Wang, Shuu-Jiun and Roxas, Artemio A and Saravia, Bibiana and Kim, Byung-Kun and Chowdhury, Debashish and Riachi, Naji and Tai, Mei-Ling Sharon and Tanprawate, Surat and Ngoc, Tai Tran and Zhao, Yi Jing and Mikol, Daniel D and Pandhi, Shaloo and Wen, Shihua and Mondal, Subhayan and Tenenbaum, Nadia and Hours-Zesiger, Peggy (2021) Randomised, controlled trial of erenumab for the prevention of episodic migraine in patients from Asia, the Middle East, and Latin America: The EMPOwER study. Cephalalgia, 41 (13). pp. 1285-1297. ISSN 0333-1024, DOI https://doi.org/10.1177/03331024211024160.
Full text not available from this repository.Abstract
Objective EMPOwER, a double-blind, randomised, phase 3 study, evaluated the efficacy and safety of erenumab in adults with episodic migraine from Asia, the Middle East, and Latin America. Methods Randomised patients (N = 900) received monthly subcutaneous injections of placebo, erenumab 70 mg, or 140 mg (3:3:2) for 3 months. Primary endpoint was change from baseline in monthly migraine days at Month 3. Other endpoints included achievement of >= 50%, >= 75%, and 100% reduction in monthly migraine days, change in monthly acute migraine-specific medication treatment days, patient-reported outcomes, and safety assessment. Results At baseline, mean (standard deviation) age was 37.5 (9.9) years, 81.9% were women, and monthly migraine days was 8.2 (2.8). At Month 3, change from baseline in monthly migraine days (primary endpoint) was -3.1, -4.2, and -4.8 days for placebo, erenumab 70 mg, and erenumab 140 mg, respectively, with a statistically significant difference for erenumab versus placebo (P = 0.002 [70 mg], P < 0.001 [140 mg]). Both erenumab doses were also significantly superior to placebo on all secondary endpoints, including the proportion of patients achieving >= 50% reduction from baseline in monthly migraine days, change from baseline in monthly acute migraine-specific medication treatment days and change from baseline in the Headache Impact Test-6 (TM) scores. The safety profile of erenumab was comparable with placebo; no new safety signals were observed. Conclusions This study of erenumab in patients with episodic migraine from Asia, the Middle East, and Latin America met all primary and secondary endpoints. A consistent numerical benefit was observed with erenumab 140 mg versus erenumab 70 mg across all efficacy endpoints. These findings extend evidence of erenumab's efficacy and safety to patients under-represented in previous trials. ClinicalTrials.gov identifier: NCT03333109
| Item Type: | Article |
|---|---|
| Funders: | Novartis Pharma AG, Basel, Switzerland |
| Uncontrolled Keywords: | Asia; Calcitonin gene-related peptide; Episodic migraine; Erenumab; Latin America; Randomised controlled trial |
| Subjects: | R Medicine R Medicine > RS Pharmacy and materia medica |
| Depositing User: | Ms. Juhaida Abd Rahim |
| Date Deposited: | 22 Feb 2022 03:46 |
| Last Modified: | 22 Feb 2022 03:46 |
| URI: | http://eprints.um.edu.my/id/eprint/26231 |
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