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
| Autor: | Karin S. Coyne, Monique Klaver, Klaudia Traudtner, Zalmai Hakimi, Marcus J. Drake, Roman Sokol, Jameel Nazir, Matthias Oelke, Isaac Odeyemi, Julie Dorey, Philippe van Kerrebroeck |
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| Přispěvatelé: | Urologie, MUMC+: MA Urologie (9), RS: MHeNs - R3 - Neuroscience |
| Rok vydání: | 2015 |
| Předmět: |
Male
Tamsulosin medicine.medical_specialty Urology Fixed-dose combination 030232 urology & nephrology Prostatic Hyperplasia urologic and male genital diseases Placebo 03 medical and health sciences 0302 clinical medicine Quality of life Double-Blind Method Lower Urinary Tract Symptoms Lower urinary tract symptoms medicine Humans benign prostatic hyperplasia solifenacin Sulfonamides Solifenacin business.industry Solifenacin Succinate Middle Aged medicine.disease humanities health-related quality of life Overactive bladder 030220 oncology & carcinogenesis Quality of Life Urological Agents International Prostate Symptom Score business medicine.drug |
| Zdroj: | BJU International, 117(1), 165-172. Wiley |
| ISSN: | 1464-410X 1464-4096 |
| Popis: | Objective To evaluate the effect of a fixed-dose combination (FDC) of solifenacin and an oral-controlled absorption system (OCAS™) formulation of tamsulosin (TOCAS) on health-related quality of life (HRQoL) in men with lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). Patients and methods Men 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, double-blind 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. Results In 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. Conclusions In 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. |
| Databáze: | OpenAIRE |
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