Revefenacin, a once-daily, lung-selective, long-acting muscarinic antagonist for nebulized therapy: Safety and tolerability results of a 52-week phase 3 trial in moderate to very severe chronic obstructive pulmonary disease
| العنوان: | Revefenacin, a once-daily, lung-selective, long-acting muscarinic antagonist for nebulized therapy: Safety and tolerability results of a 52-week phase 3 trial in moderate to very severe chronic obstructive pulmonary disease |
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| المؤلفون: | Lorna Dean, Chris N. Barnes, Brett Haumann, Edmund J. Moran, Glenn Crater, James F. Donohue, Edward Kerwin, Srikanth Pendyala, Sanjay Sethi |
| المصدر: | Respiratory Medicine. 153:38-43 |
| بيانات النشر: | Elsevier BV, 2019. |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | Male, Pulmonary and Respiratory Medicine, medicine.drug_class, Vital Capacity, Muscarinic Antagonists, Severity of Illness Index, Cholinergic Antagonists, Pulmonary Disease, Chronic Obstructive, 03 medical and health sciences, 0302 clinical medicine, Forced Expiratory Volume, Bronchodilator, Administration, Inhalation, medicine, Humans, 030212 general & internal medicine, Tiotropium Bromide, Adverse effect, Adrenergic beta-2 Receptor Agonists, Aged, COPD, Lung, business.industry, Nebulizers and Vaporizers, Incidence (epidemiology), Muscarinic antagonist, Drug Tolerance, Middle Aged, medicine.disease, Revefenacin, Bronchodilator Agents, medicine.anatomical_structure, 030228 respiratory system, Tolerability, Case-Control Studies, Anesthesia, Benzamides, Disease Progression, Drug Therapy, Combination, Female, Carbamates, Safety, business, medicine.drug |
| الوصف: | Background Prior replicate 12-week phase 3 trials demonstrated that once-daily doses of revefenacin inhalation solution at 88 μg and 175 μg produced significant bronchodilation over 24 h post dose in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). The objective was to characterize the safety profile of revefenacin 88 μg and 175 μg over 52 weeks of treatment. Methods In this randomized, parallel-group, 52-week trial (NCT02518139), 1055 participants with moderate to very severe COPD received revefenacin 88 μg or 175 μg in a double-blind manner, or open-label active control tiotropium. Results Treatment-emergent adverse events (AEs) were comparable across all treatment groups (n [%] patients; revefenacin 88 μg, 272 [74.7%]; 175 μg, 242 [72.2%]; tiotropium, 275 [77.2%]). Numerically fewer COPD exacerbations (n [%] patients) were observed with revefenacin 175 μg (73 [21.8%]) than with 88 μg (107 [29.4%]) or tiotropium (100 [28.1%]). Serious AEs were comparable with revefenacin 88 μg (58 [15.9%] and tiotropium (58 [16.3%]), but were lower with revefenacin 175 μg (43 [12.8%]), and mortality was low. In patients using revefenacin 88 μg or tiotropium with a concurrent long-acting β-agonist (LABA) product, the incidence of AEs was slightly higher than without concurrent LABA. LABA did not affect the incidence of AEs for patients who received revefenacin 175 μg. Conclusions Revefenacin was generally well tolerated over 52 weeks of treatment, and had a safety profile that supports its use as a long-term once-daily bronchodilator for the nebulized treatment of COPD. |
| تدمد: | 0954-6111 0251-8139 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e70b84fff26e49acca0a271d4e5397b6Test https://doi.org/10.1016/j.rmed.2019.05.010Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....e70b84fff26e49acca0a271d4e5397b6 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 09546111 02518139 |
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