9) Bahra A, Gawel MJ, Hardebo JE, Millson D, Breen SA, Goadsby PJ.
Oral zolmitriptan is effective in the acute treatment of cluster
headache. Neurology. 2000 May 9;54(9):1832-9.
|
論文抄録
|
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.
|
結果
|
反復性群発頭痛の患者では zolmitriptan 10 mg と placebo で 30 分後 頭痛軽減の割合に有意差を認めた (47% versus 29%; p = 0.02). 30 分後に頭痛軽度またはなしの割合は zolmitriptan 10 mg, zolmitriptan 5 mg, and placebo でそれぞれ 60%, 57%, and 42% h (10mg と 5mg でこ placebo と比較し p </= 0.01 ). 第 2 のエンドポイントでも zolmitriptan 10 mg と 5 mg は placebo に比較し有効性があった.
慢性群発頭痛の患者では zolmitriptan 5 mg o または 10 mg の投与は placebo と比較し効果がなかった.
Zolmitriptan 5 mg と 10 mg は 認容性にすぐれていた.
|
備考
|
Publication Types:
• Clinical Trial
• Multicenter Study
• Randomized Controlled Trial
MeSH Terms:
• Acute Disease
• Administration, Oral
• Adult
• Aged
• Cluster Headache/drug therapy*
• Comparative Study
• Cross-Over Studies
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Human
• Male
• Middle Aged
• Oxazoles/administration & dosage*
• Oxazoles/adverse effects
• Oxazolidinones*
• Pain Measurement
• Serotonin Agonists/administration & dosage*
• Serotonin Agonists/adverse effects
• Support, Non-U.S. Gov't
• Treatment Outcome
Substances:
• Oxazoles
• Oxazolidinones
• Serotonin Agonists
• zolmitriptan
|