Safety and efficacy of combined lysine acetylsalicylate and metoclopramide: repeated intakes in migraine attacks.

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.