A pooled analysis of three phase III studies to investigate the efficacy, tolerability and safety of darifenacin, a muscarinic M3 selective receptor antagonist, in the treatment of overactive bladder
| Autor: | Peggy Norton, William D. Steers, Richard J. Millard, Georg Kralidis, Karin Glavind, Christopher R. Chapple, Paul Abrams |
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| Rok vydání: | 2005 |
| Předmět: |
Adult
Male medicine.medical_specialty Pyrrolidines Urology Placebo Double-Blind Method Tamsulosin medicine Darifenacin Humans Multicenter Studies as Topic Adverse effect Alfuzosin Aged Benzofurans Randomized Controlled Trials as Topic Aged 80 and over Receptor Muscarinic M3 business.industry Middle Aged medicine.disease Clinical trial Treatment Outcome Urinary Incontinence Clinical Trials Phase III as Topic Overactive bladder Tolerability Anesthesia Female business medicine.drug |
| Zdroj: | Chapple, C, Steers, W, Norton, P, Millard, R, Kralidis, G, Glavind, K & Abrams, P 2005, ' A pooled analysis of three phase III studies to investigate the efficacy, tolerability and safety of darifenacin, a muscarinic M-3 selective receptor antagonist, in the treatment of overactive bladder ', B J U International , vol. 95, no. 7, pp. 993-1001 . |
| ISSN: | 1464-410X 1464-4096 |
| Popis: | An international group of authors present a pooled analysis of data from their phase III multicentre double-blind clinical trials in patients with overactive bladder, which evaluated the efficacy, tolerability and safety of darifenacin. They found the drug, a muscarinic M3 selective receptor antagonist, to be effective in the treatment of this condition, with excellent tolerability and safety. A paper from Denmark compares the efficacy and safety of alfuzosin and tamsulosin in a large randomized, double-blind, placebo-controlled, multicentre study. There were similar improvements in urinary symptoms and maximum urinary flow with the two drugs compared to placebo, but the incidence of sexual function adverse events was higher with tamsulosin than placebo. OBJECTIVE To evaluate the efficacy, tolerability and safety of darifenacin, a muscarinic M3 selective receptor antagonist (M3 SRA), from an analysis of pooled data from three phase III, multicentre, double-blind clinical trials in patients with overactive bladder (OAB). PATIENTS AND METHODS After a 4-week washout/run-in period, 1059 adults (85% women) with symptoms of OAB (frequency and urgency with urge incontinence) for ≥ 6 months were randomized to once-daily oral treatment with darifenacin (7.5 mg, 337; or 15 mg, 334) or matching placebo (388) for 12 weeks. Efficacy was evaluated using electronic patient diaries that recorded incontinence episodes (including those resulting in a change of clothing or pads), frequency and severity of urgency, voiding frequency, and bladder capacity (volume voided). Safety was evaluated by analysis of adverse events (AEs), withdrawal rates and laboratory tests. RESULTS Relative to baseline, 12 weeks of treatment with darifenacin resulted in a significant reduction in the median (% change, interquartile range) number of incontinence episodes per week; 7.5 mg (−8.8, −68.4%, −15.1 to −4.4); 15 mg; (−10.6, −76.8%, −17.3 to −5.8: both P |
| Databáze: | OpenAIRE |
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