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Oncotarget May 2017High-grade prostatic intraepithelial neoplasia (HGPIN) is the precursor or premalignant form of prostate cancer. At least 30% patients with a confirmed HGPIN will... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
High-grade prostatic intraepithelial neoplasia (HGPIN) is the precursor or premalignant form of prostate cancer. At least 30% patients with a confirmed HGPIN will develop prostate cancer within 1 year after repeated biopsy. HGPIN patients are the appropriate at-risk population for chemoprevention strategies investigation against prostate cancer. However the commonly used chemoprevention agents that targeted on hormonal imbalance or lifestyle-related factors showed varied results in HGPIN patients.
METHODS
Literature searches were conducted in PubMed, EMBASE and Cochrane library according to Cochrane guidelines before January 31st, 2017. Direct meta-analysis were performed to summarize the efficacy of candidate chemopreventative agents Dutasteride, Flutamide, Toremifene, Selenium, Green tea components, Lycopene and natural food products combination. Adjusted indirect meta-analyses were employed to compare the relative efficacy of these candidate chemoprevention agents head-to-head.
RESULTS
The overall incidence of prostate cancer in HGPIN was slightly decreased by chemoprevention agents (25.7% vs 31.5%, RR = 0.92, 95% CI: 0.83-1.03, P = 0.183), with minor heterogeneity (I2 = 22.3%, ð2 = 15.08, P = 0.237), but without statistical significance. Subgroup analysis showed that green tea catechins significantly decreased prostate cancer in HGPIN patients (7.60% vs 23.1%, RR = 0.39, 95% CI: 0.16-10.97, P P = 0.044), with moderate heterogeneity (I2 = 47.9%, ð2 = 1.92, P = 0.166). The adjusted indirect meta-analysis favored green tea catechins over other chemoprevention agents, and significantly when compared to natural food products combination (RR = 0.355, 95% CI: 0.134-0.934).
CONCLUSION
The overall efficacy of chemoprevention agents in HGPIN patients is limited. But Green tea catechins showed the superiority to decrease prostate cancer in HGPIN patients.
Topics: Anticarcinogenic Agents; Biological Products; Chemoprevention; Humans; Male; Odds Ratio; Prostatic Intraepithelial Neoplasia; Prostatic Neoplasms; Treatment Outcome
PubMed: 28415774
DOI: 10.18632/oncotarget.16230 -
Urologia Internationalis 2017This systematic review and meta-analysis were performed to evaluate the efficacy of preoperative dutasteride treatment for reducing surgical blood loss in patients... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
This systematic review and meta-analysis were performed to evaluate the efficacy of preoperative dutasteride treatment for reducing surgical blood loss in patients undergoing transurethral resection of the prostate (TURP).
METHODS
A systematic search was performed from the electronic databases including PubMed, EMBASE, and Cochrane Library by May 2016. We followed the search strategy based on Preferred Reporting Items for Systematic Reviews and Meta-analysis statement when examining the literature. Identified articles were strictly appraised for quality and relevance.
RESULTS
Five randomized controlled trials (RCTs) and 5 retrospective cohort studies involving 1,022 patients with benign prostate hyperplasia were analyzed based on the inclusion criteria. Pooled analysis revealed that preoperative treatment with dutasteride had a significantly smaller decrease in hemoglobin (weighted mean difference [WMD] -0.47, 95% CI -0.70 to -0.24, p < 0.0001) and hematocrit levels (WMD -1.03, 95% CI -1.73 to -0.33, p = 0.004); However, no significant difference has been found in terms of the total blood loss during TURP and blood loos per gram of resected prostatic tissue, the weight of resected prostate tissue, the microvessel density of the prostate, and the transfusion rate between the dutasteride and the control group.
CONCLUSIONS
This systematic review and meta-analysis indicate that preoperative treatment with dutasteride could reduce surgical bleeding during TURP, but the findings of this study should be further confirmed by well-designed prospective RCTs with a larger patient series.
Topics: 5-alpha Reductase Inhibitors; Blood Loss, Surgical; Blood Transfusion; Dutasteride; Hemoglobins; Humans; Male; Microcirculation; Prospective Studies; Prostate; Prostatic Hyperplasia; Randomized Controlled Trials as Topic; Retrospective Studies; Transurethral Resection of Prostate; Treatment Outcome; Vascular Endothelial Growth Factor A
PubMed: 28006778
DOI: 10.1159/000453669 -
The Journal of Clinical and Aesthetic... Jul 2016Finasteride and dutasteride, both 5-alpha reductase inhibitors, are considered first-line treatment for androgenetic hair loss in men and used increasingly in women. In... (Review)
Review
Finasteride and dutasteride, both 5-alpha reductase inhibitors, are considered first-line treatment for androgenetic hair loss in men and used increasingly in women. In each case, patients are expected to take the medications indefinitely despite the lack of research regarding long-term adverse effects. Concerns regarding the adverse effects of these medications has led the United States National Institutes of Health to add a link for post-finasteride syndrome to its Genetic and Rare Disease Information Center. Herein, the authors report the results of a literature search reviewing adverse events of 5-alpha reductase inhibitors as they relate to prostate cancer, psychological effects, sexual health, and use in women. Several large studies found no increase in incidence of prostate cancer, a possible increase of high-grade cancer when detected, and no change in survival rate with 5-alpha reductase inhibitor use. Currently, there is no direct link between 5-alpha reductase inhibitor use and depression; however, several small studies have led to depression being listed as a side effect on the medication packaging. Sexual effects including erectile dysfunction and decreased libido and ejaculate were reported in as many as 3.4 to 15.8 percent of men. To date, there are very few studies evaluating 5-alpha reductase inhibitor use in women. Risks include birth defects in male fetuses if used in pregnancy, decreased libido, headache, gastrointestinal discomfort, and isolated reports of changes in menstruation, acne, and dizziness. Overall, 5-alpha reductase inhibitors were well-tolerated in both men and women, but not without risk, highlighting the importance of patient education prior to treatment.
PubMed: 27672412
DOI: No ID Found -
The Journal of Sexual Medicine Sep 20165α-Reductase inhibitors (5ARIs) are widely used for the treatment of benign prostatic hyperplasia (BPH) and androgenetic alopecia (AGA). (Review)
Review
INTRODUCTION
5α-Reductase inhibitors (5ARIs) are widely used for the treatment of benign prostatic hyperplasia (BPH) and androgenetic alopecia (AGA).
AIM
To review all the available data on the effect of 5ARIs on sexual function and assess whether 5ARIs increase the risk of sexual dysfunction.
METHODS
A systematic search of the literature was conducted using the Medline, Embase, and Cochrane databases. The search was limited to articles published in English and up to October 2015. Article selection proceeded according to the search strategy based on Preferred Reporting Items for Systematic Reviews and Meta-analyses criteria. Data were analyzed using Stata 12.0. A fixed- or a random-effects model was used to calculate the overall combined risk estimates. Publication bias was assessed using Begg and Egger tests.
MAIN OUTCOME MEASURES
Sexual dysfunction, erectile dysfunction, and decreased libido.
RESULTS
After screening 493 articles, 17 randomized controlled trials with 17,494 patients were included. Nine studies evaluated the efficacy of 5ARIs in men with BPH. The other eight reported using 5ARIs in the treatment of men with AGA. The mean age of participants was 60.10 years across all studies. We included 10 trials (6,779 patients) on the efficacy and safety of finasteride, 4 trials (6,222 patients) on the safety and tolerability of dutasteride, and 3 trials (4,493 patients) using finasteride and dutasteride for AGA. The pooled relative risks for sexual dysfunction were 2.56 (95% CI = 1.48-4.42) in men with BPH and 1.21 (95% CI = 0.85-1.72) in men with AGA; those for erectile dysfunction were 1.55 (95% CI = 1.14-2.12) in men with BPH and 0.66 (95% CI = 0.20-2.25) in men with AGA; and those for decreased libido were 1.69 (95% CI = 1.03-2.79) in men with BPH and 1.16 (95% CI = 0.50-2.72) in men with AGA. Estimates of the total effects were generally consistent with the sensitivity analysis. No evidence of publication bias was observed.
CONCLUSION
Evidence from the randomized controlled trials suggested that 5ARIs were associated with increased adverse effects on sexual function in men with BPH compared with placebo. However, the association was not statistically significant in men with AGA. Well-designed randomized controlled trials are indicated to study further the mechanism and effects of 5ARIs on sexual function.
Topics: 5-alpha Reductase Inhibitors; Drug Therapy, Combination; Ejaculation; Erectile Dysfunction; Finasteride; Humans; Libido; Male; Middle Aged; Prostatic Hyperplasia; Randomized Controlled Trials as Topic
PubMed: 27475241
DOI: 10.1016/j.jsxm.2016.07.006 -
The Aging Male : the Official Journal... Sep 2016Lower urinary tract symptoms (LUTS) secondary to benign prostatic obstruction (BPO) represent one of the most common clinical complaints in adult men. Several drugs used... (Meta-Analysis)
Meta-Analysis Review
Impact of combination therapy 5-alpha reductase inhibitors (5-ARI) plus alpha-blockers (AB) on erectile dysfunction and decrease of libido in patients with LUTS/BPH: a systematic review with meta-analysis.
Lower urinary tract symptoms (LUTS) secondary to benign prostatic obstruction (BPO) represent one of the most common clinical complaints in adult men. Several drugs used for LUTS/BPO may strongly affect sexual function and bother. The aim of this systematic review and meta-analysis was to evaluate the impact of combination therapy with alpha-blockers (AB), 5-alpha reductase inhibitors (5-ARI) on the risk of erectile dysfunction(ED) and libido alterations (LA) from randomized clinical trial (RCT). Based on the inclusion and exclusion criteria, five RCTs involving 6131 patients were included in the analysis. According to the analysis, the overall prevalence of ED and LA were significantly greater in the combination treatment group than in the AB group (7.93% versus 4.66%; OR 1.81; p < 0.0001 and 3.69% versus 2.36%; OR 1.58; p = 0.003, respectively). The combination therapy increased the risk of ED compared to monotherapy with 5-ARI (7.93% versus 6.47%; OR 1.25; p = 0.04) but not the risk of LA (3.51% versus 3.37; OR 1.03; p = 0.84). In our systematic meta-analysis, we demonstrated that combination therapy with ABs and 5-ARIs was associated with significantly higher risk of ED and LA compared with single monotherapy. Combination therapy showed similar risk of LA compared with 5-ARI monotherapy.
Topics: 5-alpha Reductase Inhibitors; Adrenergic alpha-Antagonists; Drug Therapy, Combination; Erectile Dysfunction; Humans; Libido; Lower Urinary Tract Symptoms; Male; Prostatic Hyperplasia
PubMed: 27310433
DOI: 10.1080/13685538.2016.1195361 -
The Cochrane Database of Systematic... May 2016Female pattern hair loss (FPHL), or androgenic alopecia, is the most common type of hair loss affecting women. It is characterised by progressive shortening of the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Female pattern hair loss (FPHL), or androgenic alopecia, is the most common type of hair loss affecting women. It is characterised by progressive shortening of the duration of the growth phase of the hair with successive hair cycles, and progressive follicular miniaturisation with conversion of terminal to vellus hair follicles (terminal hairs are thicker and longer, while vellus hairs are soft, fine, and short). The frontal hair line may or may not be preserved. Hair loss can have a serious psychological impact on women.
OBJECTIVES
To determine the efficacy and safety of the available options for the treatment of female pattern hair loss in women.
SEARCH METHODS
We updated our searches of the following databases to July 2015: the Cochrane Skin Group Specialised Register, CENTRAL in the Cochrane Library (2015, Issue 6), MEDLINE (from 1946), EMBASE (from 1974), PsycINFO (from 1872), AMED (from 1985), LILACS (from 1982), PubMed (from 1947), and Web of Science (from 1945). We also searched five trial registries and checked the reference lists of included and excluded studies.
SELECTION CRITERIA
We included randomised controlled trials that assessed the efficacy of interventions for FPHL in women.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trial quality, extracted data and carried out analyses.
MAIN RESULTS
We included 47 trials, with 5290 participants, of which 25 trials were new to this update. Only five trials were at 'low risk of bias', 26 were at 'unclear risk', and 16 were at 'high risk of bias'.The included trials evaluated a wide range of interventions, and 17 studies evaluated minoxidil. Pooled data from six studies indicated that a greater proportion of participants (157/593) treated with minoxidil (2% and one study with 1%) reported a moderate to marked increase in their hair regrowth when compared with placebo (77/555) (risk ratio (RR) = 1.93, 95% confidence interval (CI) 1.51 to 2.47; moderate quality evidence). These results were confirmed by the investigator-rated assessments in seven studies with 1181 participants (RR 2.35, 95% CI 1.68 to 3.28; moderate quality evidence). Only one study reported on quality of life (QoL) (260 participants), albeit inadequately (low quality evidence). There was an important increase of 13.18 in total hair count per cm² in the minoxidil group compared to the placebo group (95% CI 10.92 to 15.44; low quality evidence) in eight studies (1242 participants). There were 40/407 adverse events in the twice daily minoxidil 2% group versus 28/320 in the placebo group (RR 1.24, 95% CI 0.82 to 1.87; low quality evidence). There was also no statistically significant difference in adverse events between any of the individual concentrations against placebo.Four studies (1006 participants) evaluated minoxidil 2% versus 5%. In one study, 25/57 participants in the minoxidil 2% group experienced moderate to greatly increased hair regrowth versus 22/56 in the 5% group (RR 1.12, 95% CI 0.72 to 1.73). In another study, 209 participants experienced no difference based on a visual analogue scale (P = 0.062; low quality evidence). The assessments of the investigators based on three studies (586 participants) were in agreement with these findings (moderate quality evidence). One study assessed QoL (209 participants) and reported limited data (low quality evidence). Four trials (1006 participants) did not show a difference in number of adverse events between the two concentrations (RR 1.02, 95% CI 0.91 to 1.20; low quality evidence). Both concentrations did not show a difference in increase in total hair count at end of study in three trials with 631 participants (mean difference (MD) -2.12, 95% CI -5.47 to 1.23; low quality evidence).Three studies investigated finasteride 1 mg compared to placebo. In the finasteride group 30/67 participants experienced improvement compared to 33/70 in the placebo group (RR 0.95, 95% CI 0.66 to 1.37; low quality evidence). This was consistent with the investigators' assessments (RR 0.77, 95% CI 0.31 to 1.90; low quality evidence). QoL was not assessed. Only one study addressed adverse events (137 participants) (RR 1.03, 95% CI 0.45 to 2.34; low quality evidence). In two studies (219 participants) there was no clinically meaningful difference in change of hair count, whilst one study (12 participants) favoured finasteride (low quality evidence).Two studies (141 participants) evaluated low-level laser comb therapy compared to a sham device. According to the participants, the low-level laser comb was not more effective than the sham device (RR 1.54, 95% CI 0.96 to 2.49; and RR 1.18, 95% CI 0.74 to 1.89; moderate quality evidence). However, there was a difference in favour of low-level laser comb for change from baseline in hair count (MD 17.40, 95% CI 9.74 to 25.06; and MD 17.60, 95% CI 11.97 to 23.23; low quality evidence). These studies did not assess QoL and did not report adverse events per treatment arm and only in a generic way (low quality evidence). Low-level laser therapy against sham comparisons in two separate studies also showed an increase in total hair count but with limited further data.Single studies addressed the other comparisons and provided limited evidence of either the efficacy or safety of these interventions, or were unlikely to be examined in future trials.
AUTHORS' CONCLUSIONS
Although there was a predominance of included studies at unclear to high risk of bias, there was evidence to support the efficacy and safety of topical minoxidil in the treatment of FPHL (mainly moderate to low quality evidence). Furthermore, there was no difference in effect between the minoxidil 2% and 5% with the quality of evidence rated moderate to low for most outcomes. Finasteride was no more effective than placebo (low quality evidence). There were inconsistent results in the studies that evaluated laser devices (moderate to low quality evidence), but there was an improvement in total hair count measured from baseline.Further randomised controlled trials of other widely-used treatments, such as spironolactone, finasteride (different dosages), dutasteride, cyproterone acetate, and laser-based therapy are needed.
Topics: Alopecia; Drug Administration Schedule; Female; Finasteride; Hair; Humans; Low-Level Light Therapy; Minoxidil; Randomized Controlled Trials as Topic
PubMed: 27225981
DOI: 10.1002/14651858.CD007628.pub4 -
Age and Ageing Sep 2015we aimed to systematically review drugs to treat lower urinary tract symptoms (LUTS) regularly used in older persons to classify appropriate and inappropriate drugs... (Review)
Review
Appropriateness of oral drugs for long-term treatment of lower urinary tract symptoms in older persons: results of a systematic literature review and international consensus validation process (LUTS-FORTA 2014).
AIM
we aimed to systematically review drugs to treat lower urinary tract symptoms (LUTS) regularly used in older persons to classify appropriate and inappropriate drugs based on efficacy, safety and tolerability by using the Fit fOR The Aged (FORTA) classification.
METHODS
to evaluate the efficacy, safety and tolerability of drugs used for treatment of LUTS in older persons, a systematic review was performed. Papers on clinical trials and summaries of individual product characteristics were analysed regarding efficacy and safety in older persons (≥65 years). The most frequently used drugs were selected based on current prescription data. An interdisciplinary international expert panel assessed the drugs in a Delphi process.
RESULTS
for the 16 drugs included here, a total of 896 citations were identified; of those, only 25 reported clinical trials with explicit data on, or solely performed in older people, underlining the lack of evidence in older people for drug treatment of LUTS. No drug was rated at the FORTA-A-level (indispensable). Only three were assigned to FORTA B (beneficial): dutasteride, fesoterodine and finasteride. The majority was rated FORTA C (questionable): darifenacin, mirabegron, extended release oxybutynin, silodosin, solifenacin, tadalafil, tamsulosin, tolterodine and trospium. FORTA D (avoid) was assigned to alfuzosin, doxazosin, immediate release oxybutynin, propiverine and terazosin.
CONCLUSIONS
dutasteride, fesoterodine and finasteride were classified as beneficial in older persons or frail elderly people (FORTA B). For most drugs, in particular those from the group of α-blockers and antimuscarinics, use in this group seems questionable (FORTA C) or should be avoided (FORTA D).
Topics: 5-alpha Reductase Inhibitors; Administration, Oral; Adrenergic alpha-Antagonists; Age Factors; Aged; Aging; Consensus; Delphi Technique; Humans; Lower Urinary Tract Symptoms; Muscarinic Antagonists; Patient Selection; Risk Assessment; Risk Factors; Treatment Outcome; Urological Agents
PubMed: 26104505
DOI: 10.1093/ageing/afv077 -
The Journal of Sexual Medicine Jun 2014Several drugs, currently used to treat lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), can be associated with bothersome sexual side... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
Several drugs, currently used to treat lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), can be associated with bothersome sexual side effects, including ejaculatory dysfunction (EjD).
AIM
To provide a systematic review and meta-analysis of the available randomized clinical trials (RCTs) reporting the impact of medical treatments for LUTS due to BPH on ejaculatory function.
MAIN OUTCOME MEASURE
EjD related to medical treatments for LUTS.
METHODS
A systematic literature search was performed using PubMed, Scopus and Cochrane databases. EjD was identified using both free text ("ejaculat*," "retrograde ejaculation," "anejaculation," "ejaculatory dysfunction") and Mesh ("Ejaculation") searches.
RESULTS
Of 101 retrieved articles, 23 were included in the present meta-analysis. EjD was significantly more common with alpha-blockers (ABs) than with placebo (OR:5.88; P < 0.0001), in particular, considering Tamsulosin (OR:8.58; P = 0.006) or Silodosin (OR:32.5; P < 0.0001), with Tamsulosin associated with significantly lower risk of EjD than Silodosin (OR:0.09; P < 0.00001). Conversely, Doxazosin and Terazosin were associated with a risk similar to placebo. Meta-regression showed that EjD was associated with IPSS and with Qmax both before and after treatment with ABs, while multivariate analysis demonstrated that EjD was independently associated with the improvement of IPSS (adj.r:0.2012; P < 0.0001) and Qmax (adj.r:0.522; P < 0.0001). EjD was significantly more common with 5ARIs as compared with placebo (OR:2.73; P < 0.0001). Both Finasteride (OR 2.70; P < 0.0001) and Dutasteride (OR 2.81; P = 0.0002) were associated with significantly higher risk of EjD than placebo. EjD was significantly more common with combination therapy as compared with ABs alone (OR:3.75; P < 0.0001),or with 5ARIs alone (OR:2.76; P = 0.02).
CONCLUSIONS
ABs and 5ARI were both associated with significantly higher risk of EjD than placebo. More the AB is effective over time, greater is the incidence of EjD. Finasteride has the same risk of Dutasteride to cause EjD. Combination therapy with ABs and 5ARIs resulted in a 3-fold increased risk of EjD as compared with ABs or 5ARIs alone. These data can be relevant both for drug selection and patients counseling.
Topics: Adrenergic alpha-1 Receptor Antagonists; Azasteroids; Doxazosin; Dutasteride; Ejaculation; Finasteride; Humans; Lower Urinary Tract Symptoms; Male; Prostatic Hyperplasia; Sexual Dysfunction, Physiological; Sulfonamides; Tamsulosin; Urological Agents
PubMed: 24708055
DOI: 10.1111/jsm.12525 -
World Journal of Urology Aug 2014To determine the efficacy and safety of dutasteride, alone or in combination, versus a placebo or control, used for the treatment of benign prostatic hyperplasia. (Meta-Analysis)
Meta-Analysis Review
PURPOSE
To determine the efficacy and safety of dutasteride, alone or in combination, versus a placebo or control, used for the treatment of benign prostatic hyperplasia.
METHODS
Pubmed(®) and the Cochrane Library were searched for randomized controlled trials longer than 6 months in duration. The subjects in the trials were men aged 40 or over, with moderate to severe symptoms of benign prostatic hyperplasia (BPH) as determined by International Prostate Symptom Score (IPSS). We pooled data from a total of nine different clinical trials.
RESULTS
Dutasteride was superior to placebo in improving urinary symptoms measured by IPSS (∆ = -1.78, 95 % CI -3.01 to -0.55), peak urinary flow (Q max) (∆ = 1.27 mL/s, 95 % CI 0.97-1.57), and change in total prostate volume (TPV) (∆ = -17.40 cm(3), 95 % CI -25.77 to -9.02) while it resulted in more frequent drug-related adverse events (RR 1.35, 95 % CI 1.19-1.54). Combination therapy with dutasteride and tamsulosin resulted in significantly greater improvements in IPSS and Q max than tamsulosin monotherapy (∆ = -1.80 mL/s, 95 % CI -1.81 to -1.79 and ∆ = 1.60 mL/s, 95 % CI 1.59-1.61, respectively). When comparing dutasteride with finasteride, no significant differences in symptom improvement or the rate of adverse events were observed.
CONCLUSIONS
Dutasteride can be used to improve urinary symptoms (IPSS and Q max) and reduce TPV but with awareness of its potential adverse events. Combination therapy with tamsulosin can be considered when further improvements in symptoms are desired.
Topics: Adult; Aged; Aged, 80 and over; Azasteroids; Drug Therapy, Combination; Dutasteride; Finasteride; Humans; Male; Middle Aged; Organ Size; Prostate; Prostatic Hyperplasia; Randomized Controlled Trials as Topic; Sulfonamides; Tamsulosin; Treatment Outcome; Urological Agents
PubMed: 24500194
DOI: 10.1007/s00345-014-1258-9 -
Systematic review evaluating cardiovascular events of the 5-alpha reductase inhibitor - Dutasteride.Journal of Clinical Pharmacy and... Oct 2013A recently published large, long-term randomized controlled trial (RCT) brought into question the safety of dutasteride after a significantly increased risk of 'cardiac... (Meta-Analysis)
Meta-Analysis
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, 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.
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.
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
PubMed: 23815285
DOI: 10.1111/jcpt.12080