title: Safety and efficacy of combined lysine acetylsalicylate and metoclopramide: repeated intakes in migraine attacks.
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.
authors.affiliation: Department of Internal Medicine 4, Centre Migraines et Céphalées, Hôpital Louis Mourier, Colombes, France.
authors.forename: A
authors.initials: A
authors.lastname: Pradalier
authors.forename: H
authors.initials: H
authors.lastname: Chabriat
authors.forename: J
authors.initials: J
authors.lastname: Danchot
authors.forename: G
authors.initials: G
authors.lastname: Baudesson
authors.forename: J E
authors.initials: JE
authors.lastname: Joire
mesh_terms: D000328:Adult; D000700:Analgesics / Q000009:adverse effects / Q000627:therapeutic use*; D000932:Antiemetics / Q000009:adverse effects / Q000627:therapeutic use*; D001241:Aspirin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D004361:Drug Tolerance; D005260:Female; D005602:France; D006801:Humans; D008239:Lysine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008297:Male; D008787:Metoclopramide / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D000932:Antiemetics; D008239:Lysine; D008787:Metoclopramide; D001241:Aspirin; C010395:acetylsalicylic acid lysinate