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Study Says Diabetes Drug Can Help Those At High Risk
Saturday, September 16, 2006 BY MARILYNN MARCHIONE AND MARIA CHENG
Associated Press
The largest diabetes prevention study ever done has found that a drug already used to treat the disease also can help keep "pre-diabetics" from developing it. But many experts say that losing weight and exercising remain a safer, cheaper approach.
The drug, rosiglitazone, or Avandia, appeared to cut the risk of developing Type 2 diabetes by more than half, doctors reported yesterday. Type 2 is the most common form of diabetes and a public health menace that afflicts more than 200 million people worldwide.
Avandia also helped restore normal blood-sugar function in many of those who took it.
A second part of the study found that a different drug, a blood pressure medication called ramipril, or Altace, made no difference in the risk of developing diabetes but helped normalize blood sugar for some.
The research was long-awaited, and the Avandia results at first glance seem impressive. However, experts say it is difficult to determine how much of the improvement was due to the drug, because study volunteers also were regularly counseled about healthy diets and lifestyles.
"We know that lifestyle changes alone can reduce the risk of developing diabetes by up to 58 percent," said Martin Abrahamson, medical director of the Joslin Diabetes Center in Boston, who had no ties to the study.
Those benefits come without the $90-to-$170-a-month cost and side effects of Avandia, said Alvin Powers, director of diabetes research at Vanderbilt University Medical Center who also had no role in the research.
"Fluid retention, congestive heart failure, and weight gain are known side effects of Avandia" when it's used to treat diabetes, Powers noted.
Results of the study were reported yesterday at a diabetes meeting in Denmark. The Avandia findings were published online by the British medical journal The Lancet; the Altace results were posted online by the New England Journal of Medicine. Both will appear in print editions later.
The study was paid for by the Canadian Institutes of Health Research and companies that make the drugs. (GlaxoSmithKline PLC makes Avandia; Sanofi-Aventis SA and King Pharmaceuticals market Altace.) Some study leaders consult for the companies.
The aim was preventing Type 2 diabetes, the form that is linked to obesity and sometimes leads to kidney failure, amputations and death. It occurs when the body does not make enough insulin or cannot effectively use what it manages to produce.
About 18 million Americans have Type 2 diabetes, and another 40 million have blood-sugar abnormalities called pre-diabetes. Research suggests that as many as half of pre-diabetics develop diabetes within three years.
Doctors at McMaster University in Canada and in 20 other countries assigned 5,000 pre-diabetics to get either Avandia, Altace, both drugs or no drug.
In the Lancet study, 306 of the 2,365 people given Avandia for an average of three years developed diabetes or died, compared with 686 of the 2,634 who did not receive that drug.
Fourteen of those given Avandia developed heart failure, while only two cases of heart failure occurred in people who didn't take the drug. Some doctors believe the heart risk is manageable as long as physicians carefully check patients taking the drug for heart abnormalities.
However, Powers said a drug to prevent one disease -- diabetes -- must not bring a substantial risk of another. Otherwise, doctors will be unwilling to prescribe it, especially when lifestyle changes and other drugs such as metformin can prevent diabetes, too, although sometimes to a lesser extent.
"Diet and exercise are still our best way to prevent this," said Julie Ingelfinger, who wrote an editorial in the New England Journal on the study results.
Still, some doctors were encouraged by Avandia's potential. "This underscores the fact that diabetes is preventable, and that we might have another means to do that with," said Peter Sheehan, director of diabetes at the Cabrini Medical Center in New York, who had no ties to the study.
The study's leader, Hertzel Gerstein of McMaster University, acknowledged a "synergistic effect" between Avandia and exercise, because both sensitize the body to the effects of insulin.
Jeffrey Probstfield, a University of Washington professor who led the U.S. portion of the study, said he would advise pre-diabetics to try the drug.
"I'm a strict adherent to the lifestyle approach," but the drug adds one more tool people can use to avoid a deadly and disabling disease, he said.
Associated Press
The largest diabetes prevention study ever done has found that a drug already used to treat the disease also can help keep "pre-diabetics" from developing it. But many experts say that losing weight and exercising remain a safer, cheaper approach.
The drug, rosiglitazone, or Avandia, appeared to cut the risk of developing Type 2 diabetes by more than half, doctors reported yesterday. Type 2 is the most common form of diabetes and a public health menace that afflicts more than 200 million people worldwide.
Avandia also helped restore normal blood-sugar function in many of those who took it.
A second part of the study found that a different drug, a blood pressure medication called ramipril, or Altace, made no difference in the risk of developing diabetes but helped normalize blood sugar for some.
The research was long-awaited, and the Avandia results at first glance seem impressive. However, experts say it is difficult to determine how much of the improvement was due to the drug, because study volunteers also were regularly counseled about healthy diets and lifestyles.
"We know that lifestyle changes alone can reduce the risk of developing diabetes by up to 58 percent," said Martin Abrahamson, medical director of the Joslin Diabetes Center in Boston, who had no ties to the study.
Those benefits come without the $90-to-$170-a-month cost and side effects of Avandia, said Alvin Powers, director of diabetes research at Vanderbilt University Medical Center who also had no role in the research.
"Fluid retention, congestive heart failure, and weight gain are known side effects of Avandia" when it's used to treat diabetes, Powers noted.
Results of the study were reported yesterday at a diabetes meeting in Denmark. The Avandia findings were published online by the British medical journal The Lancet; the Altace results were posted online by the New England Journal of Medicine. Both will appear in print editions later.
The study was paid for by the Canadian Institutes of Health Research and companies that make the drugs. (GlaxoSmithKline PLC makes Avandia; Sanofi-Aventis SA and King Pharmaceuticals market Altace.) Some study leaders consult for the companies.
The aim was preventing Type 2 diabetes, the form that is linked to obesity and sometimes leads to kidney failure, amputations and death. It occurs when the body does not make enough insulin or cannot effectively use what it manages to produce.
About 18 million Americans have Type 2 diabetes, and another 40 million have blood-sugar abnormalities called pre-diabetes. Research suggests that as many as half of pre-diabetics develop diabetes within three years.
Doctors at McMaster University in Canada and in 20 other countries assigned 5,000 pre-diabetics to get either Avandia, Altace, both drugs or no drug.
In the Lancet study, 306 of the 2,365 people given Avandia for an average of three years developed diabetes or died, compared with 686 of the 2,634 who did not receive that drug.
Fourteen of those given Avandia developed heart failure, while only two cases of heart failure occurred in people who didn't take the drug. Some doctors believe the heart risk is manageable as long as physicians carefully check patients taking the drug for heart abnormalities.
However, Powers said a drug to prevent one disease -- diabetes -- must not bring a substantial risk of another. Otherwise, doctors will be unwilling to prescribe it, especially when lifestyle changes and other drugs such as metformin can prevent diabetes, too, although sometimes to a lesser extent.
"Diet and exercise are still our best way to prevent this," said Julie Ingelfinger, who wrote an editorial in the New England Journal on the study results.
Still, some doctors were encouraged by Avandia's potential. "This underscores the fact that diabetes is preventable, and that we might have another means to do that with," said Peter Sheehan, director of diabetes at the Cabrini Medical Center in New York, who had no ties to the study.
The study's leader, Hertzel Gerstein of McMaster University, acknowledged a "synergistic effect" between Avandia and exercise, because both sensitize the body to the effects of insulin.
Jeffrey Probstfield, a University of Washington professor who led the U.S. portion of the study, said he would advise pre-diabetics to try the drug.
"I'm a strict adherent to the lifestyle approach," but the drug adds one more tool people can use to avoid a deadly and disabling disease, he said.
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