November 1996

Rizatriptan vs Sumatriptan in the Acute Treatment of MigraineA Placebo-Controlled, Dose-Ranging Study

Author Affiliations

From the Department of Neurology, Leiden University Hospital, Leiden, the Netherlands (Drs Visser, Terwindt, and Ferrari), and Merck Research Laboratories, West Point, Pa (Drs Visser, Reines, Jiang, and Lines). For a list of the participants in the Dutch/US Rizatriptan Study Group, see the acknowledgment section.

Arch Neurol. 1996;53(11):1132-1137. doi:10.1001/archneur.1996.00550110072014

Background:  Rizatriptan (MK-462) is a new 5-hydroxytryptamine1D (serotonin1D; 5-HT1D) receptor agonist for the acute treatment of migraine that has improved pharmacokinetic properties compared with sumatriptan succinate.

Objective:  To assess the efficacy and tolerability of 10-, 20-, and 40-mg doses of oral rizatriptan vs a 100-mg dose of oral sumatriptan succinate and placebo for the acute treatment of migraine.

Design:  Randomized, double-blind, parallel-group, placebo-controlled, outpatient trial.

Setting:  Ten US and 4 Dutch investigator centers.

Patients:  Patients who had migraine with or without aura (N=449).

Main Outcome Measure:  The proportion of patients whose conditions improved from severe or moderate headache immediately before dosing to mild or no headache at 2 hours after drug administration (ie, headache relief).

Results:  The proportion of patients with headache relief was 18% for placebo; 46% for sumatriptan; and 52% for 10-mg, 56% for 20-mg, and 67% for 40-mg rizatriptan. All differences with placebo were statistically significant (P<.001), and 40-mg rizatriptan was superior to sumatriptan (P=.01). The proportion of patients who became free of pain at 2 hours was 3% for the placebo-treated group; 22% for the sumatriptan-treated group; and 26%, 35%, and 47% for the group of patients who took the 10-, 20-, and 40-mg doses of rizatriptan, respectively (all differences with placebo, P<.005; 40-mg rizatripan vs sumatriptan, P=.001). The recurrence of headache within 24 hours was found to be equal across all treatment groups—approximately 40%. Adverse events (most commonly short-lasting mild or moderate dizziness and drowsiness) occurred more frequently after a 40-mg dose of rizatriptan was given than after the other treatments.

Conclusions:  The antimigraine effect of 10- and 20-mg rizatriptan was superior to placebo, and comparable with that of 100-mg sumatriptan succinate; the efficacy of 40-mg rizatriptan was superior to that of both placebo and 100-mg sumatriptan succinate, although it was associated with a high frequency of adverse events.