Switch to
Predicate | Object |
---|---|
rdf:type | |
lifeskim:mentions | |
pubmed:issue |
5
|
pubmed:dateCreated |
1992-12-15
|
pubmed:abstractText |
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.
|
pubmed:language |
eng
|
pubmed:journal | |
pubmed:citationSubset |
IM
|
pubmed:chemical |
http://linkedlifedata.com/resource/pubmed/chemical/Indoles,
http://linkedlifedata.com/resource/pubmed/chemical/Placebos,
http://linkedlifedata.com/resource/pubmed/chemical/Serotonin Receptor Agonists,
http://linkedlifedata.com/resource/pubmed/chemical/Sulfonamides,
http://linkedlifedata.com/resource/pubmed/chemical/Sumatriptan
|
pubmed:status |
MEDLINE
|
pubmed:month |
Oct
|
pubmed:issn |
0333-1024
|
pubmed:author | |
pubmed:issnType |
Print
|
pubmed:volume |
12
|
pubmed:owner |
NLM
|
pubmed:authorsComplete |
Y
|
pubmed:pagination |
308-13
|
pubmed:dateRevised |
2010-11-18
|
pubmed:meshHeading |
pubmed-meshheading:1330318-Adolescent,
pubmed-meshheading:1330318-Adult,
pubmed-meshheading:1330318-Dose-Response Relationship, Drug,
pubmed-meshheading:1330318-Double-Blind Method,
pubmed-meshheading:1330318-Female,
pubmed-meshheading:1330318-Humans,
pubmed-meshheading:1330318-Indoles,
pubmed-meshheading:1330318-Injections, Subcutaneous,
pubmed-meshheading:1330318-Middle Aged,
pubmed-meshheading:1330318-Migraine Disorders,
pubmed-meshheading:1330318-Placebos,
pubmed-meshheading:1330318-Serotonin Receptor Agonists,
pubmed-meshheading:1330318-Sulfonamides,
pubmed-meshheading:1330318-Sumatriptan,
pubmed-meshheading:1330318-Time Factors,
pubmed-meshheading:1330318-Treatment Outcome
|
pubmed:year |
1992
|
pubmed:articleTitle |
Treatment of migraine attacks with subcutaneous sumatriptan: first placebo-controlled study. The Subcutaneous Sumatriptan International Study Group.
|
pubmed:affiliation |
Department of Neurology, University Hospital Leiden, The Netherlands.
|
pubmed:publicationType |
Journal Article,
Clinical Trial,
Randomized Controlled Trial
|