Comparison of intravenous valproate with intravenous lysine-acetylsalicylic acid in acute migraine attacks.
OBJECTIVE
The study compared efficacy and tolerability of intravenous valproate (iVPA) with intravenous lysine-acetylsalicylic acid (iLAS) in acute migraine attacks. Background.-iLAS has been proven to be a highly effective treatment in acute migraine attacks, but it is not available in many countries and contraindicated in patients with asthma or peptic ulcers. Current data suggest that iVPA may be effective in the treatment of acute migraine attacks.


METHODS
In this randomized, double-blind, parallel-group phase-II study, 40 patients with acute migraine attacks (onset <5 hours, severe or moderate headache on a four-point IHS scale) alternately received iVPA 800 mg or iLAS 1000 mg. Primary outcome criteria were the percentage of patients reporting pain relief after 1 hour and patients who remained sustained pain free for 24 hours following drug administration. Secondary outcome criteria were relief of pain and associated migrainous symptoms (nausea, photophobia, and phonophobia) at 1, 2, 24, and 48 hours following drug administration.


RESULTS
There were no significant differences in demographic and clinical features between both treatment groups. Percentage of pain relief after 1 hour in the iVPA and iLAS groups were 25% and 30%, respectively, and of sustained pain free for 24 hours were 20% and 30%, respectively, without significant differences (P = 1 and P= .72, respectively). Both drugs improved associated migrainous symptoms without significant differences at the different time points, but again with a trend in favor of iLAS. No adverse events were observed.


CONCLUSIONS
Both drugs were effective in acute migraine attacks with a trend in favor of iLAS. As both drugs were well tolerated, further studies with higher doses of iVPA for the treatment of acute migraine attacks are recommended.
Leniger
Tobias
T
Department of Neurology, University of Essen, Hufelandstr.55, 45122 Essen, Germany.
Pageler
Lutz
L
Stude
Philipp
P
Diener
Hans Christoph
HC
Limmroth
Volker
V
D000208:Acute Disease; D000700:Analgesics / Q000008:administration & dosage*; D001241:Aspirin / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D004311:Double-Blind Method; D018682:GABA Agents / Q000008:administration & dosage*; D006801:Humans; D007262:Infusions, Intravenous; D008239:Lysine / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D008881:Migraine Disorders / Q000188:drug therapy*; D016896:Treatment Outcome; D014635:Valproic Acid / Q000008:administration & dosage*
D000700:Analgesics; D018682:GABA Agents; D014635:Valproic Acid; D008239:Lysine; D001241:Aspirin; C010395:acetylsalicylic acid lysinate