Trimigren in stopping migraine attacks: an open prospective multicenter comparative study of rectal suppository and tablet forms of sumatriptan

Efficacy and safety of sumatriptan in rectal suppository (50 mg) and tablet forms (50 mg) in stopping migraine attacks has been studied in 80 patients with migraine with- or without aura. Dynamics of migraine pain intensity measured with the VAS 30 min, 1, 2, 6 and 24 h after the first dose of drug was a primary index of efficacy. Secondary indices were the VAS intensity of nausea, vomiting, photophobia, phonophobia, duration of each migraine attack, quality of life parameters of a patient during the migraine attack assessed with the 24-hour questionnaire, severity of migraine course on the MIDAS, percentage of patients with complete regression of migraine pain, at least in 2 out of 3 attacks. To assess drug safety, any adverse effects, data of instrumental methods (clinical and biochemical blood tests, clinical urine test), EKG were taken into account. Rectal suppository had the more rapid effect on headache reduction compared to tablets. Changes of intensity of concomitant symptoms (nausea, vomiting, photophobia, phonophobia) as well as other secondary indices of drug efficacy were similar in both groups. in the group treated with rectal suppository, 9 (22,5%) patients had 12 adverse effects. In the group treated with tablets, 22 adverse effects were noted in 15 (37,5%) patients. Adverse effects related to the cardio-vascular system were observed less often in the group treated with rectal suppository (6,6 and 32%, respectively, p=0,004).