ABSTRACT
ABSTRACT The result of more than thirty years of research, anti-CGRP monoclonal antibodies are currently the state of the art for migraine preventive therapy. Their efficacy and safety, supported by an already large and growing body of evidence, are added by many other advantages: an early onset of action, favorable posology, negligible pharmacological interaction, and a broad-reaching efficacy in many challenging clinical contexts. When compared to standard prophylactics, these novel medications seem at least as efficacious, clearly more tolerable and, consequently, with a superior adherence profile. Furthermore, recently published analyses indicate that they are cost-effective, especially among those with chronic migraine. Yet, current guidelines endorse their use only after multiple other preventives have failed or have been deemed not tolerable. Although this recommendation may have been sensible at first, the now available data strongly point that time has come for anti-CGRP monoclonal antibodies to be acknowledged as first-line treatments for migraine patients with severe disability. For these individuals, delaying treatment until several other alternatives have failed incurs in significant losses, both economically and to many relevant aspects of their lives.
RESUMO Frutos de mais de 30 anos de pesquisa, os anticorpos monoclonais anti-CGRP são atualmente o que há de mais moderno no tratamento preventivo da migrânea. À sua eficácia e segurança, já bem estabelecidos por um grande corpo de evidências, acrescentam-se outras vantagens: um início precoce de ação, posologia favorável, mínima interação farmacológica, e eficácia comprovada em uma variedade de contextos clínicos frequentemente desafiadores. Quando comparados a outros profiláticos, estas medicações aparentam ser ao menos tão eficazes, evidentemente mais toleráveis e, portanto, com melhor perfil de adesão. Ademais, estudos recentemente publicados indicam que elas são custo-efetivas, especialmente entre pacientes com migrânea crônica. Ainda assim, as diretrizes atuais orientam o seu uso apenas caso haja refratariedade ou intolerância a múltiplos outros preventivos. Apesar de esta recomendação poder ter sido sensata a priori, os dados disponíveis atualmente corroboram que já é tempo de estes anticorpos monoclonais serem reconhecidos como tratamentos de primeira linha para a migrânea associada à incapacidade grave. Para estes pacientes, demorar a oferecer este tratamento até que outras múltiplas alternativas tenham falhado, leva a perdas significativas, tanto economicamente quanto em múltiplos outros aspectos relevantes das suas vidas.
ABSTRACT
OBJECTIVE：To systemat ically evaluate the efficacy and safety of Ubrogepant and Rimegepant in the treatment of acute migraine ，and to provide evidence-based reference for the clinical treatment. METHODS ：Retrieved from PubMed ，Embase， Cochrane Library ，CNKI，VIP，Wanfang database and Clinicaltrials. gov ，randomized controlled trials （RCTs） about the Ubrogepant and Rimegepant （trial group ）versus placebo （control group ）in the treatment of acute migraine were collected during the inception to Jan. 2020. After literature screening and data extraction ，quality assessment was performed using the bias risk assessment tool provided by the Cochrane system evaluator manual 5.1.0. Meta-analysis was performed by using Stata 16.0 software. RESULTS ：Eight RCTs with a total of 7 989 patients were included. The results of Meta-analysis showed that the proportion of patients who were free from pain at 2 h postdose in Ubrogepant group [RR ＝1.65，95％CI（1.38，1.98），P＜0.001] and Rimegepant group [RR ＝1.69，95％CI（1.46，1.95），P＜0.001]，the proportion of patients who were free from the most bothersome symptom at 2 h postdose in Ubrogepant group [RR ＝1.35，95％ CI（1.20，1.53），P＜0.001] and Rimegepant group [RR ＝1.37，95％CI（1.24，1.51），P＜0.001]，and other secondary outcome indicators （ i.e. the proportion of patients with pain relief at 2 h postdose ，the proportion of patients with sustained freedom from pain from 2-24 h postdose ，the proportion of patients with sustained pain relief from 2-24 h postdose ，the proportion of patients without photophobia at 2 h postdose ，the proportion of patients without phonophobia at 2 h postdose ，the proportion of patients without nausea at 2 h postdose ）were all significantly better than control group （P＜0.05）. In terms of safety ，there was no statistical significance in the incidence of total ADR between Ubrogepant group and control group [RR ＝1.04，95％CI（0.87，1.25），P＝0.646]，but the incidence of total ADR in Rimegepant group were significantly higher than control group [RR ＝1.23，95％ CI（1.01，1.50），P＝0.043]. There was no statistical significance in other security indicators （i.e. incidence of nausea ，dizziness，dry mouth ，somnolence，urinary tract infection）in 2 groups（P＞0.05）. CONCLUSIONS ：Ubrogepant and Rimegepant are effective in the treatment of acute migraine. Ubrogepant is safe ，while Rimegepant may increase the incidence of ADR.