| VESIcare is effective in reducing what many OAB patients consider their most distressful symptom: incontinence.6,16
Drier at 12 weeks
51% of subjects who took VESIcare once-daily 5 mg reported no incontinence episodes in their consecutive three-day diary prior to the end of the study, compared to 38% of subjects who were administered placebo.6
Drier at 1 year
60% of patients treated with VESIcare reported no incontinence episodes at the end of a 40-week, open-label extension safety study in a post hoc responder analysis.17
For first 4 weeks of extension, patients took 5 mg and for remaining 36 weeks were allowed flexible dosing of VESIcare 5 mg or 10 mg. Primary objective was to assess safety and tolerability of long-term treatment. Post hoc responder analysis in patients who reported incontinence at baseline and no incontinence episodes for 3 consecutive days prior to study visits.
Drier than tolterodine
59% of patients receiving VESIcare 5 mg or 10 mg reported no incontinence episodes at 12 weeks, versus 49% of receiving tolterodine 4 mg extended release in a head-to-head study (P=0.006).18 In terms of the study’s primary endpoint, mean change from baseline in micturitions per 24 hours, demonstrated VESIcare to be noninferior to tolterodine (P = 0.004).18
Results from a double-blind, double-dummy, 12-week study comparing efficacy and safety of VESIcare in a flexible-dosing regimen of 5 mg or 10 mg and tolterodine 4 mg extended release. The primary endpoint, mean change from baseline in micturitions/24 h, demonstrated VESIcare to be noninferior to tolterodine (P=0.004). The most common drug-related,
treatment-emergent adverse
events reported by patients
were dry mouth (30.0%, 24.1%),
constipation (6.4%, 2.5%),
headache (2.7%, 3.6%), and
dyspepsia (2.2%, 0.8%)
with VESIcare (n=593) and
tolterodine (n=607), respectively.
Warning Time
Warning Time is defined in one study as the duration from the first sensation of urgency to voiding.19 Because the difference between making it to the restroom and having an incontinence episode may be a matter of seconds, an increase in Warning Time may help to improve some of your patients’ chances of staying drier.
VESIcare is the first once-daily OAB treatment that has demonstrated the ability to significantly increase Warning Time compared to placebo at the approved dose. The effects of VESIcare 5 and 10 mg on Warning Time were assessed in a 12-week, double-blind, placebo-controlled trial. The primary endpoint of the trial was mean change in urgency episodes per twenty-four hours. The median change in Warning Time from baseline for patients on VESIcare was 31.5 seconds, compared to 12 seconds for those on placebo.19
Results from a 12-week, placebo controlled study of the efficacy and safety of VESIcare 5 mg and 10 mg in a flexible-dosing regimen.
The primary endpoint, mean change in urgency episodes/24 h: VESIcare provided significantly greater reductions compared with placebo (P<0.0001).
Other secondary endpoints: VESIcare provided significantly greater reductions in micturitions/24 h and incontinence episodes/24 h compared to placebo (P<0.05); no difference was observed for nocturia-related endpoints compared to placebo.
The most common drug-related, treatment-emergent adverse events reported by patients were dry mouth (25.3%, 9.0%), constipation (14.8%, 9.3%), blurred vision (3.8%, 1.1%), dizziness (3.2%, 1.9%), and fatigue (2.7%, 1.1%) with VESIcare 5 mg or 10 mg and placebo, respectively.
|