Calcitonin gene-related peptide receptor antagonist ubrogepant for the treatment of acute migraine: A meta-analysis.
Journal
Medicine
ISSN: 1536-5964
Titre abrégé: Medicine (Baltimore)
Pays: United States
ID NLM: 2985248R
Informations de publication
Date de publication:
26 Feb 2021
26 Feb 2021
Historique:
received:
06
09
2020
accepted:
16
01
2021
entrez:
5
3
2021
pubmed:
6
3
2021
medline:
17
3
2021
Statut:
ppublish
Résumé
The objective of this study is to systematically evaluate the efficacy and safety of the calcitonin gene-related peptide (CGRP) receptor antagonist ubrogepant for the treatment of acute migraine. Randomized controlled trials (RCTs) of ubrogepant for treatment of acute migraine were identified in PubMed, MEDLINE, EMBASE, and the Cochrane Library from database establishment to June 2020; we also searched ClinicalTrials.gov manually during the same period. Then, RevMan 5.3 software was used to perform a meta-analysis on each outcome measure. A total of 5 RCTs involving 4903 patients were included; there were 3358 cases in the ubrogepant group and 1545 cases in the placebo group. The meta-analysis showed the following results: at 2 hours postdose, the percentages of participants reporting pain relief and the absence of photophobia, nausea, and phonophobia were significantly higher in the ubrogepant group than in the placebo group (odds ratio [OR] = 1.71, 95%CI: 1.48-1.97, P < .00001; OR = 1.33, 95%CI: 1.22-1.45, P < .00001; OR = 1.07, 95%CI: 1.03-1.11, P = .0006; OR = 1.21, 95%CI: 1.14-1.28, P < .00001). The incidence of common adverse events was similar between the 2 groups (P > .05). Ubrogepant is effective and safe for the treatment of acute migraine. PROSPERO CRD42019145286.
Sections du résumé
BACKGROUND
BACKGROUND
The objective of this study is to systematically evaluate the efficacy and safety of the calcitonin gene-related peptide (CGRP) receptor antagonist ubrogepant for the treatment of acute migraine.
METHODS
METHODS
Randomized controlled trials (RCTs) of ubrogepant for treatment of acute migraine were identified in PubMed, MEDLINE, EMBASE, and the Cochrane Library from database establishment to June 2020; we also searched ClinicalTrials.gov manually during the same period. Then, RevMan 5.3 software was used to perform a meta-analysis on each outcome measure.
RESULTS
RESULTS
A total of 5 RCTs involving 4903 patients were included; there were 3358 cases in the ubrogepant group and 1545 cases in the placebo group. The meta-analysis showed the following results: at 2 hours postdose, the percentages of participants reporting pain relief and the absence of photophobia, nausea, and phonophobia were significantly higher in the ubrogepant group than in the placebo group (odds ratio [OR] = 1.71, 95%CI: 1.48-1.97, P < .00001; OR = 1.33, 95%CI: 1.22-1.45, P < .00001; OR = 1.07, 95%CI: 1.03-1.11, P = .0006; OR = 1.21, 95%CI: 1.14-1.28, P < .00001). The incidence of common adverse events was similar between the 2 groups (P > .05).
CONCLUSION
CONCLUSIONS
Ubrogepant is effective and safe for the treatment of acute migraine.
REGISTRATION NUMBER
BACKGROUND
PROSPERO CRD42019145286.
Identifiants
pubmed: 33663087
doi: 10.1097/MD.0000000000024741
pii: 00005792-202102260-00050
pmc: PMC7909234
doi:
Substances chimiques
Calcitonin Gene-Related Peptide Receptor Antagonists
0
Pyridines
0
Pyrroles
0
ubrogepant
AD0O8X2QJR
Types de publication
Journal Article
Meta-Analysis
Langues
eng
Sous-ensembles de citation
IM
Pagination
e24741Subventions
Organisme : Chongqing Science and Technology Commission
ID : cstc2017shmsA130105
Organisme : Chongqing Wanzhou Science and Technology Commission
ID : wzstc-2017002
Informations de copyright
Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.
Déclaration de conflit d'intérêts
The authors have no conflicts of interest to disclose.
Références
Goadsby PJ, Holland PR, Martins-Oliveira M, et al. Pathophysiology of migraine: a disorder of sensory processing. J Physiol Rev 2017;97:553–622. DOI 10.1152/physrev.00034.2015.
doi: 10.1152/physrev.00034.2015
Kelman L. The postdrome of the acute migraine attack. J Cephalalgia 2006;26:214–20. DOI 10.1111/j.1468-2982.2005.01026.x.
doi: 10.1111/j.1468-2982.2005.01026.x
Kelman L, Rains JC. Headache and sleep: examination of sleep patterns and complaints in a large clinical sample of migraineurs. J Headache 2005;45:904–10. DOI 10.1111/j.1526-4610.2005.05159.x.
doi: 10.1111/j.1526-4610.2005.05159.x
Gori S, Lucchesi C, Balacci F, et al. Preferential occurrence of attacks during night sleep and/or upon awakening negatively affects migraine clinical presentation. J Funct Neurol 2015;30:119–23. DOI 10.11138/fneur/2015.30.2.119.
doi: 10.11138/fneur/2015.30.2.119
GBD 2015 Neurological Disorders Collaborator Group. Global, regional, and national burden of neurological disorders during 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Neurol 2017;16:877–97. DOI 10.1016/S1474-4422(17)30299-5.
doi: 10.1016/S1474-4422(17)30299-5
Ashina M. Migraine. N Engl J Med 2020;383:1866–76. DOI 10.1056/NEJMra1915327.
doi: 10.1056/NEJMra1915327
Youssef PE, Mack KJ. Episodic and chronic migraine in children. Dev Med Child Neurol 2020;62:34–41. DOI 10.1111/dmcn.14338.
doi: 10.1111/dmcn.14338
Negro A, Martelletti P. Gepants for the treatment of migraine. J Expert Opin Investig Drugs 2019;28:555–67. DOI 10.1080/13543784.2019.1618830.
doi: 10.1080/13543784.2019.1618830
Dodick D, Lipton RB, Martin V, et al. Consensus statement: cardiovascular safety profile of triptans (5-HT agonists) in the acute treatment of migraine. J Headache 2004;44:414–25. DOI 10.1111/j.1526-4610.2004.04078.x.
doi: 10.1111/j.1526-4610.2004.04078.x
Negro A, Martelletti P. Chronic migraine plus medication overuse headache: two entities or not? J Headache Pain 2011;12:593–601. DOI 10.1007/s10194-011-0388-3.
doi: 10.1007/s10194-011-0388-3
Zhang CB, Zhong XY, Li MY, et al. Meta analysis of the efficacy and safety of galcanezumab in the prophylactic treatment of migraine. J Chin J New Drugs Clin Med 2019;38:367–72. DOI 10.14109/j.cnki.xyylc.2019.06.011.
doi: 10.14109/j.cnki.xyylc.2019.06.011
Gupta S, Mehrotra S, Villalón CM, et al. Characterisation of CGRP receptors in human and porcine isolated coronary arteries: evidence for CGRP receptor heterogeneity. J Eur J Pharmacol 2006;530:107–16. DOI 10.1016/j.ejphar.2005.11.020.
doi: 10.1016/j.ejphar.2005.11.020
Smillie SJ, Brain SD. Calcitonin gene-related peptide (CGRP) and its role in hypertension. J Neuropeptides 2011;45:93–104. DOI 10.1016/j.npep.2010.12.002.
doi: 10.1016/j.npep.2010.12.002
Chan C, Goadsby PJ. Recent advances in pharmacotherapy for episodic migrain. J CNS Drugs 2019;33:1053–71. DOI 10.1007/s40263-019-00665-9.
doi: 10.1007/s40263-019-00665-9
Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions 5.1.0 [updated March 2011]. Section 8:174–218.
Allergan. A pharmacokinetic Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-007). 2012; https://clinicaltrials.gov/ct2/show/NCT01657370
Voss T, Lipton RB, Dodick DW, et al. A phase IIb randomized, double-blind, placebo-controlled trial of ubrogepant for the acute treatment of migraine. J Cephalalgia 2016;36:887–98. DOI 10.1177/0333102416653233.
doi: 10.1177/0333102416653233
Lipton RB, Dodick DW, Ailani J, et al. Effect of ubrogepant vs placebo on pain and the most bothersome associated symptom in the acute treatment of migraine: the ACHIEVE II randomized clinical trial. JAMA 2019;322:1887–98. DOI 10.1001/jama.2019.16711.
doi: 10.1001/jama.2019.16711
Dodick DW, Lipton RB, Ailani J, et al. Ubrogepant for the treatment of migraine. J N Engl J Med 2019;381:2230–41. DOI 10.1056/NEJMoa1813049.
doi: 10.1056/NEJMoa1813049
Goadsby PJ, Tepper SJ, Watkins PB. Safety and tolerability of ubrogepant following intermittent, high-frequency dosing: randomized, placebo-controlled trial in healthy adults. J Cephalalgia 2019;39:1753–61. DOI 10.1177/0333102419869918.
doi: 10.1177/0333102419869918
Do TP, Guo S, Ashina M. Therapeutic novelties in migraine: new drugs, new hope? J Headache Pain 2019;20:37DOI 10.1186/s10194-019-0974-3.
doi: 10.1186/s10194-019-0974-3
Allergan. An extension study to evaluate the long-term safety and tolerability of ubrogepant in the treatment of migraine. https://clinicaltrials.gov/ct2/show/NCT02873221 , 2018