ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLE (Page 5 of 7)

14 CLINICAL STUDIES

ESPS2 (European Stroke Prevention Study-2) was a double-blind, placebo-controlled, 24-month study in which 6602 patients over the age of 18 years had an ischemic stroke (76%) or transient ischemic attack (TIA, 24%) within three months prior to entry. Patients were enrolled in 13 European countries between February 1989 and May 1995 and were randomized to one of four treatment groups: aspirin and extended-release dipyridamole 25 mg/200 mg; extended-release dipyridamole (ER-DP) 200 mg alone; aspirin (ASA) 25 mg alone; or placebo. The mean age in this population was 66.7 years with 58% of them being males. Patients received one capsule twice daily (morning and evening). Efficacy assessments included analyses of stroke (fatal or nonfatal) and death (from all causes) as confirmed by a blinded morbidity and mortality assessment group. There were no differences with regard to efficacy based on age or gender; patients who were older had a trend towards more events.

Stroke Endpoint

Aspirin and extended-release dipyridamole capsules 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 3). Aspirin and extended-release dipyridamole capsules reduced the risk of stroke by 36.8% compared to placebo (p <0.001).

Table 3 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
Aspirin and extended-release dipyridamole 1650 157 (9.5%) 89.9% (88.4%, 91.4%)
ER-DP 1654 211(12.8%) 86.7% (85%, 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
Aspirin and extended-release dipyridamole vs. ER-DP 0.002 b 24.4% 0.72 (0.58, 0.90)
Aspirin and extended-release dipyridamole vs. ASA 0.008 b 22.1% 0.74 (0.59, 0.92)
Aspirin and extended-release dipyridamole vs. Placebo <0.001 b 36.8% 0.59 (0.48, 0.73)
ER-DP vs. Placebo 0.036 a 16.5% 0.82 (0.67, 1.00)
ASA vs. Placebo 0.009 b 18.9% 0.80 (0.66, 0.97)

a 0.010 <p-value ≤0.050; b p-value ≤0.010.

Note: ER-DP = extended-release dipyridamole 200 mg; ASA = aspirin 25 mg. The dosage regimen for all treatment groups is BID.

Figure 1 ESPS2: Cumulative Stroke Rate (Fatal or Nonfatal)

Over 24 months of Follow-Up

Cumulative stroke rate figure
(click image for full-size original)

Combined Stroke or Death Endpoint

In ESPS2, aspirin and extended-release dipyridamole capsule reduced the risk of stroke or death by 24.2% compared to placebo.

Aspirin and extended-release dipyridamole capsule 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.

Death Endpoint

The incidence rate of all-cause mortality was 11.3% for aspirin and extended-release dipyridamole, 11% for aspirin alone, 11.4% for extended-release dipyridamole alone and 12.3% for placebo alone. The differences between the aspirin and extended-release dipyridamole, aspirin alone and extended-release dipyridamole alone treatment groups were not statistically significant. These incidence rates for aspirin and extended-release dipyridamole and aspirin alone are consistent with previous aspirin studies in stroke and TIA patients.

16 HOW SUPPLIED/STORAGE AND HANDLING

Aspirin and extended-release Dipyridamole 25 mg/200 mg capsules are available as a hard gelatin capsule, with red opaque colored cap and ivory opaque colored body, size ‘0 Xel’ hard gelatin capsule imprinted with ‘M’ on cap and ‘25’ on body in black ink, containing yellow colored extended-release pellets of Dipyridamole and a yellow colored immediate release pellets of Aspirin.

Bottles of 60 NDC 42571-274-60

Store at 25 ° C (77 ° F); excursions permitted to 15 ° to 30 ° C (59 ° to 86 ° F) [see USP Controlled Room Temperature]. Protect from excessive moisture.

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