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Aggrenox

Clinical Pharmacology
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Clinical Pharmacology

Aggrenox

Aggrenox reduced the risk of stroke by 22.1% compared to aspirin 50 mg/day alone (p = 0.008) and reduced the risk of stroke by 24.4% compared to extended-release dipyridamole 400 mg/day alone (p = 0.002) (Table 1). Aggrenox reduced the risk of stroke by 36.8% compared to placebo (p < 0.001).

Table 1: Summary of First Stroke (Fatal or Nonfatal): ESPS2: Intent-to-Treat Population

  Total
Number
of
Patients
n		 Number of
Patients With
Stroke Within 2
Years
n (%)		 Kaplan-Meier
Estimate of
Survival at 2
Years
(95% C.I.)		 Gehan-
Wilcoxon Test
P-value		 Risk
Reduction
at 2 Years		 Odds Ratio
(95% C.I.)
Individual Treatment Group
Aggrenox 1650 157
( 9.5%)		 89.9%
(88.4%, 91.4%)		 - - -
ER-DP 1654 211
(12.8%)		 86.7%
(85.0%, 88.4%)		 - - -
ASA 1649 206
(12.5%)		 87.1%
(85.4%, 88.7%)		 - - -
Placebo 1649 250
(15.2%)		 84.1%
(82.2%, 85.9%)		 - - -
Pairwise Treatment Group Comparisons
Aggrenox vs. ER-DP - - - 0.002** 24.4% 0.72
(0.58, 0.90)
Aggrenox vs. ASA - - - 0.008** 22.1% 0.74
(0.59, 0.92)
Aggrenox vs. Placebo - - - < 0.001** 36.8% 0.59
(0.48, 0.73)
ER-DP vs. Placebo - - - 0.036* 16.5% 0.82
(0.67, 1.00)
ASA vs. Placebo - - - 0.009** 18.9% 0.80
(0.66, 0.97)
*0.010 < p-value ≤ 0.050; **p-value ≤ 0.010.
Note: ER-DP = extended-release dipyridamole 200 mg; ASA = aspirin 25 mg. The dosage regimen for alltreatment groups is BID

ESPS2: Cumulative Stroke Rate (Fatal or Nonfatal) Over 24 months of Follow-Up

Combined Stroke or Death Endpoint

In ESPS2, Aggrenox reduced the risk of stroke or death by 12.1% compared to aspirin alone and by 10.3% compared to extended-release dipyridamole alone. These results were not statistically significant. Aggrenox reduced the risk of stroke or death by 24.2% compared to placebo.

Death Endpoint
Brand Name: Aggrenox
Generic Name: Aspirin, Extended-Release Dipyridamole

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