title: Long-term Consequences of Finasteride vs Placebo in the Prostate Cancer Prevention Trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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: 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.
authors: Joseph M
authors: JM
authors: Unger
authors: 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).
authors: Cathee
authors: C
authors: Till
authors: 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).
authors: Ian M
authors: IM
authors: Thompson
authors: 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).
authors: Catherine M
authors: CM
authors: Tangen
authors: 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).
authors: Phyllis J
authors: PJ
authors: Goodman
authors: 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).
authors: Jason D
authors: JD
authors: Wright
authors: 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).
authors: William E
authors: WE
authors: Barlow
authors: 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).
authors: Scott D
authors: SD
authors: Ramsey
authors: 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).
authors: Lori M
authors: LM
authors: Minasian
authors: 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).
authors: Dawn L
authors: DL
authors: Hershman
mesh_terms: D058891:5-alpha Reductase Inhibitors / Q000627:therapeutic use*; D000067575:Administrative Claims, Healthcare; D000368:Aged; D002986:Clinical Trials as Topic; D003863:Depression / Q000453:epidemiology*; D018120:Finasteride / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000453:epidemiology*; D008297:Male; D008498:Medical Record Linkage; D006278:Medicare; D008875:Middle Aged; D011471:Prostatic Neoplasms / Q000517:prevention & control*; D065840:Protective Factors; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D014481:United States / Q000453:epidemiology
chemical_list: D058891:5-alpha Reductase Inhibitors; D018120:Finasteride