“Both studies…were similar in terms of patient populations, protocol design, doses of zolmitriptan, and clinical endpoints,” Cecilia Hedlund and co-investigators report in the October issue of Headache. The purpose of this project was to conduct subgroup analyses based on gender and headache type (episodic or chronic).
The trials were conducted at 9 study centers in Europe and the U.S. Inclusion criteria included duration of cluster attacks of at least 45 minutes if left untreated.
Patients treated three attacks, at least 24 hours apart, with 5 mg or 10 mg of zolmitriptan nasal spray or placebo, without realizing which treatment they were using. Headache response was defined as “a reduction in headache pain from moderate, severe, or very severe pretreatment to mild or no pain post-treatment.”
The 10-mg dose was significantly more effective than the lower dose (63.1% vs 48.3%; odds ratios 8.68 vs 3.48 compared with placebo, p = 0.028) and both doses were significantly more effective than placebo (29.5%, p < 0.0005).
Patients were also significantly more likely to be pain-free at 30 minutes and to report adequate pain relief in the active treatment groups compared with placebo.
Subgroup analysis for episodic cluster headache revealed a statistically significant better response in the 10 mg group, whereas both doses were more effective than placebo for chronic headache.
Response rates were similar in men and women at both doses.
There was no unexpected adverse event in any group. Those reported by more than one individual were dysgeusia, nausea, dizziness, headache, somnolence, chest discomfort, fatigue, and vomiting.
“Therefore,” the researchers conclude, “zolmitriptan nasal spray could be considered as a first-line treatment in appropriate patients for the acute treatment of cluster headache.”