Polycystic ovary syndrome and combined oral contraceptive use: a comparison of clinical practice in the United States to treatment guidelines

Abstract

The October 2010 ESHRE/ASRM polycystic ovary syndrome (PCOS) workshop concluded: (1) all combined oral contraceptives (COC) appear to have equal efficacy for PCOS, (2) addition of antiandrogens (spironolactone) to COCs has little treatment benefit and (3) metformin does not improve the live-birth rate and should only be used with impaired glucose tolerance. We compared these guidelines to current practice in the United States IMS claims-database. Time-series analyses were conducted by calendar-year in women with PCOS to evaluate prescribing preferences for COCs, concomitant use of spironolactone, and utilization of metformin. Trends were analyzed with linear regression. Our cohort included 1.6 million women taking COCs, 46 780 with a PCOS claim. Drospirenone utilization increased by 1.52% (SE:0.48%, p = 0.007) per-year more in women with PCOS (4.16%, SE:0.45%, p < 0.001) than in women without PCOS (2.64%, SE:0.17%, p < 0.001)). Concomitant use of drospirenone and spironolactone was common (14.26%) and increased by 0.75% (SE:0.15%, p = 0.002) per-year. Although plasma glucose tests were unavailable, women with PCOS were more likely to take metformin than have a diabetes claim (45.8% versus 15.2%, p < 0.001), indicating some women likely receive metformin solely for PCOS. Our data suggests further attention is needed to medication management of PCOS to bridge the gap between guidelines and practice.

• Drug utilization, oral contraceptives,
• polycystic ovary syndrome,

Acknowledgments

Author contributions

All authors took part in the study design and the analysis and interpretation of the data. The manuscript was drafted by Steven Bird and critically revised for important intellectual content by all authors. The statistical analysis was completed by Steven Bid and the study guarantor is Joseph Delaney.

Declaration of interest

This work was supported by an unrestricted operating grant funded in part by the McGill University Health Center, Fonds de la Recherche en Santé du Québec, and the Ministère de la Santé et des Services Sociaux. Dr Brophy is a physician scientist who receives peer review financial support from le Fonds de la Recherche en Santé du Québec. Dr Delaney receives peer review financial support from AHRQ. Dr Hartzema holds a grant from the National Institute of Health and is the PI for the Observational Medical Outcomes Partnership (OMOP), a private-public partnership designed to help improve drug safety monitoring.

FDA/CDER Disclaimer: Steven Bird is employed by the Food and Drug Administration. This study represents the opinions of the authors and not those of the Food and Drug Administration

The authors have no other conflicts of interest to declare.

The study was approved by the University of Florida IRB.