By Lee Bowman
SCRIPPS HOWARD NEWS SERVICE
Giving those at high risk of developing diabetes preventive doses of a drug already used to treat it cuts their odds of getting it by about 60 percent, according to the results of an international trial reported Friday.
The study, set up by researchers at McMaster University in Hamilton, Ontario, included 5,269 people under treatment at 191 clinics in 21 nations. It was set up to test the preventive ability of both the diabetes drug, called rosiglitazone and marketed by GlaxoSmithKline as Avandia, and a blood-pressure drug, called remipril and sold as Altace by Sanofi-Aventis and King Pharmaceuticals, that earlier studies had hinted might also help prevent diabetes.
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The companies and the Canadian Institutes of Health sponsored the trial. Researchers presented some results of the study at the annual meeting of the European Association for the Study of Diabetes in Copenhagen, Denmark. The full reports were published online in The Lancet (the Avandia trial) and The New England Journal of Medicine (the Altace trial), and will appear in future print editions. Results of the part of the study that used a combined dose of the drugs were not presented.
Type 2 diabetes occurs when the body doesn’t respond properly to the hormone insulin, produced by the pancreas, thus causing a buildup of sugar (glucose) levels in the blood that eventually causes tissue damage. Trial participants had glucose levels that were starting to indicate possible trouble, but they didn’t yet have diabetes.
While not everyone with “pre-diabetes” symptoms goes on to develop type 2 diabetes, studies suggest that between 22 percent and 55 percent do progress to the disease within three years.
Worldwide, about 5 percent of adults have type 2 diabetes, with another 8 percent to 10 percent having pre-diabetes. The rates are rising rapidly due to increased obesity and reduced physical activity among people in both developed and developing nations. Body fat impairs the ability of the body to use insulin properly.
In the United States, an estimated 18 million people have type 2 diabetes, and 41 million have pre-diabetes, researchers say.
Each patient in the study took one of the medications, a combination or a placebo over three years. They were also regularly counseled on the importance of maintaining a healthy lifestyle and diet. The study offered no indication as to how much those changes may have contributed to the outcomes.
Avandia, which helps the body respond to its own insulin and may also aid the body’s ability to produce insulin, appeared to benefit almost all the patients who took it.
Among those taking it, only 12 percent (280 individuals) developed diabetes, compared to 26 percent (658 patients) who got the placebo. The active drug normalized glucose levels in 51 percent of those who took it, compared with 30 percent in the placebo group.
Fourteen people in the Avandia group developed heart failure, compared to two in the placebo group.
There was no significant difference in diabetes incidence between those talking Altace and the placebo. But by the end of the study, significantly more people taking the active drug (43 percent) had normal glucose levels compared to those getting the placebo (38 percent).
Although many experts argue that the disease can be prevented in many people through diet and exercise without the added expense and risk of drugs, the McMaster researchers suggest that the difficulty of getting patients to stick with such changes argues for a more aggressive approach.
“Balancing both the benefits and the risks suggests that for every 1,000 people treated with rosiglitazone for three years, about 144 cases of diabetes will be prevented, with an excess of four or five cases of congestive heart failure.”
“If we can prevent diabetes, we may also be able to prevent the serious cardiovascular, eye, kidney and other health consequences of diabetes,” said Dr. Hertzel Gerstein, a professor of medicine and an endocrinologist at McMaster and a leader of the study.
Copyright 2006
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