Dose response with darifenacin, a novel once-daily M3 selective receptor antagonist for the treatment of overactive bladder: results of a fixed dose study

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• 作者：Simon Hill (1)
  Vik Khullar (2)
  Jean-Jacques Wyndaele (3)
  Karine Lheritier (4)
  
• 关键词：Muscarinic antagonists ; Urinary incontinence ; Darifenacin ; Clinical trial
• 刊名：International Urogynecology Journal
• 出版年：2006
• 出版时间：May 2006
• 年：2006
• 卷：17
• 期：3
• 页码：239-247
• 全文大小：338KB
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• 作者单位：Simon Hill (1)
  Vik Khullar (2)
  Jean-Jacques Wyndaele (3)
  Karine Lheritier (4)
  
  1. Department of Obstetrics and Gynaecology, Queen’s Park Hospital, Haslingden Road, Blackburn, UK
  2. Department of Urogynaecology, St. Mary’s Hospital, Imperial College, London, UK
  3. Department of Urology, Universitair Ziekenhuis, Antwerp, Belgium
  4. Novartis Pharma AG, CH-4002, Basel, Switzerland
  

文摘

This study evaluated the efficacy, tolerability, and safety of darifenacin, an M3 selective receptor antagonist (M3 SRA), in patients with overactive bladder (OAB). In a multicenter, double-blind, placebo-controlled dose-ranging study, 439 adult OAB patients (85.4% female) were randomized to darifenacin controlled-release tablets 7.5?mg (n = 108), 15?mg (n = 107) or 30?mg (n = 115) qd, or placebo (n = 109) for 12?weeks. Darifenacin significantly reduced the median number of incontinence episodes/week (?8.7, ?6.5, and ?7.3% from baseline at 7.5, 15, and 30?mg, respectively, vs ?6% with placebo, all p< 0.01) and dose relatedly improved micturition frequency, frequency and severity of urgency, nocturia, and bladder capacity. Darifenacin was well tolerated. Adverse events were commonly mild to moderate dry mouth and constipation. There were no safety concerns. Darifenacin is effective and well tolerated in the treatment of OAB, with 7.5 and 15?mg doses offering flexibility of dosing for optimal treatment outcome.