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DGDispatch
Tolterodine Increases Heart Rate Compared With Darifenacin, Placebo in Patients With Overactive Bladder: Presented at ICS
By Sandra Ripley Distelhorst
SAN FRANCISCO -- October 3, 2009 -- Careful selection of antimuscarinic treatment for overactive bladder (OAB) symptoms may be warranted due to increased cardiovascular risks, researchers reported here at the 39th Annual Meeting of the International Continence Society (ICS).
On October 1, Brian Olshansky, MD, Department of Internal Medicine, University of Iowa, Iowa City, Iowa, presented the results of a study that found that darifenacin and tolterodine differ in their effects on heart rate in healthy volunteers.
The prospective, 3-way crossover, double-blind, double-dummy, multicentre study included 117 patients (mean age, 58 years) who were randomised to 1 of 6 treatment sequences. Each sequence consisted of 7-day treatment with darifenacin 15 mg once daily, tolterodine 4 mg once daily, or placebo, separated by 14-day washout periods.
Change from baseline in mean heart rate was assessed using 24-hour ambulatory electrocardiogram (Holter monitoring) at steady-state exposure (day 7 of each treatment period). Hourly heart rate, heart rate variability, and adverse events (AEs) were also recorded.
In all, 108 patients completed all 3 treatment periods. Mean change from baseline in 24-hour heart rate was higher with tolterodine versus darifenacin (P = .0004) and tolterodine versus placebo (P = .0037), but similar between darifenacin versus placebo (P = .5219).
In addition, more patients had an increase in heart rate on tolterodine compared with darifenacin and placebo, although there were no statistically significant differences between darifenacin and placebo. However, a greater proportion of patients receiving darifenacin had a decrease in heart rate (>=1 to >=3 bpm) compared with those receiving tolterodine (P < .02).
AEs were reported by 20.5% of patients receiving tolterodine, 31.0% receiving darifenacin, and 18.4% of patients receiving placebo. The most commonly reported AEs were dry mouth and constipation. During the study, 1 serious AE was reported -- hypersensitivity reaction to darifenacin.
The study demonstrates that darifenacin and tolterodine differ in their effects on heart rate in healthy volunteers. The changes in heart rate and heart rate variability seen with tolterodine versus placebo compared with darifenacin versus placebo may be the result of differences in M2 receptor selectivity between these drugs.
Funding for this study was provided by Procter & Gamble and Novartis.
[Presentation title: Differential Effects of Darifenacin and Tolterodine on Heart Rate (HR) and Heart Rate Variability (HRV): A Three-Way Crossover, Randomised Study in Healthy Subjects. Abstract 441]
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