Pooled data analyses revealed that tadalafil 5 mg once daily allows the clinical ly-meaningful improvement of LUTS and nocturnal voiding frequency independent of both erectile dysfunction severity and improvement .
PDE5-Is are safe and effective in improving both LUTS and erectile function in appropriately selected men with LUTS/BPE .
We found evidence to confirm that phosphodiesterase type 5 inhibitors are a valid treatment option for men affected by bothersome urinary symptoms with or without erectile dysfunction
CONTEXT Several pre clinical reports , r and omized controlled trials , systematic review s , and posthoc analyses corroborate the role of phosphodiesterase type 5 inhibitors ( PDE5-Is ) in the treatment of men with lower urinary tract symptoms ( LUTS ) associated with benign prostatic enlargement ( BPE ) .
OBJECTIVE Up date of the latest evidence on the mechanisms of action , evaluate the current meta-analyses , and emphasize the results of pooled data analyses of PDE5-Is in LUTS/BPE .
PATIENT SUMMARY We review ed recent literature on phosphodiesterase type 5 inhibitors in men with lower urinary tract symptoms associated with prostatic enlargement .
Efficacy and safety of tadalafil 5 mg once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia: subgroup analyses of pooled data from 4 multinational, randomized, placebo-controlled clinical studies.
OBJECTIVE To assess the efficacy and safety of tadalafil , a phosphodiesterase 5 ( PDE5 ) inhibitor efficacious for erectile dysfunction and lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( LUTS/BPH ) , in population subgroups , using pooled data from 4 international , r and omized , placebo-controlled studies in men with LUTS/BPH . METHODS The safety data base included 1500 men r and omized to tadalafil 5 mg once daily or placebo for 12 weeks . Changes in total International Prostate Symptom Score ( IPSS ) , IPSS- quality of life index , and BPH impact index were examined overall , and changes in IPSS or adverse events ( AEs ) were examined across subgroups of interest . Treatment-group differences were assessed using analysis of covariance . RESULTS Results of pooled data confirmed that tadalafil ( N = 752 ) result ed in significant improvements from baseline vs placebo ( N = 746 ) in IPSS ( mean difference -2.3 ; P < .001 ) , and also in BPH impact index and IPSS- quality of life index ( both P < .001 ) . Subgroup analyses demonstrated that IPSS improvements were significant regardless of baseline LUTS severity ( IPSS < 20/≥20 ) , age ( ≤65/>65 years ) , recent previous use of α-blockers or PDE5 inhibitors , total testosterone level ( < 300/≥300 ng/dL ) , or prostate-specific antigen predicted prostate volume ( < 40/≥40 mL ) . [ corrected ] Rates of treatment emergent AEs were comparable between subgroups of baseline age ( ≤65/>65 years ) , previous PDE5 inhibitor use , and the presence or absence of pre-existing diabetes , hypertension , or cardiovascular disease ( including hypertension ) , but somewhat higher for recent previous α-blocker use . CONCLUSION In these pooled data analyses , tadalafil 5 mg improved LUTS/BPH across subgroups of age , LUTS severity , testosterone levels , and prostate volume . Rates of AEs were similar across the subgroups assessed
Pooled data analyses revealed that tadalafil 5 mg once daily allows the clinical ly-meaningful improvement of LUTS and nocturnal voiding frequency independent of both erectile dysfunction severity and improvement .
PDE5-Is are safe and effective in improving both LUTS and erectile function in appropriately selected men with LUTS/BPE .
We found evidence to confirm that phosphodiesterase type 5 inhibitors are a valid treatment option for men affected by bothersome urinary symptoms with or without erectile dysfunction
CONTEXT Several pre clinical reports , r and omized controlled trials , systematic review s , and posthoc analyses corroborate the role of phosphodiesterase type 5 inhibitors ( PDE5-Is ) in the treatment of men with lower urinary tract symptoms ( LUTS ) associated with benign prostatic enlargement ( BPE ) .
OBJECTIVE Up date of the latest evidence on the mechanisms of action , evaluate the current meta-analyses , and emphasize the results of pooled data analyses of PDE5-Is in LUTS/BPE .
PATIENT SUMMARY We review ed recent literature on phosphodiesterase type 5 inhibitors in men with lower urinary tract symptoms associated with prostatic enlargement .