VESIcare has demonstrated efficacy in overactive bladder (OAB) symptoms of urge urinary incontinence and urinary frequency1,2

Micturitions

Demonstrated efficacy in reducing micturition frequency1,2

Mean change from baseline in micturition episodes/24 h at week 121,2*

change in micturition episodes

*Pooled data from four 12-week, randomized, double-blind, placebo-controlled pivotal studies.

Mean change from baseline in micturition episodes/24 h at week 12 was the primary endpoint for each trial.

SPECIAL POPULATIONS

In placebo-controlled clinical studies, similar safety and effectiveness were observed between older (623 patients ≥65 years and 189 patients ≥75 years) and younger adult patients (1188 patients <65 years) treated with VESIcare.2

NEXT: Incontinence Episodes

Incontinence episodes

Demonstrated efficacy in reducing incontinence episodes1,2

Mean change from baseline in incontinence episodes/24 h at week 121,2,*

change in incontinence episodes

*Pooled data from four 12-week, randomized, double-blind, placebo-controlled pivotal studies.

Mean change from baseline in micturition episodes/24 h at week 12 was the primary endpoint for each trial.

Mean change from baseline in incontinence episodes/24 h at week 12 for patients with incontinence at baseline was a secondary endpoint.

SPECIAL POPULATIONS

In placebo-controlled clinical studies, similar safety and effectiveness were observed between older (623 patients ≥65 years and 189 patients ≥75 years) and younger adult patients (1188 patients <65 years) treated with VESIcare.2

NEXT: Volume Voided

Volume voided

Significant increase in volume voided/micturition at week 121,2

Mean change from baseline to endpoint in volume voided/micturition (mL)*

  • VESIcare 5 MG: n=552, mean baseIine=149.0 mL
  • PLACEBO: n=1135, mean baseIine=165.5 mL
  • VESIcare 10 MG: n=1156, mean baseIine=163.4 mL
change in volume voided

*Pooled data from four 12-week, randomized, double-blind, placebo-controlled pivotal studies.

Mean change from baseline in micturition episodes/24 h at week 12 was the primary endpoint for each trial.

Mean change from baseline in volume voided/micturition at week 12 was a secondary endpoint.

P<0.001.

NEXT: Safety

Geriatric Use

In placebo-controlled clinical studies, similar safety and effectiveness were observed between older (623 patients ≥65 years and 189 patients ≥75 years) and younger adult patients (1188 patients <65 years) treated with VESIcare.2

Study Design

PIVOTAL TRIALS

VESIcare was evaluated in four 12-week, randomized, double-blind, parallel-group, placebo-controlled pivotal studies for the treatment of overactive bladder (OAB) in patients having symptoms of urinary frequency, urgency, and/or urge or mixed incontinence (with predominance of urge). Adults with symptoms of OAB for ≥3 months were randomized to VESIcare (n=1811) or placebo (n=1216). Two of the four studies evaluated VESIcare 5 mg and 10 mg once daily, and the other two evaluated VESIcare 10 mg once daily.

All patients completing the 12-week studies were eligible to enter an open label long-term extension study and 81% of patients enrolling completed the additional 40-week treatment period. The majority of patients were Caucasian (93%) and female (80%) with a mean age of 58 years.2

PRIMARY ENDPOINT

The primary endpoint for each trial was mean change from baseline to week 12 in micturitions/24 hours. Pooled data from four trials demonstrated a mean reduction in micturitions/24 h with VESIcare 5 mg (2.3) and 10 mg (2.7) vs placebo (1.4), P<0.001. N values and baseline values: VESIcare 5 mg (n=552, baseline=12.1); VESIcare 10 mg (n=1158, baseline=11.9); Placebo (n=1138, baseline=11.9).1,2

Indication and Dosage

VESIcare® (solifenacin succinate) tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. The recommended dose of VESIcare is 5 mg once daily. If the 5-mg dose is well tolerated, the dose may be increased to 10 mg once daily.

Important Safety Information

VESIcare is contraindicated in patients with urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, and in patients with hypersensitivity to the product.

Angioedema of the face, lips, tongue and/or larynx have been reported with VESIcare. Cases of angioedema have been reported to occur hours after the first dose or after multiple doses. Angioedema associated with upper airway swelling may be life threatening. If involvement of the tongue, hypopharynx, or larynx occurs, VESIcare should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided. Anaphylactic reactions have been reported rarely in patients treated with VESIcare. VESIcare should not be used in patients with a known or suspected hypersensitivity to solifenacin succinate. In patients who develop anaphylactic reactions, VESIcare should be discontinued and appropriate therapy and/or measures should be taken.

VESIcare should be administered with caution to patients with clinically significant bladder outflow obstruction, decreased gastrointestinal motility, controlled narrow-angle glaucoma, or reduced renal or hepatic function. Doses of VESIcare higher than 5 mg are not recommended in patients with severe renal impairment, moderate hepatic impairment, or when administered with ketoconazole or other potent CYP3A4 inhibitors. Use of VESIcare in patients with severe hepatic impairment is not recommended.

Anticholinergic central nervous system (CNS) effects have been reported with VESIcare use, including headache, confusion, hallucinations and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing dose, and be advised not to drive or operate heavy machinery until they know how VESIcare affects them. If a patient experiences these effects, dose reduction or drug discontinuation should be considered.

In placebo-controlled studies, for the 10-mg dose, three intestinal serious adverse events were reported (one fecal impaction, one colonic obstruction, and one intestinal obstruction). For the 5‑mg dose, one serious adverse event (angioneurotic edema) was reported.

In placebo-controlled studies, the most common adverse reactions reported by patients were dry mouth (10.9%, 27.6%, 4.2%), constipation (5.4%, 13.4%, 2.9%), blurred vision (3.8%, 4.8%, 1.8%), and urinary tract infection (2.8%, 4.8%, 2.8%) with VESIcare 5 mg, 10 mg, and placebo, respectively.

Please click here for complete Prescribing Information.

References

  1. Chapple CR, Cardozo L, Steers WD, Govier FE. Solifenacin significantly improves all symptoms of overactive bladder syndrome. Int J Clin Pract 2006;60(8):959-66. Erratum in: Int J Clin Pract 2006;60(11):1517-8.
  2. VESIcare® [Prescribing Information]. Northbrook, IL: Astellas Pharma US, Inc.

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Study Design

PIVOTAL TRIALS

VESIcare was evaluated in four 12-week, randomized, double-blind, parallel-group, placebo-controlled pivotal studies for the treatment of overactive bladder (OAB) in patients having symptoms of urinary frequency, urgency, and/or urge or mixed incontinence (with predominance of urge). Adults with symptoms of OAB for ≥3 months were randomized to VESIcare (n=1811) or placebo (n=1216). Two of the four studies evaluated VESIcare 5 mg and 10 mg once daily, and the other two evaluated VESIcare 10 mg once daily.

PRIMARY ENDPOINT

The primary endpoint for each trial was mean change from baseline to week 12 in micturitions/24 hours. Pooled data from four trials demonstrated a mean reduction in micturitions/24 h with VESIcare 5 mg (2.3) and 10 mg (2.7) vs placebo (1.4), P<0.001. N values and baseline values: VESIcare 5 mg (n=552, baseline=12.1); VESIcare 10 mg (n=1158, baseline=11.9); Placebo (n=1138, baseline=11.9).1,2

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