18-MONTH LONG-TERM ANALYSIS OF THE EFFECT IVENESS, SAFETY AND TOLERABILITY OF SUBCUTANEOUS SUMATRIPTAN IN ACUTE MIGRAINE TREATMENT

The aim of the open prospective study was to investigate the efficacy, safety and tolerability of subcutaneous sumatriptan in acute migraine treatment. Patient self-treatment was monitored over a time period of 6-18 months with 6 mg of sumatriptan administered subcutaneously by a n autoinjector. In total, 2,263 patients participated in the study. He adache intensity was documented by the patient in a headache diary bef ore and 1 and 2h after application. During the study period from Octob er 1991 to June 1993, 43,691 migraine attacks were investigated. Treat ment with sumatriptan was efficient in 89.5% of the attacks. Headache relief was achieved in 71%. Headache reoccurred in 22.7% of the attack s, and therefore a second injection was administered. An intraindividu al treatment efficacy of 80-100% was achieved in 82.9% of the patients . During long-term treatment the ratio of effective treatment and head ache frequency was constant 4.9% of the patients withdrew from the stu dy because of adverse events and because they felt the treatment was n ot effective. A total of 44.5% of the patients reported adverse events that were serious in 1.7%. Subcutaneous self-treatment with sumatript an in the acute treatment of migraine is effective and well tolerated by the patients.