BACKGROUND: Migraine is a common, very disabling pain condition: the occurrence of an acute attack often requires bedrest and prevents from participating in normal activities. Nonsteroidal anti-inflammatory drugs are widely used in the symptomatic treatment of migraine. Aim of this study was to evaluate the efficacy and safety of a potent new formulation, dexketoprofen trometamol (DT), in the treatment of migraine pain. METHODS: The study enrollment was 42 women (mean age 37.2 +/- 12.2, range 21-65) suffering from migraine, with (n = 6) and without (n = 36) aura, diagnosed according to the International Headache Society criteria. Patients were asked to treat a single attack with a 25 mg dose of DT. The primary efficacy criterion was the change in migraine pain, recorded on a Visual Analogue Scale (VAS) immediately before and at 30, 60, 120, 240 minutes after assumption. The presence of accompanying symptoms and the onset of side effects were also considered. RESULTS: Pain intensity significantly decreased after drug intake, showing a tendency toward a reduction along the time. The drop in mean VAS values resulted already significant at 30 minutes after DT assumption. Also the reported incidence of accompanying symptoms (nausea, vomiting, photophobia and phonophobia) significantly decreased after treatment. No serious adverse event was reported during the study. All the adverse events recorded were of mild severity and did not require any specific medical treatment. CONCLUSIONS: DT proved to be an effective and safe oral therapy for the treatment of migraine attack.
BACKGROUND:Migraine is a common, very disabling pain condition: the occurrence of an acute attack often requires bedrest and prevents from participating in normal activities. Nonsteroidal anti-inflammatory drugs are widely used in the symptomatic treatment of migraine. Aim of this study was to evaluate the efficacy and safety of a potent new formulation, dexketoprofen trometamol (DT), in the treatment of migraine pain. METHODS: The study enrollment was 42 women (mean age 37.2 +/- 12.2, range 21-65) suffering from migraine, with (n = 6) and without (n = 36) aura, diagnosed according to the International Headache Society criteria. Patients were asked to treat a single attack with a 25 mg dose of DT. The primary efficacy criterion was the change in migraine pain, recorded on a Visual Analogue Scale (VAS) immediately before and at 30, 60, 120, 240 minutes after assumption. The presence of accompanying symptoms and the onset of side effects were also considered. RESULTS:Pain intensity significantly decreased after drug intake, showing a tendency toward a reduction along the time. The drop in mean VAS values resulted already significant at 30 minutes after DT assumption. Also the reported incidence of accompanying symptoms (nausea, vomiting, photophobia and phonophobia) significantly decreased after treatment. No serious adverse event was reported during the study. All the adverse events recorded were of mild severity and did not require any specific medical treatment. CONCLUSIONS:DT proved to be an effective and safe oral therapy for the treatment of migraine attack.