Safety and Tolerability Results from the PILLAR Study: A Phase IV, Double-Blind, Randomized, Placebo-Controlled Study of
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ORIGINAL RESEARCH ARTICLE
Safety and Tolerability Results from the PILLAR Study: A Phase IV, Double‑Blind, Randomized, Placebo‑Controlled Study of Mirabegron in Patients ≥ 65 years with Overactive Bladder‑Wet Sender Herschorn1 · David Staskin2 · Carol R. Schermer3 · Rita M. Kristy3 · Adrian Wagg4
© The Author(s) 2020
Abstract Background In older patients with overactive bladder (OAB), mirabegron, a β3-adrenoreceptor agonist, represents an alternative treatment that may have a favorable risk–benefit profile. Objectives Our objective was to further examine the safety and tolerability of mirabegron versus placebo treatment in patients aged ≥ 65 years with OAB-wet. Methods We conducted a 12-week, double-blind, randomized, placebo-controlled phase IV study to compare mirabegron with placebo. Community-dwelling patients aged ≥ 65 years with OAB-wet (one or more incontinence episode and three or more urgency episodes, and an average of eight or more micturitions/24 h over a 3-day diary) were randomized to receive placebo or mirabegron 25 mg/day (optional dose escalation to 50 mg/day at week 4 or 8). Safety analyses were performed for adverse events (AEs) and vital signs on all randomized patients who received one or more dose of study drug. Results Treatment-emergent AEs (TEAEs), the majority mild or moderate in severity, were reported in 39.4% of placebo patients and 44.2 and 49.8% of those who received mirabegron 25 mg or 50 mg, respectively. The most common TEAEs in mirabegron-treated patients were urinary tract infection, headache, and diarrhea. The incidence of TEAEs was slightly higher in mirabegron patients aged ≥ 75 years than in those aged 140 mmHg and/or the average diastolic blood pressure (DBP) was > 90 mmHg at two consecutive visits after baseline in patients who were normotensive (average SBP 10 mmHg at two consecutive visits as compared with baseline (visit 3) in patients with hypertension at baseline (visit 3). 3. If treatment with antihypertensive drugs was initiated for treatment of hypertension or if the dose of prior antihypertensive drugs was increased due to an increase in blood pressure.
PILLAR was a double-blind, randomized, placebo-controlled, parallel group, multicenter, 12-week phase IV study (NCT02216214) designed to evaluate mirabegron in a flexible dosing regimen compared with placebo. The study was
The investigator could report an AE of “increased” blood pressure if the above conditions were not met but a high blood pressure was recorded. An AE of tachycardia was considered if resting heart rate (pulse rate) was > 100 bpm.
Safety and Tolerability Results from PILLAR: Mirabegron in Patients ≥65 years with OAB-Wet
For home blood pressure monitoring, validated devices and detailed operating instructions for measuring blood pressure and pulse rate were provided to patients. Patients measured their blood pressure and pulse rate three times, each about 2 min apart for 3 days prior to each study visit. Measurements were recorded in the morning before breakfast prior to taking study
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