Table 4.
Results of a 6-arm factorials study of the acute treatment of migraine and TTHa [33]
Measure | AAC-100 | APAP + ASA | APAP | ASA | Caffeine | Placebo |
---|---|---|---|---|---|---|
PID @ 2 h (mm) | 44.7 | 40.2 | 39.5 | 40.7 | 31.4 | 24.6 |
Active vs placebo | <0.0001 | <0.0001 | <0.0001 | <0.0001 | <0.02 | – |
Active vs AAC-100 | – | 0.002 | 0.02 | 0.003 | <0.0001 | <0.0001 |
Weighted SPID (%) | 66.6 | 62.0 | 57.5 | 62.2 | 46.7 | 40.2 |
P vs placebo | <0.0001 | <0.0001 | <0.0001 | <0.0001 | 0.0993 | – |
P vs AAC-100 | – | 0.02 | 0.07 | 0.0002 | <0.0001 | <0.0001 |
Functional disability @ 2 h (%) | 53.9 | 49.4 | 48.6 | 48.4 | 39.4 | 30.5 |
P vs placebo | <0.0001 | <0.0001 | <0.0001 | <0.0001 | 0.1491 | – |
P vs AAC-100 | – | 0.08 | 0.08 | 0.04 | <0.0001 | <0.0001 |
Global assessment of efficacy (%) | 25.2 | 21.4 | 15.4 | 18.7 | 20.8 | 10.9 |
P vs placebo | <0.0001 | <0.0001 | <0.0001 | <0.0001 | 0.0132 | – |
P vs AAC-100 | – | 0.01 | <0.0001 | 0.009 | <0.0001 | <0.0001 |
AAC-100, acetaminophen 400 mg, aspirin 500 mg, caffeine 100 mg per 2-tablet dose; APAP + ASA, acetaminophen 400+ aspirin 500 mg per 2-tablet dose; APAP, acetaminophen 400 mg per 2-tablet dose; ASA, aspirin 500 mg per 2-tablet dose; caffeine, caffeine 100 mg per 2-tablet dose; PID, pain intensity difference from baseline; SPID, sum of pain intensity differences
aThe study population included patients with migraine (84%) and TTH (13%) who typically treated attacks with non-prescription analgesics