Mirabegron safe, effective for overactive bladders in elderly patients
Mirabegron cuts the number of micturitions and incontinence episodes in elderly patients with overactive bladders (OABs), a recent study has shown.
Researchers randomly assigned 887 OAB patients to receive mirabegron 25 mg (n=226; mean age, 71.6±5.8 years; 74 percent female) or 50 mg (n=219; mean age, 71.7±5.2 years; 68 percent female), or placebo (n=442; mean age, 71.9±6.0 years; 73 percent female). The coprimary endpoints were the change in micturitions and incontinence episodes within 24 hours from baseline to end of treatment.
Significant improvements were found in the mirabegron group relative to the placebo group. The mean number of micturitions over a 24-hour period was significantly reduced (difference, –0.7±0.2, 95 percent confidence interval [CI], –1.0 to –0.3), as was the mean number of incontinence episodes (difference, –0.6±0.1, 95 percent CI, –0.8 to –0.3).
There were also significant improvements in the secondary endpoints, such as the mean volume voided per micturition (difference, 13.7±4.5, 95 percent CI, 5.0–22.4), mean number of urgency episodes in 24 hours (difference, –0.94±0.22, 95 percent CI, –1.37 to –0.41) and mean number of urgency incontinence episodes in 24 hours (difference, –0.56±0.14, 95 percent CI, –0.83 to –0.29).
Mirabegron also had an acceptable safety profile. Thirty-nine percent of the placebo group and 47 percent of the mirabegron patients showed treatment-emergent adverse events (TEAEs). Of these, 57 and 84 were deemed possibly or probably related to the drug, respectively. Serious TEAEs were reported in 12 and 15 patients in the respective groups.