Zolmitriptan nasal spray in the acute treatment of cluster headache: a meta-analysis of two studies.

Abstract

OBJECTIVE:

To conduct an individual subject meta-analysis of available controlled studies of zolmitriptan nasal spray in the acute treatment of cluster headache.

BACKGROUND:

Two double-blind, placebo-controlled, randomized, crossover studies of zolmitriptan nasal spray in the acute treatment of cluster headache, with similar patient populations, protocol designs, doses, and clinical endpoints have been published.

METHODS:

In both double-blind studies, each patient was to treat 3 attacks, 1 with placebo, 1 with zolmitriptan 5 mg, and 1 with zolmitriptan 10 mg in a randomized, crossover manner. Headache intensity was rated on a 5-point scale (none to very severe). The primary endpoint was headache relief at 30 minutes post dose: reduction from moderate, severe, or very severe pain to mild or none. A multilevel, random-effects, logistic regression model was used to analyze the data.

RESULTS:

A total of 121 patients (100 male; 64.5% with episodic cluster headache) provided efficacy data for at least 1 attack. Zolmitriptan 5 mg and 10 mg were significantly more effective at providing headache relief at 30 minutes post treatment than placebo (odds ratio 3.48; 95% confidence interval 1.49-8.10 and odds ratio 8.68; 95% confidence interval: 3.35-22.5, respectively). For episodic cluster headache, response rates were 35.6%, 51.7%, and 73.7% for placebo, zolmitriptan 5 mg (odds ratio 2.5; P = .06 vs placebo), and 10 mg (odds ratio 9.9; P < .001 vs placebo), respectively. For chronic cluster headache, response rates were 17.2%, 41.9%, and 40.7% for placebo, zolmitriptan 5 mg (odds ratio 8.1; P = .035), and 10 mg (odds ratio 7.6; P = .046), respectively. Zolmitriptan was well tolerated in both studies with no serious adverse events reported.

CONCLUSION:

Zolmitriptan nasal spray at a dose of 5 mg and 10 mg is efficacious in the acute treatment of episodic and chronic cluster headache.

• Authors: Cecilia Hedlund, Alan M Rapoport, David W Dodick, Peter J Goadsby
• Journal: Headache (Headache) Vol. 49 Issue 9 Pg. 1315-23 (Oct 2009) ISSN: 1526-4610 [Electronic] United States
• PMID: 19788472 (Publication Type: Journal Article, Meta-Analysis, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Oxazolidinones
• Serotonin Receptor Agonists
• Tryptamines
• zolmitriptan

Topics

• Acute Disease (therapy)
• Adolescent
• Adult
• Aged
• Chronic Disease (drug therapy)
• Cluster Headache (drug therapy)
• Cross-Over Studies
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Oxazolidinones (administration & dosage)
• Placebo Effect
• Serotonin Receptor Agonists (administration & dosage)
• Treatment Outcome
• Tryptamines (administration & dosage)
• Young Adult