BACKGROUND: Dutasteride has been shown to significantly improve symptoms of benign prostatic hyperplasia (BPH) and reduce clinical progression. Recent data from studies evaluating 5-alpha reductase inhibitors (5-ARIs) for the prevention of prostate cancer, however, suggest 5ARIs, including dutasteride, may be associated with increased incidence of Gleason 8-10 prostate tumours. This meta-analysis was undertaken to quantify the effect of dutasteride on detection of prostate cancer and high-grade prostate cancer. METHODS: Our meta-analysis includes data from GlaxoSmithKline-sponsored phase III randomized clinical trials (with a study duration of ≥2 years) evaluating the effect of dutasteride, alone or in combination with tamsulosin, to treat BPH or to reduce the risk of prostate cancer. The incidence of prostate cancer, including Gleason 7-10 and Gleason 8-10, for patients taking either dutasteride, dutasteride plus tamsulosin, tamsulosin alone, or placebo, were evaluated using the Mantel-Haenszel Risk Ratio (MHRR) method of conducting meta-analyses. RESULTS: The meta-analysis demonstrated that in a population with symptomatic BPH and/or at increased risk of prostate cancer, a statistically significant lower number of detectable prostate cancers was found in men taking dutasteride compared to control groups (MHRR: 0.66, 95% CI 0.52-0.85). In our analysis, there was no increased risk for Gleason 7-10 (MHRR: 0.83, 95% CI 0.56-1.21) or Gleason 8-10 prostate cancers (MHRR: 0.99, 95% CI 0.39-2.53) in men taking dutasteride over control groups. There were several limitations that need to be considered when interpreting these results. CONCLUSION: These data provide support for the continued use of dutasteride in the treatment of symptomatic BPH patients.
BACKGROUND:Dutasteride has been shown to significantly improve symptoms of benign prostatic hyperplasia (BPH) and reduce clinical progression. Recent data from studies evaluating 5-alpha reductase inhibitors (5-ARIs) for the prevention of prostate cancer, however, suggest 5ARIs, including dutasteride, may be associated with increased incidence of Gleason 8-10prostate tumours. This meta-analysis was undertaken to quantify the effect of dutasteride on detection of prostate cancer and high-grade prostate cancer. METHODS: Our meta-analysis includes data from GlaxoSmithKline-sponsored phase III randomized clinical trials (with a study duration of ≥2 years) evaluating the effect of dutasteride, alone or in combination with tamsulosin, to treat BPH or to reduce the risk of prostate cancer. The incidence of prostate cancer, including Gleason 7-10 and Gleason 8-10, for patients taking either dutasteride, dutasteride plus tamsulosin, tamsulosin alone, or placebo, were evaluated using the Mantel-Haenszel Risk Ratio (MHRR) method of conducting meta-analyses. RESULTS: The meta-analysis demonstrated that in a population with symptomatic BPH and/or at increased risk of prostate cancer, a statistically significant lower number of detectable prostate cancers was found in men taking dutasteride compared to control groups (MHRR: 0.66, 95% CI 0.52-0.85). In our analysis, there was no increased risk for Gleason 7-10 (MHRR: 0.83, 95% CI 0.56-1.21) or Gleason 8-10prostate cancers (MHRR: 0.99, 95% CI 0.39-2.53) in men taking dutasteride over control groups. There were several limitations that need to be considered when interpreting these results. CONCLUSION: These data provide support for the continued use of dutasteride in the treatment of symptomatic BPH patients.
Authors: Laurence Klotz; Michael Chetner; Joseph Chin; Tony Finelli; Neil Fleshner; Yves Fradet; Larry Goldenberg; J Curtis Nickel; Robert Siemens; Alan So; Linda Sugar; Alexandre Zlotta; Eric Klein; Howard Parnes; David Penson Journal: Can Urol Assoc J Date: 2012-04 Impact factor: 1.862
Authors: Neil E Fleshner; M Scott Lucia; Blair Egerdie; Lorne Aaron; Gregg Eure; Indrani Nandy; Libby Black; Roger S Rittmaster Journal: Lancet Date: 2012-01-24 Impact factor: 79.321
Authors: Gerald L Andriole; David G Bostwick; Otis W Brawley; Leonard G Gomella; Michael Marberger; Francesco Montorsi; Curtis A Pettaway; Teuvo L Tammela; Claudio Teloken; Donald J Tindall; Matthew C Somerville; Timothy H Wilson; Ivy L Fowler; Roger S Rittmaster Journal: N Engl J Med Date: 2010-04-01 Impact factor: 91.245
Authors: Athanase Billis; Marbele S Guimaraes; Leandro L L Freitas; Luciana Meirelles; Luis A Magna; Ubirajara Ferreira Journal: J Urol Date: 2008-06-11 Impact factor: 7.450
Authors: Marc R Theoret; Yang-Min Ning; Jenny J Zhang; Robert Justice; Patricia Keegan; Richard Pazdur Journal: N Engl J Med Date: 2011-06-15 Impact factor: 91.245
Authors: Michael Marberger; Stephen J Freedland; Gerald L Andriole; Mark Emberton; Curtis Pettaway; Francesco Montorsi; Claudio Teloken; Roger S Rittmaster; Matthew C Somerville; Ramiro Castro Journal: BJU Int Date: 2011-06-23 Impact factor: 5.588