RELPAX

Study Descriptions
 
Adapted from Sandrini et al, Neurology, 2002.
Results from a multicenter, randomized, double-blind, placebo-controlled, parallel-group study of eletriptan (40 mg) and oral sumatriptan (50, 100 mg) in patients (N=774) with moderate to severe migraine headache. Headache response was defined as an improvement from headache severity grade 2 to 3 at baseline to grade 0 or 1 postdose. Headache response rates at 1 and 2 hours, respectively, were 12%, and 31% for placebo; 24%, and 50% for sumatriptan 50 mg: 27% and 53% for sumatriptan 100 mg; and 30% and 64% for eletriptan 40 mg. All doses of eletriptan were superior to sumatriptan at 2 hours for headache response and complete pain relief (P<.05). Sustained headache response at 24 hours was 50% for eletriptan 40 mg, 34% for sumatriptan 50 mg, 38% for sumatriptan 100 mg, and 21% for placebo; statistical comparisons between eletriptan vs placebo and both doses of sumatriptan were significantly different (P<.05). Eletriptan and sumatriptan were well tolerated.
 
Adapted from Mathew et al, Headache, 2003.
Results from a multicenter, randomized, double-blind, placebo-controlled, parallel-group study of oral eletriptan 40 mg and oral sumatriptan 100 mg in patients (N=2113) with moderate to severe migraine headache. Headache response was defined as reduction from a severe or moderate headache to a mild headache or no pain postdose. Secondary endpoints included headache response rates at 1 hour, pain-free rates, absence of associated symptoms, functional response at 1 and 2 hours, and sustained headache response. Headache response rates at 2 hours postdose were significantly higher for eletriptan 40 mg (67%) than for sumatriptan 100 mg (59%; P<.001) and placebo (26%; P<.0001). Sustained headache response at 24 hours was 43% for eletriptan 40 mg, 34% for sumatriptan 100 mg, and 14% for placebo; differences vs placebo were statistically significant (P<.0001). Eletriptan 40 mg consistently showed significant (P<.01) efficacy over sumatriptan 100 mg across secondary clinical outcomes. Both eletriptan and sumatriptan were well tolerated and most adverse events were mild and transient.