title: The Cardiovascular Safety of Dutasteride.
abstract: Randomized controlled trials suggest an increased risk of heart failure with dutasteride, which inhibits both the type 1 and type 2 isoforms of 5α-reductase. In contrast, no such association has been suggested for finasteride, which selectively inhibits the type 2 isoform. We investigated the risk of cardiovascular events among patients receiving dutasteride relative to finasteride.
  
  
  
  We performed a population based cohort study of Ontario men 66 years old or older who commenced treatment with dutasteride or finasteride between October 1, 2005 and March 31, 2015. For each individual treated with dutasteride, we identified 1 treated with finasteride, matching on a propensity score and calendar quarter of treatment initiation to account for temporal changes in prescribing. The primary outcome was hospitalization for heart failure. Secondary analyses were done to examine acute myocardial infarction and stroke. Cox proportional hazards regression was used to adjust for differences between groups.
  
  
  
  We studied 36,311 men who commenced dutasteride and 36,311 treated with finasteride. In the primary analysis, we found no difference in the risk of heart failure among patients receiving dutasteride relative to those receiving finasteride (adjusted HR 0.98, 95% CI 0.88-1.08). Similarly, we found no difference in the risk of acute myocardial infarction (HR 0.94, 95% CI 0.82-1.08) or stroke (HR 1.03, 95% CI 0.88-1.20).
  
  
  
  In this population based cohort study of more than 72,000 older men, dutasteride was not associated with an increased risk of cardiovascular events relative to finasteride.
authors.affiliation: Department of Family and Community Medicine (SCS), University of Toronto, Toronto, Ontario, Canada; University of Toronto (JMP, MMM, DJ), Toronto, Ontario, Canada; Institute for Clinical Evaluative Sciences (EMM, JMP, MMM, DJ), Toronto, Ontario, Canada; Li Ka Shing Knowledge Institute and Applied Health Research Centre, St. Michael's Hospital (MMM), Toronto, Ontario, Canada; Sunnybrook Research Institute (DJ), Toronto, Ontario, Canada; Department of Family Medicine, McMaster University (JMP), Hamilton, Ontario, Canada; Centre for Health Services and Policy Research, School of Population and Public Health, University of British Columbia (SCS, MRL), Vancouver, British Columbia, Canada; King Saud University (MMM), Riyadh, Saudi Arabia.
authors.forename: Sean C
authors.initials: SC
authors.lastname: Skeldon
authors.affiliation: Department of Family and Community Medicine (SCS), University of Toronto, Toronto, Ontario, Canada; University of Toronto (JMP, MMM, DJ), Toronto, Ontario, Canada; Institute for Clinical Evaluative Sciences (EMM, JMP, MMM, DJ), Toronto, Ontario, Canada; Li Ka Shing Knowledge Institute and Applied Health Research Centre, St. Michael's Hospital (MMM), Toronto, Ontario, Canada; Sunnybrook Research Institute (DJ), Toronto, Ontario, Canada; Department of Family Medicine, McMaster University (JMP), Hamilton, Ontario, Canada; Centre for Health Services and Policy Research, School of Population and Public Health, University of British Columbia (SCS, MRL), Vancouver, British Columbia, Canada; King Saud University (MMM), Riyadh, Saudi Arabia.
authors.forename: Erin M
authors.initials: EM
authors.lastname: Macdonald
authors.affiliation: Department of Family and Community Medicine (SCS), University of Toronto, Toronto, Ontario, Canada; University of Toronto (JMP, MMM, DJ), Toronto, Ontario, Canada; Institute for Clinical Evaluative Sciences (EMM, JMP, MMM, DJ), Toronto, Ontario, Canada; Li Ka Shing Knowledge Institute and Applied Health Research Centre, St. Michael's Hospital (MMM), Toronto, Ontario, Canada; Sunnybrook Research Institute (DJ), Toronto, Ontario, Canada; Department of Family Medicine, McMaster University (JMP), Hamilton, Ontario, Canada; Centre for Health Services and Policy Research, School of Population and Public Health, University of British Columbia (SCS, MRL), Vancouver, British Columbia, Canada; King Saud University (MMM), Riyadh, Saudi Arabia.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Law
authors.affiliation: Department of Family and Community Medicine (SCS), University of Toronto, Toronto, Ontario, Canada; University of Toronto (JMP, MMM, DJ), Toronto, Ontario, Canada; Institute for Clinical Evaluative Sciences (EMM, JMP, MMM, DJ), Toronto, Ontario, Canada; Li Ka Shing Knowledge Institute and Applied Health Research Centre, St. Michael's Hospital (MMM), Toronto, Ontario, Canada; Sunnybrook Research Institute (DJ), Toronto, Ontario, Canada; Department of Family Medicine, McMaster University (JMP), Hamilton, Ontario, Canada; Centre for Health Services and Policy Research, School of Population and Public Health, University of British Columbia (SCS, MRL), Vancouver, British Columbia, Canada; King Saud University (MMM), Riyadh, Saudi Arabia.
authors.forename: Anjie
authors.initials: A
authors.lastname: Huang
authors.affiliation: Department of Family and Community Medicine (SCS), University of Toronto, Toronto, Ontario, Canada; University of Toronto (JMP, MMM, DJ), Toronto, Ontario, Canada; Institute for Clinical Evaluative Sciences (EMM, JMP, MMM, DJ), Toronto, Ontario, Canada; Li Ka Shing Knowledge Institute and Applied Health Research Centre, St. Michael's Hospital (MMM), Toronto, Ontario, Canada; Sunnybrook Research Institute (DJ), Toronto, Ontario, Canada; Department of Family Medicine, McMaster University (JMP), Hamilton, Ontario, Canada; Centre for Health Services and Policy Research, School of Population and Public Health, University of British Columbia (SCS, MRL), Vancouver, British Columbia, Canada; King Saud University (MMM), Riyadh, Saudi Arabia.
authors.forename: J Michael
authors.initials: JM
authors.lastname: Paterson
authors.affiliation: Department of Family and Community Medicine (SCS), University of Toronto, Toronto, Ontario, Canada; University of Toronto (JMP, MMM, DJ), Toronto, Ontario, Canada; Institute for Clinical Evaluative Sciences (EMM, JMP, MMM, DJ), Toronto, Ontario, Canada; Li Ka Shing Knowledge Institute and Applied Health Research Centre, St. Michael's Hospital (MMM), Toronto, Ontario, Canada; Sunnybrook Research Institute (DJ), Toronto, Ontario, Canada; Department of Family Medicine, McMaster University (JMP), Hamilton, Ontario, Canada; Centre for Health Services and Policy Research, School of Population and Public Health, University of British Columbia (SCS, MRL), Vancouver, British Columbia, Canada; King Saud University (MMM), Riyadh, Saudi Arabia.
authors.forename: Muhammad M
authors.initials: MM
authors.lastname: Mamdani
authors.affiliation: Department of Family and Community Medicine (SCS), University of Toronto, Toronto, Ontario, Canada; University of Toronto (JMP, MMM, DJ), Toronto, Ontario, Canada; Institute for Clinical Evaluative Sciences (EMM, JMP, MMM, DJ), Toronto, Ontario, Canada; Li Ka Shing Knowledge Institute and Applied Health Research Centre, St. Michael's Hospital (MMM), Toronto, Ontario, Canada; Sunnybrook Research Institute (DJ), Toronto, Ontario, Canada; Department of Family Medicine, McMaster University (JMP), Hamilton, Ontario, Canada; Centre for Health Services and Policy Research, School of Population and Public Health, University of British Columbia (SCS, MRL), Vancouver, British Columbia, Canada; King Saud University (MMM), Riyadh, Saudi Arabia. Electronic address: dnj@ices.on.ca.
authors.forename: David
authors.initials: D
authors.lastname: Juurlink
mesh_terms: D058891:5-alpha Reductase Inhibitors / Q000009:adverse effects*; D000368:Aged; D015331:Cohort Studies; D016208:Databases, Factual; D000068538:Dutasteride / Q000009:adverse effects*; D018120:Finasteride / Q000009:adverse effects*; D006333:Heart Failure / Q000139:chemically induced* / Q000453:epidemiology; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D009203:Myocardial Infarction / Q000139:chemically induced* / Q000453:epidemiology; D009864:Ontario; D011470:Prostatic Hyperplasia / Q000188:drug therapy; D020521:Stroke / Q000139:chemically induced* / Q000453:epidemiology
chemical_list: D058891:5-alpha Reductase Inhibitors; D018120:Finasteride; D000068538:Dutasteride
keywords: drug-related side effects and adverse reactions; dutasteride; finasteride; heart failure; prostatic hyperplasia