Low incidence of adverse events in study of more than 12,000 women; no suicide attempts reported
FRIDAY, July 27 (HealthDay News) -- Duloxetine appears safe for the routine clinical care of women with stress urinary incontinence (SUI), according to a study published online July 23 in the British Journal of Clinical Pharmacology.
Martin C. Michel, M.D., from the Johannes Gutenberg University in Mainz, Germany, and colleagues conducted an observational study involving 6,854 patients seen by urologists and gynecologists and 5,879 patients seen by primary care physicians; all patients were newly started on treatment for moderate-to-severe symptoms of stress urinary incontinence. Study participants were treated in a parallel 12-week (urologist and gynecologist patients) or 24-week (primary care physician) design and received duloxetine or other conservative treatment.
The researchers found that, for most patients, duloxetine doses were lower than recommended. The qualitative spectrum of adverse events with duloxetine was similar to that seen in controlled studies, but the frequency was lower than in controlled studies (15.9 and 9.1 percent in the 12- and 24-week treatment groups, respectively). Factors that correlated with increased adverse event risk included investigator specialization (gynecologist versus urologist and primary care physician), initial duloxetine dose (80 versus 20 mg/d), and use of any concurrent medication. A positive screen for depressive disorder was very common in the 24-week study, but there were no attempts of suicide reported in either study.
"In conclusion, our observational study with a large number of patients and large overall duloxetine exposure in terms of patient years confirmed the qualitative pattern of adverse events reported from controlled studies but with a much lower overall incidence," the authors write. "Moreover, we did not detect any rare, previously unreported adverse events."
Several authors disclosed financial relationships with pharmaceutical companies, including Eli Lilly, which funded the study and manufactures duloxetine.