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Zavegepant for Acute Treatment of Migraine: A Systematic Review and Meta-analysis of Randomized Controlled Trials.
Suresh, Vinay; Bardhan, Mainak; Dave, Tirth; Shamim, Muhammad Aaqib; Suresh, Dilip; Satish, Poorvikha; Dhakal, Bishal; Bhonsale, Aman; Roy, Priyanka; Padhi, Bijaya Kumar; Monteith, Teshamae.
Afiliación
  • Suresh V; King George's Medical University, Lucknow, India.
  • Bardhan M; Miami Cancer Institute, Baptist Health South Florida, Miami, FL.
  • Dave T; Bukovinian State Medical University, Chernivtsi, Ukraine.
  • Shamim MA; Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, India.
  • Suresh D; Madras Medical College, Chennai, India.
  • Satish P; St John's Medical College, Bangalore, India.
  • Dhakal B; Bardibas Field Hospital, Nepalese Army Institute of Health Sciences, Kathmandu, Nepal.
  • Bhonsale A; All India Institute of Medical Sciences, Nagpur, India.
  • Roy P; Department of Labour, Government of West Bengal, Kolkata, India.
  • Padhi BK; Department of Community Medicine and School of Public Health, Postgraduate Institute of Medical Education and Research, India.
  • Monteith T; University of Miami, Miller School of Medicine, Miami, FL.
Clin Neuropharmacol ; 47(3): 72-81, 2024.
Article en En | MEDLINE | ID: mdl-38743600
ABSTRACT

OBJECTIVE:

Evaluate the safety and efficacy of zavegepant (BHV-3500), a recently approved nasal spray containing a third-generation calcitonin gene-related peptide receptor antagonist, for treating acute migraine attacks.

METHODS:

A comprehensive search was conducted across various databases up to 06/26/2023 to identify relevant randomized clinical trials (RCTs) on zavegepant's efficacy and safety in treatment of acute migraine attacks. Primary

outcome:

freedom from pain at 2 hours postdose. Safety outcomes were evaluated based on adverse events (AEs), with zavegepant 10 mg and placebo groups compared for incidence of AEs.

RESULTS:

Two RCTs, involving 2061 participants (1014 receiving zavegepant and 1047 receiving placebo), were quantitatively analyzed. An additional trial was included for qualitative synthesis. Zavegepant 10 mg exhibited a significantly higher likelihood of achieving freedom from pain at 2 hours postdose compared with the placebo group (risk ratio [RR] 1.54, 95% confidence interval [CI] 1.28 to 1.84). It also showed superior relief from the most bothersome symptoms at 2 hours postdose compared with placebo (RR 1.26, 95% CI 1.13 to 1.42). However, the zavegepant 10 mg group experienced a higher incidence of AEs compared with placebo (RR 1.78, 95% CI 1.5 to 2.12), with dysgeusia being the most reported AE (RR 4.18, 95% CI 3.05 to 5.72).

CONCLUSION:

Zavegepant 10 mg is more effective than placebo in treating acute migraine attacks, providing compelling evidence of its efficacy in relieving migraine pain and most bothersome associated symptoms. Further trials are necessary to confirm its efficacy, tolerability, and safety in diverse clinic-based settings with varied patient populations.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Ensayos Clínicos Controlados Aleatorios como Asunto / Antagonistas del Receptor Peptídico Relacionado con el Gen de la Calcitonina / Trastornos Migrañosos Límite: Humans Idioma: En Revista: Clin Neuropharmacol Año: 2024 Tipo del documento: Article País de afiliación: India Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Ensayos Clínicos Controlados Aleatorios como Asunto / Antagonistas del Receptor Peptídico Relacionado con el Gen de la Calcitonina / Trastornos Migrañosos Límite: Humans Idioma: En Revista: Clin Neuropharmacol Año: 2024 Tipo del documento: Article País de afiliación: India Pais de publicación: Estados Unidos