Joseph M Unger1, Cathee Till2, Ian M Thompson2, Catherine M Tangen2, Phyllis J Goodman2, Jason D Wright2, William E Barlow2, Scott D Ramsey2, Lori M Minasian2, Dawn L Hershman2. 1. SWOG Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, WA (JMU, CT, CMT, PJG, WEB); Cancer Therapy and Research Center, University of Texas Health Science Center at San Antonio, San Antonio, TX (IMTJr); Columbia University, New York, NY (JDW, DLH); Fred Hutchinson Cancer Research Center, Seattle, WA (SDR); Division of Cancer Prevention, U.S. National Cancer Institute, Rockville, MD (LMM) junger@fredhutch.org. 2. SWOG Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, WA (JMU, CT, CMT, PJG, WEB); Cancer Therapy and Research Center, University of Texas Health Science Center at San Antonio, San Antonio, TX (IMTJr); Columbia University, New York, NY (JDW, DLH); Fred Hutchinson Cancer Research Center, Seattle, WA (SDR); Division of Cancer Prevention, U.S. National Cancer Institute, Rockville, MD (LMM).
Abstract
BACKGROUND: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. METHODS: 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. RESULTS: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. CONCLUSIONS: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.
RCT Entities:
BACKGROUND: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. METHODS: 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. RESULTS: 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. Finasteridepatients 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. CONCLUSIONS: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.
Authors: J D McConnell; R Bruskewitz; P Walsh; G Andriole; M Lieber; H L Holtgrewe; P Albertsen; C G Roehrborn; J C Nickel; D Z Wang; A M Taylor; J Waldstreicher Journal: N Engl J Med Date: 1998-02-26 Impact factor: 91.245
Authors: Mary W Redman; Catherine M Tangen; Phyllis J Goodman; M Scott Lucia; Charles A Coltman; Ian M Thompson Journal: Cancer Prev Res (Phila) Date: 2008-05-18
Authors: Patricia A Ganz; Michael A Hussey; Carol M Moinpour; Joseph M Unger; Laura F Hutchins; Shaker R Dakhil; Jeffrey K Giguere; J Wendall Goodwin; Silvana Martino; Kathy S Albain Journal: J Clin Oncol Date: 2008-01-28 Impact factor: 44.544
Authors: Ian M Thompson; Phyllis J Goodman; Catherine M Tangen; Howard L Parnes; Lori M Minasian; Paul A Godley; M Scott Lucia; Leslie G Ford Journal: N Engl J Med Date: 2013-08-15 Impact factor: 91.245
Authors: Blayne Welk; Eric McArthur; Michael Ordon; Kelly K Anderson; Jade Hayward; Stephanie Dixon Journal: JAMA Intern Med Date: 2017-05-01 Impact factor: 21.873
Authors: Joseph M Unger; Dawn L Hershman; Cathee Till; Catherine M Tangen; William E Barlow; Scott D Ramsey; Phyllis J Goodman; Ian M Thompson Journal: J Natl Cancer Inst Date: 2018-11-01 Impact factor: 13.506
Authors: Mark A Preston; Lorelei A Mucci; Jane B Vaselkiv; Carl Ceraolo; Kathryn M Wilson; Claire H Pernar; Emily M Rencsok; Konrad H Stopsack; Sydney T Grob; Anna Plym; Edward L Giovannucci; Aria F Olumi; Adam S Kibel Journal: Cancer Epidemiol Biomarkers Prev Date: 2022-07-01 Impact factor: 4.090
Authors: Jae Heon Kim; Sung Ryul Shim; Yash Khandwala; Francesco Del Giudice; Simon Sorensen; Benjamin I Chung Journal: World J Mens Health Date: 2019-05-23 Impact factor: 5.400