Welcome to What’s it Worth! Join your host Dr. Diana Langworthy as we co-mingle with co-primary clues! Our expert guest for this episode is Dr. Natalie Heinrich, Medication Therapy Management Clinical Pharmacist in Neurology at M Health Fairview. We're discussing a trial evaluated the efficacy of zavegepant, a novel CGRP antagonist for nasal administration, for the treatment of acute migraine attack. Join us as we discuss the key points of co-primary outcomes, populations and power.
Key Points
- Migraine disease affects 1 in 6 Americans and is a leading cause of disability
- Triptan medications have been used for decades to treat migraine attacks, yet they have several contraindications due to vasoconstrictive effects
- CGRP inhibitors are a new class of medications that target a specific peptide involved in migraine disease pathophysiology
- Treatment for some disease states requires studies that involve two co-primary outcomes that are deemed equally important to determine true efficacy of an intervention
- Does migraine disease fit the co-primary mold and is zavegepant ready for the migraine toolbox? --> Tune in to find out!
References
- [EPISODE TRIAL] Lipton RB, Croop R, Stock DA, et al. Safety, tolerability, and efficacy of zavegepant 10mg nasal spray for the acute treatment of migraine in the USA: a phase 3, double-blind, randomised, placebo-controlled multicentre trial. Lancet Neurol 2023;22(3):209-217.
- Croop R, Madonia J, Stock DA, et al. Zavegepant nasal spray for the acute treatment of migraine: a phase 2/3 double-blind, randomized, placebo-controlled, dose-ranging trial. Headache 2022;62:1153-1163.
- Product Information: Zavzpret(R), zavegepant 10mg/1 nasal spray. Pfizer Laboratories Div Pfizer Inc, New York, NY. 2023.
- Ailani J, Burch RC, Robbins MS, et al. The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice. Headache 2021;61:1021-1039.
- Burch R, Rizzoli P, Loder E. The Prevalence and Impact of Migraine and Severe Headache in the United States: Figures and Trends from Government Health Studies. Headache 2018;58(4):496-505.
Contact Information
Podcast email: whatsitworthpodcast@gmail.com
Host Information
Dr. Diana R. Langworthy, PharmD, BCPS
Clinical Associate Professor, University of Minnesota College of Pharmacy
Clinical Pharmacist - Inpatient Internal Medicine, M Health Fairview East Bank Hospital
Expert Guest Information
Dr. Natalie Heinrich, PharmD
Medication Therapy Management Clinical Pharmacist, Neurology
Clinics and Surgery Center, M Health Fairview
