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 .
Long-term safety and efficacy of single-tablet combinations of solifenacin and tamsulosin oral controlled absorption system in men with storage and voiding lower urinary tract symptoms: results from the NEPTUNE Study and NEPTUNE II open-label extension.
BACKGROUND Short-term trials have demonstrated the efficacy and safety of combination therapy using antimuscarinics and α-blockers in men with lower urinary tract symptoms ( LUTS ) . The Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS ( oral controlled absorption system ) in Males with Lower Urinary Tract Symptoms ( NEPTUNE ) II is the first long-term study using solifenacin ( Soli ) and the oral controlled absorption system formulation of tamsulosin ( TOCAS ) . OBJECTIVE To evaluate long-term ( up to 52 wk ) safety and efficacy of flexible dosing of two fixed-dose combinations ( FDC ) of Soli plus TOCAS in men with moderate to severe storage symptoms and voiding symptoms . DESIGN , SETTING , AND PARTICIPANTS Patients with both storage and voiding LUTS , maximum urinary flow rate of 4.0 - 12.0 ml/s , prostate size < 75 ml , and postvoid residuals ≤ 150 ml , who completed the 12-wk , double-blind NEPTUNE study could continue in the 40-wk , open-label NEPTUNE II study . INTERVENTION FDC of Soli 6 mg plus TOCAS 0.4 mg , or Soli 9 mg plus TOCAS 0.4 mg ; patients could switch between doses in NEPTUNE II . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Safety and efficacy data from NEPTUNE and NEPTUNE II were combined to cover a 52-wk period . Primary efficacy end points were total International Prostate Symptom Score ( IPSS ) and total urgency and frequency score ( TUFS ) ; secondary end points included IPSS storage and voiding subscores , micturition diary variables , and quality of life parameters . RESULTS In all , 1066 men completed NEPTUNE and received one dose or more of study medication in NEPTUNE II . Treatment-emergent adverse events were reported in 499 ( 46.8 % ) patients who participated in NEPTUNE II ; most were mild or moderate . Urinary retention occurred in 13 of 1208 ( 1.1 % ) patients receiving one or more FDCs in NEPTUNE and /or NEPTUNE II ; 8 ( 0.7 % ) required catheterisation ( acute urinary retention [ AUR ] ) . Reductions in total IPSS and TUFS during NEPTUNE were maintained for up to 52 wk of FDC treatment , with mean reductions of 9.0 ( st and ard deviation [ SD ] : 5.7 ) and 10.1 ( SD : 9.2 ) , respectively , from baseline to end of treatment . Clinical ly relevant improvements were also observed for secondary efficacy end points . CONCLUSIONS Long-term treatment with FDC Soli plus TOCAS was well tolerated and efficacious in men with storage and voiding LUTS , with a low incidence of AUR . PATIENT SUMMARY Treatment with solifenacin plus tamsulosin in a fixed-dose combination tablet was well tolerated by men with lower urinary tract symptoms . Improvements in symptoms were achieved after 4 wk of treatment , with further improvements at week 16 maintained for up to 52 wk throughout the study
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 .