Conflict of Interest: Cecilia Hedlund is an employee of AstraZeneca and owns stock in AstraZeneca. Alan M. Rapoport, MD, has received funds from AstraZeneca for conducting a clinical trial 3 years ago. David W. Dodick, MD, has received research support from AstraZeneca, Advanced Neurostimulation Systems, Medtronic. He has received consulting honoraria from Allergan, Merck, Pfizer, Endo, Kowa, HS Lundbeck, NuPathe, Neuraxon, Neuralieve, Coherex, St Jude, Eli Lilly. Peter J. Goadsby, MD, PhD, DSc, devised the study proposal, study design, and protocol for the European study to AstraZeneca, who provided clinical trial materials and very limited administrative support. He has had no other financial or other inducements to this work.
Zolmitriptan Nasal Spray in the Acute Treatment of Cluster Headache: A Meta-Analysis of Two Studies
Article first published online: 29 SEP 2009
© 2009 the Authors. Journal compilation © 2009 American Headache Society
Headache: The Journal of Head and Face Pain
Volume 49, Issue 9, pages 1315–1323, October 2009
How to Cite
Hedlund, C., Rapoport, A. M., Dodick, D. W. and Goadsby, P. J. (2009), Zolmitriptan Nasal Spray in the Acute Treatment of Cluster Headache: A Meta-Analysis of Two Studies. Headache: The Journal of Head and Face Pain, 49: 1315–1323. doi: 10.1111/j.1526-4610.2009.01518.x
- Issue published online: 29 SEP 2009
- Article first published online: 29 SEP 2009
- Accepted for publication June 25, 2009.
- cluster headache;
- acute headache treatment
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.