Literature DB >> 8881946

The safety of finasteride used in benign prostatic hypertrophy: a non-interventional observational cohort study in 14,772 patients.

L Wilton1, G Pearce, E Edet, S Freemantle, M D Stephens, R D Mann.   

Abstract

OBJECTIVE: To examine the safety of finasteride as used in general medical practice to treat benign prostatic hypertrophy (BPH). PATIENTS AND METHODS: Information was collected on 14,772 patients who were included in an observational cohort study conducted using Prescription-Event Monitoring.
RESULTS: Finasteride was reported to have been effective in 60% of the patients in whom an opinion on efficacy was recorded. Impotence or ejaculatory failure was reported in 2.1% of the patients, decreased libido in 1% and gynaecomastia and related conditions in 0.4%. Impotence was the most frequent reason for stopping treatment with finasteride and was the most commonly reported adverse reaction to the drug. Of the patients included in the elderly cohort involved in this study, 819 (5.5%) died; none of these deaths was attributed to finasteride.
CONCLUSION: Impotence or ejaculatory failure, decreased libido and gynaecomastia in a small proportion of patients were associated with the use of finasteride. The results of this study strongly suggest that this drug is acceptably safe when used in accordance with the current prescribing information.

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Year:  1996        PMID: 8881946     DOI: 10.1046/j.1464-410x.1996.00091.x

Source DB:  PubMed          Journal:  Br J Urol        ISSN: 0007-1331


  16 in total

Review 1.  Adverse effects of 5α-reductase inhibitors: What do we know, don't know, and need to know?

Authors:  Abdulmaged M Traish; Roberto Cosimo Melcangi; Marco Bortolato; Luis M Garcia-Segura; Michael Zitzmann
Journal:  Rev Endocr Metab Disord       Date:  2015-09       Impact factor: 6.514

Review 2.  Prescription-event monitoring--recent progress and future horizons.

Authors:  R D Mann
Journal:  Br J Clin Pharmacol       Date:  1998-09       Impact factor: 4.335

3.  5α-Reductase inhibitors increase acute coronary syndrome risk in patients with benign prostate hyperplasia.

Authors:  C-H Chou; C-L Lin; M-C Lin; F-C Sung; C-H Kao
Journal:  J Endocrinol Invest       Date:  2015-03-17       Impact factor: 4.256

Review 4.  Investigation of the Plausibility of 5-Alpha-Reductase Inhibitor Syndrome.

Authors:  Raymond Fertig; Jerry Shapiro; Wilma Bergfeld; Antonella Tosti
Journal:  Skin Appendage Disord       Date:  2016-09-23

5.  Effect of testosterone supplementation with and without a dual 5α-reductase inhibitor on fat-free mass in men with suppressed testosterone production: a randomized controlled trial.

Authors:  Shalender Bhasin; Thomas G Travison; Thomas W Storer; Kishore Lakshman; Manas Kaushik; Norman A Mazer; Ahn-Hoa Ngyuen; Maithili N Davda; Hernan Jara; Adam Aakil; Stephan Anderson; Philip E Knapp; Samson Hanka; Nurahmed Mohammed; Pierre Daou; Renee Miciek; Jagadish Ulloor; Anqi Zhang; Brad Brooks; Katie Orwoll; Leife Hede-Brierley; Richard Eder; Ayan Elmi; Geeta Bhasin; Lauren Collins; Ravinder Singh; Shehzad Basaria
Journal:  JAMA       Date:  2012-03-07       Impact factor: 56.272

Review 6.  Finasteride: an update of its use in the management of symptomatic benign prostatic hyperplasia.

Authors:  M I Wilde; K L Goa
Journal:  Drugs       Date:  1999-04       Impact factor: 9.546

7.  Short-Term Efficacy of Autologous Cellular Micrografts in Male and Female Androgenetic Alopecia: A Retrospective Cohort Study.

Authors:  Shadi Zari
Journal:  Clin Cosmet Investig Dermatol       Date:  2021-11-19

8.  Finasteride induced Gynecomastia: Case report and Review of the Literature.

Authors:  Yuval Ramot; Tali Czarnowicki; Abraham Zlotogorski
Journal:  Int J Trichology       Date:  2009-01

9.  The effect of 5alpha-reductase inhibition with dutasteride and finasteride on bone mineral density, serum lipoproteins, hemoglobin, prostate specific antigen and sexual function in healthy young men.

Authors:  John K Amory; Bradley D Anawalt; Alvin M Matsumoto; Stephanie T Page; William J Bremner; Christina Wang; Ronald S Swerdloff; Richard V Clark
Journal:  J Urol       Date:  2008-04-18       Impact factor: 7.450

10.  [Androgenetic alopecia].

Authors:  R Hoffman
Journal:  Hautarzt       Date:  2004-01       Impact factor: 0.751

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