Efficacy of desmopressin (Minirin) in the treatment of nocturia: a double-blind placebo-controlled study in women.
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Resumo
OBJECTIVE
The purpose of this study was to investigate the efficacy and safety of oral desmopressin in the treatment of nocturia in women.
METHODS
Women aged 18 years or older with nocturia (>or=2 voids per night with a nocturia index score >1) received desmopressin (0.1 mg, 0.2 mg, or 0.4 mg) during a 3-week dose-titration period. After a 1-week washout period, patients who responded in this period received desmopressin or placebo in a double-blind fashion for 3 weeks.
RESULTS
In double-blind phase, 144 patients were randomly assigned to groups (desmopressin, n=72; placebo, n=72). For desmopressin, 33 (46%) patients had a 50% or greater reduction in nocturnal voids against baseline levels compared with 5 (7%) patients receiving placebo (P<.0001). The mean number of nocturnal voids, duration of sleep until the first nocturnal void, nocturnal diuresis, and ratios of nocturnal per 24 hours and nocturnal per daytime urine volumes changed significantly in favor of desmopressin versus placebo (P<.0001). In the dose-titration phase headache (22%), nausea (8%), and hyponatremia (6%) were reported. Two deaths occurred, although neither could be directly associated with the study drug.
CONCLUSIONS
Oral desmopressin is an effective and well-tolerated treatment for nocturia in women.
