Journal Article

Effects of Prandial Versus Fasting Glycemia on Cardiovascular Outcomes in Type 2 Diabetes: The HEART2D trial

Wilson, Peter W.F, Milicevic, Zvonko, Jermendy, György, Kowalska, Irina, Kerr, Lisa, Gitt, Anselm K, Raz, Itamar, Campaigne, Barbara N, Strojek, Krzysztof, Jacober, Scott J, Bozikov, Velimir

2009

Overview

OBJECTIVE:--Hyperglycemia and Its Effect After Acute Myocardial Infarction on Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus (HEART2D) is a multinational, randomized, controlled trial designed to compare the effects of prandial versus fasting glycemic control on risk for cardiovascular outcomes in patients with type 2 diabetes after acute myocardial infarction (AMI). RESEARCH DESIGN AND METHODS--Patients (type 2 diabetes, aged 30-75 years) were randomly assigned within 21 days after AMI to the 1) prandial strategy (PRANDIAL) (three premeal doses of insulin lispro targeting 2-h postprandial blood glucose <7.5 mmol/l) or the 2) basal strategy (BASAL) (NPH twice daily or insulin glargine once daily targeting fasting/premeal blood glucose <6.7 mmol/l). RESULTS:--A total of 1,115 patients were randomly assigned (PRANDIAL n = 557; BASAL n = 558), and the mean patient participation after randomization was 963 days (range 1-1,687 days). The trial was stopped for lack of efficacy. Risks of first combined adjudicated primary cardiovascular events in the PRANDIAL (n = 174, 31.2%) and BASAL (n = 181, 32.4%) groups were similar (hazard ratio 0.98 [95% CI 0.8-1.21]). Mean A1C did not differ between the PRANDIAL and BASAL groups (7.7 ± 0.1 vs. 7.8 ± 0.1%; P = 0.4) during the study. The PRANDIAL group showed a lower daily mean postprandial blood glucose (7.8 vs. 8.6 mmol/l; P < 0.01) and 2-h postprandial blood glucose excursion (0.1 vs. 1.3 mmol/l; P < 0.001) versus the BASAL group. The BASAL group showed lower mean fasting blood glucose (7.0 vs. 8.1 mmol/l; P < 0.001) and similar daily fasting/premeal blood glucose (7.7 vs. 7.3 mmol/l; P = 0.233) versus the PRANDIAL group. CONCLUSIONS:--Treating diabetic survivors of AMI with prandial versus basal strategies achieved differences in fasting blood glucose, less-than-expected differences in postprandial blood glucose, similar levels of A1C, and no difference in risk for future cardiovascular event rates.

• Publisher: American Diabetes Association
• Subject: Adult / adverse effects / Aged / analogs & derivatives / Biological and medical sciences / blood glucose / Blood sugar / Body Weight / Body Weight - drug effects / Cardiac patients / Cardiovascular System / Cardiovascular System - drug effects / Cardiovascular System - metabolism / Cholesterol / Clinical Care/Education/Nutrition/Psychosocial Research / Clinical trials / Diabetes / Diabetes Mellitus, Type 2 / Diabetes Mellitus, Type 2 - drug therapy / Diabetes therapy / Diabetes. Impaired glucose tolerance / Diabetics / Drug Administration Schedule / drug effects / drug therapy / Endocrine pancreas. Apud cells (diseases) / Endocrinopathies / Etiopathogenesis. Screening. Investigations. Target tissue resistance / Fasting / Female / glycemic control / glycemic effect / Heart attack / Heart attacks / Humans / Hyperglycemia / Hypoglycemic Agents / Hypoglycemic Agents - adverse effects / Hypoglycemic Agents - pharmacology / Hypoglycemic Agents - therapeutic use / Insulin / Insulin - adverse effects / Insulin - analogs & derivatives / Insulin - therapeutic use / Insulin Glargine / Insulin Lispro / Insulin, Long-Acting / Male / Medical research / Medical sciences / Medicine, Experimental / Metabolic diseases / metabolism / Middle Aged / Miscellaneous / Mortality / myocardial infarction / noninsulin-dependent diabetes mellitus / Patient outcomes / patients / Pharmaceutical industry / pharmacology / Postprandial Period / Public health. Hygiene / Public health. Hygiene-occupational medicine / risk / Risk Factors / risk reduction / therapeutic use / Treatment Outcome / Type 2 diabetes