How to interpret results of the HEART2D trial?

Ivan Tkáč, Zvonko Milićević, G. Jermendy

Research output: Contribution to journalArticle

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Abstract

HEART2D was a multinational, randomized, controlled trial designed to compare the effects of prandial insulin versus basal insulin on risk for subsequent cardiovascular (CV) outcomes in patients with type 2 diabetes (T2D) after acute myocardial infarction (MI). Trial design was based on the hypothesis that 2.5 mmol/L postprandial blood glucose (BG) difference between groups would result in risk reduction of 19 to 23% over the planned follow up period (18-36 mo) in the group with lower postprandial BG. One thousand one hundred and fifteen (1115) patients were randomized [prandial strategy (N = 557), basal strategy (N = 558)]. HEART2D was stopped after futility rule implementation at the fourth interim analy sis. The risk of a first combined adjudicated CV events in the prandial group (N = 174, 31.2%) and basal (N = 181, 32.4%) groups was similar (HR = 0.98; 95% CI [0.8, 1.21]). The results of HEART2D left the question of the role of postprandial hyperglycemia in diabetic CV disease unanswered. Here, we discuss possible reasons for this outcome, in cluding characteristics of daily BG profiles in the two treatment groups, event rate, risk factors other than standard CV risk factors and glycemic variables. The main reasons for this outcome of HEART2D study could be smaller than expected on-study differences between the study groups in postprandial hyperglycemia, and low event rate. Further trials with larger patient populations and improved designs, focusing also on diabetic patients with lower cardiovascular risk and lower baseline HbA1c levels are needed in order to shed more light on this important clinical problem.

Original languageEnglish
JournalDiabetes Research and Clinical Practice
Volume86
Issue numberSUPLL.1
DOIs
Publication statusPublished - Dec 2009

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Meals
Blood Glucose
Hyperglycemia
Insulin
Medical Futility
Risk Reduction Behavior
Type 2 Diabetes Mellitus
Cardiovascular Diseases
Randomized Controlled Trials
Myocardial Infarction
Outcome Assessment (Health Care)
Population
Therapeutics

Keywords

  • Cardiovascular disease
  • Glucose lowering treatment
  • HEART2D study
  • Type 2 diabetes mellitus

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Internal Medicine
  • Endocrinology

Cite this

How to interpret results of the HEART2D trial? / Tkáč, Ivan; Milićević, Zvonko; Jermendy, G.

In: Diabetes Research and Clinical Practice, Vol. 86, No. SUPLL.1, 12.2009.

Research output: Contribution to journalArticle

Tkáč, Ivan ; Milićević, Zvonko ; Jermendy, G. / How to interpret results of the HEART2D trial?. In: Diabetes Research and Clinical Practice. 2009 ; Vol. 86, No. SUPLL.1.
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abstract = "HEART2D was a multinational, randomized, controlled trial designed to compare the effects of prandial insulin versus basal insulin on risk for subsequent cardiovascular (CV) outcomes in patients with type 2 diabetes (T2D) after acute myocardial infarction (MI). Trial design was based on the hypothesis that 2.5 mmol/L postprandial blood glucose (BG) difference between groups would result in risk reduction of 19 to 23{\%} over the planned follow up period (18-36 mo) in the group with lower postprandial BG. One thousand one hundred and fifteen (1115) patients were randomized [prandial strategy (N = 557), basal strategy (N = 558)]. HEART2D was stopped after futility rule implementation at the fourth interim analy sis. The risk of a first combined adjudicated CV events in the prandial group (N = 174, 31.2{\%}) and basal (N = 181, 32.4{\%}) groups was similar (HR = 0.98; 95{\%} CI [0.8, 1.21]). The results of HEART2D left the question of the role of postprandial hyperglycemia in diabetic CV disease unanswered. Here, we discuss possible reasons for this outcome, in cluding characteristics of daily BG profiles in the two treatment groups, event rate, risk factors other than standard CV risk factors and glycemic variables. The main reasons for this outcome of HEART2D study could be smaller than expected on-study differences between the study groups in postprandial hyperglycemia, and low event rate. Further trials with larger patient populations and improved designs, focusing also on diabetic patients with lower cardiovascular risk and lower baseline HbA1c levels are needed in order to shed more light on this important clinical problem.",
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