title: Effect of dose escalation on the tolerability and efficacy of duloxetine in the treatment of women with stress urinary incontinence.
abstract: To assess the impact of duloxetine dose escalation on tolerability and efficacy, 516 women with stress urinary incontinence were randomized to receive placebo or duloxetine in one of three regimens: 40 mg BID for 8 weeks, 40 mg QD for 2 weeks escalating to 40 mg BID for 6 weeks or 20 mg BID for 2 weeks escalating to 40 mg BID for 6 weeks. A non-inferiority analysis confirmed that the 20 mg BID starting dose was significantly better than the other two duloxetine regimens for nausea reduction (16.5% vs 25.2% and 29.4%). There were also significant differences in the discontinuation rates (7.5% vs 11.8% and 16.2%). The efficacy after 4 weeks was significantly better with duloxetine than with placebo. Starting duloxetine at 20 mg BID for 2 weeks before increasing to 40 mg BID significantly improved tolerability but did not impact duloxetine efficacy after all the subjects had been on 40 mg BID for at least 2 weeks.
authors.affiliation: Hospital Universitario De Canarias, Santa Cruz De Tenerife, Spain.
authors.forename: David
authors.initials: D
authors.lastname: Castro-Diaz
authors.forename: Paulo C R
authors.initials: PC
authors.lastname: Palma
authors.forename: Céline
authors.initials: C
authors.lastname: Bouchard
authors.forename: Francois
authors.initials: F
authors.lastname: Haab
authors.forename: Christian
authors.initials: C
authors.lastname: Hampel
authors.forename: Roberto
authors.initials: R
authors.lastname: Carone
authors.forename: Sebastian
authors.initials: S
authors.lastname: Zepeda Contreras
authors.forename: Henry
authors.initials: H
authors.lastname: Rodriguez Ginorio
authors.forename: Simon
authors.initials: S
authors.lastname: Voss
authors.forename: Ilker
authors.initials: I
authors.lastname: Yalcin
authors.forename: Richard C
authors.initials: RC
authors.lastname: Bump
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D000068736:Duloxetine Hydrochloride; D005260:Female; D006801:Humans; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D013876:Thiophenes / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000188:drug therapy*
chemical_list: D000068736:Duloxetine Hydrochloride; D017367:Selective Serotonin Reuptake Inhibitors; D013876:Thiophenes