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Overactive bladder drug may not increase risk for CV events
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Patients with overactive bladder who were dispensed mirabegron did not have an increased risk for CV events compared with other treatments, according to a study published in JAMA Internal Medicine.
“Our results support current prescribing trends, which is that this drug is being used more often that there was no signal that mirabegron was associated with any added risk compared to what normal treatments they would use,” Mina Tadrous, PharmD, PhD, scientist at the Women’s College Research Institute at Women’s College Hospital in Toronto, told Cardiology Today.
Researchers analyzed data from 38,818 patients (median age, 76 years; 65% women) aged at least 66 years who were treated for overactive bladder between June 2015 and March 2017. Patients were treated with mirabegron (n = 16,948; Myrbetriq, Astellas Pharma) or other overactive bladder drugs (n = 21,870).
The primary outcome of interest was any ED visit or hospitalization for arrhythmia or tachycardia. The secondary outcome of interest was any visit or hospitalization for stroke or MI.
Highly prevalent conditions in this cohort included diabetes (35.4%) and hypertension (78.3%).
“Our study was needed because clinical trials often don’t include patients who have multiple comorbidities, especially multiple cardiovascular risks,” Tadrous said in an interview. “In our cohort, we found that the population was obviously much different, much more complex than the clinical trial population. Our results give prescribers a bit more confidence to prescribe these drugs in their regular practice guided by more information on the cardiovascular risks associated with the treatment.”
At 1 year, the cumulative incidence of tachycardia or arrhythmia events was similar in patients prescribed mirabegron and those prescribed other drugs (3.6% vs. 3.8%, respectively; HR = 0.93; 95% CI, 0.8-1.09). Compared with other drugs, mirabegron was not linked to an increased risk for stroke or MI (HR = 1.06; 95% CI, 0.89-1.27).
Consistent results were seen in subgroup analyses for patients treated with mirabegron or other drugs (2.4% vs. 2.3%, respectively; HR = 0.95; 95% CI, 0.75-1.2).
“We explored a subpopulation of people who were at higher risk,” Tadrous told Cardiology Today. “We are a little bit concerned that this population may not have been big enough, so continued monitoring of those patients at the highest risk is necessary. With any observational studies, replication with other jurisdictions outside of Ontario is necessary as well.” – by Darlene Dobkowski
For more information:
Mina Tadrous, PharmD, PhD, can be reached at Women’s College Research Institute, Women’s College Hospital, 76 Grenville St., Toronto, ON M5S 1B2; email: mina.tadrous@wchospital.ca.
Disclosures: Tadrous reports he received grants from the Ministry of Health and Long-Term Care during the study. Please see the study for all other authors’ relevant financial disclosures.
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