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Clinical experience with oral sumatriptan: a placebo-controlled, dose-ranging study. Oral Sumatriptan Dose-defining
1Farnham Road Hospital, Guildford, United Kingdom.
Journal of Neurology
|January 1, 1991
Summary
Sumatriptan, a 5-hydroxytryptamine (5-HT)1-like receptor agonist, effectively treats acute migraine attacks. The 100 mg oral dose demonstrated comparable efficacy to higher doses with similar tolerability to placebo.
Area of Science:
- Neurology
- Pharmacology
Background:
- Migraine is a common neurological disorder.
- Acute treatment of migraine attacks requires effective and well-tolerated therapies.
Purpose of the Study:
- To evaluate the efficacy and tolerability of 100, 200, and 300 mg sumatriptan in oral dispersible form for acute migraine treatment.
- To compare sumatriptan's effectiveness against a placebo.
Main Methods:
- Double-blind, placebo-controlled, multicentre study.
- 1130 patients recruited across 51 centres in eight countries.
- Interim analysis of 538 patients for efficacy and 227 for tolerability.
Main Results:
- At 2 hours, 67-75% of patients on sumatriptan (100-300 mg) reported improved headache severity versus 22% on placebo (P < 0.001).
- Adverse events were mild, transient, and dose-related, with 100 mg sumatriptan showing a similar profile to placebo.
- Nausea/vomiting and bitter taste were common; withdrawal rates due to adverse events were low and similar for placebo and 100 mg sumatriptan.
Conclusions:
- 100 mg oral sumatriptan is well-tolerated for acute migraine treatment.
- The efficacy of 100 mg sumatriptan is comparable to higher doses (200 mg and 300 mg).
- Sumatriptan offers an effective treatment option for migraine attacks.