Overactive bladder: Two drugs found better than one

June 15, 2015

A two-drug treatment regimen works better than monotherapy for incontinent overactive bladder patients, researchers reported at the AUA annual meeting in New Orleans.

A two-drug treatment regimen works better than monotherapy for incontinent overactive bladder patients, researchers reported at the AUA annual meeting in New Orleans.

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The beta-3 adrenergic agonist mirabegron (Myrbetriq) used as add-on therapy with the antimuscarinic drug solifenacin (VESIcare) proved more effective in treating overactive bladder than solifenacin alone in the phase IIIb BESIDE clinical trial. The international trial studied 2,174 patients with similar demographic and baseline characteristics who had had an inadequate response to 4 weeks of monotherapy with solifenacin, 5 mg daily.

Patients were randomized to receive 12 weeks of combination therapy (solifenacin, 5 mg daily plus mirabegron, 50 mg  [25 mg daily of mirabegron during the first 4 weeks]), monotherapy with 5 mg of solifenacin daily, or monotherapy with 10 mg of solifenacin daily. Researchers evaluated the change in mean number of incontinence episodes per 24 hours between baseline and end of treatment (the primary efficacy endpoint) and change in mean number of micturitions per 24 hours. They also assessed the number of incontinence episodes during a 3-day diary at the end of treatment.

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Combination therapy reduced the mean daily number of incontinence episodes by 1.80 compared with 1.53 episodes for monotherapy with 5 mg of solifenacin, a statistically significant difference (p=.001). The mean number of daily micturitions in the combination group decreased by 1.53 compared with 1.14 in the solifenacin, 5 mg group, also statistically significant (p<.001).

Combination therapy was noninferior to solifenacin, 10 mg daily for both mean number of micturitions per 24 hours and number of incontinence episodes during the 3-day diary. It was superior to 10-mg monotherapy for decrease in micturitions per 24 hours and superior to both 5-mg and 10-mg monotherapy for increase in urine volume voided per micturition.

Patients tolerated all three treatments well, with no new adverse events reported beyond the known profiles for solifenacin and mirabegron. The most common adverse events, reported by at least 2% of patients, were dry mouth, constipation, and peripheral edema.

“The findings hold out hope for people with severe urinary symptoms of urgency or urgency incontinence,” said lead investigator Marcus Drake, MA, DM, of the University of Bristol and Bristol Urological Institute, Bristol, UK. “We can now anticipate future availability of effective and well-tolerated therapy, and reduce the need for invasive surgical treatments.”

The BESIDE trial was funded by Astellas Pharma Inc., the manufacturer of mirabegron and solifenacin.

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