Efficacy and tolerability of subcutaneous sumatriptan administered using the IMITREX STATdose System.

The efficacy and tolerability of subcutaneous (SC) sumatriptan administered with the IMITREX (sumatriptan succinate) STATdose System, which circumvents the need for patients or health care professionals to handle a syringe, were evaluated in two randomized, double-masked, parallel-group, placebo-controlled, multicenter studies. In the clinic, 158 adults with migraine diagnosed according to International Headache Society criteria received SC sumatriptan (6 mg) or placebo delivered with the IMITREX STATdose System for treatment of a migraine attack. By 120 minutes after SC dosing, 73% and 79% of sumatriptan-treated patients, compared with 28% and 37% of placebo-treated patients in studies 1 and 2, respectively, experienced headache relief (a statistically significant difference). Clinical disability scores 120 minutes after dosing showed that 75% and 85% of sumatriptan-treated patients, compared with 30% and 42% of placebo-treated patients, were normal or only mildly impaired (a statistically significant difference). Similar efficacy rates were observed for nausea, phonophobia, and photophobia. No serious or unusual adverse events occurred, and no clinically relevant abnormalities in laboratory test values were reported. Based on these results, we concluded that SC sumatriptan (6 mg) administered using the IMITREX STATdose System is effective for the treatment of migraine. The efficacy and tolerability profiles of SC sumatriptan administered with this device are similar to those reported for SC sumatriptan administered with a conventional syringe.

Impact of sumatriptan on workplace productivity, nonwork activities, and health-related quality of life among hospital employees with migraine.

This prospective, open-label study evaluated the effects of subcutaneous sumatriptan versus usual therapy on workplace productivity, activity time outside of work, and health-related quality of life in 43 men or women who were hospital employees diagnosed with migraine according to international Headache Society criteria. Patients treated migraines with their usual therapy for 12 to 18 weeks followed by subcutaneous sumatriptan for 6 months. Health-related quality of life measurements obtained at baseline, after usual therapy, and after sumatriptan therapy included the Short Form-36 Health Survey and the Migraine-Specific Quality of Life Questionnaire. Patient daily diaries were used to capture data on migraine symptoms and on Lost Workplace Productivity and Non-workplace Activity Time. Traditional clinical efficacy measures were obtained to support the pharmacoeconomic data. Clinical data showed that the percentage of treated migraine days per patient on which the patient experienced relief (moderate or severe pain reduced to mild or none) was 75% with sumatriptan and 25% with usual therapy. The mean time to meaningful relief was 1.1 hours during the sumatriptan phase and 4.2 hours during the usual therapy phase. Lost Workplace Productivity and Nonworkplace Activity Time was 35% lower with sumatriptan therapy (1.5 hours) compared with usual therapy (2.3 hours). Time missed from work due to symptoms, time worked with symptoms, and time normal activities were carried on with symptoms were each lower during sumatriptan therapy compared with usual therapy. Scores on each of the three Migraine-Specific Quality of Life Questionnaire dimensions and on the Role-Emotional dimension of the Short Form-36 were significantly more favorable after sumatriptan than after usual therapy (P < 0.05). These data demonstrate that treatment of migraines with sumatriptan for 6 months following usual therapy for 12 to 18 weeks was associated with improvement in clinical efficacy, reduction in lost workplace productivity and nonworkplace activity time, and enhancement of key dimensions of health-related quality of life among employees of a large university hospital.

Oral sumatriptan for the acute treatment of migraine: evaluation of three dosage strengths.

This randomized, double-blind, parallel-group, placebo-controlled study evaluated the efficacy and tolerability of oral sumatriptan (Imitrex tablets) in 259 migraineurs. In the clinic, patients received oral sumatriptan 25 mg, 50 mg, or 100 mg, or placebo for the treatment of a migraine attack. The results indicate that by 2 hours post-dose, 50 to 56% of patients treated with any of the three doses, compared with 26% of patients treated with placebo, achieved relief of headache (p < 0.05 for each sumatriptan group vs placebo). By 4 hours postdose, 68 to 71% of sumatriptan-treated patients, compared with 38% of placebo-treated patients, achieved relief of headache (p < 0.05 for each sumatriptan group vs placebo). Oral sumatriptan was similarly effective at relieving nausea and photophobia and at reducing clinical disability. The pattern and incidence of adverse events did not differ between treatment groups. All doses--25 mg, 50 mg, and 100 mg--of sumatriptan were effective and generally well tolerated. Dosing should be individualized according to the needs of the patient.