First head-to-head study comparing Aimovig, an anti-CGRP pathway therapy, to topiramate for episodic and chronic migraine is published in Cephalalgia.
Topiramate is one of the most commonly prescribed medications in migraine prevention with an estimated 600,000 new-to-brand prescriptions written in the U.S. each year. Published in Cephalalgia, the results of the study conducted by Novartis showed that patients in the Aimovig treatment arm experienced a significantly lower discontinuation rate due to adverse events and superior efficacy, with a greater proportion of patients achieving at least a 50 percent reduction from baseline in their monthly migraine days (MMDs), compared with topiramate.
In this head-to-head Phase IV study, patients in the Aimovig arm demonstrated a significantly lower discontinuation rate due to adverse events versus patients in the topiramate arm (10.6% versus 38.9%) . Additionally, significantly more patients in the Aimovig arm achieved at least a 50% reduction from baseline in their MMDs than those in the topiramate group (55.4% versus 31.2%).
In the topiramate group, the most frequent adverse events that led to discontinuation of the study medication were paraesthesia, disturbance in attention, fatigue, and nausea. In the Aimovig group, these were fatigue, nausea, disturbance in attention and dizziness. Additional study treatment-related adverse events reported by greater then 2% in any trial group included constipation, decreased appetite, taste disorder, vertigo, dysgeusia, weight loss, dry mouth, irritability, mood swings, diarrhea, depression, sleep disorder, depressed mood, hypoesthesia, upper abdominal pain, aphasia, insomnia, memory impairment, dyspepsia, dysesthesia and headache.
"We're extremely encouraged by these new results, which demonstrate lower discontinuation rates due to adverse events and superior efficacy versus topiramate in migraine prevention and strengthen our confidence that Aimovig has significant potential to help many more patients living with migraine," said Rob Lenz, M.D., Ph.D., senior vice president of Global Development at Amgen.
Migraine is a highly debilitating disease that has a significant impact on people's lives, including time spent with family and friends, or at work. Aimovig is the first FDA-approved migraine preventive treatment that targets the CGRP receptor. It is self-administered once monthly subcutaneously via the SureClick autoinjector, does not require a loading dose and is easy to use.
See-Reuter U, Ehrlich M, Gendolla A, et al. "Erenumab versus topiramate for the prevention of migraine – a randomized, double-blind, active-controlled phase 4 trial". Cephalalgia. November 2021.
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