EVIDENCE SYNTHESIS The most studied combination therapy for the treatment of male LUTS is the α1-adrenoceptor antagonist/5α-reductase inhibitor combination .
This combination seems to be more efficacious in terms of several outcome variables , in particular in men who have moderate-to-severe LUTS and are at risk of disease progression .
Also in terms of nocturia improvements , this combination is significantly more effective than the monotherapy .
The other often studied combination treatment , in both male and female patients with LUTS , was the combination of antimuscarinics ( in particular solifenacin ) and mirabegron .
This combination seems to be more effective in comparison with the monotherapies with respect to urinary incontinence and urgency urinary incontinence episodes and several other objective and subjective parameters , without relevant increase of adverse events .
The combination of hormone therapy and antimuscarinics in women with LUTS does not seem to be useful .
For the treatment of LUTS in men and women , combination therapy appears to be a promising option to optimize the efficacy of the available drugs for those who do not experience sufficient benefit with monotherapy .
This add-on scenario offers the possibility to have a more tailored approach to the management of LUTS , always seeking the optimal balance between efficacy and tolerability for a given patient .
PATIENT SUMMARY Some combination of drugs may offer advantages over monotherapies for the treatment of voiding and storage complaints in men and women
CONTEXT Several drugs are approved and available for the treatment of lower urinary tract symptoms ( LUTS ) in men and women .
However , the vast majority of available data , upon which the approval and recommendation in guidelines are based , considered only the role of the monotherapies and did not evaluate possible combination therapies .
OBJECTIVE This systematic review analyzes the efficacy and adverse events of combination therapies for male and female LUTS .
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
EVIDENCE SYNTHESIS The most studied combination therapy for the treatment of male LUTS is the α1-adrenoceptor antagonist/5α-reductase inhibitor combination .
This combination seems to be more efficacious in terms of several outcome variables , in particular in men who have moderate-to-severe LUTS and are at risk of disease progression .
Also in terms of nocturia improvements , this combination is significantly more effective than the monotherapy .
The other often studied combination treatment , in both male and female patients with LUTS , was the combination of antimuscarinics ( in particular solifenacin ) and mirabegron .
This combination seems to be more effective in comparison with the monotherapies with respect to urinary incontinence and urgency urinary incontinence episodes and several other objective and subjective parameters , without relevant increase of adverse events .
The combination of hormone therapy and antimuscarinics in women with LUTS does not seem to be useful .
For the treatment of LUTS in men and women , combination therapy appears to be a promising option to optimize the efficacy of the available drugs for those who do not experience sufficient benefit with monotherapy .
This add-on scenario offers the possibility to have a more tailored approach to the management of LUTS , always seeking the optimal balance between efficacy and tolerability for a given patient .
PATIENT SUMMARY Some combination of drugs may offer advantages over monotherapies for the treatment of voiding and storage complaints in men and women
CONTEXT Several drugs are approved and available for the treatment of lower urinary tract symptoms ( LUTS ) in men and women .
However , the vast majority of available data , upon which the approval and recommendation in guidelines are based , considered only the role of the monotherapies and did not evaluate possible combination therapies .
OBJECTIVE This systematic review analyzes the efficacy and adverse events of combination therapies for male and female LUTS .