Open-labeled long-term study of the efficacy, safety, and tolerability of subcutaneous sumatriptan in acute migraine treatment

Cephalalgia. 1999 Sep;19(7):676-83; discussion 626. doi: 10.1046/j.1468-2982.1999.019007676.x.

Abstract

In a multicenter study, a long-term analysis was made of the efficacy, safety, and tolerability of subcutaneous (s.c.) sumatriptan in the acute treatment of migraine attacks over a period of up to 18 months. A total of 2263 patients took part in the study, all able to perform their own acute treatment of migraine attacks at home by s.c. administration of 6 mg of sumatriptan. A headache diary was used by each patient to record the various migraine parameters before the injection and 1 h and 2 h after it. A total of 43,691 attacks were treated and analyzed during the study period from October 1991 to June 1993. Therapy was successful in 89.5% of attacks. Freedom from headache was achieved in 71.0% of cases. In 22.7% of the attacks a second injection was administered on recurrence of the headache; 82.9% of the patients achieved an intraindividual therapy success rate ranging from over 80% to 100%. In the course of treatment there was no change in either the therapy success rate or in the frequency of attacks. Some 4.9% of the patients withdrew from the study because of insufficient efficacy or adverse events. A total of 44.5% of patients reported adverse events, and these were rated serious in the case of 1.7%. S.c. administration of sumatriptan for acute migraine therapy is an effective treatment method, with reliable action, that can be used with good tolerability provided the contraindications are taken into account.

Publication types

  • Multicenter Study

MeSH terms

  • Adolescent
  • Adrenergic beta-Antagonists / administration & dosage
  • Adrenergic beta-Antagonists / therapeutic use
  • Adult
  • Aged
  • Analgesics / administration & dosage
  • Analgesics / therapeutic use
  • Antiemetics / administration & dosage
  • Antiemetics / therapeutic use
  • Calcium Channel Blockers / administration & dosage
  • Calcium Channel Blockers / therapeutic use
  • Cohort Studies
  • Drug Evaluation
  • Drug Interactions
  • Drug Therapy, Combination
  • Female
  • Headache / chemically induced
  • Humans
  • Injections, Subcutaneous
  • Male
  • Middle Aged
  • Migraine Disorders / drug therapy*
  • Patient Dropouts
  • Prospective Studies
  • Recurrence
  • Safety
  • Serotonin Receptor Agonists / administration & dosage
  • Serotonin Receptor Agonists / adverse effects
  • Serotonin Receptor Agonists / therapeutic use*
  • Sumatriptan / administration & dosage
  • Sumatriptan / adverse effects
  • Sumatriptan / therapeutic use*
  • Time Factors
  • Vasoconstrictor Agents / administration & dosage
  • Vasoconstrictor Agents / adverse effects
  • Vasoconstrictor Agents / therapeutic use*

Substances

  • Adrenergic beta-Antagonists
  • Analgesics
  • Antiemetics
  • Calcium Channel Blockers
  • Serotonin Receptor Agonists
  • Vasoconstrictor Agents
  • Sumatriptan