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- Title
Long-term Consequences of Finasteride vs Placebo in the Prostate Cancer Prevention Trial.
- Authors
Unger, Joseph M.; Till, Cathee; Thompson, Jr., Ian M.; Tangen, Catherine M.; Goodman, Phyllis J.; Wright, Jason D.; Barlow, William E.; Ramsey, Scott D.; Minasian, Lori M.; Hershman, Dawn L.; Thompson, Ian M Jr
- Abstract
<bold>Background: </bold>Finasteride has been found to reduce the risk of low-grade prostate cancer but to have no impact on overall survival. The long-term adverse and beneficial consequences of finasteride have not been examined.<bold>Methods: </bold>We used a linkage between data from the Prostate Cancer Prevention Trial (PCPT) and Medicare claims. Patients were examined by randomized study arm (finasteride vs placebo for 7 years) for long-term consequences of the intervention, including cardiac, endocrine, and sexual dysfunction, depression, diabetes, and benign prostatic hyperplasia (BPH)-related events. To examine time to events, we used cumulative incidence and Cox regression, adjusting for covariates. All statistical tests were two-sided.<bold>Results: </bold>A total of 13 935 of 18 880 participants (73.8%) in the PCPT were linked to Medicare claims, with median Medicare follow-up assessment time of 16 years from trial registration. There were no differences between finasteride and placebo participants with respect to important baseline factors or amount of Medicare follow-up assessment time. Finasteride patients had a 10% higher risk of new claims for depression (hazard ratio [HR] = 1.10, 95% confidence interval [CI] = 1.01 to 1.19, P = .04) and a 6% lower risk of procedures for BPH-related events (primarily lower urinary tract symptoms; HR = 0.94, 95% CI = 0.89 to 1.00, P = .03). No other differences were found in rates of long-term consequences of intervention in the two study arms.<bold>Conclusions: </bold>Finasteride use is associated with reduced need for procedures for relief of BPH-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 BPH, hair growth, or prevention of cancer.
- Subjects
UNITED States; FINASTERIDE; PLACEBOS; PROSTATE cancer prevention; SEXUAL dysfunction; MEDICARE; BENIGN prostatic hyperplasia; DIABETES; ENZYME inhibitors; PROSTATE tumors; CLINICAL trials; MENTAL depression; LONGITUDINAL method; MEDICAL record linkage; PROBABILITY theory; RESEARCH funding; RISK assessment; TIME; URINARY organs; THERAPEUTICS; PREVENTION
- Publication
JNCI: Journal of the National Cancer Institute, 2016, Vol 108, Issue 12, p1
- ISSN
0027-8874
- Publication type
journal article
- DOI
10.1093/jnci/djw168