Rizatriptan vs Sumatriptan in the Acute Treatment of Migraine: A Placebo-Controlled, Dose-Ranging Study

doi:10.1001/archneur.1996.00550110072014

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Vol. 53 No. 11, November 1996

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Rizatriptan vs Sumatriptan in the Acute Treatment of Migraine

A Placebo-Controlled, Dose-Ranging Study

W. Hester Visser, MD, PhD; Gisela M. Terwindt, MD; Scott A. Reines, MD, PhD; Kai Jiang, PhD; Chris R. Lines, PhD; Michel D. Ferrari, MD, PhD; Dutch/US Rizatriptan Study Group

Arch Neurol. 1996;53(11):1132-1137.

Abstract

Background
Rizatriptan (MK-462) is a new 5-hydroxytryptamine_1D (serotonin_1D;5-HT_1D) receptor agonist for the acute treatment of migrainethat has improved pharmacokinetic properties compared with sumatriptansuccinate.

Objective
To assess the efficacy and tolerability of 10-, 20-, and 40-mgdoses of oral rizatriptan vs a 100-mg dose of oral sumatriptansuccinate 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 severeor moderate headache immediately before dosing to mild or noheadache at 2 hours after drug administration (ie, headacherelief).

Results
The proportion of patients with headache relief was 18% forplacebo; 46% for sumatriptan; and 52% for 10-mg, 56% for 20-mg,and 67% for 40-mg rizatriptan. All differences with placebowere statistically significant (P<.001), and 40-mg rizatriptanwas superior to sumatriptan (P=.01). The proportion of patientswho became free of pain at 2 hours was 3% for the placebo-treatedgroup; 22% for the sumatriptan-treated group; and 26%, 35%,and 47% for the group of patients who took the 10-, 20-, and40-mg doses of rizatriptan, respectively (all differences withplacebo, P<.005; 40-mg rizatripan vs sumatriptan, P=.001).The recurrence of headache within 24 hours was found to be equalacross all treatment groups—approximately 40%. Adverseevents (most commonly short-lasting mild or moderate dizzinessand drowsiness) occurred more frequently after a 40-mg doseof rizatriptan was given than after the other treatments.

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

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.

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