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CENTRAL SEROUS CHORIORETINOPATHY AND PHOSPHODIESTERASE-5 INHIBITORS: A Case–Control Postmarketing Surveillance Study

FRENCH, DUSTIN D. PhD*; MARGO, CURTIS E. MD, MPH

doi: 10.1097/IAE.0b013e3181b7740f
Original Articles
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Purpose: The purpose of this study was to determine if there is an increased risk of central serous chorioretinopathy (CSC) associated with prescription exposure to phosphodiesterase-5 (PDE-5) inhibitors.

Methods: A case–control study linking 2 National Veterans Health Administration databases (clinical and pharmacy) for fiscal years 2004 to 2005. The likelihood of past exposure to PDE-5 inhibitors among newly diagnosed patients with CSC, identified through International Classification of Diseases, 9th Edition, Clinical Modification codes, was compared with 2 age-matched control groups after excluding subjects with risk factors for CSC.

Results: Among 577 men, aged 59 years and younger with newly diagnosed CSC during the study year, 111 were prescribed a PDE-5 inhibitor (19.2%). The proportions of age-matched controls prescribed a PDE-5 inhibitor in the 2 groups were 18.5% and 21.5%. The odds ratio of exposure was 1.05 (95% confidence limit: 0.74–1.22) and 0.87 (95% confidence limit: 0.68–1.12).

Conclusion: Patients with CSC had no increase in prescription exposure to PDE-5 inhibitors than did age-matched control subjects. Although the findings in this study do not support an association between CSC and PDE-5 inhibitors, postmarketing surveillance methods for drug-related side effects have acknowledged limitations.

A retrospective case-control study suggests no association of phosphodiesterase-5 inhibitors and central serous chorioretinopathy.

From the *Regenstrief Institute Inc., Indiana University School of Medicine, Indianapolis, Indiana; and †Department of Ophthalmology and Pathology, College of Medicine, University of South Florida, Tampa, Florida.

The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs.

The authors have never received financial support from or collaborated in any way with the companies that manufacture the drugs studied in this article. The study was not requested or commissioned by a commercial drug company.

Reprint requests: Dustin D. French, PhD, VA Center of Excellence on Implementing Evidence Based Practice, Regenstrief Institute Inc., Indiana University School of Medicine, VA Medical Center, HSR&D (11H), 1481 West 10th Street, Indianapolis, IN 46202; e-mail: Drddfrench@yahoo.com; Dustin.French2@va.gov

© The Ophthalmic Communications Society, Inc.