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No difference observed between prandial, fasting strategies
HEART2D findings showed no difference for future CV events.
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The HEART2D study was stopped early after findings demonstrated there was no difference between the effects of prandial and basal treatments on future cardiovascular events in patients with type 2 diabetes and recent acute myocardial infarction.
The researchers randomized 1,115 patients into the HEART2D study for a mean of 963 days. They randomly assigned patients to the prandial strategy of three premeal doses of insulin lispro with a target of two-hour postprandial blood glucose <7.5 mmol/L (n=557) or to the basal strategy of twice-daily NPH or once-daily insulin glargine with a target of fasting/premeal blood glucose <6.7 mmol/L (n=558).
The American College of Cardiology, American Diabetes Association and American Heart Association issued a position statement based on findings from the ACCORD, ADVANCE and VADT trials. In the statement, published in the January 2009 issue of Diabetes Care and reported in the February 10 issue of Endocrine Today, clinicians were advised to continue following evidence-based recommendations for blood pressure treatment for CVD risk reduction
“As with other trials (DIGAMI-2, ACCORD, ADVANCE and VADT), research in this area is challenging and further investigations on the relationship between glycemia and CV outcomes may be warranted,” Scott J. Jacober, DO, research physician for Eli Lilly and Company, said in a press release.
Similar results
The mean postprandial blood glucose was 7.8 mmol/L in the prandial group and 8.6 mmol/L in the basal group (P<.01). The two-hour postprandial blood glucose excursion was lower in the prandial group (0.1 mmol/L) vs. the basal group (1.3 mmol/L; P<.001).
The mean fasting blood glucose was 8.1 mmol/L in the prandial group vs. the basal group (7.0 mmol/L; P<.001). Premeal blood glucose was lower in the prandial group (7.3 mmol/L) vs. the basal group (7.7 mmol/L; P=.233).
The mean HbA1c was similar between the prandial (7.7%) and basal (7.8%; P=.40) groups. The HR was 0.98 (95% CI, 0.8-1.21) for prandial group patients (31.2%) and basal group patients (32.4%) who experienced a first combined adjudicated CV event, according to the study.
In an editorial published in this month’s issue of Diabetes Care, Antonio Ceriello, MD, professor of diabetes and endocrinology at University of Warwick, United Kingdom, stressed that starting to control hyperglycemia when CVD is already present may not have a beneficial effect.
“At the same time, we have again learned how difficult optimal control of hyperglycemia is — a goal that seems to be mandatory at a very early stage of diabetes,” he wrote. – by Christen Haigh
Ceriello A. Diabetes Care. 2009;32:521-522.
Raz I. Diabetes Care. 2009;32:381-386.