title: Effect of early intervention with sumatriptan on migraine pain: retrospective analyses of data from three clinical trials.
abstract: OBJECTIVE
  This study assessed the efficacy of sumatriptan 50- and 100-mg tablets in the treatment of migraine attacks while the pain is mild rather than 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 might 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 S2CM09, 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 medication, clinical disability (as measured on a 4-point disability scale), migraine-associated symptoms, meaningful pain relief (patient defined), time to meaningful relief, sustained pain-free response, and proportion of attacks 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. Rates 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 moderate/severe pain at 2 hours (sumatriptan 50 mg: mild pain, 51%; moderate/severe 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 treated early with sumatriptan 50 or 100 mg were associated with normal function 4 hours after dosing compared with placebo (70% and 93% vs 46%, respectively). 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 pain-free rates at 2 hours after dosing (P < 0.001) than did ergotamine plus caffeine (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 metoclopramide.
authors.affiliation: Headache Care Center, Springfield, Missouri, USA.
authors.forename: R K
authors.initials: RK
authors.lastname: Cady
authors.forename: F
authors.initials: F
authors.lastname: Sheftell
authors.forename: R B
authors.initials: RB
authors.lastname: Lipton
authors.forename: S
authors.initials: S
authors.lastname: O'Quinn
authors.forename: M
authors.initials: M
authors.lastname: Jones
authors.forename: D G
authors.initials: DG
authors.lastname: Putnam
authors.forename: A
authors.initials: A
authors.lastname: Crisp
authors.forename: A
authors.initials: A
authors.lastname: Metz
authors.forename: S
authors.initials: S
authors.lastname: McNeal
mesh_terms: D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D006801:Humans; D008881:Migraine Disorders / Q000150:complications / Q000188:drug therapy*; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010919:Placebos; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D017366:Serotonin Receptor Agonists / Q000627:therapeutic use*; D018170:Sumatriptan / Q000627:therapeutic use*
chemical_list: D010919:Placebos; D017366:Serotonin Receptor Agonists; D018170:Sumatriptan