Gillian L. Booth, MD, MSc
In patients with poorly controlled type 2 diabetes, how does intensive glucose control compare with standard control for reducing cardiovascular (CV) events?
Randomized controlled trial (Veterans Affairs Diabetes Trial [VADT]). ClinicalTrials.gov NCT00032487.
Unclear allocation concealment.*
Blinded (outcome assessors).*
Median 5.6 years.
20 sites in the USA.
1791 patients (mean age 60 y, 97% men) who had inadequate responses to maximum doses of an oral agent or insulin therapy. Exclusion criteria included glycated hemoglobin (Hb) level < 7.5%, CV event in the past 6 months, advanced congestive heart failure (CHF), severe angina, body mass index (BMI) > 40 kg/m2, serum creatinine level > 1.6 mg/dL (141 µmol/L), and alanine aminotransferase level > 3 times the upper normal limit.
Intensive (n = 892) or standard glucose control (n = 899). Patients were given oral metformin plus rosiglitazone (BMI ≥ 27 kg/m2) or oral glimepiride plus rosiglitazone (BMI < 27 kg/m2). The intensive-control group started with maximum doses, and the standard-control group started with half-maximum doses. Patients in the intensive-control group who did not achieve glycated Hb levels < 6% and patients in the standard-control group who did not achieve levels < 9% were started on insulin. The goal of intensive control was absolute reduction in glycated Hb levels by 1.5% compared with standard control.
First major CV event (composite endpoint of myocardial infarction [MI], stroke, CV death, CHF, surgery for vascular disease, inoperable coronary disease, and amputation for ischemic gangrene). Secondary outcomes included all-cause mortality and microvascular complications.
86% (intention-to-treat analysis).
Groups did not differ for the composite endpoint (Table), individual components of the composite endpoint, all-cause mortality (Table), or microvascular complications.
Intensive glucose control and standard control did not differ for reducing cardiovascular events or death in patients with poorly controlled type 2 diabetes.
Intensive vs standard glucose control in poorly controlled type 2 diabetes†
†Abbreviations defined in Glossary. RRR, RRI, NNT, NNH, and CI calculated from data in article.
‡Myocardial infarction, stroke, CV death, congestive heart failure, surgery for vascular disease, inoperable coronary disease, and amputation for ischemic gangrene.
Booth GL. Intensive and standard glucose control did not differ for major CV events or death in poorly controlled type 2 diabetes. Ann Intern Med. 2009;150:JC3–8. doi: 10.7326/0003-4819-150-6-200903170-02008
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Published: Ann Intern Med. 2009;150(6):JC3-8.
Cardiology, Coronary Risk Factors, Diabetes, Endocrine and Metabolism.
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