Safety and efficacy of combined lysine acetylsalicylate and metoclopramide: repeated intakes in migraine attacks.
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| Abstract |
The efficacy of the combination of lysine acetylsalicylate and metoclopramide in the treatment of migraine attacks has been established previously. The value of repeated doses of such a combination has been reported in a recent study. The purposes of this open-label study performed by general practitioners on a very large sample of migraine sufferers were to confirm that repeated doses of the combined treatment are efficient and well-tolerated, and to assess the efficacy of treatment according to the initial headache intensity. Three thousand seven hundred twenty-seven general practitioners entered 7259 migraine sufferers. Patients had to use a first dose, the efficacy of which was assessed 2 hours later. In the case of failure, they were then able to take a second dose and possibly a third dose, 2 hours after the second, in the case of persistent failure. Twelve thousand five hundred sixty-two migraine attacks were analyzed. Tolerance, as assessed by the patients, was considered as good in more than 85% of attacks, whatever the number of doses utilized. Five hundred thirty-five adverse effects were reported after the use of 22,697 sachets. Of 12,515 attacks documented for efficacy, patients considered the treatment as good or excellent in 80% of attacks treated with one dose, 55% of those treated with two doses, and 27% of those treated with three doses. Relief of headache (reduction of its severity from grade 3 or 2 to 1 or 0) was observed in 51% of episodes after the first sachet, 51% of episodes treated with a second sachet, and 56% of episodes treated with a third sachet. The first dose of treatment was found to be more effective when the initial severity of the headache was moderate (improvement in 66% of attacks) than when it was severe (improvement in 30% of attacks). Efficacy appeared to increase according to the number of doses when headache was initially severe. This trial confirms that repeated doses of this combination is well-tolerated and effective. Our results show that repeated doses are particularly useful for severe attacks.
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| Authors | A Pradalier, H Chabriat, J Danchot, G Baudesson, J E Joire |
| Journal | Headache (Headache) Vol. 39 Issue 2 Pg. 125-31 (Feb 1999) ISSN: 1526-4610 [Electronic] United States |
| PMID | 15613205 (Publication Type: Clinical Trial, Journal Article, Multicenter Study) |
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