Diclofenac epolamine is effective in the treatment of acute migraine attacks. A randomized, crossover, double blind, placebo-controlled, clinical study.
Hydrosoluble diclofenac epolamine (DHEP) represents an interesting approach to acute migraine attacks, where gastrointestinal motility and drug absorption are often reduced. Its efficacy was investigated in a randomized, crossover, double-blind trial on 155 patients who treated four consecutive mild-to-moderate migraine attacks, either with DHEP (65-mg sachet) or placebo. If pain was not relieved within 1 h, a second dose was given. The total number of treated attacks was 481. A pain-free condition was achieved within 2 h in 45.8% and 25.1% of attacks treated, respectively, with DHEP or placebo (P < 0.0001), with a therapeutic gain of 20.7%. Time to attack resolution, light and noise sensitivity and impact on working ability were significantly reduced by DHEP compared with placebo. Moreover, significantly fewer patients required a second drug dose or a rescue medication when treated with DHEP than with placebo. No adverse reaction was recorded. In conclusion, DHEP was effective and safe for pain relief in patients with an acute mild-to-moderate migraine attack.
Vécsei
L
L
Department of Neurology, Albert Szent-Györgyi Medical and Pharmaceutical Centre, University of Szeged and Neurology Research Group of the Hungarian Academy of Sciences and University of Szeged, Szeged, Hungary. giuseppe.mautone@ibsa.ch
Gallacchi
G
G
Sági
I
I
Semjén
J
J
Tajti
J
J
Szok
D
D
Müller
M
M
Vadass
P
P
Kerékgyártó
M
M
D000328:Adult; D000700:Analgesics / Q000008:administration & dosage; D004008:Diclofenac / Q000008:administration & dosage*; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy* / Q000453:epidemiology*; D010147:Pain Measurement / Q000187:drug effects*; D015990:Placebo Effect; D016896:Treatment Outcome
D000700:Analgesics; D004008:Diclofenac