Mirabegron Use in Hypertensive Patients
Mirabegron is NOT contraindicated in patients with well-controlled hypertension, but it IS contraindicated in severe uncontrolled hypertension (systolic ≥180 mmHg and/or diastolic ≥110 mmHg). 1
FDA-Approved Contraindication
- Severe uncontrolled hypertension (systolic BP ≥180 mmHg and/or diastolic BP ≥110 mmHg) is the only hypertension-related contraindication for mirabegron. 1
- The FDA label explicitly states that mirabegron is "not recommended for use in patients with severe uncontrolled hypertension" but does not prohibit use in patients with controlled or mild-to-moderate hypertension. 1
Blood Pressure Effects: What to Expect
- In healthy volunteers, mirabegron 50 mg caused mean increases of approximately 3.5/1.5 mmHg (systolic/diastolic) compared to placebo. 1
- However, in actual OAB patients taking mirabegron as monotherapy, the mean increase was much smaller: approximately 0.5 to 1 mmHg greater than placebo at the 50 mg dose. 1
- Real-world data from 263 OAB patients showed no significant change in systolic BP overall after 12 weeks of mirabegron, though 20.2% of patients experienced an increase ≥10 mmHg (more common in elderly patients ≥65 years). 2
- A meta-analysis of seven RCTs comparing mirabegron to antimuscarinics found no statistical difference in hypertension events, BP changes from baseline, or BP changes from placebo. 3
Clinical Algorithm for Use in Hypertensive Patients
Well-Controlled Hypertension (BP <130/80 mmHg)
- Mirabegron may be used safely with close BP monitoring. 4
- Periodic blood pressure determinations are recommended throughout treatment. 1
- In a study of 46 women with well-controlled hypertension, 73.6% had improvement in OAB symptoms, and only 3 patients (6.5%) experienced BP increases requiring discontinuation. 4
Uncontrolled but Non-Severe Hypertension (BP 140-179/<110 mmHg)
- Optimize antihypertensive therapy first before initiating mirabegron. 5
- Ensure medication adherence, maximize antihypertensive doses, and eliminate other BP-elevating substances. 5
- Once BP is controlled, mirabegron may be initiated with frequent BP monitoring (weekly for first month, then monthly). 6, 1
Severe Uncontrolled Hypertension (BP ≥180/110 mmHg)
- Do NOT prescribe mirabegron. This is an absolute contraindication per FDA labeling. 1
- Consider antimuscarinic agents (e.g., tolterodine, solifenacin) as alternatives, which do not affect blood pressure. 3
Monitoring Requirements
- Periodic blood pressure monitoring is mandatory in all hypertensive patients taking mirabegron, especially during the first 4-8 weeks of therapy. 6, 1
- The European Association of Urology specifically recommends monitoring BP periodically in hypertensive patients, as mirabegron may cause BP increases. 6
- Home BP monitoring may aid in earlier detection of worsening control in the small segment of patients who develop hypertension on mirabegron. 4
Comparative Safety Profile
- Mirabegron has a similar incidence of hypertension adverse events compared to placebo in clinical trials. 7
- The overall incidence of adverse events is similar between mirabegron and tolterodine, but mirabegron causes significantly less dry mouth than antimuscarinic agents. 7, 3
- In European real-world data from 52,078 patients, only 0.3-1.3% had severe uncontrolled hypertension at mirabegron initiation, suggesting clinicians are appropriately avoiding use in contraindicated patients. 8
Common Pitfalls to Avoid
- Do not assume all hypertensive patients are contraindicated – only those with severe uncontrolled hypertension (≥180/110 mmHg) are excluded. 1
- Do not fail to monitor BP – even patients with well-controlled hypertension can develop BP elevations (occurs in ~20% of patients, more common in elderly). 2
- Do not continue mirabegron if BP becomes uncontrolled – discontinue immediately if BP rises to severe levels or cannot be controlled with antihypertensive adjustments. 4
- Elderly patients (≥65 years) are at higher risk for BP increases and require more vigilant monitoring. 2