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 .
Silodosin therapy for lower urinary tract symptoms in men with suspected benign prostatic hyperplasia: results of an international, randomized, double-blind, placebo- and active-controlled clinical trial performed in Europe.
BACKGROUND Silodosin is a new selective therapy with a high pharmacologic selectivity for the α(1A)-adrenoreceptor . OBJECTIVE Our aim was to test silodosin 's superiority to placebo and noninferiority to tamsulosin and discuss the findings in the context of a comprehensive literature review of the new compound silodosin . DESIGN , SETTING , AND PARTICIPANTS We conducted a multicenter double-blind , placebo- and active-controlled parallel group study . A total of 1228 men ≥50 yr of age with an International Prostate Symptom Score ( IPSS ) ≥13 and a urine maximum flow rate ( Q(max ) ) > 4 and ≤15 ml/s were selected at 72 sites in 11 European countries . The patients were entered into a 2-wk wash-out and a 4-wk placebo run-in period . A total of 955 patients were r and omized ( 2:2:1 ) to silodosin 8 mg ( n=381 ) , tamsulosin 0.4 mg ( n=384 ) , or placebo ( n=190 ) once daily for 12 wk . MEASUREMENTS We calculated the change from baseline in IPSS total score ( primary ) , storage and voiding subscores , quality of life ( QoL ) due to urinary symptoms , and Q(max ) . Responders were defined on the basis of IPSS and Q(max ) by a decrease of ≥25 % and an increase of ≥30 % from baseline , respectively . RESULTS AND LIMITATIONS The change from baseline in the IPSS total score with silodosin and tamsulosin was significantly superior to that with placebo ( p<0.001 ) : difference active placebo of -2.3 ( 95 % confidence interval [ CI ] , -3.2 , -1.4 ) with silodosin and -2.0 ( 95 % CI,-2.9 , -1.1 ) with  tamsulosin . Responder rates according to total IPSS were significantly higher ( p<0.001 ) with silodosin ( 66.8 % ) and tamsulosin ( 65.4 % ) than with placebo ( 50.8 % ) . Active treatments were also superior to  placebo in the IPSS storage and voiding subscore analyses , as well as in QoL due to urinary symptoms . Of note , only silodosin significantly reduced nocturia versus placebo ( the change from baseline was -0.9 , -0.8 , and -0.7 for silodosin , tamsulosin , and placebo , respectively ; p=0.013 for silodosin vs placebo ) . An increase in Q(max ) was observed in all groups . The adjusted mean change from baseline to end point was 3.77 ml/s for silodosin , 3.53 ml/s for tamsulosin , and 2.93 ml/s for placebo , but the change for silodosin and tamsulosin was not statistically significant versus placebo because of a particularly high placebo response ( silodosin vs placebo : p=0.089 ; tamsulosin vs placebo : p=0.221 ) . At end point , the percentage of responders by Q(max ) was 46.6 % , 46.5 % , and 40.5 % in the silodosin , tamsulosin , and placebo treatment groups , respectively . This difference was not statistically significantly ( p=0.155 silodosin vs placebo and p=0.141 tamsulosin vs placebo ) . Active treatments were well tolerated , and discontinuation rates due to adverse events were low in all groups ( 2.1 % , 1.0 % , and 1.6 % with silodosin , tamsulosin , and placebo , respectively ) . The most frequent adverse event with silodosin was a reduced or absent ejaculation during orgasm ( 14 % ) , a reversible effect as a consequence of the potent and selective α(1A)-adrenoreceptor antagonism of the drug . The incidence was higher than that observed with tamsulosin ( 2 % ) ; however , only 1.3 % of silodosin-treated patients discontinued treatment due to this adverse event . CONCLUSIONS Silodosin is an effective and well-tolerated treatment for the relief of both voiding and storage symptoms in patients with lower urinary tract symptoms suggestive of bladder outlet obstruction thought to be associated with benign prostatic hyperplasia . Its overall efficacy is not inferior to tamsulosin . Only silodosin showed a significant effect on nocturia over placebo . TRIAL REGISTRATION Clinical Trials.gov Identifier NCT00359905
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 .