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A comparative study of oral acetylsalicyclic acid and metoprolol for the prophylactic treatment of migraine. A randomized, controlled, double-blind, parallel group phase III study.
Diener, H. C.; Hartung, E.; Chrubasik, J. et al.
2001In Cephalalgia, 21 (2), p. 120-8
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Keywords :
Adolescent; Adult; Aged; Aspirin/administration & dosage/adverse effects; Female; Humans; Male; Metoprolol/administration & dosage/adverse effects; Middle Aged; Migraine Disorders/drug therapy; Treatment Outcome
Abstract :
[en] This study was a multinational, multicentre, double-blind, active controlled phase III trial designed to investigate efficacy and safety of 300 mg acetylsalicyclic acid (ASA) (n = 135) vs. 200 mg metoprolol (n = 135) in the prophylaxis of migraine. In total 270 (51 male and 219 female) patients, aged 18-65 years, suffering between two and six migraine attacks per month were recruited. The main objective was to show equivalence with respect to efficacy, defined as a 50% reduction in the rate of migraine attacks. A run-in phase was carried out with placebo for 4 weeks, followed by a 16-week drug phase. In both treatment groups the median frequency of migraine attacks improved during the study period, from three to two in the ASA group and from three to one in the metoprolol group; 45.2% of all metoprolol patients were responders compared with 29.6% with ASA. Medication-related adverse events were less frequent in the ASA group (37) than in the metoprolol group (73). The findings from this trial show that metoprolol is superior to ASA for migraine prophylaxis but has more side-effects. Acetylsalicylic acid is better tolerated than metoprolol. Using a strict responder criterion ASA showed a responder rate comparable with the placebo rate in the literature.
Disciplines :
Neurology
Neurosciences & behavior
Author, co-author :
Diener, H. C.
Hartung, E.
Chrubasik, J.
Evers, S.
Schoenen, Jean  ;  Université de Liège - ULiège > Département des sciences biomédicales et précliniques > Neuro-anatomie
Eikermann, A.
Latta, G.
Hauke, W.
Language :
English
Title :
A comparative study of oral acetylsalicyclic acid and metoprolol for the prophylactic treatment of migraine. A randomized, controlled, double-blind, parallel group phase III study.
Publication date :
2001
Journal title :
Cephalalgia
ISSN :
0333-1024
eISSN :
1468-2982
Publisher :
Blackwell Science, Osney Mead Oxford, United Kingdom
Volume :
21
Issue :
2
Pages :
120-8
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 28 September 2009

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