Aggrenox®

Cardiac Safety Study

MI in Patients Who Received Dipyridamole or ASA and in Those Who Did Not (Factorial Analysis)

MI Dipyridamole No Dipyridamole Total ASA No ASA Total
Yes 83 (2.5%) 84 (2.5%) 167 74 (2.2%) 93 (2.8%) 167
No 3221 (97.5%) 3214 (97.5%) 6435 3225 (97.8%) 3210 (7.2%) 6435
Total 3304 3298 6602 3299 3303 6602
chi² test: p = 0.928 chi² test: p = 0.139

In the two-year observation period, 167 new MIs occurred: 83 in patients on dipyridamole and 84 in patients not on dipyridamole. There was a trend for fewer MIs in patients who were on ASA than in those who were not on ASA (74 vs. 93, respectively). Numbers were to small to achieve significance in statistical testing.

Mortality in Patients Who Received Dipyridamole or ASA and in Those Who Did Not (Factorial Analysis)

Mortality Dipyridamole No Dipyridamole Total ASA No ASA Total
Yes 375 (11.3%) 386 (11.7%) 761 368 (11.2%) 393 (11.9%) 761
No 2929 (88.7%) 2912 (88.3%) 5841 2931 (88.8%) 2910 (88,1%) 5841
Total 3304 3298 6602 3299 6602
chi² test: p = 0.652 chi² test: p = 0.344

Altogether, 761 patients died during the two-year observation period. There was no difference in all-cause mortality in patients who received dipyridamole (375) compared with those who did not (386). The same was true for patients on ASA (386) or not (393). Mortality was identical in patients with CHD or prior MI irrespective of wether they took dipyridamole (213) or not (208) or ASA (209) or not (212).

Conclusion

Dipyridamole did not result in a higher number of cardiac events, e.g. angina pectoris, MI, or death from all causes. The combination of dipyridamole plus ASA was superior to either drug alone in the prevention of stroke.

References

Diener et al. Int J Clin Pract 2001; 55 (3): 162-163.
PubMed Abstract
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