dutasteride and Cardiovascular-Diseases

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.. We searched MEDLINE and EMBASE, unpublished articles identified through FDA/EMEA websites, study registers of pharmaceutical companies and reference lists of articles.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.. 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, I(2) = 20%), myocardial infarction (RR 1·00; 95% CI 0·77-1·30, I(2) = 0%) and stroke (RR, 1·20; 95% CI 0·88-1·64, I(2) = 0%) as compared to controls.. We did not find consistent evidence of a significant association between dutasteride therapy and the risk of cardiovascular adverse events.

Topics: 5-alpha Reductase Inhibitors; Azasteroids; Cardiovascular Diseases; Double-Blind Method; Drug-Related Side Effects and Adverse Reactions; Dutasteride; Humans; Male; Prostatic Diseases; Randomized Controlled Trials as Topic; Risk

Benign prostatic hyperplasia (BPH) is extremely common in the aging man and may cause significant lower urinary tract symptoms (LUTS) necessitating treatment. Drug treatment is the mainstay of treatment for symptomatic BPH and is directed at relaxing prostatic smooth muscle, reducing prostate volume, or a combination of these effects. The most commonly used drugs for this indication are alpha1-adrenergic receptor antagonists, which relax prostatic smooth muscle, and 5-alpha-reductase inhibitors, which reduce prostatic androgen levels and consequently prostate size. Invasive interventions include the gold standard, transurethral resection of the prostate (TURP), and several minimally invasive surgical options. Although effective in alleviating symptoms, TURP carries a higher risk of morbidity and complications, including sexual side effects (mainly ejaculatory dysfunction), than medical therapy or minimally invasive techniques. Treatment for BPH, whether medical or surgical, must take patients' comorbid conditions into consideration so that LUTS may be effectively relieved, with the smallest risk of exacerbating any concomitant conditions.

Topics: 5-alpha Reductase Inhibitors; Adrenergic alpha-Antagonists; Azasteroids; Cardiovascular Diseases; Comorbidity; Doxazosin; Drug Therapy, Combination; Dutasteride; Enzyme Inhibitors; Erectile Dysfunction; Finasteride; Global Health; Humans; Male; Prazosin; Prostatic Hyperplasia; Quinazolines; Sulfonamides; Tamsulosin; Transurethral Resection of Prostate; Treatment Outcome