Efficacy and tolerability of darifenacin, a muscarinic M3 selective receptor antagonist (M3 SRA), compared with oxybutynin in the treatment of patients with overactive bladder.
A randomized, double-blind, placebo-controlled, four-way crossover, safety study of darifenacin versus oxybutynin was carried out on 76 patients with overactive bladder (OAB). Adults with OAB received 2 weeks each of darifenacin 15 and 30 mg once daily (q.d.), oxybutynin 5 mg three times daily (t.i.d.) and placebo, in random sequence at 10-day intervals. Darifenacin and oxybutynin significantly reduced incontinence episodes, and the number/severity of urgency episodes (all P<0.05 versus placebo). Improvements in OAB symptoms with darifenacin were dose-dependent. Dry mouth was less common with darifenacin 15 mg than oxybutynin (13% and 36%; P<0.05), while constipation was comparable (10% and 8%, respectively). Corresponding rates for darifenacin 30 mg were 34% and 21%, respectively. Patients only reported blurred vision or dizziness with oxybutynin (3% and 2%, respectively). Darifenacin (15 mg q.d.) provides comparable efficacy with improved tolerability versus oxybutynin (5 mg t.i.d.) in the treatment of patients with OAB.
Zinner
Norman
N
Western Clinical Research, Inc., Los Angeles, California, USA. wewedoc@aol.com
Tuttle
John
J
Marks
Leonard
L
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001572:Benzofurans / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008333:Mandelic Acids / Q000627:therapeutic use*; D008875:Middle Aged; D011759:Pyrrolidines / Q000627:therapeutic use*; D043587:Receptor, Muscarinic M3 / Q000037:antagonists & inhibitors*; D016896:Treatment Outcome; D014549:Urinary Incontinence / Q000188:drug therapy* / Q000378:metabolism / Q000503:physiopathology; D014563:Urodynamics / Q000502:physiology
D001572:Benzofurans; D008333:Mandelic Acids; D011759:Pyrrolidines; D043587:Receptor, Muscarinic M3; C101207:darifenacin; C005419:oxybutynin