The Second US Trial SAAB

The next trial measured incontinence episode frequency, IQOL, stress-pad test weights, and 24-h pad weights with about 35 patients in each dose group and restricted itself to stress and mixed UI patients.35 Unexpectedly, only the 20 mg group showed statistically significant improvement in all measures, while those at dose 40 mg showed significance in only stress-pad test and IQOL, and the 30 mg dose group only showed significance in IQOL (Figures 6 and 8). In hindsight, this absence of a dose response is not surprising since the dose increments of 20, 30, and 40 mg duloxetine are proportional to increments of, for example, 1, 1.5, and 2 aspirins. One might not expect to see a dose-dependent reduction in headaches in groups of 35 patients across those doses of aspirin. When all duloxetine arms were pooled, significance was retained for all measures except 24-h pad weights, which still showed twice as much reduction as placebo. As in the first trial, the overall incidence of adverse events on placebo was actually worse than any of the duloxetine groups. However, nausea (now recognized as the most prominent side effect of duloxetine) did show a higher (though not significant) increase with duloxetine compared to placebo. In a dose-related pattern similar to the efficacy described above, the highest rate of

Patients showing 70% improvement p = 0.14

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