Effectiveness of Intranasal Zolmitriptan in Acute Cluster Headache

Abstract

Background: Cluster headache is a form of primary headache in which attacks are rapid in onset with very severe pain. The mainstays of acute therapy are inhaled oxygen and sumatriptan succinate injection. Objective: To evaluate zolmitriptan nasal spray in the acute treatment of cluster headache. Methods: Ninety-two patients, aged 40 ± 10 years (mean ± SD) (80 men and 12 women), with International Headache Society-defined cluster headache were randomized into a placebo-controlled, double-blind crossover study. Patients treated 3 headache attacks using placebo for 1 attack, 5 mg of zolmitriptan nasal spray (ZNS5) for 1 attack, and 10 mg of zolmitriptan nasal spray for 1 attack. The primary end point was headache relief at 30 minutes, defined as reduction from moderate, severe, or very severe pain to no or mild pain. The study was approved by the appropriate ethics committees. Results: Sixty-nine patients were available for an intentionto-treat analysis. The 30-minute headache relief rates were placebo, 21%; ZNS5, 40%; and ZNS10, 62%. Modeling the response as a binary outcome, the Wald test was significant for the overall regression (2 1 =29.4; PϽ.001), with both ZNS5 and ZNS10 giving significant effects against placebo. Headache relief rates for patients with episodic cluster headache were 30% for placebo, 47% for ZNS5, and 80% for ZNS10, while corresponding rates for patients with chronic cluster headache were 14%, 28%, and 36%, respectively. Zolmitriptan was also well tolerated. Conclusion: Five-milligram and 10-mg doses of zolmitriptan intranasal spray are effective within 30 minutes and well tolerated in the treatment of acute cluster headache.

Triptans for acute cluster headache

“…Most required that participants had previously tolerated treatment with a triptan, and/or had no contraindications, but Ekbom 1991 and Ekbom 1993 recruited only sumatriptan-naïve participants. In four studies participants self-treated their headaches at home (Bahra 2000;Cittadini 2006;Van Vliet 2003), while in the other two medication was administered by a physician or nurse in hospital (Ekbom 1991;Ekbom 1993). We included these hospital-based studies because although the intervention was not self-administered in these cases, subcutaneous sumatriptan can be, and is commonly, self-administered.…”

“…The studies included participants with diagnoses of both episodic and chronic types of cluster headache, with between 56% and 75% having episodic-type headaches. Two studies reported some results for episodic and chronic headaches separately (Bahra 2000;Cittadini 2006). No participants were using prophylactic medication, and, as noted above, all studies had an appropriate washout period between study doses, co-analgesics or rescue medication.…”

“…No study directly compared one drug with another. Oral zolmitriptan 5 mg and 10 mg were tested in one study (Bahra 2000), and intranasal zolmitriptan 5 mg and 10 mg in two studies (Cittadini 2006;). …”

“…Three studies scored 5/5 (Bahra 2000;Ekbom 1991;, and three scored 4/5 (Cittadini 2006;Ekbom 1993;Van Vliet 2003). Points were lost due to failure to adequately report the method of randomisation or blinding.…”

“…One (Bahra 2000) used an oral, and two (Cittadini 2006) used an intranasal formulation. All tested both 5 mg and 10 mg doses; 231 participants were treated with zolmitriptan 5 mg, 223 with zolmitriptan 10 mg, and 226 with placebo.…”