Hypoglycemia and heart attacks

Researchers with the VA Diabetes Trial, one of three major studies out this week designed to see if tight glucose control reduces heart disease, reported today that the strongest predictor of heart attack or stroke was not high blood glucose, but the opposite: very low blood glucose.

Study participants who had hypoglycemia severe enough to cause impaired consciousness within the last three months were also at highest risk for cardiovascular death or death from any cause, said Dr. Carlos Abraira, professor of medicine at the Miami VA Medical Center, and a co-chair of the VA study.

In findings that add to those of the ACCORD and ADVANCE trials being reported here this week at the ADA’s Scientific Sessions, researchers with the 7 ½-year VA trial said their study suggests that the benefits of tight glucose control may be greater if started at the time of diagnosis.

“If you treat patients intensively early in the disease, there is a benefit,’’ said Dr. William C. Duckworth, co-chair of the study and director of research at the Carl T. Hayden VA Medical Center in Phoenix, Ariz. “If you wait 15 years (before starting), the benefit goes away, and may even be detrimental.’’

The three studies – ACCORD, ADVANCE and the VA trial – each looked at somewhat different populations and used different strategies to lower blood glucose, but none found any significant improvement in cardiovascular risk as a result of tight glucose control. ADVANCE reported a strong benefit in reducing kidney disease and a trend toward improvement in heart risk, though not statistically significant; ACCORD found a negative effect of tight glucose control on heart risk, resulting in excess deaths that prompted a halt to part of the study earlier this year. The significant risk of hypoglycemia was not noted in ACCORD or ADVANCE.

The VA trial, conducted at 20 Veterans’ Affairs Medical Centers around the U.S., involved 1,791 veterans with type 2 diabetes, 97% of them male. Their average age was 60, and their health was poorer, compared to patients in the two previously reported studies: 40% of them entered the study with a history of heart attack, stroke, bypass surgery or other heart conditions, 80% had high blood pressure, more than half had high cholesterol or other lipid abnormalities, and nearly all were obese. They started out with an average A1C of 9.5%. The ADA recommends a target of 7% on the A1C, a measurement of blood sugar control over two or three months.

All study participants received treatment for high blood pressure and lipids, and all saw improvements. In addition, those given standard glucose-lowering treatments, such as oral medications and insulin, dropped to 8.4% A1C. Those given more intensive treatment, including more insulin and medications aimed at reducing blood sugar levels further, reached 6.9% within six months. Both groups maintained these A1C levels for the six years of their involvement in the study.

Another potentially significant finding of the study is that there was no association between rosiglitizone (Avandia) and heart attack, said statistician Thomas Moritz of Hines VA Hospital, Hines, Ill. He said most patients in the study were taking the drug, and “in every type of analysis we did, the frequency and dose of rosiglitizone was higher in people who did not have the (cardiovascular) event, which would suggest rosiglitizone did not harm our patients.’’

There was a slightly higher rate of cardiovascular death in the group receiving intensive treatment, said Dr. Duckworth, but it was not statistically significant, and overall, there were far fewer heart problems than had been expected. The predicted number of heart attacks and strokes in the study had been 650-700, but there were actually only 263 in the standard-treatment group and 231 in the intensive-treatment group. Dr. Duckworth attributes that to good basic medical care, including control of blood pressure, cholesterol and triglycerides.

The trial’s results will help guide doctors treating diabetes. “It will make our approach simpler, in that we have a better idea of what to focus on,’’ said Dr. Duckworth. “There should be a huge emphasis on early intensive treatment and a large emphasis on reducing hypoglycemia.’’

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Researchers with the VA Diabetes Trial, one of three major studies out this week designed to see if tight glucose control reduces heart disease.