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Table 1. Percentage of Patients With Headache Response (No or Mild Pain) 2 and 4 Hours Following Treatment Placebo
2 hr 4 hr IMITREX
Tablets
25 mg
2 hr 4 hr Text Continues Below
IMITREX
Tablets
50 mg
2 hr 4 hr IMITREX
Tablets
100 mg
2 hr 4 hr Study 1 27% 38% 52% * 67% * 61% ** 78% ** 62%* * 79% **
(n = 94) (n = 298) (n = 296) (n = 296)
Study 2 26% 38% 52% * 70% * 50% * 68% * 56% * 71% *
(n = 65) (n = 66) (n = 62) (n = 66)
Study 3 17% 19% 52% * 65% * 54% * 72% * 57% * 78% *
(n = 47) (n = 48) (n = 46) (n = 46) *
p< 0.05 in comparison with placebo. *
p< 0.05 in comparison with 25 mg. The estimated probability of achieving an initial headache response over the 4 hours following treatment is depicted in Figure 1. Figure 1. Estimated Probability of Achieving Initial Headache Response
Within 240 Minutes * * The figure shows the probability over time of obtaining headache response (no or mild pain) following treatment with sumatriptan. The averages displayed are based on pooled data from the 3 clinical controlled trials providing evidence of efficacy. Kaplan-Meier plot with patients not achieving response and/ or taking rescue within 240 minutes censored to 240 minutes. For patients with migraine-associated nausea, photophobia, and/ or phonophobia at baseline, there was a lower incidence of these symptoms at 2 hours (Study 1) and at 4 hours (Studies 1, 2, and 3) following administration of IMITREX Tablets compared to placebo. As early as 2 hours in Studies 2 and 3 or 4 hours in Study 1, through 24 hours following the initial dose of study treatment, patients were allowed to use additional treatment for pain relief in the form of a second dose of study treatment or other medication. The estimated probability of patients taking a second dose or other medication for migraine over the 24 hours following the initial dose of study treatment is summarized in Figure 2. Figure 2. The Estimated Probability of Patients Taking a Second Dose or Other Medication for Migraine Over the 24 Hours Following the Initial Dose of Study Treatment * * Kaplan-Meier plot based on data obtained in the 3 clinical controlled trials providing evidence of efficacy with patients not using additional treatments censored to 24 hours.
Plot also includes patients who had no response to the initial dose. No remedication was allowed within 2 hours postdose. There is evidence that doses above 50 mg do not provide a greater effect than 50 mg. There was no evidence to suggest that treatment with sumatriptan was associated with an increase in the severity of recurrent headaches. The efficacy of IMITREX Tablets was unaffected by presence of aura; duration of headache prior to treatment; gender, age, or weight of the patient; relationship to menses; or concomitant use of common migraine prophylactic drugs (e. g., beta-blockers, calcium channel blockers, tricyclic antidepressants). There were insufficient data to assess the impact of race on efficacy. Page: << Prev | 1 | 2 | 3 | 4 | 5
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