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
| Autor: | Adrian Wagg, David R. Staskin, Sender Herschorn, Carol R. Schermer, Rita M Kristy |
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| Rok vydání: | 2020 |
| Předmět: |
Diarrhea
Male medicine.medical_specialty Placebo-controlled study Adrenergic beta-3 Receptor Agonists Placebo Severity of Illness Index law.invention 03 medical and health sciences 0302 clinical medicine Double-Blind Method Randomized controlled trial law Internal medicine medicine Humans Pharmacology (medical) Original Research Article 030212 general & internal medicine Adverse effect Aged Dose-Response Relationship Drug Urinary Bladder Overactive business.industry Age Factors Headache Middle Aged medicine.disease Clinical trial Thiazoles Treatment Outcome Urinary Incontinence Tolerability Overactive bladder Acetanilides Female Geriatrics and Gerontology Mirabegron business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Drugs & Aging |
| ISSN: | 1179-1969 1170-229X |
| DOI: | 10.1007/s40266-020-00783-w |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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