Effect of early intervention with sumatriptan on migraine pain: Retrospective analyses of data from three clinical trials

Objective: This study assessed the efficacy of sumatriptan 50- and 100-mg t ablets in the treatment of migraine attacks while the pain is mild rather t han moderate/severe. Background: Results from The Spectrum Study suggested that early treatment of migraine attacks with sumatriptan 50-mg tablets while the pain is mild m ight enhance pain-free response and reduce headache recurrence. Methods: Retrospective analyses of headaches treated during mild pain were performed using data from 3 studies of sumatriptan tablets (protocols S2CM0 9, S2BT25, and S2BT26). Our primary interest was pain-free response 2 and 4 hours after dosing; secondary interests were use of a second dose of medic ation, clinical disability (as measured on a 4-point disability scale), mig raine-associated symptoms, meaningful pain relief (patient defined), time t o meaningful relief, sustained pain-free response, and proportion of attack s in which pain had worsened 2 and 4 hours after dosing, all of which were compared in headaches treated during mild versus moderate/severe pain. Results: In S2CM09, 92 patients treated 118 headaches during mild pain. Rat es of pain-free response were higher 2 hours after dosing with sumatriptan 50 mg (51%) or 100 mg (67%; P < 0.05) compared with placebo (28%), and were higher with early treatment of mild pain compared with treatment of modera te/severe pain at 2 hours (sumatriptan 50 mg: mild pain, 51%; moderate/seve re pain, 31%; P < 0.05; sumatriptan 100 mg: mild pain, 67%; moderate/severe pain, 36%) and 4 hours (50 mg: 75% vs 56%; 100 mg: 90% vs 61%; P < 0.05). Early intervention also resulted in less redosing than when moderate/severe pain was treated (50 mg: 21% vs 32%; 100 mg: 20% vs 29%). More attacks tre ated early with sumatriptan 50 or 100 mg were associated with normal functi on 4 hours after dosing compared with placebo (70% and 93% vs 46%, respecti vely). Sustained pain-free response rates 2 to 24 hours after early dosing with sumatriptan 50 or 100 mg were also higher (34% and 53%, respectively) compared with treatment of moderate/severe pain (19% and 24%, respectively) . Early treatment with sumatriptan 100 mg produced significantly higher pai n-free rates at 2 hours after dosing (P < 0.001) than did ergotamine plus c affeine (S2BT25: 69% vs 34%, respectively) or aspirin plus metoclopramide ( S2BT26: 73% vs 25%, respectively). Conclusions: Sumatriptan 50- and 100-mg tablets are effective whether pain is mild or moderate/severe. However, treatment with sumatriptan while pain is mild provides high pain-free response rates while reducing the need for redosing, benefits not seen with ergotamine plus caffeine or aspirin plus m etoclopramide.