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PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
4
pubmed:dateCreated
2008-3-4
pubmed:abstractText
The study was designed to compare the response to almotriptan in migraine patients who take medication early in the course of the attack with that when medication is taken after pain has become moderate or severe. A randomized, four-arm, multicentre, multinational, double-blind, placebo-controlled trial of almotriptan (12.5 mg) comparing treatment administration when pain intensity was mild and within 1 h of headache onset vs. pain that had become moderate or severe was conducted. Of 491 migraineurs enrolled, 403 were evaluable [intention-to-treat population (ITT)]. Their mean age was 38 years, 84% were female and they had a mean of 3.7 attacks/month. Of these patients, 10% did not take medication according to their randomly allocated basal pain intensity (mild or moderate/severe) and were subsequently reassigned to that group for this analysis-'Act when Mild (AwM)' group. In the almotriptan arms, 53% of mild basal pain and 38% of moderate/severe basal pain patients were pain free at 2 h (P = 0.03; primary end-point). Corresponding proportions in the placebo groups were 25% and 17% (statistically significant vs. respective almotriptan arms). Secondary end-points (ITT) were also significantly in favour of early intervention with almotriptan, both between and across treatment groups, such as sustained pain free: 45.6% vs. 30.5% (P = 0.02). Adverse events were reported in < 5% of treated patients in all groups (NS), with no serious events. Treatment with almotriptan while migraine pain is still mild provides statistically significant and clinically relevant enhancements in efficacy compared with treatment when pain has reached higher severity levels.
pubmed:commentsCorrections
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Apr
pubmed:issn
1468-2982
pubmed:author
pubmed:issnType
Electronic
pubmed:volume
28
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
383-91
pubmed:dateRevised
2010-11-18
pubmed:meshHeading
pubmed-meshheading:18294251-Activities of Daily Living, pubmed-meshheading:18294251-Acute Disease, pubmed-meshheading:18294251-Adolescent, pubmed-meshheading:18294251-Adult, pubmed-meshheading:18294251-Aged, pubmed-meshheading:18294251-Double-Blind Method, pubmed-meshheading:18294251-Female, pubmed-meshheading:18294251-Humans, pubmed-meshheading:18294251-Male, pubmed-meshheading:18294251-Middle Aged, pubmed-meshheading:18294251-Migraine with Aura, pubmed-meshheading:18294251-Migraine without Aura, pubmed-meshheading:18294251-Neck Pain, pubmed-meshheading:18294251-Placebos, pubmed-meshheading:18294251-Recurrence, pubmed-meshheading:18294251-Serotonin Receptor Agonists, pubmed-meshheading:18294251-Severity of Illness Index, pubmed-meshheading:18294251-Shoulder Pain, pubmed-meshheading:18294251-Time Factors, pubmed-meshheading:18294251-Treatment Outcome, pubmed-meshheading:18294251-Tryptamines
pubmed:year
2008
pubmed:articleTitle
Early vs. non-early intervention in acute migraine-'Act when Mild (AwM)'. A double-blind, placebo-controlled trial of almotriptan.
pubmed:affiliation
Headache Group, Institute of Neurology, London, UK. peterg@ion.ucl.ac.uk
pubmed:publicationType
Journal Article, Comparative Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Multicenter Study