- Newer Medications for Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia [entered retrospectively]
- Objective. To assess the efficacy, comparative effectiveness, and adverse effects of drugs newly used (last 10 years) within several drug classes (i.e., alpha blockers – silodosin; antimuscarinics - tolterodine, solifenacin, fesoterodine; beta-3 adrenoceptor agonists – mirabegron; phosphodiesterase type 5 (PDE-5) inhibitors - tadalafil, sildenafil) to treat lower urinary tract symptoms attributed to BPH.
Data sources. Ovid MEDLINE®, the Cochrane Central Register of Controlled Trials, and Ovid Embase bibliographic databases; hand searches of references of relevant studies.
Review methods. We searched bibliographic databases from earliest electronic indexing through March 2015. Two investigators screened titles and abstracts of search results and full-text of relevant references for eligibility. Eligible studies included randomized controlled trials (RCTs) and long-term (>1 year duration) observational studies for long-term adverse effects. We assessed risk of bias for RCTs, extracted data, pooled data for analysis when appropriate and feasible and evaluated strength of evidence for comparisons and outcomes.
Results. We searched bibliographic databases through July 2015 for studies testing specific drugs or combinations that included newly used drugs. We synthesized evidence from 57 unique trials and 7 observational studies. All trials lasted less than 3 months. Silodosin was more effective than placebo in improving LUTS, but was similar to tamsulosin, and there were more adverse effects with silodosin, including abnormal ejaculation. Solifenacin/alpha blocker (AB) combination therapy was better than placebo, but tolterodine/AB, solifenacin/AB, and fesoterodine/AB combination therapy were similar to AB monotherapy, and there was often evidence of higher adverse effects with combination therapy. Tadalafil improved LUTS more than placebo but had more adverse effects. Traditional ABs achieved better or similar outcomes than tadalafil; most evidence on comparative adverse effects was insufficient. We identified trials testing other drugs (mirabegron, oxybutynin, darifenacin, sildenafil, and vardenafil), but found the evidence insufficient to draw conclusions about efficacy, comparative effectiveness, or adverse effects. Evidence was insufficient on long-term effectiveness, other relevant outcomes (prevention of symptom progression, acute urinary retention or need for surgical intervention) or adverse effects.
Conclusions. Several drugs newly used, along or in combination with traditional drugs, to treat LUTS attributed to BPH show some evidence of short-term symptom efficacy when compared to placebo. However, outcomes are similar to traditional alpha-blocker therapy and adverse effects are often higher with the newly used drugs or combination therapies. Data were not available to assess long-term maintenance, prevention of disease progression (including acute urinary retention or need for surgical intervention), and adverse effects.
- Authors of Report
- Methodology description
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Data entered retrospectively.
Word tables contain basic study information, population characteristics, and risk of bias assessments for included studies.
- Funding Source