Up to two-thirds of men with lower urinary tract symptoms (LUTS) do not adequately respond to monotherapy. Vesomni™/Urizia™/Volutsa™ is a fixed-dose combination of 6mg solifenacin (an antimuscarinic) and 0.4mg tamsulosin (an α-blocker) used in men with LUTS associated with benign prostatic hyperplasia (BPH) and has been commercially available in Europe since 2013. The EUROPA study evaluated the real-world impact of Vesomni on quality of life (QoL) and treatment satisfaction in men with LUTS associated with BPH.

EUROPA was an observational study conducted at 48 sites in 6 European countries. Men with LUTS associated with BPH who were not adequately responding to monotherapy (ie, 5α-reductase inhibitor and/or α-blocker) and who were prescribed Vesomni™ in routine clinical practice were invited to participate. Retrospective data (1 year) were collected and patients were followed for 1 year after Vesomni™ was prescribed. Assessments were performed at baseline, Weeks 4-8, Weeks 9-18 (optional), Weeks 19-39 (optional), and Weeks 40-52 (end of study). The primary end point was change from baseline in QoL, as assessed by the Overactive Bladder Questionnaire (OAB-q; 0-100 numeric rating scale) symptom bother subscale. Secondary end points were change from baseline in total OAB-q and coping, concern, sleep, and social interaction subscales of the OAB-q, treatment satisfaction (visual analog scale, 0-100), International Prostate Symptom Score (IPSS), health status assessed by EQ-5D-5L (visual analog scale, 0-100), and change in treatment patterns (adherence, discontinuation, and switching). An additional exploratory end point was the proportion of patients who achieved a clinically meaningful improvement for selected outcome measures. Safety/tolerability was assessed by the incidence of treatment-emergent adverse events (TEAEs).

Of the 589 patients enrolled, 575 received ≥1 dose of Vesomni and 493 had ≥1 QoL assessment. Treatment persistence throughout the study was high; ~80% of patients remained on Vesomni until the end-of-study visit. Vesomni yielded clinically meaningful (≥10-point) improvements in OAB-q symptom bother scores at Weeks 4-8 and 40-52 (Figure 1A); adjusted mean (95% CI) change from baseline was -16.40 (-24.31, -8.49) and -19.59 (-28.26, -10.92), respectively. Clinically meaningful (≥10-point) improvements in the OAB-q coping, concern, and sleep subscales were also achieved (Figure 1B); adjusted mean (95% CI) change from baseline to Weeks 40-52 was 19.37 (10.86, 27.89) for coping, 15.02 (7.35, 22.69) for concern, 18.65 (7.44, 29.86) for sleep, 9.85 (3.90, 15.81) for social interaction, and 16.09 (9.07, 23.11) for total. At the end of study visit, clinically meaningful (≥10-point) improvements in symptom bother, coping, concern, sleep, and social interaction subscales were achieved in 84.6%, 67.3%, 60.8%, 68.9%, and 40.3% of patients, respectively. Treatment satisfaction improved by Weeks 4-8 and continued to improve to the end of study; adjusted mean (95% CI) change from baseline was 12.85 (-3.06, 28.77) at Weeks 4-8 and 37.76 (22.31, 53.20) at Weeks 40-52. Health status per EQ-5D-5L improved from baseline; adjusted mean (95% CI) change from baseline was 4.96 (-4.19, 14.11) at Weeks 4-8 and 7.24 (-1.24, 15.72) at Weeks 40-52. Clinically meaningful improvements in total IPSS (≥3-point), IPSS Storage (≥3-point), and IPSS-QoL (≥0.5-point) scores were also achieved (Figure 2). A total of 195/575 (33.9%) patients reported 383 TEAEs, 219/383 (57.2%) were possibly or probably related to Vesomni; 25/575 (4.3%) reported 34 serious TEAEs, 29/34 (85.3%) were possibly or probably related to Vesomni. Four cases of urinary retention were reported, none of which were acute. Four deaths occurred, none of which were related to Vesomni.

EUROPA is the first large-scale European report of a treatment benefit of Vesomni in routine clinical practice. Clinically meaningful improvements were observed as early as 2 months and continued for up to 12 months. The discontinuation rate was low; ~80% of patients remained on Vesomni until the end-of-study visit. None of the four cases of urinary retention were acute/required catheterization, indicating a low incidence of this perceived risk associated with combination (α-blocker + antimuscarinic) treatment.

These results support the use of Vesomni in men with LUTS associated with BPH who are not adequately responding to monotherapy in Europe.