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

Author:

Raz Itamar1,Wilson Peter W.F.2,Strojek Krzysztof3,Kowalska Irina4,Bozikov Velimir5,Gitt Anselm K.6,Jermendy György7,Campaigne Barbara N.8,Kerr Lisa8,Milicevic Zvonko8,Jacober Scott J.8

Affiliation:

1. Internal Medicine, Hadassah Hospital, Jerusalem, Israel

2. Cardiology, Emory University, Atlanta, GA

3. Internal Diseases, Diabetology and Nephrology, Silesian Medical University, Zabrze, Poland

4. Endocrinology, Diabetology and Internal Medicine, Medical University of Bialystok, Bialystok, Poland

5. Endocrinology, Diabetes and Metabolic Diseases, University Hospital Dubrava, Zagreb, Croatia

6. Cardiology, Herzzentrum Ludwigshafen, Ludwigshafen, Germany

7. Medical Department, Bajcsy-Zsilinszky Teaching Hospital, Budapest, Hungary

8. Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana

Abstract

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

Advanced and Specialized Nursing,Endocrinology, Diabetes and Metabolism,Internal Medicine

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