Time Course of Incident Adverse Experiences Associated with Doxazosin, Finasteride, and Combination Therapy in Men with Benign Prostatic Hyperplasia: the Medical Therapy of Prostatic Symptoms (MTOPS) Trial

We examined first (incident) reports of selected adverse experiences (AEs) over time associated with medical therapy in men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).

We studied the six most common AEs (non-sexual function-related AEs: dizziness, orthostatic hypotension, and weakness; sexual function-related AEs: impotence, decreased libido, and abnormal ejaculation) reported in the Medical Therapy of Prostatic Symptoms (MTOPS) Study. A total of 3,047 men were randomized to placebo, doxazosin, finasteride, or combination therapy and followed for a mean of 4. 5 years. We compared the incidence rates of AEs at Year 1 to rates thereafter.

For each assigned treatment group, the incidence rates were significantly higher for all six of the AEs examined at Year 1 compared with rates thereafter. Men assigned to combination therapy experienced the highest rates at Year 1; they were from 3. 4- to 10. 6-fold higher than post-Year 1 rates. The incidence rates for orthostatic hypotension and dizziness were significantly higher in the doxazosin and combination therapy groups compared with the placebo group at Year 1. The incidence rates for the three examined sexual function-related AEs were significantly higher in the finasteride and combination therapy groups compared with the placebo group at Year 1.

Rates of first report of sexual function-related and other AEs associated with doxazosin, finasteride, and combination therapy were greatest during the first year of treatment. These patterns should be considered by both patients and their physicians when treatment for LUTS with these drugs is initiated.

The Journal of urology. 2015 Dec 08 [Epub ahead of print]

Steven A Kaplan, Jeannette Y Lee, Alan G Meehan, John W Kusek

Weill Cornell Medical College, New York, NY. University of Arkansas for Medical Sciences, Little Rock, AR. , Merck & Co. , Inc. , Kenilworth, NJ. , National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD.