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© 2004 by the American Diabetes Association, Inc.
Letters: Comments and Responses |
Aspirin Resistance in Diabetic Patients
Response to Sacco et al.
From the Research Laboratories, Centre for High Technology Research and Education in Biomedical Sciences, Catholic University, Campobasso, Italy
Address correspondence to Giovanni de Gaetano, MD, PhD, Head, Research Laboratories, Centre for High Technology Research and Education in Biomedical Sciences, Catholic University, 86100 Campobasso, Italy. E-mail: gdegaetano{at}rm.unicatt.it
The results in the small diabetic subgroup of the Primary Prevention Project (PPP) study (744 patients), implemented by 287 additional patients (enrolled in outpatient clinics) were recently published in Diabetes Care (1). The PPP trial (2) was originally designed to test the hypothesis that platelet thromboxane (TxA2) generation would act as an intermediate "common" mechanism of cardiovascular risk in addition to specific risk factors (namely old age, hypertension, hypercholesterolemia, diabetes, obesity, and family history of myocardial infarction). The results of the original PPP trial extended the indications for aspirin treatment beyond secondary prevention in men and women with major cardiovascular risk factors, as routinely seen in a unique scenario such as general practice. As there was no obvious excess risk for hemorrhagic cerebrovascular complications, the results of the PPP trial not only widened the categories of candidates to a low-cost prophylaxis but also offered clear support to a crucial pathogenic role of platelet TxA2 in the final steps of the atherosclerotic process (3). Sacco et al. (1) now suggest that diabetic patients are less responsive to aspirin therapy than other high-risk individuals enrolled in the PPP trial. It was not shown, however, whether aspirin would have in contrast been effective if other similarly small subgroups of people at risk would have been compared with the rest of the selected population. This is of importance, as it has been previously reported that aspirin may be less effective in subjects with hypertension (4) or hypercholesterolemia (4–6). On one hand, a significantly higher percentage of subjects with hypertension and hypercholesterolemia were present in the diabetic group randomized to aspirin, compared with the no-aspirin group (1); this could have further contributed to the negative results. On the other hand, it appears somewhat contradictory to state that a clear benefit of aspirin could only be shown in the heterogeneous group of nondiabetic patients, which included 68.8% hypertensive and 39.9% hypercholesterolemic subjects (1). It therefore appears premature to raise the fashionable issue of "aspirin resistance" (7,8) in diabetic patients (1) until adequately sized, statistically powered clinical trials and/or large meta-analyses can match the efficacy and safety of aspirin in primary prevention in different subgroups of patients with different vascular risk profiles, rather than in small groups of diabetic patients.
References
- Sacco M, Pellegrini F, Roncaglioni MC, Avanzini F, Tognoni G, Nicolucci A, PPP Collaborative Group: Primary prevention of cardiovascular events with low-dose aspirin and vitamin E in type 2 diabetic patients: results of the Primary Prevention Project (PPP) trial. Diabetes Care 26:3264–3272, 2003
[Abstract/Free Full Text]
- Collaborative Group of the Primary Prevention Project (PPP): Low-dose aspirin and vitamin E in people at cardiovascular risk: a randomised trial in general practice: Collaborative Group of the Primary Prevention Project. Lancet 357:89–95, 2001 [Erratum appears in Lancet 357:1134, 2001]
- de Gaetano G: Aspirin and the prevention of ischemic heart disease: a Socratic dialogue between a cardiologist, a clinical pharmacologist and an expert of blood platelets. Ital Heart J 2:582–588, 2001[Medline]
- Meade TW, Brennan PJ: Determination of who may derive most benefit from aspirin in primary prevention: subgroup results from a randomised controlled trial. BMJ 321:13–17, 2000
[Abstract/Free Full Text]
- Steering Committee of the Physicians’ Health Study Research Group: Final report on the aspirin component of the ongoing Physicians’ Health Study. N Engl J Med 321:129–135, 1989[Abstract]
- Friend M, Vucenik I, Miller M: Platelet responsiveness to aspirin in patients with hyperlipidaemia. BMJ 326:82–83, 2003
[Free Full Text]
- Patrono C: Aspirin resistance: definition, mechanisms and clinical read-outs. J Thromb Haemost 1:1710–1713, 2003[Medline]
- de Gaetano G, Cerletti C: Aspirin resistance: a revival of platelet aggregation tests? J Thromb Haemost 1:2048–2050, 2003[Medline]
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  M. Sacco, F. Pellegrini, M. C. Roncaglioni, F. Avanzini, G. Tognoni, and A. Nicolucci Aspirin Resistance in Diabetic Patients: Response to de Gaetano Diabetes Care, May 1, 2004; 27(5): 1246 - 1246. [Full Text] [PDF]
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