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Aim: To evaluate the impact of Vesomni/Urizia/Volutsa, a fixed‐dose combination tablet containing 6 mg solifenacin (antimuscarinic) and 0.4 mg tamsulosin (α‐blocker), on health‐related quality of life (HRQoL) and treatment satisfaction in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in routine clinical practice. Methods: EUROPA was a noninterventional study of men with LUTS/BPH not responding to monotherapy who were prescribed Vesomni in routine clinical practice. Data were collected retrospectively (1 year) and prospectively (1 year). Assessments were performed at baseline, weeks 4 to 8, weeks 9 to 18 (optional), weeks 19 to 39 (optional), and Weeks 40 to 52. The primary endpoint was change from baseline in HRQoL, as assessed by the Overactive Bladder Questionnaire (OAB‐q) symptom bother subscale score. Change from baseline in OAB‐q total and coping, sleep, and social interaction subscale scores, treatment satisfaction‐visual analog scale (TS‐VAS), International Prostate Symptom Score (IPSS), and European Quality of Life 5‐Dimension‐5‐Level (EQ‐5D‐5L) questionnaire were also evaluated. Results: Five hundred and eighty‐nine patients were enrolled. The mean changes in adjusted mean (95% confidence interval [CI]) OAB‐q symptom bother subscale scores were −16.40 (−24.31, −8.49) at weeks 4 to 8 and −19.59 (−28.26, −10.92) at weeks 40 to 52; at weeks 40 to 52, changes were clinically meaningful in 84.6% of patients. Adjusted mean (95% CI) change from baseline to weeks 40 to 52 were 15.02 (7.35, 22.69), 19.37 (10.86, 27.89), 18.65 (7.44, 29.86), 9.85 (3.90, 15.81), and 16.09 (9.07, 23.11) for concern, coping, sleep, social interaction, and total, respectively. TS‐VAS, IPSS, and EQ‐5D‐5L all improved, and treatment persistence at weeks 40 to 52 was 77.1%. Urinary retention was reported in four (0.7%) patients. Conclusions: Vesomni was well‐tolerated and improved HRQoL and treatment satisfaction in patients with LUTS/BPH. [ABSTRACT FROM AUTHOR]

The aim of the current study is pharmacoeconomic evaluation of using combined drug Vesomni (controlled release tablets tamsulosin 0.4 mg + solifenacin 6 mg) for treatment of patients with storage symptoms associated with benign prostatic hyperplasia, who do not respond to first line tamsulosin therapy.Materials and methods. We consider three therapy options: 1) combined drug Vesomni; 2) combination of tamsulosin (modified release capsules 0.4 mg) and solifenacin (5 mg); 3) combination of tamsulosin (controlled release tablets 0.4 mg) and solifenacin (5 mg). These options are evaluated with cost minimization and budget impact analysis.Results. We found that approx. 250,000 patients in Russia need combined tamsulosin and solifenacin therapy, including 35,400 patients eligible for government reimbursement. Using combined drug is cost saving alternative that annually requires 22,000 rubles per patient, which is 2,000 rubles less than second best option. The overall healthcare annual expenses of using combined drug are 5,7 billion rubles (500 million rubles less than for second best option), and government reimbursement costs are 606 million rubles (74 million less than for second best option).Conclusion. Using combined drug Vesomni for treatment of patients with storage symptoms associated with benign prostatic hyperplasia is cost saving alternative compared to combination of monotheraphy regimens.