Responder and health‐related quality of life analyses in men with lower urinary tract symptoms treated with a fixed‐dose combination of solifenacin and tamsulosin oral‐controlled absorption system: results from the NEPTUNE study

Abstract

Responder and health-related quality of life analyses in men with lower urinary tract symptoms treated with a fixed-dose combination of solifenacin and tamsulosin oral-controlled absorption system: results from the NEPTUNE study ObjectiveTo evaluate the effect of a fixed-dose combination (FDC) of solifenacin and an oral-controlled absorption system (OCAS TM ) formulation of tamsulosin (TOCAS) on healthrelated quality of life (HRQoL) in men with lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). Patients and methodsMen with moderate-to-severe storage symptoms and voiding symptoms were treated for 12 weeks with a FDC of solifenacin 6 or 9 mg plus TOCAS (0.4 mg), TOCAS monotherapy (0.4 mg) or placebo in a randomised, doubleblind study (NEPTUNE). The co-primary endpoints were Total Urgency Frequency Score (TUFS) and total International Prostate Symptom Score (IPSS). HRQoL was assessed by several secondary endpoints: IPSS QoL index, overactive bladder questionnaire (OAB-q), and Patient Global Impression (PGI) scale. The correlation between symptom improvement (TUFS) and HRQoL was assessed by Spearman rank correlation coefficients. Single and double responder analyses, using subjective and objective measures, were also performed. ResultsIn the responder analyses, men treated with a FDC of solifenacin 6 mg plus TOCAS consistently had significantly improved outcomes compared with placebo (8/8 responder analyses performed) and TOCAS (6/8 responder analyses performed). There was a significant correlation (P < 0.001) between the reduction in TUFS and the improvement in HRQoL defined by IPSS QoL score, OAB-q symptom bother score, PGI overall bladder symptoms and PGI general health. ConclusionsIn men with LUTS/BPH who have moderate-to-severe storage symptoms and voiding symptoms, the reduction in symptoms with a once-daily FDC of solifenacin and TOCAS was associated with consistent patient-relevant improvements in HRQoL compared with placebo and TOCAS monotherapy.Keywords benign prostatic hyperplasia, health-related quality of life, lower urinary tract symptoms, solifenacin, tamsulosin

Vesomni improves the quality of life in men with lower urinary tract symptoms in routine clinical practice in Europe

“…Furthermore, treatment satisfaction and patient‐reported health status were also improved. These results are consistent with those observed in clinical trial settings that demonstrated improvements in clinical outcomes and HRQoL with Vesomni …”

“…Monotherapy with α‐blockers and 5‐ARIs are among the currently available medications that can improve HRQoL by relieving urinary symptoms; 5‐ARIs are also effective in reducing the risk of complications associated with BPH . However, since α‐blockers and 5‐ARIs predominantly improve voiding symptoms, add‐on therapy with an antimuscarinic is often required to relieve residual storage symptoms . The efficacy of α‐blockers in combination with antimuscarinics has been demonstrated in numerous clinical trials conducted in different countries, including some European countries .…”

“…20 However, since α-blockers and 5-ARIs predominantly improve voiding symptoms, add-on therapy with an antimuscarinic is often required to relieve residual storage symptoms. 21 The efficacy of α-blockers in combination with antimuscarinics has been demonstrated in numerous clinical trials conducted in different countries, including some European countries. 14,22 The current European guidelines on the management of LUTS recommend the combination of an α-blocker and antimuscarinics in patients with moderate-to-severe LUTS whose storage symptoms do not improve with monotherapy.…”

Pharmacology of the lower urinary tract: update on LUTS treatment

“…[95][96][97][98] Two studies evaluated the fixed combination of tamsulosin 0.4 mg and solifenacin 6 and 9 mg versus tamsulosin alone and placebo in men with moderate-to-severe LUTS. 95,99 The results of these studies showed that the combination of solifenacin 6 mg and tamsulosin significantly improved storage and voiding symptoms, as well as QoL parameters, over placebo. In a 52-week extension of the initial studies, clinical efficacy was maintained while urinary retention occurred in only 1.1% of the patients, with only 0.7% of them requiring a permanent catheter.…”

Effectiveness of Complex Therapy of Benign Prostatic Hyperplasia in Patients With Metabolic Syndrome

“…Основными препаратами для медикаментозного лечения ДГПЖ/СНМП являются альфа-1-адреноблокаторы, ингибиторы 5-альфа-редутазы, ингибиторы фосфодиэстеразы 5 типа и М-холиноблокаторы (по показаниям) [9][10][11].…”