N E Wells1, T J Steiner. 1. Pfizer Central Research, Sandwich, England. Nicholas_Wells@Sandwich.Pfizer.com
Abstract
BACKGROUND: The growing literature on the economics of migraine and its treatment generally indicates that the direct healthcare costs of managing the disorder are relatively low compared with the personal and societal burdens resulting from the disruption to normal functioning caused by migraine attacks. OBJECTIVE: To investigate the effectiveness of eletriptan, a new selective serotonin (5-hydroxytryptamine; 5-HT)5-HTIB/ID agonist, in reducing both the patient-focused burden of migraine and the amount of work time foregone during a single attack. DESIGN: In a phase III, multinational, randomised clinical trial, 692 patients treated a migraine attack witheletriptan 40 mg or 80 mg, or placebo. Patients responded to a questionnaire seeking information concerning the amount of time lost from usual activities during the attack. Time loss assessments were made 24 hours after the last dose taken and recorded in a diary. MAIN OUTCOME MEASURES AND RESULTS: Patients receiving either dose of the active compound were unable to perform their usual activities for a median period of 4 hours compared with 9 hours experienced by those taking placebo. This difference was highly statistically significant (p < 0.001). The time saving associated with eletriptan usage reflected the differences in efficacy findings in the clinical component of the study. CONCLUSION: In this placebo-controlled trial, eletriptan produced a significant reduction in the loss of usual functioning time associated with a migraine attack. This gain clearly represents a substantial benefit to patients with migraine irrespective of how it might most appropriately be valued in monetary terms. Further methodological progress in this area is warranted.
RCT Entities:
BACKGROUND: The growing literature on the economics of migraine and its treatment generally indicates that the direct healthcare costs of managing the disorder are relatively low compared with the personal and societal burdens resulting from the disruption to normal functioning caused by migraine attacks. OBJECTIVE: To investigate the effectiveness of eletriptan, a new selective serotonin (5-hydroxytryptamine; 5-HT)5-HTIB/ID agonist, in reducing both the patient-focused burden of migraine and the amount of work time foregone during a single attack. DESIGN: In a phase III, multinational, randomised clinical trial, 692 patients treated a migraine attack with eletriptan 40 mg or 80 mg, or placebo. Patients responded to a questionnaire seeking information concerning the amount of time lost from usual activities during the attack. Time loss assessments were made 24 hours after the last dose taken and recorded in a diary. MAIN OUTCOME MEASURES AND RESULTS:Patients receiving either dose of the active compound were unable to perform their usual activities for a median period of 4 hours compared with 9 hours experienced by those taking placebo. This difference was highly statistically significant (p < 0.001). The time saving associated with eletriptan usage reflected the differences in efficacy findings in the clinical component of the study. CONCLUSION: In this placebo-controlled trial, eletriptan produced a significant reduction in the loss of usual functioning time associated with a migraine attack. This gain clearly represents a substantial benefit to patients with migraine irrespective of how it might most appropriately be valued in monetary terms. Further methodological progress in this area is warranted.