Number №3, 2019 - page 134-143

Vesomni improves the quality of life in men with lower urinary tract symptoms in routine clinical practice in Europe DOI: doi 10.29188/2222-8543-2019-11-3-134-143

Rees J., Foley S., Huang M., Arias J.R., Skoumal L., Walters C., Yavuz Y., Wachter S. De
Information about authors:
  • Jonathan Rees - Department of Brockway Medical Centre, Tyntesfield Medical Group, Bristol, UK
  • Steve Foley - Department of Urology, Royal Berkshire Hospital, Reading, RG 1 5AN, Berkshire, UK
  • Moses Huang - Department of European Medical Affairs, Astellas Pharma Europe Ltd., Chertsey, UK
  • José Rosa Arias - Department of Urology, Hospital Santiago Apóstol, Miranda de Ebro-Burgos, Spain
  • René Skoumal - Department of Urology, Urocentrum Brno, Brno, Czechia
  • Carien Walters - Department of Medical and Clinical Operations EMEA, Astellas Pharma Europe Ltd., Chertsey, UK
  • Yalcin Yavuz - Department of Data Science, Formerly with Astellas Pharma Global Development, Leiden, The Netherlands
209

Contacts: Jonathan Rees, jonathanrees@nhs.net

Aim: To evaluate the impact of Vesomni/Urizia/Volutsa, a fixed‐dose combination tablet containing 6mg 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). Assessmentswere performed at baseline,weeks 4 to 8,weeks 9 to 18 (optional),weeks 19 to 39 (optional), and Weeks 40 to 52.The primary endpointwaschange 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, treatmentsatisfaction‐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 scoreswere −16.40 (−24.31, −8.49) atweeks 4 to 8 and −19.59 (−28.26, −10.92) atweeks 40 to 52; atweeks 40 to 52,changeswere 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)forconcern,coping,sleep,social interaction, and total,respectively. TS‐VAS,IPSS, and EQ‐5D‐5L all improved, and treat- ment 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. Key words: benign prostatic hyperplasia, Study EUROPE, lower urinary tract symptoms, male, quality of life, treatment satisfaction, Vesomni.

For citation: J. Rees, S. Foley, M. Huang, J.R. Arias, R. Skoumal, C. Walters, Y. Yavuz, S. De Wachter. Vesomni improves the quality of life in men with lower urinary tract symptoms in routine clinical practice in Europe. Experimental and clinical urology 2019;(3):134-143

AttachmentSize
Download583.11 KB
benign prostatic hyperplasia, Study EUROPE, lower urinary tract symptoms, male, quality of life, treatment satisfaction, Vesomni

Readera - Социальная платформа публикаций

Crossref makes research outputs easy to find, cite, link, and assess