(Recasts lead, adds embargoed study) By Julie Steenhuysen CHICAGO, Feb 6 (Reuters) - The popular diabetes drug Avandia did not cause higher rates of death in a study testing ways to prevent heart problems in high-risk diabetics, researchers said on Wednesday, who instead blamed overly aggressive therapy. They said high-risk patients with type-2 diabetes who got intensive treatment to bring their blood sugar or glucose down to normal died at a higher rate than patients allowed higher blood sugar levels. But no drug or combination of drugs appeared to be responsible, including GlaxoSmithKline Plc's <GSK.N><GSK.L> Avandia, they said. The researchers said they would adjust the trial, called ACCORD, so the blood sugar of patients would not be lowered so much. The National Heart, Lung and Blood Institute, which funded and helped organize the trial, stressed that all the patients in the study were less likely to die than similar type-2 diabetics in the general population. The study of 10,251 patients involved older adults, average age 62, who had type 2 diabetes for more than 10 years. "They had diabetes plus other risk factors which placed them at even higher risk for heart disease," Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute told reporters in a telephone briefing. Patients in one group were given aggressive treatment to lower their blood sugar levels -- a measure known as hemoglobin A1c -- to below 6 percent, far below the current target of under 7 percent and closer to what is seen in non-diabetics. These patients died at a higher rate than a second group whose A1c levels were kept to the 7 to 7.9 percent range. Nabel cautioned the study does not apply to all type-2 diabetics and the current target of lowering A1c to below 7 percent is likely appropriate for most patients. NO LINK TO ANY DRUG Doctors treating the patients in both the aggressive and standard therapy groups could use any approved diabetes drug, including metformin, insulins and thiazolidinediones such as Actos or Avandia, known generically as rosiglitazone. In May, a U.S. analysis linked Avandia to a 43 percent higher risk of heart attack. U.S. and European regulators now require strongly worded warnings about heart risks on the packages of Avandia and similar drugs. "We specifically tried to determine whether there was any link between this particular medication and the increased deaths. At this time we have found no link," said Dr. William Friedewald of Columbia University in New York, one of the directors of the trial. They said 257 patients in the intensive treatment group died, compared with 203 who got standard treatment. All the patients were also treated for high blood pressure and cholesterol. Friedewald said patients in the intensive treatment group had fewer nonfatal heart problems, but they had more unexpected sudden deaths, even without a clear heart attack. "It appeared that, if a heart attack did occur, it was more likely to be fatal," he told the briefing. The findings contradict conventional thinking about diabetes control -- that lowering blood glucose to the normal range would protect patients from heart attacks, as well as kidney disease, nerve damage and blindness. A smaller study published on Wednesday in the New England Journal of Medicine by researchers in Denmark showed patients treated with intensive therapy -- including efforts to control blood sugar, cholesterol and blood pressure -- had a lower risk of heart problems, including heart attacks. But in those patients, the blood sugar levels were only brought down to about 7.7 percent, much higher than the goal in the intensive therapy group in the ACCORD study. The American Diabetes Association on Wednesday advised patients with diabetes to maintain good control of blood glucose and talk to their doctors before making any changes. (Additional reporting by Ben Hirschler in London, Lewis Krauskopf in New York, Maggie Fox in Washington, editing by Richard Chang/Andre Grenon)
