Intensive Diabetes Treatment and its Affects on Cardiovascular Disease and Stroke Risk in Patients with Type 1 Diabetes
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Status:
Completed. Published December 2005.
Purpose:
Whether the use of intensive therapy as compared with conventional therapy during the Diabetes Control and Complications Trial (DCCT) affected the long-term incidence
of cardiovascular and ischemic disease.
Year Started:
1983
Year Finished:
1993
Design:
Multicenter, randomized, controlled trial.
Exclusion Criteria
Patients with a history of cardiovascular disease or with hypertension (defined by a blood pressure of 140/90 mm Hg or more) or hypercholesterolemia (defined by a serum cholesterol level obtained after an overnight fast that was at least 3 SD above age- and sex-specific means).
Patient Involvement:
Patients were randomized into one of two groups: the intensive therapy group or the conventional thearapy group. Intensive therapy consisted of three or more daily injections of insulin or treatment with an external insulin pump, with dose adjustments based on at least four self-monitored glucose measurements per day. Daily glucose goals were 70 to 120 mg per deciliter (3.9 to 6.7 mmol per liter) before meals and peak levels of less than 180 mg per deciliter (10.0 mmol per liter) after meals. The goal for
glycosylated hemoglobin was less than 6.05 percent — 2 SD above the mean value for persons without diabetes. Conventional therapy had no glucose goals beyond those needed to prevent symptoms of hyperglycemia and hypoglycemia
and consisted of one or two daily injections of insulin.
Primary Outcome:
Nonfatal myocardial infarction or stroke; mortality judged
to be due to cardiovascular disease; subclinical myocardial infarction; angina, confirmed by ischemic changes on exercise tolerance testing or by clinically significant obstruction on coronary angiography; or the need for revascularization with angioplasty or coronary-artery bypass.
Secondary Outcome:
Subclinical (“silent”) myocardial infarctions identified on the annual electrocardiograms.
Results:
46 cardiovascular disease events occurred in 31 patients who had received intensive treatment in the DCCT, as compared with 98 events in 52 patients who had received conventional treatment. Intensive treatment reduced the risk of any cardiovascular disease event by 42 percent (95 percent confidence interval, 9 to 63 percent; P = 0.02) and the risk of nonfatal myocardial infarction, stroke, or death from cardiovascular disease by 57 percent (95 percent confidence interval, 12 to 79 percent; P = 0.02).
Source of Information:
N Engl J Med 2005;353:2643-53.
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This information last updated on: 12/27/2005
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