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Olshansky B, 1 Foote J, 2 Arguinzoniz M, 3 Lheritier K, 3 Quebe-Fehling E, 3 Steel M 3

The effects of darifenacin and tolterodine on heart rate (HR) in patients with overactive bladder (OAB). Olshansky B, 1 Foote J, 2 Arguinzoniz M, 3 Lheritier K, 3 Quebe-Fehling E, 3 Steel M 3

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Olshansky B, 1 Foote J, 2 Arguinzoniz M, 3 Lheritier K, 3 Quebe-Fehling E, 3 Steel M 3

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  1. The effects of darifenacin and tolterodine on heart rate (HR) in patients with overactive bladder (OAB) Olshansky B,1 Foote J,2Arguinzoniz M,3 Lheritier K,3 Quebe-Fehling E,3 Steel M3 1University of Iowa Hospitals, Iowa, IA, USA; 2Midtown Urology and Surgical Center, Atlanta, GA, USA; 3Novartis Pharma AG, Basel, Switzerland 1

  2. Randomised, double-blind, 12-week trial in adult patients with OAB: baseline characteristics Darifenacin15 mg od(n=112) Tolterodine2 mg bid(n=223) Placebo(n=115) Mean age (years) 60.3 59.3 58.5 Aged ≥65 years (%) 42.9 39.0 33.0 Females (%) 79.5 83.4 89.6 With hypertensive disease (%) 29.5 26.0 30.4 Taking antihypertensivesa (%) 20.5 18.8 27.0 Taking beta-blockers (%) 8.9 9.9 7.0 Average number of incontinence episodes per weekb 16.2 17.0 15.8 aIncludes: alpha-blockers, angiotensin II receptor antagonists, angiotensin converting enzyme inhibitors, antihypertensive diuretic combinations, calcium channel blockers, centrally-acting antihypertensives and other antihypertensive drugs. bBased on the full analysis set, n=109, 221 and 114 for darifenacin, tolterodine and placebo, respectively. 2

  3. Significant HR increases with tolterodine but not darifenacin 3 HR=heart rate (as assessed by pulse rate); bpm=beats per minute

  4. Darifenacin 15 mg od More patients with increased HR on tolterodine than darifenacin Patients with increase in HR from baseline to last observation (%) Placebo p=0.0046 Tolterodine 2 mg bid p=0.0042 p=0.0248 HR=heart rate (as assessed by pulse rate) Comparisons using Fisher’s exact test (two-sided). All comparisons not shown were p>0.05 4

  5. Summary and conclusions • In this analysis, darifenacin was associated with no significant increase in HR or BP from baseline (similar to placebo) • In contrast, tolterodine was associated with significant increases in HR, and higher proportions of patients with a 5 or 10 bpm increase in HR than either placebo or darifenacin • The clinically relevant increase of ≥10 bpm in 22.8% patients receiving tolterodine is of particular note • There were no significant changes in BP in any treatment group • Overall, darifenacin demonstrated a good cardiac safety profile, which may be explained by its high relative selectivity for the M3 receptor (M2-sparing properties) • This profile is of clinical relevance for all patients with OAB, and is likely to be of particular importance for older patients at risk for cardiovascular comorbidities and those on polypharmacy 5

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