Aggrenox®

US Headache Study

Comparison of Treatment Groups on Global Assessment of Pain Intensity and Pain Relief

Headache response at 2 hours was 69.4% in the placebo group and 75.5% in the acetaminophen group (NS). No significant differences were detected between the two groups in baseline pain. A total of 16 (16%) participants in the placebo group required rescue medication, vs. 19 (19.2%) in the treatment group (NS). No significant differences were detected between groups in the pain intensity ratings 1, 2, and 4 hours after treatment. After 2 hours of treatment, 61 (62.7%) subjects rated placebo treatment as at least good, compared with 60 (61.2%) in the acetaminophen group (NS). After 4 hours, the proportions were 72.4% and 64.5% (NS).

Comparison of Treatment Groups on Global Assessment of Headache Severity

  1 hour post (n=198)
  Placebo n=99 Acetaminophen n=99 M-H chi-square p value
Pain intensity
No headache 12 (12.12) 12 (12.12) 0.7391
Mild 37 (37.37) 36 (36.36)  
Moderate 36 (36.36) 42 (42.42)  
Severe 14 (14.14) 9 (9.09)  
Total* 99 (50.00) 99 (50.00)  
  2 hours post ( n=196)
  Placebo n=98 Acetaminophen n=98 M-H chi-square p value
Pain intensity
No headache 30 (30.61) 29 (29.59) 0.3683
Mild 38 (38.78) 45 (45.92)  
Moderate 21 (21.43 21 (21.43)  
Severe 9 (9.18) 3 (3.06)  
Total* 98 (50.00) 98 (50.00)  
  4 hours post ( n=179 )
  Placebo n=87 Acetaminophen n=92 M-H chi-square p value
Values are n (%)
* 100 participants were assigned to the control group. One participant is missing 1-hour data, 2 participants are missing 2-hour data, and 13 participants are missing 4-hour data. Ninety-nine participants were assigned to the treatment group. One participant is missing 2-hour data and 6 participants are missing 4-hour data.
Pain intensity
No headache 50 (57.47) 56 (60.87) 0.2978
Mild 17 (19.54) 23 (25.00)  
Moderate 16 (18.39) 10 (10.87)  
Severe 4 (4.60) 3 (3.26)  
Total* 87 (48.60) 92 (51.40)