Abstract
BackgroundThe systematic use of aspirin and statins in patients with diabetes and no previous cardiovascular events is controversial. We sought to assess the effects of aspirin and statins on the thrombotic risk assessed by thrombin generation (TG) among patients with type II diabetes mellitus and no previous cardiovascular events.Methodology/Principal FindingsProspective, randomized, open, blinded to events evaluation, controlled, 2×2 factorial clinical trial including 30 patients randomly allocated to aspirin 100 mg/d, atorvastatin 40 mg/d, both or none. Outcome measurements included changes in TG levels after treatment (8 to 10 weeks), assessed by a calibrated automated thrombogram. At baseline all groups had similar clinical and biochemical profiles, including TG levels. There was no interaction between aspirin and atorvastatin. Atorvastatin significantly reduced TG measured as peak TG with saline (85.09±55.34 nmol vs 153.26±75.55 nmol for atorvastatin and control groups, respectively; p = 0.018). On the other hand, aspirin had no effect on TG (121.51±81.83 nmol vs 116.85±67.66 nmol, for aspirin and control groups, respectively; p = 0.716). The effects of treatments on measurements of TG using other agonists were consistent.Conclusions/SignificanceWhile waiting for data from ongoing large clinical randomized trials to definitively outline the role of aspirin in primary prevention, our study shows that among diabetic patients without previous vascular events, statins but not aspirin reduce thrombotic risk assessed by TG.Trial RegistrationClinicalTrials.gov NCT00793754
Highlights
Individuals with type 2 diabetes have a two- to four-fold increased risk of cardiovascular disease (CVD) compared with non-diabetic subjects [1]
Conclusions/Significance: While waiting for data from ongoing large clinical randomized trials to definitively outline the role of aspirin in primary prevention, our study shows that among diabetic patients without previous vascular events, statins but not aspirin reduce thrombotic risk assessed by thrombin generation (TG)
There were no lost during the follow up, but in four patients measurements of TG was not available due to blood samples were not adequate for assays
Summary
Individuals with type 2 diabetes have a two- to four-fold increased risk of cardiovascular disease (CVD) compared with non-diabetic subjects [1]. Recommendations [3] regarding the use of aspirin for the prevention of cardiovascular events in patients with diabetes reflect an extrapolation of data derived from other high risk populations, rather than reliable trialbased evidence in individuals with diabetes [4]. Statins had been proven effective for primary prevention in populations with known moderate to high risk of cardiovascular events [10,11]. This recommendation is valid for patients with and without diabetes [10,11]. We sought to assess the effects of aspirin and statins on the thrombotic risk assessed by thrombin generation (TG) among patients with type II diabetes mellitus and no previous cardiovascular events
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