Safety and Efficacy of Mirabegron: Analysis of a Large Integrated Clinical Trial Database of Patients with Overactive Bladder Receiving Mirabegron, Antimuscarinics, or Placebo

Autor: Nurul Choudhury, Sender Herschorn, Matthias Stoelzel, John Heesakkers, Christopher R. Chapple, Linda Cardozo, Francisco Cruz, Emad Siddiqui, David R. Staskin
Rok vydání: 2020
Předmět:
Male
medicine.medical_specialty
Databases
Factual
Tolterodine Tartrate
Urology
030232 urology & nephrology
MEDLINE
Adrenergic beta-3 Receptor Agonists
Muscarinic Antagonists
Placebo
03 medical and health sciences
0302 clinical medicine
All institutes and research themes of the Radboud University Medical Center
Double-Blind Method
Internal medicine
medicine
Nocturia
Humans
Medical history
Aged
Solifenacin
Urinary Bladder
Overactive
business.industry
Solifenacin Succinate
Middle Aged
medicine.disease
Clinical trial
Thiazoles
Editorial Commentary
Treatment Outcome
Reconstructive and regenerative medicine Radboud Institute for Molecular Life Sciences [Radboudumc 10]
Reproductive Medicine
Overactive bladder
030220 oncology & carcinogenesis
Acetanilides
Female
Tolterodine
medicine.symptom
Mirabegron
business
medicine.drug
Zdroj: European Urology, 77, 119-128
European Urology, 77, 1, pp. 119-128
Transl Androl Urol
ISSN: 0302-2838
DOI: 10.1016/j.eururo.2019.09.024
Popis: Mirabegron, a β3-adrenoreceptor agonist, is an alternative drug to antimuscarinics for overactive bladder (OAB) symptoms.To summarise safety and efficacy reporting of mirabegron treatment for OAB symptoms.Pooled data analysed from 10 phase 2-4, double-blind, 12-wk mirabegron monotherapy studies in adults with OAB who had received one or more doses of study drug.Mirabegron: 25 and 50mg; antimuscarinics: solifenacin (2.5, 5, and 10mg) and tolterodine extended release (4mg).Baseline OAB-related characteristics, intrinsic and extrinsic factors, and analyses by age (65 vs ≥65yr and75 vs ≥75yr) and sex were assessed. Solifenacin 2.5 and 10mg groups were not included in the efficacy analyses (small patient numbers). Safety was evaluated using the proportion of treatment-emergent adverse events. Efficacy variables were derived from bladder diaries (baseline and week 12).Baseline hypertension and diabetes were more frequent across treatment groups in the older versus younger age groups and in men versus women. Within sexes, frequencies were similar between treatment groups. Some differences were observed in baseline characteristics, including type of incontinence and medical history between sexes. No previously unreported safety concerns were identified. Improvements in efficacy (mean number of incontinence episodes/24h, micturitions/24h, urgency episodes/24h, volume voided/micturition, and nocturia episodes) versus placebo were observed in all treatment groups. Significant treatment-by-subgroup interactions included change from baseline in the mean number of incontinence episodes/24h by age (65 vs ≥65yr), nocturia by age (65 vs ≥65yr and75 vs ≥75yr), and urgency episodes by previous OAB medication.Data from this integrated database of 10 mirabegron studies reaffirm the safety and efficacy profiles of mirabegron, solifenacin, and tolterodine in adults of different age groups and sexes.Overactive bladder is a complex of symptoms including a compelling desire to pass urine that leads to increased frequency, which may lead to a degree of incontinence if you do not reach the toilet in time and may wake you from sleep. We pooled data from 10 different studies of mirabegron in patients with overactive bladder symptoms, and looked at the effect in the total number of patients who received the treatment, as well as in different age groups and between men and women. No new safety concerns were identified, and mirabegron improved the symptoms of overactive bladder.
Databáze: OpenAIRE
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