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Keywords:

  • antimuscarinic;
  • efficacy;
  • lower urinary tract symptoms;
  • overactive bladder;
  • pregabalin;
  • safety

Abstract

Aims

To assess the efficacy and safety of pregabalin alone or in combination with tolterodine extended release (ER) in subjects with idiopathic OAB.

Methods

This 26-week, multicenter, randomized, double-blind, placebo-controlled, three-period crossover study enrolled women aged ≥18 years that were diagnosed with OAB and reported ≥8 micturitions/24 hr and ≥4 urgency episodes/week on 5-day bladder diary at baseline. Subjects were randomized to 1 of 10 treatment sequences and received three of five treatments, each for 4 weeks with 4-week washout periods: standard-dose pregabalin/tolterodine ER (150 mg twice daily [BID]/4 mg once daily [QD], n = 102), pregabalin alone (150 mg BID, n = 105), tolterodine ER alone (4 mg QD, n = 104), low-dose pregabalin/tolterodine ER (75 mg BID/2 mg QD, n = 105), and placebo (n = 103). Subjects completed 5-day diaries at the end of treatment and washout periods. The primary endpoint was change from baseline to week 4 in mean voided volume (MVV) per micturition. The primary comparison was standard-dose pregabalin/tolterodine ER versus tolterodine ER alone; secondary comparisons were pregabalin alone versus tolterodine ER alone and versus placebo.

Results

Baseline-adjusted changes in MVV were significantly greater after treatment with standard-dose pregabalin/tolterodine ER (39.5 ml) versus tolterodine ER alone (15.5 ml; P < 0.0001), and with pregabalin alone (27.4 ml) versus tolterodine ER alone (P = 0.005) and placebo (11.9 ml; P = 0.0006). Treatments were generally well tolerated; discontinuation rates due to adverse events were 4%, 2%, 5%, 0%, and 1% with standard- and low-dose pregabalin/tolterodine ER, pregabalin, tolterodine ER, and placebo, respectively.

Conclusions

Pregabalin, alone or with tolterodine ER may offer an alternative treatment option for idiopathic OAB in women. Neurourol. Urodynam. 30:75–82, 2011. © 2010 Wiley-Liss, Inc.