The Prostate Cancer Prevention Trial (PCPT) was a randomized, double-blind, placebo-controlled study of the efficacy of finasteride in preventing prostate cancer in 18,882 men aged 55 years or older. The PCPT offered an opportunity to prospectively study the effects of finasteride and other covariates on sexual dysfunction.
We assessed sexual dysfunction in 17,313 PCPT participants during a 7-year period. A battery of questionnaires assessed sexual dysfunction (Sexual Activity Scale score); age; race; SF-36 Mental Health Inventory-5, Physical Function, and Vitality scores; body mass index; smoking status; and the presence of diabetes and hypertension. Assessments began at month 6 after random assignment and included the Sexual Activity Scale score at randomization as a covariate. Two-sided general t tests, with a cutoff of P value less than .05, were used to determine the statistical significance for mixed model effects with correlated random time slopes and intercepts. The changing impact of covariates on sexual dysfunction was also assessed at 6 months, 3.5 years, and 6.5 years after randomization.
Finasteride increased sexual dysfunction only slightly and its impact diminished over time; the increase in the Sexual Activity Scale score relative to placebo of 3.21 points (95% confidence interval [CI] = 2.83 to 3.59 points; P<.001) at the first assessment decreased to 2.11 points (95% CI = 1.44 to 2.81 points; P<.001) at the end of study. These Sexual Activity score values were small on a scale of 0-100, the range observed in the study, and in comparison with individual variation. After adjustment for all covariates, mean sexual dysfunction increased in both arms from baseline (6 months after randomization) by 1.26 Sexual Activity points (95% CI = 1.16 to 1.36 points; P<.001) per year, corresponding to a cumulative increase of 8.22 points (95% CI = 7.52 to 8.92 points; P<.001) over the study period.
The effect of finasteride on sexual functioning is minimal for most men and should not impact the decision to prescribe or take finasteride.
"The minimal effect of finasteride on sexual function was further confirmed by the Prostate Cancer Prevention Trial, a randomized, double-blind, placebo-controlled clinical trial which is described in further detail later in this review.27 Sexual dysfunction was studied in over 17,000 patients during a 7-year period. "
[Show abstract][Hide abstract] ABSTRACT: Benign prostatic hyperplasia (BPH) is a complex and progressive disease common in aging men. While associated with bothersome lower urinary tract symptoms, it may also result in additional serious complications such as refractory hematuria, acute urinary retention, and BPH-related surgery. Medical therapy has been offered as an approach to halt this progression and perhaps reverse the pathophysiology of BPH. While alpha-blockers provide rapid relief in the form of improved flow rate, their effects may not reduce the overall risk of BPH-related complications. 5alpha-reductase inhibitors were therefore introduced to affect the underlying disease process by inhibiting the enzyme which converts testosterone to dihydrotesterone, the primary androgen involved in normal and abnormal prostate growth. Through this inhibition, prostate size is decreased, thereby reducing the risk of acute urinary retention and BPH-related surgery while providing symptom control. These effects are most pronounced in men with enlarged prostates (>25 mL) who are at the greatest risk of disease progression. This article reviews the literature for finasteride used in the treatment of BPH and provides evidence for its efficacy, safety and tolerability, applicability for combination therapy, and considerations of its effects on prostate cancer risk.
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