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Overactive Bladder

Mirabegron is supposed to raise blood pressure. In 2,091 Korean patients, 8.8 percent saw a rise of 10 mmHg or more

95 institutions, three months of treatment, and a set of thresholds rather than an average. 2.3 percent rose by 20 mmHg or more — which is the figure a hypertensive patient should be given.

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In short

In a retrospective multicentre observational study of 2,091 Korean adults with overactive bladder prescribed a generic prolonged-release mirabegron 50 mg once daily for at least three months across 95 medical institutions between July 2020 and July 2021, 8.8 percent had an increase in systolic blood pressure of 10 mmHg or more after three months, 3.7 percent an increase of 15 mmHg or more and 2.3 percent of 20 mmHg or more, while diastolic pressure rose by 5 mmHg or more in 16.8 percent and by 10 mmHg or more in 6.7 percent, with adverse events in 2.1 percent and mean medication coverage of 73.6 percent.

Key takeaways

  • 2,091 Korean adults with overactive bladder were treated with prolonged-release mirabegron 50 mg daily for at least three months across 95 medical institutions.
  • Systolic blood pressure rose by 10 mmHg or more in 8.8 percent of patients after three months.
  • The rise reached 15 mmHg or more in 3.7 percent and 20 mmHg or more in 2.3 percent.
  • Diastolic pressure rose by 5 mmHg or more in 16.8 percent and by 10 mmHg or more in 6.7 percent.
  • Overall adverse event incidence was 2.1 percent, and the events were mostly mild.
  • Mean medication coverage — the share of the period actually covered by dispensed drug — was 73.6 percent.
  • Overactive bladder symptoms improved significantly in the subgroup for which symptom scores were available.

The blood pressure warning attached to mirabegron is the main reason clinicians hesitate over it, and it is usually communicated as a mean change of a few millimetres of mercury. A mean is the wrong shape for this question. Nobody is harmed by an average; they are harmed by being one of the people at the top of the distribution.

Thresholds instead of an average

8.8% / 3.7% / 2.3%

share of 2,091 Korean patients whose systolic blood pressure rose by 10, 15 and 20 mmHg or more after three months on mirabegronLee JH et al., Investigative and Clinical Urology, 2026

Reported this way the finding becomes usable. Roughly one patient in eleven will see a systolic rise of at least 10 mmHg, one in twenty-seven at least 15, and one in forty-three at least 20. The diastolic figures are higher at the lower threshold — 16.8 percent rose by 5 mmHg or more — and fall to 6.7 percent at 10 mmHg.

The authors' summary is that there was no clinically meaningful increase in blood pressure, and across the cohort that is defensible. It is also the kind of statement that a patient with poorly controlled hypertension should not be handed without the distribution behind it, because the 2.3 percent is where the clinical decision actually lives.

What has no control group here either

This is retrospective and uncontrolled. Blood pressure measured at a clinic three months apart moves for reasons that have nothing to do with a bladder drug — season, time of day, cuff, white-coat effect, whether the patient walked in. Some proportion of the 8.8 percent is that noise. Without an untreated comparison group the study cannot say how much, and it does not claim to.

The compliance number

Mean medication coverage was 73.6 percent, meaning patients held dispensed drug for roughly three-quarters of the period they were nominally being treated. That is a quietly important figure for interpreting everything else in the study: a quarter of the exposure being measured did not happen, which pushes both the efficacy and the blood pressure findings towards the null.

Sources

  1. 1

    Lee JH, Kim A, Shim JS, Ko KJ

    Blood pressure increases and other safety and medication compliance in overactive bladder patients treated with Selebeta PR tablets: A noninterventional, multicenter, retrospective observational study

    Investigative and Clinical Urology 2026;67(3):273-280

    doi:10.4111/icu.20250489 · PMID:42065663

    https://doi.org/10.4111/icu.20250489
  2. 2

    Lee KS, Cho J, Kang D, Ko KJ, Foo CY, Stoelzel M, Hadi FA, Kim S

    A Retrospective Database Analysis of Anticholinergic Burden Among Older Patients With and Without Overactive Bladder in South Korea

    International Neurourology Journal 2025;29(3):188-196

    doi:10.5213/inj.2550112.056 · PMID:41077792

    https://doi.org/10.5213/inj.2550112.056