This combination seems to be more efficacious in terms of several outcome variables in patients whose prostate volume is between 30 ml and 40 ml when treatment is maintained for > 1 yr ; when given for < 1 yr , α1-blockers alone are just as effective .
The combination of α1-blocker/5-ARI shows a slightly increased rate of adverse events .
It remains unknown whether its safety and superiority over either drug as monotherapy are sustained after > 6 yr .
The α1-blocker/muscarinic receptor antagonist ( antimuscarinic ) combination was most frequently assessed as an add-on therapy to already existing α1-blocker therapy .
Inconsistent data derive from heterogeneous study population s and different study design s. Currently , the α1-blocker/antimuscarinic combination appears to be a second-line add-on for patients with insufficient symptom relief after monotherapy .
The combination seems to be safe in men with postvoid residual < 200 ml .
The α1-blocker/phosphodiesterase type 5 inhibitor combination is a new treatment option with only preliminary reports .
CONCLUSIONS An α1-blocker/5-ARI combination is beneficial for patients whose prostate volume is between 30 ml and 40 ml when medical treatment is intended for > 1 yr .
Based on short-term follow-up studies , add-on of antimuscarinics to α1-blockers is an option when postvoid residual is < 200 ml
BACKGROUND Several drugs are approved for the treatment of lower urinary tract symptoms ( LUTS ) in men , but these are mostly used by clinicians as monotherapies .
The combination of different compounds , each of which targets a different aspect of LUTS , seems appealing .
However , only few clinical trials have evaluated the effects of combination therapies .
OBJECTIVE This systematic review analyzes the efficacy and adverse events of combination therapies for male LUTS .
Simultaneous administration of vardenafil and tamsulosin does not induce clinically significant hypotension in patients with benign prostatic hyperplasia.
OBJECTIVES To assess the pharmacodynamic effects of coadministered vardenafil and tamsulosin in patients with benign prostatic hyperplasia ( BPH ) undergoing stable tamsulosin therapy . METHODS In this Phase 1 , placebo-controlled , two-stage , two-way , crossover study , 22 patients undergoing stable ( longer than 4 weeks ) tamsulosin therapy for BPH ( 18 using 0.4 mg and 4 using 0.8 mg tamsulosin daily ) received vardenafil 10 mg ( or placebo ) , followed by vardenafil 20 mg ( or placebo ) , simultaneously with tamsulosin . The mean maximal change from baseline with vardenafil use versus placebo was evaluated for supine and st and ing blood pressure and heart rate for up to 6 hours after dosing . RESULTS In patients receiving vardenafil 10 mg , the mean maximal change from baseline versus placebo in supine systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , and heart rate was -4.5 mm Hg ( 95 % confidence interval [ CI ] -8.2 to -0.8 ) , -2.3 mm Hg ( 95 % CI -4.9 to 0.4 ) , and 3.7 beats per minute ( 95 % CI 1.1 to 6.3 ) , respectively . In patients receiving vardenafil 20 mg , the mean maximal change from baseline versus placebo in supine SBP , DBP , and heart rate was -4.0 mm Hg ( 95 % CI -6.3 to -1.8 ) , -2.9 mm Hg ( 95 % CI -5.6 to -0.2 ) , and 0.8 beats per minute ( 95 % CI -1.2 to 2.9 ) , respectively . These hemodynamic changes were similar to those obtained in the st and ing position . Two placebo patients and 1 vardenafil 10-mg patient had a drop of 20 mm Hg or more in st and ing DBP ; 1 vardenafil 10-mg patient had a st and ing SBP drop of 30 mm Hg or more . No patient exhibited symptomatic hypotension ( SBP less than 85 mm Hg with dizziness ) . Three patients receiving vardenafil 20 mg/tamsulosin 0.4 mg reported dizziness , but never had an SBP of less than 95 mm Hg . No serious adverse events were reported . CONCLUSIONS In this study , no evidence was found that coadministered vardenafil and tamsulosin induced clinical ly significant hypotension in patients with BPH
This combination seems to be more efficacious in terms of several outcome variables in patients whose prostate volume is between 30 ml and 40 ml when treatment is maintained for > 1 yr ; when given for < 1 yr , α1-blockers alone are just as effective .
The combination of α1-blocker/5-ARI shows a slightly increased rate of adverse events .
It remains unknown whether its safety and superiority over either drug as monotherapy are sustained after > 6 yr .
The α1-blocker/muscarinic receptor antagonist ( antimuscarinic ) combination was most frequently assessed as an add-on therapy to already existing α1-blocker therapy .
Inconsistent data derive from heterogeneous study population s and different study design s. Currently , the α1-blocker/antimuscarinic combination appears to be a second-line add-on for patients with insufficient symptom relief after monotherapy .
The combination seems to be safe in men with postvoid residual < 200 ml .
The α1-blocker/phosphodiesterase type 5 inhibitor combination is a new treatment option with only preliminary reports .
CONCLUSIONS An α1-blocker/5-ARI combination is beneficial for patients whose prostate volume is between 30 ml and 40 ml when medical treatment is intended for > 1 yr .
Based on short-term follow-up studies , add-on of antimuscarinics to α1-blockers is an option when postvoid residual is < 200 ml
BACKGROUND Several drugs are approved for the treatment of lower urinary tract symptoms ( LUTS ) in men , but these are mostly used by clinicians as monotherapies .
The combination of different compounds , each of which targets a different aspect of LUTS , seems appealing .
However , only few clinical trials have evaluated the effects of combination therapies .
OBJECTIVE This systematic review analyzes the efficacy and adverse events of combination therapies for male LUTS .