Summary What is known and objectives A recently published large, long-term randomized controlled trial (RCT) brought into question the safety of dutasteride after a significantly increased risk of 'cardiac failure' was noted in the dutasteride arm of the trial compared with placebo. Our objective was to perform a meta-analysis to assess the risk of cardiovascular adverse events with the use of dutasteride for the prevention or treatment of prostatic disease. Methods We searched MEDLINE and EMBASE, unpublished articles identified through FDA/EMEA websites, study registers of pharmaceutical companies and reference lists of articles. Parallel-group, randomized controlled trials where men received dutasteride for the prevention of prostate cancer or treatment of prostatic hyperplasia against any comparator intervention were included. Heart failure was the primary outcome of interest but we also looked at myocardial infarction and stroke. Fixed-effect meta-analysis of pooled relative risk (RR) ratios of adverse effect outcomes was conducted. Results and discussion In all, 12 RCTs were included in the meta-analysis after detailed screening of 564 citations. The total number of participants was 18 802, and study duration ranged from 6 to 208 weeks. Only two trials provided details on adequate allocation concealment, whereas all the trials stated they were double blind in nature. Dutasteride was not associated with a statistically significant increased risk of heart failure (RR 1·05; 95% confidence interval [CI], 0·71-1·57, I2 = 20%), myocardial infarction (RR 1·00; 95% CI 0·77-1·30, I2 = 0%) and stroke (RR, 1·20; 95% CI 0·88-1·64, I2 = 0%) as compared to controls. What is new and conclusion We did not find consistent evidence of a significant association between dutasteride therapy and the risk of cardiovascular adverse events.
- cardiovascular adverse effects
- systematic review (6)
ASJC Scopus subject areas
- Pharmacology (medical)