Studies: Intense care doesn't help diabetics

LOS ANGELES — It seemed like a good idea at the time. Diabetics are at an unusually high risk of heart disease, heart attacks and strokes, so treating them intensively to sharply reduce blood pressure, cholesterol levels and sugar levels should be highly beneficial. But a decade of studies in thousands of patients show that is not the case.

Two new reports from a major nationwide trial called ACCORD released Sunday show lowering either blood pressure or cholesterol levels below current guidelines do not provide additional benefit and, in fact, increase the risk of side effects. A third arm of the study, released two years ago, shows lowering blood sugar levels excessively actually increases the risk of heart disease.

The results are very disappointing, researchers say, because they suggest clinicians may have reached the limit for what they can do for diabetic patients without the development of totally new therapeutic approaches.

But the good news is, the findings "reduce the cost and potential side effects of drug therapy" and mean patients will not have to work as hard at reducing blood sugars, lipids and blood pressure, said Dr. Denise Simons-Morton of the National Heart, Lung and Blood Institute, which funded the trial.

"The take-home message is that the standard care approaches are pretty good. If we try to go beyond them, it doesn't provide additional benefit."

Diabetes has become a tremendous problem in the United States, with at least 21 million people now afflicted with Type 2 diabetes — in which cells do not respond properly to insulin produced by the pancreas — and millions more at risk because of obesity. Most diabetics also have high blood pressure and high cholesterol levels, factors that bring their risk of heart attack and stroke to the same level as that of people who already have suffered a heart attack.

Many doctors have reasoned aggressively lowering blood pressure and lipids below nationally recommended levels might decrease the risk of heart disease, and ACCORD was created to study the possibility.

In one arm of the study, Dr. William Cushman of the Veterans Affairs Medical Center in Memphis and his colleagues at 77 medical centers enrolled 4,733 diabetics with high-cholesterol levels and existing cardiovascular disease or a high risk of developing it. They were randomly assigned to treatment regimens to lower their systolic blood pressure — the top number in a blood-pressure measurement — below 140 mm Hg, the standard treatment goal for diabetics, or below 120 mm Hg, the target goal.

Patients in the intensive- treatment group took an average of 3.6 medications to lower blood pressure, while those in the normal treatment group took two.

Cushman reported Sunday at an Atlanta meeting of the American College of Cardiology and in a paper published online in the New England Journal of Medicine that the treatment group achieved an average systolic blood pressure of 119 mm Hg but that they had no decrease in heart attacks, cardiovascular disease or deaths.

They did have fewer strokes, 62 in the normal-treatment group compared with 36 in the intensive-treatment group, but that was offset by such side effects as abnormally low blood pressure or high levels of potassium. Some laboratory measures of kidney function also were abnormal in the intensive-treatment group, but there was no increase in kidney failure.