Duloxetine for the treatment of stress urinary incontinence in women: an integrated analysis of safety.
OBJECTIVE
The objective was to characterize the safety of duloxetine for treatment of stress urinary incontinence (SUI) in women, using an integrated database generated from four published placebo-controlled clinical trials.


METHODS
The database included 1913 women randomized to duloxetine (N=958) or placebo (N=955), examining adverse events (AEs), serious adverse events (SAEs), vital signs, electrocardiograms, and laboratory analytes. AEs occurring initially or worsening during the double-blind treatment period were considered treatment-emergent (TEAE). Differences between duloxetine-treated and placebo-treated groups were compared statistically.


RESULTS
Common TEAEs included: nausea (23.2%), dry mouth (13.4%), fatigue (12.7%), insomnia (12.6%), constipation (11.0%), headache (9.7%), dizziness (9.5%), somnolence (6.8%), and diarrhea (5.1%). Most TEAEs that emerged early were mild to moderate, rarely worsened, and resolved quickly. Overall AE discontinuation rates were 20.5% for duloxetine and 3.9% for placebo (P<.001). Most discontinuations (83%) occurred within the first month of treatment. SAEs were uncommon and did not differ between treatments. Statistically significant, but clinically unimportant mean increases in heart rate (2.4 bpm) and systolic and diastolic blood pressure (<or=2 mmHg) occurred. No arrhythmogenic potential was observed and any rare, transient, asymptomatic increases in hepatocellular enzymes normalized.


CONCLUSIONS
Duloxetine was safe and tolerable, although transient AEs were not uncommon.
Hurley
Daniel J
DJ
Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA. hurley_dan@lilly.com
Turner
Catherine L
CL
Yalcin
Ilker
I
Viktrup
Lars
L
Baygani
Simin K
SK
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003248:Constipation / Q000139:chemically induced; D003967:Diarrhea / Q000139:chemically induced; D006970:Disorders of Excessive Somnolence / Q000139:chemically induced; D004244:Dizziness / Q000139:chemically induced; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions; D000068736:Duloxetine Hydrochloride; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008099:Liver / Q000187:drug effects / Q000201:enzymology; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D007319:Sleep Initiation and Maintenance Disorders / Q000139:chemically induced; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*; D014550:Urinary Incontinence, Stress / Q000188:drug therapy*; D014987:Xerostomia / Q000139:chemically induced
D013876:Thiophenes; D000068736:Duloxetine Hydrochloride