Zolmitriptan (Zomig)
Neurology. 2007 Aug 28;69(9):821-6.
Zolmitriptan nasal spray in the acute treatment of cluster headache: a double-blind study.
Rapoport AM, Mathew NT, Silberstein SD, Dodick D, Tepper SJ, Sheftell FD, Bigal ME.
Department of Neurology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. alanrapoport@gmail.com
OBJECTIVE: To evaluate the efficacy and tolerability of zolmitriptan 5 mg and 10 mg nasal spray (ZNS) vs placebo in the acute treatment of cluster headache.
Design/METHODS: We conducted a multicenter, double-blind, randomized, three-period crossover study using ZNS 5 mg, ZNS 10 mg, and placebo. Headache intensity was rated by a 5-point scale: none, mild, moderate, severe, or very severe. The primary efficacy measure was headache response (pain reduced from moderate, severe, or very severe at baseline, to mild or none) at 30 minutes. Logistic regression was used to account for treatment period effect as well as for cluster headache subtype effect.
RESULTS: A total of 52 adult patients treated 151 attacks. For the primary endpoint, both doses reached significance at 30 minutes (placebo = 30%, ZNS 5 mg = 50%, ZNS 10 mg = 63.3%). For headache relief, ZNS 10 mg separated from placebo at 10 minutes (24.5% vs 10%). Zolmitriptan 5 mg separated from placebo at 20 minutes (38.5% vs 20%). For pain-free status, ZNS 10 mg was superior to placebo at 15 minutes (22.0% vs 6%). Both doses had higher pain-free rates than placebo at 30 minutes (placebo = 20%, ZNS 5 mg = 38.5%, ZNS 10 mg = 46.9%). Side effects were mild and seen in 16% of those attacks treated with placebo, 25% of attacks treated with ZNS 5 mg, and 32.7% treated with ZNS 10 mg.
Conclusions/Relevance: Zolmitriptan nasal spray, at doses of 5 and 10 mg, is effective and tolerable for the acute treatment of cluster headache.
PMID: 17724283
----------
Arch Neurol. 2006 Nov;63(11):1537-42. Epub 2006 Sep 11.
Effectiveness of Intranasal Zolmitriptan in Acute Cluster Headache: A Randomized, Placebo-Controlled, Double-blind Crossover Study
Institute of Neurology, The National Hospital for Neurology and Neurosurgery, Queen Square, London, England.
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 intention-to-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 (
21 = 29.4;
P<.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.
Trial Registration controlled-trials.com Identifier ISCRTN27362692.
PMID: 16966497
----------
Neurologia. 2006 Apr;21(3):131-4. [Article in Spanish]
Experience with intranasal zolmitriptan in cluster headache
Pascual J, Navarro A, Caminero AB, Jurado C.Servicio de Neurologia, Hospital Universitario Marques de Valdecilla, Santander. juliopascual@telefonica.net
INTRODUCTION: The objective is to analyse our experience with the new intranasal formulation of zolmitriptan 5 mg in the symptomatic treatment of cluster headache in daily clinical practice. PATIENTS AND METHODS: We collected a total of 18 patients with cluster headache and experience with intranasal zolmitriptan; 17 had used subcutaneous sumatriptan and 8 oral triptans. The main reasons for trying intranasal zolmitriptan were: poor tolerability in 12 patients and insufficient efficacy in 6. RESULTS: Among the 17 patients experienced in subcutaneous sumatriptan, 12 (71 %) preferred nasal zolmitriptan, 2 (18 %) subcutaneous sumatriptan and 2 (12 %) did not express any preference. The reasons for preferring intranasal zolmitriptan were: higher convenience (n = 6), better tolerability (n = 5), lower price (n = 2) and higher efficacy (n = 1). Seven out of the 8 patients who had taken oral triptans preferred nasal zolmitriptan, in all cases due to higher subjective efficacy. A total of 11 patients showed efficacy within 30 minutes. Only 3 patients referred to adverse events, always mild. CONCLUSIONS: The 5 mg nasal formulation of zolmitriptan is a potential new option for the symptomatic treatment of cluster headache. This formulation should be considered in patients with poor tolerability to subcutaneous sumatriptan and in those attacks where quick access to inhaled oxygen is not possible. These results suggest that a controlled trial with nasal zolmitriptan in this indication would be worthwhile.
PMID: 16575626
----------
Neurology. 2000 May 9;54(9):1832-9.
Oral zolmitriptan is effective in the acute treatment of cluster headache.
Bahra A, Gawel MJ, Hardebo JE, Millson D, Breen SA, Goadsby PJ.Institute of Neurology, Queen Square, London, UK.
OBJECTIVE: To evaluate the efficacy and tolerability of oral zolmitriptan 5 mg and 10 mg and placebo in cluster headache. METHODS: A multicenter, double-blind, randomized, three-period, crossover, outpatient study. Adult patients received placebo and zolmitriptan 5 mg and 10 mg orally for the acute treatment of episodic or chronic cluster headache. Headache intensity was rated by a five-point scale: none, mild, moderate, severe, or very severe. Patients only treated moderate to very severe headaches. The primary efficacy measure was headache response (two-point or greater reduction from baseline in the cluster headache rating scale) at 30 minutes. Secondary efficacy measures included proportion of patients with initial headache relief within 15 and 30 minutes, mild or no pain at 30 minutes, meaningful headache relief, and use of escape medication. RESULTS: A total of 124 patients took at least one dose of study medication, with 73% having episodic and 27% chronic cluster headache. For the primary endpoint, there was a treatment-by-cluster-headache-type interaction (p = 0.0453). Therefore, results are presented separately for chronic and episodic cluster headache. In patients with episodic cluster headache, the difference between zolmitriptan 10 mg and placebo at 30 minutes reached significance (47% versus 29%; p = 0.02). Mild or no pain at 30 minutes was reported by 60%, 57%, and 42% patients treated with zolmitriptan 10 mg, zolmitriptan 5 mg, and placebo (both p </= 0.01 versus placebo). For all other secondary endpoints, zolmitriptan 10 mg was significantly superior to placebo in episodic cluster headache patients, whereas zolmitriptan 5 mg was significantly superior to placebo for three of the four secondary endpoints. In patients with chronic cluster headache, response rates following zolmitriptan 5 mg or 10 mg were not significantly different from placebo at any endpoint. Zolmitriptan 5 mg and 10 mg were well tolerated. CONCLUSION: Oral zolmitriptan is efficacious in episodic cluster headache.
PMID: 10802793
----------
Page Last Updated: 09/06/2007