Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0018681 (headache)
 56,091 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

The results of the very first large-scale placebo-controlled dose-response trial with the novel selective 5-hydroxytryptamine1-like (5HT1-like) receptor agonist sumatriptan are presented. We studied the efficacy and tolerability of subcutaneous injections of 1 mg, 2 mg and 3 mg of sumatriptan in alleviating migraine attacks in a double-blind, placebo-controlled, parallel-group, multicentre clinical trial. Six-hundred and ninety patients were randomized and 685 received study medication. At 30 min, reduction of headache severity to mild or none (primary efficacy endpoint) was achieved in 22% (95% CI: 15-28%) of placebo-treated patients and in 39% (CI: 31-46%) of patients treated with 1 mg sumatriptan, 44% (CI: 36-51%) treated with 2 mg sumatriptan and 55% (CI: 48-63%) treated with 3 mg sumatriptan. Differences from placebo were 17% (CI: 8-27%) for 1 mg sumatriptan, 22% (CI: 13-32%) for 2 mg sumatriptan and 34% (CI: 24-44%) for 3 mg sumatriptan (p < 0.001 for all three comparisons). Other migraine symptoms were also more effectively treated by sumatriptan than by placebo. Subsequently, an open-label 3 mg dose subcutaneous sumatriptan was given to partial or non-responders. Thirty minutes after this open dose the response rate to sumatriptan had improved to between 70 and 80%. Adverse events after sumatriptan were minor and short-lived. We conclude that subcutaneous sumatriptan is well tolerated in doses up to 3 + 3 mg and may rapidly abort migraine attacks.
Cephalalgia 1992 Oct
PMID:Treatment of migraine attacks with subcutaneous sumatriptan: first placebo-controlled study. The Subcutaneous Sumatriptan International Study Group. 133 Mar 18

The efficacy and safety of sumatriptan, a selective 5-HT1-like receptor agonist, were studied in a randomized, double-blind, placebo-controlled, parallel-group, multicentre, multinational clinical trial of 235 patients suffering a moderate to severe migraine attack. Patients were randomized to treat a single migraine attack at home with 6 mg sumatriptan or placebo using an auto-injector. If the migraine had not improved at 1 h, patients had the option of taking a second identical injection. The primary measure of treatment efficacy was based on a comparison of the number of patients in the two treatment groups who had a reduction in headache severity from severe or moderate to mild or none at 1 and 2 h. At 1 h, 77% of patients treating with 6 mg sumatriptan compared to 26% treating with placebo (p less than 0.001) had mild headache or none. At 2 h, the response rates for all patients had risen to 83 and 30%, respectively. Of those patients requiring a second dose at 1 h, improvement to mild or no headache at 2 h was achieved in 61% of patients receiving sumatriptan compared to 15% of those receiving placebo. Other migraine symptoms were more effectively treated by sumatriptan and patients were able to return to work or normal activities earlier. Migraine recurrence within 48 h was a feature of 46% of attacks treated by patients with either treatment. Adverse events were more frequent using sumatriptan but were minor and transient.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Self-treatment of acute migraine with subcutaneous sumatriptan using an auto-injector device. The Sumatriptan Auto-Injector Study Group. 165 40

In a multicenter open longitudinal clinical trial where 479 patients suffering from migraine with or without aura were recruited, patients treated at home one to three migraine attacks with their customary treatment, and subsequently, over a 3-month period, one to three migraine attacks with 6 mg sumatriptan sc using an autoinjector. The headache response to customary treatment was 19% at 1 h and 30.5% at 2 h, and was not significantly different when only attacks treated "adequately" according to accepted treatment recommendations were considered: 16% at 1 h and 35% at 2 h. In contrast, 69% and 82% of patients treated with 6 mg sumatriptan sc had mild headache or no headache at 1 and 2 h respectively, regardless of migraine type or duration of symptoms prior to treatment. Other migraine symptoms (nausea, vomiting, photo- and phonophobia) were effectively treated with sumatriptan. Recurrence of migraine was observed in 31% of patients and was well controlled by a second injection of sumatriptan. It is concluded that 6 mg sumatriptan sc, self-administered using an autoinjector, is well tolerated and more effective than most currently used acute treatments for migraine in a population of severely affected patients consulting a neurologist.
Cephalalgia 1994 Feb
PMID:Self-treatment of acute migraine with subcutaneous sumatriptan using an auto-injector device: comparison with customary treatment in an open, longitudinal study. 820 27

246 migraine patients (International Headache Society definition, 1-6 severe attacks per month) were randomised into a multicentre, cross-over study comparing subcutaneous (s.c.) sumatriptan 6 mg administered by an auto-injector (Glaxo device) with usual acute migraine treatments. Patients were treated for 2 months or up to 12 attacks, and then crossed over to the alternative treatment for the same duration. Usual treatments were: analgesics (including combinations), 49%; ergotamine, 24%; NSAIDs 19%; DHE, 7%. Rescue medication was allowed 2 h after the first dose. Headache was assessed on a 4-point self-rating scale (0: none, 1: mild, 2: moderate, 3: severe). Other migraine symptoms were assessed as present or absent. Quality of life was assessed before the study and at the end of each treatment period. Two hundred and seventeen patients were eligible for the cross-over analysis. At 2 h post-dosing, an average of 78% of attacks per patient were successfully relieved (grade 3 or 2 to 1 or 0) by s.c. sumatriptan, compared with 34% for the usual treatments (p < 0.001) and 63% of attacks per patient were completely relieved (grade 0) by s.c. sumatriptan compared with 15% for the usual treatments (p < 0.001). Sumatriptan-treated patients used rescue medication for 19% of their attacks, compared to 59% for comparator drugs (p = 0.001). Results for patient preference were: s.c. sumatriptan, 85%; usual treatments, 10%; no preference, 5% (p < 0.001). Sumatriptan was significantly superior to comparator drugs for all other efficacy end-points (p < 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Comparison of subcutaneous sumatriptan with usual acute treatments for migraine. French Sumatriptan Study Group. 854 14