motriptan malate) was established in three multi-center, randomized, double-blind, placebo-controlled European trials. Patients enrolled in these studies were primarily female (86%) and Caucasian (more than 98%), with a mean age of 41 years (range of 18 to 72). Patients were instructed to treat a moderate to severe migraine headache. Two hours after taking one dose of study medication, patients eva luated their headache pain. If the pain had not decreased in severity to mild or no pain, the patient was allowed to take an escape medication. If the pain had decreased to mild or no pain at 2 hours but subsequently increased in severity between 2 and 24 hours, it was considered a relapse and the patient was instructed to take a second dose of study medication. Associated symptoms of nausea, vomiting, photophobia, and phonophobia were also eva luated.
In these studies, the percentage of patients achieving a response (mild or no pain) 2 hours after treatment was significantly greater in patients who received either AXERT® 6.25 mg or 12.5 mg, compared with those who received placebo. A higher percentage of patients reported pain relief after treatment with the 12.5 mg dose than with the 6.25 mg dose. Doses greater than 12.5 mg did not lead to a significantly better response. These results are summarized in Table 3.
Table 3. Response Rates 2 Hours Following Treatment of Initial Headache in Adults
Placebo AXERT®
6.25 mg AXERT®
12.5 mg
* p value 0.002 in comparison with placebo † p value <0.001 in comparison with placebo ‡ p value 0.008 in comparison with placebo
Study 1 33.8%
(n = 80) 55.4%*
(n = 166) 58.5%†
(n = 164)
Study 2 40.0%
(n = 95) --- 57.1%‡
(n =175)
Study 3 33.0%
(n = 176) 55.6%†
(n = 360) 64.9%†
(n = 370)
The estimated probability of achieving pain relief within 2 hours following initial treatment with AXERT® in adults is shown in Figure 1.
Figure 1. Estimated Probability of Achieving an Initial Headache Response (Mild or no Pain) in 2 Hours in Adults
Figure 1
This Kaplan-Meier plot is based on data obtained in the three placebo-controlled clinical trials that provided evidence of efficacy (Studies 1, 2, and 3). Patients not achieving pain relief by 2 hours were censored at 2 hours.
For patients with migraine-associated photophobia, phonophobia, nausea, and vomiting at baseline, there was a decreased incidence of these symptoms following administration of AXERT® compared with placebo.
Two to 24 hours following the initial dose of study medication, patients were allowed to take an escape medication or a second dose of study medication for pain response. The estimated probability of patients taking escape medication or a second dose of study medication over the 24 hours following the initial dose of study medication is shown in Figure 2.
Figure 2. Estimated Probability of Adult Patients Taking Escape Medication or a Second Dose of Study Medication Over the 24 Hours Following the Initial Dose of Study Treatment
Figure 2
This Kaplan-Meier plot is based on data obtained in the three placebo-controlled trials that provided evidence of efficacy (Studies 1, 2, and 3). Patients not using additional treatment were censored at 24 hours. Remedication was not allowed within 2 hours after the initial dose of AXERT®.
The efficacy of AXERT® was unaffected by the presence of aura; by gender, weight, or age of the patien |
