Efficacy and safety of intravenous acetylsalicylic acid lysinate compared to subcutaneous sumatriptan and parenteral placebo in the acute treatment of migraine. A double-blind, double-dummy, randomized, multicenter, parallel group study

Authors


  • *G.Arnold, Berlin; A. Beckmann-Reinholdt, Königstein; W. Dinter, Düsseldorf; R.Englert, Gars am Inn; S. Evers, Münster; T. Flöter, Frankfurt am Main; M. Föh, Fulda; A. Gendolla, Essen; U. Gessner, Köln, H. Göbel, Kiel; E. Hartung, Düsseldorf; D. Jungck, Hamburg; U. Molnar, Albstadt; G. Müller-Schwefe, Göppingen; W. Paulus, Göttingen; C.Riemasch-Becker, Wiesbaden; R. Schellenberg, Linden; H. Staudenmeyer, Göppingen; L. Tarau, Wiesbaden; J. Timm, Lilienthal

HC Diener, Department of Neurology, University Essen, Hufelandstr. 55, D-45122 Essen, Germany. Fax. +49 201 723 5901, email. h.diener@uni-essen.de.

Abstract

Two-hundred-and-seventy-eight patients with acute migraine attacks with or without aura were treated in 17 centers with 1.8 g lysine acetylsalicylate i.v. (Aspisol®;=1 g acetylsalicylic acid), 6 mg sumatriptan s.c. or placebo using a double-blind, double-dummy, randomized, multicenter parallel group study design. Two-hundred-and-seventy-five of them fulfilled the criteria for efficacy analysis, corresponding to 119 patients treated with lysine acetylsalicylate (L-ASA), 114 with sumatriptan and 42 with placebo injections. Both treatments were highly effective compared to placebo (p<0.0001) in decreasing headache from severe or moderate to mild or none (verbal rating scale, VRS, placebo=23.8%). Sumatriptan showed a significantly (p=0.001) better response (91.2%) compared to L-ASA (response 73.9%). Of the patients in the L-ASA-group, 43.7% were pain-free after 2 h; 76.3% after sumatriptan and 14.3%, after placebo. It took patients on average 12.6 (L-ASA), 8.2 (sumatriptan), and 19.4 h (placebo) to be able to work again. There was no significant difference between treatment groups in recurrence of headache in responders within 24 h (18.2% L-ASA, 23.1%, sumatriptan, 20% placebo). Accompanying symptoms (nausea, vomiting, photophobia, phonophohia, and visual disturbances) improved with both verum treatments to a similar extent. L-ASA was significantly better tolerated than sumatriptan (adverse events L-ASA 7.6%, sumatriptan 37.8%). In conclusion, subcutaneous sumatriptan and lysine acetvlsalicylate i.v. are effective treatments for patients suffering from migraine attacks. Sumatriptan is more effective, but resulted in more adverse events.

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