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Higher doses of eptinezumab did not
result in considerable alterations in vital signs or modifications in
concomitant cardiovascular medication usage and exhibited a low occurrence of
cardiovascular TEAEs.
In adults with episodic or chronic migraine, eptinezumab at doses of 300 mg, 100 mg, and 1000 mg (that is greater than three times the highest authorized dose) was not linked with profound alterations in heart rate, blood pressure, or concomitant cardiovascular medicines utilization and exhibited similar occurrence of cardiovascular treatment-emergent adverse events (TEAEs) when compared to placebo therapy. The overall occurrence of cardiovascular TEAEs was found to be low.
Timothy R Smith et al. undertook this post hoc analysis of four clinical trials to find out if the rate of cardiovascular adverse events was greater for people with migraine receiving eptinezumab vs. Placebo. The cardiovascular findings in migraineurs were pooled across 4 clinical trials (phase Ib, phase II, and two phase III trials) for eptinezumab usage as a migraine preventive therapy for up to one year. TEAEs that were noted following placebo or eptinezumab (100 mg, 300 mg, 1000 mg doses) and vital signs were noted.
Across all 4 clinical trials, cardiovascular TEAEs were found to be rare. Both eptinezumab-recipients and placebo-recipients depicted comparable rates of cardiovascular TEAEs. The cardiovascular TEAEs that occurred were reported to be moderate or mild in severity. However, no severe adverse events as per FDA definition was noted.
In comparison with the placebo
group, the vital signs (heart rate, diastolic blood pressure, systolic blood
pressure) were not significantly different across the therapy groups over
fifty-six weeks. In comparison with placebo, eptinezumab therapy did not lead
to novel or altered cardiovascular medications utilized concomitantly.
The Journal of Headache and Pain
Cardiovascular outcomes in adults with migraine treated with eptinezumab for migraine prevention: pooled data from four randomized, double-blind, placebo-controlled studies
Timothy R Smith et al.
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