Long-Term Effects of Finasteride in Patients From the Prostate Cancer Prevention Trial


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In the Prostate Cancer Prevention Trial finasteride was found to reduce the risk of low-grade prostate cancer but to have no effect on overall survival. Results of the trial, in which 18,880 men were randomized to receive finasteride or placebo for 7 years, were reported in 2003.

In a recent study reported in the Journal of the National Cancer Institute, Joseph M. Unger, PhD, of the SWOG Statistical Center, Fred Hutchinson Cancer Research Center, and colleagues found that use of finasteride vs placebo was associated with a modestly increased risk of depression and a modestly reduced risk of procedures for benign prostatic hyperplasia–related events over 16 years of follow-up. The current analysis by Unger et al involved linked data from 13,935 trial participants (73.8% of the total population, including 6,941 finasteride and 6,994 placebo patients) and Medicare claims.

Long-Term Effects

Median Medicare follow-up assessment time was 16 years from trial registration. Patients in the finasteride group had a 10% higher risk of new Medicare claims for depression (hazard ratio [HR] = 1.10, P = .04) and a 6% lower risk of claims for procedures for benign prostatic hyperplasia–related events, mainly lower urinary tract symptoms (HR = 0.94, P = .03). No significant differences between the groups were found for claims for cardiac-related events (overall for ischemic or thrombotic events: HR = 1.02, P = .68), overall endocrine-related events (HR = 0.99, P = .80), diabetes (HR = 0.99, P = .77), or sexual dysfunction (HR = 1.00, P = .93).

The investigators concluded: “Finasteride use is associated with reduced need for procedures for relief of [benign prostatic hyperplasia]–related events and a modest increase in depression. Overall, there is little need to worry about long-term noncancer consequences of finasteride use in those who use it for treatment of symptomatic [benign prostatic hyperplasia], hair growth, or prevention of cancer.”

The study was supported by the National Cancer Institute.

Unger JM, et al: J Natl Cancer Inst 108:djw168, 2016.


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