Aggressive Treatments Don't Help Diabetes Patients

Heart Risk Isn't Cut for Diabetes Patients Who Aggressively Lower Blood Pressure, Blood Fats

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March 15, 2010 (Atlanta) -- Lowering blood pressure and blood fat levels to below current guidelines did not bring down higher risks of heart problems for diabetes patients, according to new results from a landmark federal study.

But for individual people with diabetes, the findings brought some good news in that the current standard of care worked better than expected, some doctors say. Also, for people with diabetes that are at particularly heightened risk of heart problems, aggressive management may still be needed, they point out.

Overall, the findings underscore the need for most people with diabetes to focus on healthy diets and lifestyles as well as to take the medications their doctors recommend to improve heart health, some experts tell WebMD.

The experts are reacting to results from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, launched 10 years ago to determine whether aggressively lowering blood sugar, blood pressure, and blood fat would reduce heart attacks and strokes in people with diabetes.

The new results show that lowering systolic blood pressure -- the top number -- to 120 rather than the usual recommended 140 did not lower heart attacks, strokes, or death from cardiovascular causes, reports William Cushman, MD, of the VA Medical Center in Memphis, Tenn.

Similarly, adding the fat-busting drug TriCor to standard cholesterol-lowering drugs called statins did not reduce the odds of heart attacks, strokes, or death from cardiovascular causes, says Henry Ginsberg, MD, of Columbia University in New York City. TriCor is a fibrate, designed to lower triglycerides while boosting HDL "good" cholesterol.

The studies were presented at the American College of Cardiology meeting and released simultaneously online by The New England Journal of Medicine.

A third part of the research -- about intensive lowering of blood sugar -- was prematurely halted two years ago when it turned out that the approach was associated with an increased, not decreased, risk of death.

Aggressive Therapy and Heart Risks

The blood pressure portion of ACCORD involved 4,733 people with diabetes at high risk of heart disease or stroke. They were given a variety of medications to keep their systolic blood pressure under 120 or under 140.

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The overall rate of heart attacks, strokes, and deaths was similar among the two groups. People who got the aggressive treatment had fewer strokes, but the absolute number of strokes was quite low, Cushman says.

A total of 3.3% of people on intensive treatment suffered serious side effects such as dangerously low blood pressure or kidney failure vs. 1.3% in the standard therapy group.

The lipid portion of ACCORD included 5,518 patients at high risk of heart problems. They were given either TriCor plus statins or a placebo plus statins.

As expected, triglyceride levels dropped more and HDL levels increased more in the group that got TriCor. But people who got TriCor were no less likely to have heart attacks, strokes, or die from heart problems.

Planned analyses of subgroups of patients suggested "a possible benefit" for people with high triglyceride and low HDL levels to start with -- the very people whom fibrate drugs are designed to help, Ginsberg says.

Lowering Blood Pressure Still Important

"I'm not surprised that [TriCor] did not benefit all diabetics," says Paul D. Thompson, MD, chief of cardiology at Hartford Hospital, Conn. He was not involved with the study.

"I think of it as a drug for increasing HDL and lowering triglycerides," he says, and such patients would be expected to continue to benefit.

The findings point to the need for individualized therapy, agrees Clyde Yancy, MD, a cardiologist at Baylor University in Dallas who is president of the American Heart Association.

Overall, patients in all the groups faced about a 2% risk of having a heart attack, stroke, or dying of cardiovascular disease a year -- regardless of whether they got intensive or standard blood-pressure lowering or a fibrate plus statin or a statin alone, he notes.

That's "better than expected [for high-risk diabetes patients]," Yancy says.

So what should people with diabetes do? Focus on maintaining a healthy weight, eating right, exercising, and taking other lifestyle steps proven to reduce heart risks, he says.

W. Douglas Weaver, MD, of the Henry Ford Health System in Detroit and a past American College of Cardiology president, stresses that the findings do not negate the need to keep blood pressure and blood fats under control.

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"Nature says high blood pressure is not good," he says.

And never stop taking medication without checking with your doctors, the experts say.

Abbott, which makes TriCor, released a statement that the findings "support the appropriate patient type and current treatment guidelines for fibrates. The top-line results of the study were widely expected, given that two-thirds of patients in the trial would not be recommended for fibrate therapy under current guidelines."

WebMD Health News Reviewed by Laura J. Martin, MD on March 15, 2010

Sources

SOURCES:

American College of Cardiology’s 59th Annual Scientific Session, Atlanta, March 14-16, 2010.

William Cushman, MD, VA Medical Center, Memphis, Tenn.

Henry Ginsberg, MD, Columbia University, New York.

Paul D. Thompson, MD, chief of cardiology, Hartford Hospital, Conn.

Clyde Yancy, MD, Baylor University, Dallas; president, American Heart Association.

W. Douglas Weaver, MD, Henry Ford Health System, Detroit.

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