Based on improvement of mean International Prostate Symptom Score and quality of life scores , the effectiveness of the newer ABs was not different from the older ABs ( moderate strength of evidence [ SOE ] ) , but had more AEs ( low SOE ) .
Antimuscarinics/AB combination therapy had similar outcomes  as AB monotherapy ( all moderate SOE ) , but often had more AEs .
Phosphodiesterase type-5 inhibitors alone or in combination with ABs had similar or inferior outcomes than ABs alone .
Evidence was insufficient for the beta-3 adrenoceptor agonist .
For all newer agents , the evidence was generally insufficient to assess long-term efficacy , prevention of symptom progression , or AEs .
None of the drugs or drug combinations newly used to treat LUTS attributed to BPH showed outcomes superior to traditional AB treatment .
Given the lack of superior outcomes , the studies ' short time-horizon , and less assurance of their safety , their current value in treating LUTS attributable to BPH appears low .
We found none of the new drugs to be better but there was more concern about side effects
CONTEXT Alpha-blockers ( ABs ) and 5-alpha reductase inhibitors have an established role in treating male lower urinary tract symptoms ( LUTS ) attributed to benign prostatic hyperplasia ( BPH ) .
Recently , newer drugs have shown promise for this indication .
OBJECTIVE To assess the comparative effectiveness and adverse effects ( AEs ) of newer drugs to treat LUTS attributed to BPH through a systematic review and meta- analysis .
PATIENT SUMMARY In this paper , we review ed the evidence of newer drugs to treat men with urinary problems attributable to an enlarged prostate .
Monotherapy with tadalafil or tamsulosin similarly improved lower urinary tract symptoms suggestive of benign prostatic hyperplasia in an international, randomised, parallel, placebo-controlled clinical trial.
BACKGROUND Tadalafil improved lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia ( BPH ; LUTS/BPH ) in clinical studies but has not been evaluated together with an active control in an international clinical study . OBJECTIVE Assess tadalafil or tamsulosin versus placebo for LUTS/BPH . DESIGN , SETTING , AND PARTICIPANTS A r and omised , double-blind , international , placebo-controlled , parallel-group study assessed men ≥45 yr of age with LUTS/BPH , International Prostate Symptom Score ( IPSS ) ≥13 , and maximum urinary flow rate ( Q(max ) ) ≥4 to ≤15ml/s . Following screening and washout , if needed , subjects completed a 4-wk placebo run-in before r and omisation to placebo ( n=172 ) , tadalafil 5 mg ( n=171 ) , or tamsulosin 0.4 mg ( n=168 ) once daily for 12 wk . MEASUREMENTS Outcomes were assessed using analysis of covariance ( ANCOVA ) or ranked analysis of variance ( ANOVA ) ( continuous variables ) and Cochran-Mantel-Haenszel test or Fisher exact test ( categorical variables ) . RESULTS AND LIMITATIONS IPSS significantly improved versus placebo through 12 wk with tadalafil ( -2.1 ; p=0.001 ; primary efficacy outcome ) and tamsulosin ( -1.5 ; p=0.023 ) and as early as 1 wk ( tadalafil and tamsulosin both -1.5 ; p<0.01 ) . BPH Impact Index significantly improved versus placebo at first assessment ( week 4 ) with tadalafil ( -0.8 ; p<0.001 ) and tamsulosin ( -0.9 ; p<0.001 ) and through 12 wk ( tadalafil -0.8 , p=0.003 ; tamsulosin -0.6 , p=0.026 ) . The IPSS Quality -of-Life Index and the Treatment Satisfaction Scale-BPH improved significantly versus placebo with tadalafil ( both p<0.05 ) but not with tamsulosin ( both p>0.1 ) . The International Index of Erectile Function-Erectile Function domain improved versus placebo with tadalafil ( 4.0 ; p<0.001 ) but not tamsulosin ( -0.4 ; p=0.699 ) . Q(max ) increased significantly versus placebo with both tadalafil ( 2.4ml/s ; p=0.009 ) and tamsulosin ( 2.2ml/s ; p=0.014 ) . Adverse event profiles were consistent with previous reports . This study was limited in not being powered to directly compare tadalafil versus tamsulosin . CONCLUSIONS Monotherapy with tadalafil or tamsulosin result ed in significant and numerically similar improvements versus placebo in LUTS/BPH and Q(max ) . However , only tadalafil improved erectile dysfunction . TRIAL REGISTRATION Clinical trials.gov ID NCT00970632
Based on improvement of mean International Prostate Symptom Score and quality of life scores , the effectiveness of the newer ABs was not different from the older ABs ( moderate strength of evidence [ SOE ] ) , but had more AEs ( low SOE ) .
Antimuscarinics/AB combination therapy had similar outcomes  as AB monotherapy ( all moderate SOE ) , but often had more AEs .
Phosphodiesterase type-5 inhibitors alone or in combination with ABs had similar or inferior outcomes than ABs alone .
Evidence was insufficient for the beta-3 adrenoceptor agonist .
For all newer agents , the evidence was generally insufficient to assess long-term efficacy , prevention of symptom progression , or AEs .
None of the drugs or drug combinations newly used to treat LUTS attributed to BPH showed outcomes superior to traditional AB treatment .
Given the lack of superior outcomes , the studies ' short time-horizon , and less assurance of their safety , their current value in treating LUTS attributable to BPH appears low .
We found none of the new drugs to be better but there was more concern about side effects
CONTEXT Alpha-blockers ( ABs ) and 5-alpha reductase inhibitors have an established role in treating male lower urinary tract symptoms ( LUTS ) attributed to benign prostatic hyperplasia ( BPH ) .
Recently , newer drugs have shown promise for this indication .
OBJECTIVE To assess the comparative effectiveness and adverse effects ( AEs ) of newer drugs to treat LUTS attributed to BPH through a systematic review and meta- analysis .
PATIENT SUMMARY In this paper , we review ed the evidence of newer drugs to treat men with urinary problems attributable to an enlarged prostate .