Diabetes primary prevention of cardiovascular events: Difference between revisions

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==Overview==
==Overview==
Context Previous trials have investigated the effects of low-dose aspirin on primary prevention of cardiovascular events, but not                    in patients with type 2 diabetes.


Objective To examine the efficacy of low-dose aspirin for the primary prevention of atherosclerotic events in patients with type 2                    diabetes.


Design, Setting, and Participants Multicenter, prospective, randomized, open-label, blinded, end-point trial conducted from December 2002 through April 2008                    at 163 institutions throughout Japan, which enrolled 2539 patients with type 2 diabetes without a history of atherosclerotic                    disease and had a median follow-up of 4.37 years.
==Primary Prevention with Aspirin==
The safety and efficacy of low-dose aspirin in the primary prevention of cardiovascular events in patients with type 2 diabetes is controversial.


Interventions Patients were assigned to the low-dose aspirin group (81 or 100 mg per day) or the nonaspirin group.
In one prospective, [[randomized]], multicenter, blinded trial, 2539 type 2 diabetes patients with no history of atherosclerotic events were followed for a median of 4.4 years were randomized to either  low-dose [[aspirin]] (81 or 100 mg per day) or placebo control. There was no difference in the risk of fatal or nonfatal ischemic heart disease, fatal or nonfatal stroke, and peripheral arterial disease:
13.6 events per 1000 person-years in the aspirin group vs 17.0 per 1000 person-years in the non-aspirin group, hazard ratio [HR], 0.80; 95% confidence interval [CI], 0.58-1.10; log-rank test, P = .16).  Thus, among patients with [[type 2 diabetes]], the use of low-dose aspirin was not effective in primary prevention of [[atherosclerotic]] events.
 
The combined end point of fatal coronary events and fatal cerebrovascular events occurred in 1 patient (stroke) in the aspirin group and 10 patients (5 fatal myocardial infarctions and 5 fatal strokes) in the nonaspirin group (HR, 0.10; 95% CI, 0.01-0.79; P = .0037). A total of 34 patients in the aspirin group and 38 patients in the nonaspirin group died from any cause (HR, 0.90; 95% CI, 0.57-1.14; log-rank test, P = .67). The composite of hemorrhagic stroke and significant gastrointestinal bleeding was not significantly different between the aspirin and nonaspirin groups. Secondary end points included each primary end point and combinations of primary end points as well as death from any cause.


Main Outcome Measures Primary end points were atherosclerotic events, including fatal or nonfatal ischemic heart disease, fatal or nonfatal stroke,                    and peripheral arterial disease. Secondary end points included each primary end point and combinations of primary end points                    as well as death from any cause.


Results A total of 154 atherosclerotic events occurred: 68 in the aspirin group (13.6 per 1000 person-years) and 86 in the nonaspirin                    group (17.0 per 1000 person-years) (hazard ratio [HR], 0.80; 95% confidence interval [CI], 0.58-1.10; log-rank test, P = .16). The combined end point of fatal coronary events and fatal cerebrovascular events occurred in 1 patient (stroke) in                    the aspirin group and 10 patients (5 fatal myocardial infarctions and 5 fatal strokes) in the nonaspirin group (HR, 0.10;                    95% CI, 0.01-0.79; P = .0037). A total of 34 patients in the aspirin group and 38 patients in the nonaspirin group died from any cause (HR, 0.90;                    95% CI, 0.57-1.14; log-rank test, P = .67). The composite of hemorrhagic stroke and significant gastrointestinal bleeding was not significantly different between                    the aspirin and nonaspirin groups.


Conclusion In this study of patients with type 2 diabetes, low-dose aspirin as primary prevention did not reduce the risk of cardiovascular                    events.


==References==
==References==

Revision as of 14:05, 12 September 2011

Template:Diabetes

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Overview

Primary Prevention with Aspirin

The safety and efficacy of low-dose aspirin in the primary prevention of cardiovascular events in patients with type 2 diabetes is controversial.

In one prospective, randomized, multicenter, blinded trial, 2539 type 2 diabetes patients with no history of atherosclerotic events were followed for a median of 4.4 years were randomized to either low-dose aspirin (81 or 100 mg per day) or placebo control. There was no difference in the risk of fatal or nonfatal ischemic heart disease, fatal or nonfatal stroke, and peripheral arterial disease: 13.6 events per 1000 person-years in the aspirin group vs 17.0 per 1000 person-years in the non-aspirin group, hazard ratio [HR], 0.80; 95% confidence interval [CI], 0.58-1.10; log-rank test, P = .16). Thus, among patients with type 2 diabetes, the use of low-dose aspirin was not effective in primary prevention of atherosclerotic events.

The combined end point of fatal coronary events and fatal cerebrovascular events occurred in 1 patient (stroke) in the aspirin group and 10 patients (5 fatal myocardial infarctions and 5 fatal strokes) in the nonaspirin group (HR, 0.10; 95% CI, 0.01-0.79; P = .0037). A total of 34 patients in the aspirin group and 38 patients in the nonaspirin group died from any cause (HR, 0.90; 95% CI, 0.57-1.14; log-rank test, P = .67). The composite of hemorrhagic stroke and significant gastrointestinal bleeding was not significantly different between the aspirin and nonaspirin groups. Secondary end points included each primary end point and combinations of primary end points as well as death from any cause.



References