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April 20, 2026Investigative and Clinical UrologyOpen Access

Selebeta PR linked to significant SBP increases in ~9% of overactive bladder patients.

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Why the study?

The study aimed to evaluate the safety, including blood pressure changes, and medication compliance associated with a generic prolonged-release formulation of mirabegron in Korean adults with overactive bladder.

Does mirabegron prolonged-release 50 mg once daily increase blood pressure in adults with overactive bladder?

Population

2,091 Korean adults with overactive bladder

Design

Multicenter, retrospective observational study

Follow-up

3 months

Key result

In adults with overactive bladder, treatment with Selebeta PR 50 mg for 3 months resulted in a systolic blood pressure increase of ≥10 mmHg in 8.8% of patients.

Authors

JLJ H LeeAKA Reum KimJSJi Sung Shim

Discussion

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Overview

Reassures clinicians on BP safety during OAB therapy; extends RCT data with real-world Korean cohort evidence.

Key Points

  • The study aimed to assess safety and medication compliance associated with Selebeta PR in overactive bladder patients, focusing on blood pressure changes.
  • Retrospective observational study design across 95 medical institutions.
  • Included patients with overactive bladder prescribed Selebeta PR for at least 3 months.
  • Primary endpoint was the percentage of patients experiencing an increase in systolic blood pressure.
  • 8.8% of patients had an SBP increase of 10 mmHg after treatment.
  • Significant improvements in OAB symptoms were noted in patients with available scores.
  • Overall adverse events incidence was low at 2.1%, with predominantly mild events.

Study Design

Type

Observational (n=2,091)

Multicenter

Yes

Structured PICO

Does mirabegron prolonged-release 50 mg once daily increase blood pressure in adults with overactive bladder?

P
Population
2,091 Korean adults (≥19 years) with overactive bladder (OAB) who were prescribed Selebeta PR once daily for at least 3 months. Mean age 67.5, 71.1% male.
I
Intervention
Mirabegron prolonged-release tablets 50 mg (Selebeta PR) oral once daily for at least 3 months
O
Outcome
Proportion of patients with an increase in systolic blood pressure (SBP) of ≥10 mmHg after 3 months of treatmentsafety

Generic mirabegron 50 mg is well-tolerated in adults with overactive bladder, with a low incidence of clinically meaningful blood pressure elevation and adverse events in real-world practice.

Limitations

  • Noninterventional nature cannot establish causal relationship between mirabegron administration and changes in blood pressure
  • Blood pressure values extracted from routine clinical records without standardized measurement conditions
  • Observation period limited to 3 months, which may not be sufficient to assess long-term cardiovascular safety
  • Only 8.9% of the total study population had complete OABSS data available for symptom improvement analysis
  • High rates of missing data for key lifestyle variables such as smoking and alcohol consumption
  • Extremely small number of patients using antihypertensive medication resulted in unstable regression estimates
  • Medication compliance assessed indirectly based on proportion of days covered (PDC)
  • Specific clinical reasons for treatment discontinuation based on physician decision were not consistently documented
  • Noninterventional nature cannot establish causality or fully control confounding factors
  • Blood pressure values extracted from routine clinical records, not standardized
  • Observation period limited to 3 months
  • Only 8.9% had complete OABSS data available for symptom improvement analysis
  • High rates of missing data for lifestyle variables (smoking, alcohol)
  • Extremely small number of patients using antihypertensive medication
  • Medication compliance assessed via PDC (indirect measure)
  • Reasons for discontinuation not consistently documented

Cite This Study

Lee et al. (2026) conducted an observational in Overactive bladder (n=2,091). Selebeta PR (mirabegron) was evaluated on Proportion of patients with an increase in systolic blood pressure (SBP) ≥10 mmHg after 3 months of treatment. In adults with overactive bladder, treatment with Selebeta PR 50 mg for 3 months resulted in a systolic blood pressure increase of ≥10 mmHg in 8.8% of patients.

synapsesocial.com/papers/69e5c22d03c2939914028979https://doi.org/10.4111/icu.20250489
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