award winners were honored Sept. 13, during the 2021 ACCP Virtual Annual Meeting.
Sarayani’s research concentration is pharmacoepidemiology, which is the intersection of the clinical pharmacology and epidemiology disciplines. His award-winning study examined a potential drug-drug interaction between oral hormonal contraceptives and topiramate, a commonly used medicine to prevent migraines, epilepsy and other health conditions. These conditions, specifically migraines, are more common among young women and topiramate is suspected to reduce the effect of oral contraceptives and could lead to more unplanned pregnancies. In addition, topiramate can produce birth defects in unborn babies, and these unplanned pregnancies would be exposed to a harmful drug.
“It is important for women who are using topiramate to treat a migraine to have effective protection from getting pregnant, especially considering the harmful effects of topiramate for fetal development,” said Almut Winterstein, R.Ph., Ph.D., a distinguished professor and the Dr. Robert and Barbara Crisafi Chair of Pharmaceutical Outcomes and Policy in the UF College of Pharmacy and Sarayani’s mentor. She also serves as director of the Center for Drug Evaluation and Safety.
Sarayani and colleagues used a national health insurance claims database to study the drug-drug interaction. They found that patients with migraines who use topiramate and oral contraceptives simultaneously have the same number of unplanned pregnancies compared to patients who use topiramate alternatives. This is the first real-world study to measure unplanned pregnancy among users of topiramate and oral contraceptive. Their findings corroborate clinical pharmacology research on hormone levels in the body which was suggestive of preserved contraceptive efficacy. This confirmatory evidence can guide clinicians and patients who need to prescribe and use topiramate and oral contraceptives concomitantly. Patients should always consult with their doctors to choose the best contraceptive option based on their clinical profile.
“Our findings complement scientific evidence from clinical pharmacology studies, and this study serves as yet another case example to show the potential value of real-world evidence and pharmacoepidemiologic research to fill the knowledge gaps and inform decision-making,” Sarayani said. “I am honored to be an ACCP Student and Trainee Abstract Award winner and have the opportunity to present my research at the organization’s annual meeting.”
In addition to Sarayani and Winterstein, additional collaborators on the project include Stephan Schmidt, Ph.D., an associate professor of pharmaceutics and the Certara Endowed Professor, and Joshua Brown, Pharm.D., Ph.D., M.S., and assistant professor of pharmaceutical outcomes and policy. The research was part of a parent project funded by the Bill and Melinda Gates Foundation, where Schmidt serves as the principal investigator.