Diclofenac Epolamine is Effective in The Treatment of Acute Migraine Attacks. A Randomized, Crossover, Double Blind, Placebo-Controlled, Clinical Study

Author:

Vécsei L1,Gallacchi G2,Sàgi I3,Semjén J4,Tajti J1,Szok D1,Müller M2,Vadass P3,Kerékgyártó M3

Affiliation:

1. 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

2. Schmerzklinik, Basel, Switzerland

3. BAZ County Hospital, Miskolc

4. Markoth Ferenc County Hospital, Eger, Hungary

Abstract

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 2h 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.

Publisher

SAGE Publications

Subject

Neurology (clinical),General Medicine

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