OnabotulinumtoxinA Safer, More Effective for Headache Prevention Than Topiramate
SAN FRANCISCO — OnabotulinumtoxinA was found to be more tolerable than topiramate for preventing headache, according to research presented at the American Headache Society's 60th Annual Scientific Meeting, held June 28–July 1, 2018, in San Francisco, California. This randomized, open-label study examined participant reported outcomes, safety, and tolerability of onabotulinumtoxinA and topiramate in adults with chronic migraines.
Subjects in the onabotulinumtoxinA arm (n=140) received a fixed dose every 12 weeks for 36 weeks, while subjects in the topiramate arm (n=142) received 50 to 100 mg per day up to 36 weeks. The efficacy end point, a reduction of at least 50% in headache days by 32 weeks, was greater in the onabotulinumtoxinA arm than the topiramate arm (40% vs 12%).
Safety and tolerability were assessed by adverse event reports, a cognitive verbal fluency test, and a depressive symptom questionnaire at baseline, 12, 24, and 36 weeks. Adverse events were higher in the topiramate arm (76.8%) vs onabotulinumtoxinA arm (45.5%), and drop out rates were higher in the topiramate arm (80.3%) vs the onabotulinumtoxinA arm (14.3%). Nervous system disorders were the most common reason for discontinuation in the topiramate arm and cognitive changes were noted on the verbal fluency test as early as 12 weeks. No new safety concerns were noted in the onabotulinumtoxinA arm, and participants treated with onabotulinumtoxinA even showed slight improvements in cognitive function and depressive symptoms.
The researchers concluded that, “[onabotulinumtoxinA] had a superior tolerability profile versus topiramate based on treatment-related [adverse events] and overall discontinuations.”
Blumenfeld A, Patel AT, Zhao X, Adams AM, Rothrock JF. A multicenter, prospective, randomized, open-label study to compare onabotulinumtoxinA and topiramate for headache prevention in adults with chronic migraine: Patient reported outcomes from the FORWARD Study. Presented at: 2018 American Headache Society Annual Scientific Meeting. June 28-July 1, 2018; San Francisco, CA. Abstract 448961.