Flexible-dose antimuscarinic decreases nocturnal urgency episodes

May 23, 2012

In treating nocturia related to urgency, flexible-dose fesoterodine (Toviaz) demonstrates statistical superiority to placebo in several areas, reported researchers from State University of New York Downstate Medical School, Brooklyn.

In treating nocturia related to urgency, flexible-dose fesoterodine (Toviaz) demonstrates statistical superiority to placebo in several areas, reported researchers from State University of New York Downstate Medical School, Brooklyn.

The large, double-blind, placebo-controlled study randomized 937 patients to once-daily placebo or flexible-dose fesoterodine for 12 weeks. Fesoterodine treatment was initiated at 4 mg, once daily and could be increased to 8 mg at the 4-week visit if needed.

The fesoterodine and control groups were similar in their baseline demographics and OAB symptoms. Nearly all nocturic micturitions were associated with urgency, and mean nocturnal urgency episodes/24 hours was close to three in both study groups.

In an intent-to-treat analysis of the primary efficacy endpoint at 12 weeks, there was a statistically significant difference favoring flexible-dose fesoterodine over placebo for reducing nocturnal urgency episodes/24 hours (–1.29 vs. –1.06; p=.0030). Flexible-dose fesoterodine also demonstrated statistical superiority to placebo in its effect for reducing nocturnal micturitions/24 hours (–1.02 vs. –0.84; p=.012), overall micturitions/24 hours (–2.42 vs. –1.86; p=.0014), and urgency episodes/24 hours (–3.50 vs. –2.72; p=.0009), as well as for improving symptom bother (p=.0006) and all health-related quality of life domains (p

Safety data showed the antimuscarinic drug was well tolerated and had a treatment-emergent adverse event profile similar to placebo.

"Nocturnal urgency is a common problem. Until now, however, only post hoc analyses of OAB study data have been done to check for a possible effect of antimuscarinic drugs in treating nocturia, and generally, the results show no to minimal clinical benefit," first author Jeffrey P. Weiss, MD, said.

"Balancing the consistency of all of the efficacy outcomes in this large, randomized, placebo-controlled study with the safety data supports the conclusion that fesoteridine is a reasonable treatment choice for OAB patients with nocturnal urgency."

Dr. Weiss is a consultant for Pfizer, Inc., Ferring Pharmaceuticals, Astellas Pharma, and Eli Lilly and Co.

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