Investigation of the clinical efficacy and safety of pregabalin alone or combined with tolterodine in female subjects with idiopathic overactive bladder

• Published in: Neurourology and urodynamics Vol. 30; no. 1; pp. 75 - 82
• Main Authors: Marencak, Josef, Cossons, Nandini H., Darekar, Amanda, Mills, Ian W.
• Format: Journal Article
• Language: English
• Published: Hoboken Wiley Subscription Services, Inc., A Wiley Company 01.01.2011
• Subjects: Adult; Aged; Analgesics - administration & dosage; Analgesics - adverse effects; antimuscarinic; Benzhydryl Compounds - administration & dosage; Benzhydryl Compounds - adverse effects; Cresols - administration & dosage; Cresols - adverse effects; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Drug Therapy, Combination; efficacy; Female; gamma-Aminobutyric Acid - administration & dosage; gamma-Aminobutyric Acid - adverse effects; gamma-Aminobutyric Acid - analogs & derivatives; Humans; lower urinary tract symptoms; Middle Aged; Muscarinic Antagonists - administration & dosage; Muscarinic Antagonists - adverse effects; overactive bladder; Phenylpropanolamine - administration & dosage; Phenylpropanolamine - adverse effects; Pregabalin; safety; Tolterodine Tartrate; Treatment Outcome; Urinary Bladder, Overactive - drug therapy; Urinary Bladder, Overactive - physiopathology; Urination - drug effects
• ISSN: 0733-2467; 1520-6777; 1520-6777
• DOI: 10.1002/nau.20928

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.