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HEART2D Study Shows No Cardiovascular Benefit by Targeting Postprandial Glucose Levels

Posted: Friday, June 20, 2008

A study examining the effects of hyperglycemia on type 2 diabetes patients after acute myocardial infarction (AMI), the Hyperglycemia and Its Effect After Acute Myocardial Infarction on Cardiovascular Outcomes in Patients With Type 2 Diabetes (HEART2D) study, found no cardiovascular benefits from tightly controlling postprandial variations in blood glucose.
The randomized, controlled, multinational trial compared a prandial insulin strategy with a basal insulin strategy by assessing the time elapsed between a patient's enrollment in the study (<21 days after an AMI) and any subsequent cardiovascular event. Cardiovascular events included cardiovascular death, nonfatal stroke or myocardial infarction, and hospitalization for coronary syndromes or bypass surgery.

Patients with type 2 diabetes were assigned to a treatment group within 3 weeks after an AMI qualified them for the study. Patients (n = 557) in the prandial group received insulin lispro before each meal, the goal being 2-hour postprandial blood glucose levels of less than 135mg/dL. (7.5 mM). Patients (n = 558) in the basal group received NPH insulin twice a day or insulin glargine once a day, with the goal of achieving a fasting blood glucose level of less than 121mg/dL (6.7 mM).

"This study really is not to show the difference between 2 different insulin regimens but to show the difference between 2 kinds of blood glucose profiles," said lead author Itamar Raz, MD, after his presentation. Dr. Raz is on the faculty of internal medicine at Hadassah University Medical Center, head of the Diabetes Unit, Department of Medicine, Hadassah University Hospital, and director of the Hadassah Center for the Prevention of Diabetes and Its Complications, Ein-Karem, Jerusalem, Israel.

A large number of patients — 220 prandial and 212 basal — dropped out of the study. "I think [a] problem with this study is, it's not a very big study. We're talking about 1100 people, and actually around less than 800 people remained until the end of the study," said Dr. Raz. "Some of the people who didn't continue the study were actually either stopped by their physician or dropped out because of very low compliance."

The target of the regimen in each group was a HbA1c level of less than 7.0%. Approximately 50% of the patients in each group achieved that target. The prandial group required more insulin to reach this target and showed a significant weight increase compared with the basal group.

Mean blood glucose levels showed significantly smaller 2-hour postprandial excursions in the prandial than in the basal group (P < .0001). However, the rate of subsequent cardiovascular events during the study was similar in both treatment groups: 181 prandial, 174 basal (hazard ratio [HR], .98). Mean HbA1c was essentially the same (7.6%) for the 2 treatment groups (P = .48).

Dr. Raz stated that, the study was suspended for "futility" resulting from the absence of any differential effect of the 2 drug regimens on cardiovascular outcomes. "We stopped the study because there was not even a slight trend, and the chance to achieve significant difference with time was minor."

Further data analysis may still yield valuable information. Replying to questions after his presentation, Dr. Raz commented: "It would also be interesting to see, for example...whether hypoglycemia by itself had any effect [on cardiovascular events]. In addition, "analysis of the relationship between length of diabetes and cardiovascular events should be done. And we'll do it," he said. "[I]t will take time, but this is one of the things that we should do."

Anne L. Peters, MD, CDE, chair of the Late Breaking Clinical Study session, commented on the study.

"It was a difficult study to do, and impressive that a difference was accomplished between the 2 groups in terms of postprandial levels," said Dr. Peters. "However, in keeping with ACCORD, ADVANCE, and the VA Study, glucose lowering is not the major short-term modulator of cardiovascular disease [CVD] risk in patients with advanced disease. Use of other CVD-modifying drugs is vital to reducing risk."

Publisher’s Comment (Diabetes In Control) :  Is it really about controlling fasting blood sugars or controlling postprandial blood sugars?  Or is it about Glucotoxicity?  Controlling blood sugars to Euglycemia?  Sometimes I just wonder what we could do if we took the money for this study and used it to educate people with diabetes and prediabetes?  

Source: Diabetes In Control: ADA 68th Scientific Sessions: Late Breaking Clinical Studies. Presented June 9, 2008.

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