Purpose: To examine the risk of persistent sexual dysfunction (PSD) with finasteride 1 mg.
Methods: We conducted a retrospective cohort study using the IMS U.S. health claims database. From an original cohort of 6,110,723 patients, we identified 1390 men who had stopped using finasteride 1 mg and 20,000 randomly selected age- and calendar time-matched users of omeprazole from 2006 to 2014. First PSD event was defined as (1) the first PSD diagnosis through the first International Classification for Diseases, Ninth Revision, Clinical Modification) code for sexual dysfunction and (2) use of a phosphodiesterase inhibitor (sildenafil, tadalafil, or vardenafil).
Results: In the primary analysis, we identified 1390 men taking finasteride 1 mg and 20,000 omeprazole users. The mean time to first PSD event after discontinuation of a finasteride 1 mg prescription was 391 days (SD, 357 days). The rate of PSD for finasteride 1 mg users and omeprazole users was 37.9 and 15.0 per 1000 person-years, respectively. For the primary analysis of sexual dysfunction, the adjusted hazard ratio (HR) comparing finasteride 1 mg users to omeprazole users was 1.62 (1.14-2.29). Adjusted HR in the secondary analysis comparing finasteride users to omeprazole users with respect to the first phosphodiesterase inhibitor was 2.73 (2.01-3.69).
Conclusions: The risk of PSD in men who stopped finasteride 1 mg therapy was higher than that for omeprazole users. Patients who stopped finasteride therapy sought physician visits for sexual dysfunction up to 1 year after stopping finasteride.
Keywords: finasteride; persistent sexual dysfunction; pharmacoepidemiologic study; propecia.
© 2016 Pharmacotherapy Publications, Inc.