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
| العنوان: | 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 |
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| المؤلفون: | Adrian Wagg, David R. Staskin, Sender Herschorn, Carol R. Schermer, Rita M Kristy |
| المصدر: | Drugs & Aging |
| بيانات النشر: | Springer Science and Business Media LLC, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | 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 |
| الوصف: | 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 |
| تدمد: | 1179-1969 1170-229X |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::952cabf2e7ecf15f6f4812d7ae1a0624 https://doi.org/10.1007/s40266-020-00783-w |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....952cabf2e7ecf15f6f4812d7ae1a0624 |
| قاعدة البيانات: | OpenAIRE |
Find this article in full text from Springer Verlag. | تدمد: | 11791969 1170229X |
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