Does Mirabegron Cause Hypotension?
No, mirabegron does not cause hypotension; instead, it is associated with small increases in blood pressure and is contraindicated in patients with severe uncontrolled hypertension. 1
Cardiovascular Effects of Mirabegron
Blood Pressure Changes
Mirabegron can cause dose-dependent increases in systolic blood pressure, not decreases, which is why blood pressure monitoring is recommended during initial treatment. 2
In real-world clinical practice, approximately 20% of patients experienced an increase in systolic blood pressure of ≥10 mmHg after 12 weeks of mirabegron treatment, with older patients (≥65 years) at higher risk (23.4% vs 7.4% in younger patients). 3
Diastolic blood pressure may actually decrease slightly with mirabegron treatment, particularly in older patients (mean decrease of 2.0 mmHg in patients ≥65 years). 3
Ambulatory blood pressure monitoring in the SYNERGY trial showed no consistent increases in mean 24-hour systolic or diastolic blood pressure with mirabegron monotherapy or combination therapy compared to placebo over 12 weeks. 4
Heart Rate Effects
Mean heart rate increased by only 1.24 beats per minute after 4 weeks of mirabegron treatment in Japanese patients with cardiovascular disease—a statistically significant but clinically acceptable change. 5
The 24-hour heart rate monitoring showed no significant signals with mirabegron treatment. 4
Safety Profile in Cardiovascular Disease
The most frequent adverse events with mirabegron are hypertension, urinary tract infections, headache, and nasopharyngitis—not hypotension. 1
Pooled analysis of 13,396 patients showed that cardiovascular adverse events occurred at comparable rates with mirabegron (0.4%-1.5%) and placebo (0.9%), with no evidence of increased cardiovascular risk. 6
In patients with well-controlled hypertension, only 6.5% experienced an increase in blood pressure requiring discontinuation of mirabegron. 7
Real-world Japanese patients with overactive bladder and coexisting cardiovascular disease (excluding severe cases) showed a cardiovascular adverse drug reaction incidence of only 5.51% with mirabegron. 5
Clinical Monitoring Recommendations
Blood pressure should be monitored periodically, especially during the initial treatment period, to detect the small subset of patients who may experience clinically significant blood pressure increases. 2
Home blood pressure monitoring may aid in earlier detection of worsening control in the small segment of patients in whom mirabegron causes hypertension. 7
Regular re-evaluation of lower urinary tract symptoms and post-void residual volume is advised, particularly in male patients. 1
Key Clinical Pitfall
The common misconception is that mirabegron causes hypotension; in reality, the concern is hypertension, which is why it is contraindicated in severe uncontrolled hypertension. 1 Clinicians should not withhold mirabegron from patients with orthostatic hypotension or low blood pressure, as it does not worsen these conditions and may even provide a slight increase in blood pressure that could be beneficial in such patients.