Drug can help prevent diabetes, study says - The Boston Globe:
"Drug can help prevent diabetes, study says Found to diminish risk by 62 percent
By Alice Dembner, Globe Staff September 16, 2006
Millions of adults at high risk of diabetes could ward off the disease by taking a drug commonly used to treat it, according to the largest diabetes prevention study yet conducted.
The drug, rosiglitazone or Avandia, taken for three years, reduced the risk of getting diabetes by 62 percent, according to a report published yesterday. The results, which come as the rate of diabetes soars worldwide, match those achieved by a moderate program of exercise and diet that doctors have had trouble getting their patients to comply with.
``Regrettably, people aren't leaping off the couch" despite the evidence that exercise can prevent diabetes, said Dr. Larry C. Deeb, president of medicine and science for the American Diabetes Association. ``Now we know that drug interventions work. We don't want to fix everything with a pill, but the ravages of this epidemic suggest that anything and everything is fair game."
In the United States, more than 21 million people have diabetes, a disease in which the body cannot process the sugar produced by digesting food. The government predicts that the number will grow to 48 million by 2050 unless there are extensive prevention efforts.
As many as 54 million Americans have a condition called prediabetes, with slightly elevated blood sugar levels, and about 10 percent of them are likely to develop diabetes each year. Uncontrolled diabetes can lead to blindness, amputations, kidney failure, heart disease, and early death. The study looked at preventing the most common form of the disease, Type 2, which most often develops in adulthood.
The drug is the third found to help prevent diabetes, but by far the most effective. A major US study in 2002 found that metformin, the inexpensive, generic drug most widely prescribed to treat diabetes, reduced the risk of developing the disease by 31 percent and another study found that the little-used drug acarbose cut the risk by 32 percent. Because both drugs showed only about half the risk reduction of a moderate program of diet and exercise, most doctors have been reluctant to recommend that patients who aren't sick take a drug every day. In fact, the American Diabetes Association recommended earlier this year that doctors refrain from prescribing drugs to prevent diabetes.
Deeb, who was not involved with the new study, said the association is likely to rethink that recommendation because of the rosiglitazone results.
Use of the drug also could get a boost if its manufacturer, GlaxoSmithKline , decides to seek approval from the Food and Drug Administration to market Avandia for diabetes prevention. Without FDA approval, doctors could prescribe the drug for prevention but the company could not advertise it for that purpose. The company helped pay for the study, but had no role in the collection or analysis of the data, according to the academic researchers at McMaster University in Ontario who led the study.
A Glaxo official said yesterday that the company will review the results and consider requesting FDA approval next year.
Rosiglitazone is not without risks. In the study, for every 1,000 people who took 8 milligrams of rosiglitazone daily, 144 cases of diabetes were averted, but four or five patients got congestive heart failure, even though patients with serious heart conditions were excluded from the study. None of the patients died of the heart failure, a chronic condition in which the heart can't pump enough blood, and fluid builds up in the lungs and other tissues. Congestive heart failure can be treated with medications.
Rosiglitazone can increase fluid retention, which probably contributed to the heart failure, and also can cause swelling in the legs. In the study, patients on rosiglitazone also gained about 5 more pounds over the study period than those taking a placebo.
Physicians will have to weigh the risks and benefits for each patient, said Dr. David Nathan, a physician at Massachusetts General Hospital who oversees a national program to prevent diabetes, but was not involved in the new study. Nathan would prefer that patients use the proven exercise and diet program -- consisting of a brisk walk 30 minutes a day and losing 5 to 10 percent of one's weight -- which offers additional health benefits. He said the drug treatments probably have merit for some patients.
Yet, he pointed out that many patients won't take drugs reliably. In the study, about one-quarter of patients didn't take the pills daily.
``We can barely get people to take drugs for diseases they have," Nathan said.
Treating millions more people with blood sugar abnormalities also would be expensive, he noted. In addition to the cost of blood tests to screen those at risk, the drug would cost $1,000 to $2,000 per person a year at retail prices on the Internet. Patients might have to take the drugs indefinitely.
The company said about 7 million US patients with full-blown diabetes have been treated with rosiglitazone since the FDA approved it for that purpose in 1999. US sales last year were $1.6 billion. The drug treats diabetes by making cells more sensitive to insulin, which the body uses to process blood sugar to provide energy. For some diabetics, drugs are not enough and they must get insulin by injection. In the new study, rosiglitazone helped restore many patients' blood sugar levels to normal.
``We now have another drug that can clearly prevent diabetes," said Dr. Hertzel C. Gerstein, a professor of medicine at McMaster University and cochairman of the study. ``If we can prevent diabetes, we may also be able to prevent the serious cardiovascular, eye, kidney, and other health consequences." Gerstein has worked as a consultant and speaker for GlaxoSmithKline.
The study, published online yesterday by The Lancet medical journal, was funded by the Canadian Institutes of Health Research and three drug companies -- Glaxo, Sanofi-Aventis, and King Pharmaceuticals. The researchers tested rosiglitazone against a placebo in 5,269 adults in 21 countries who had blood sugar levels higher than normal, but not high enough to qualify as diabetic. All participants were regularly advised to exercise and eat healthy foods. Half were given 8 milligrams of rosiglitazone each day for at least three years.
At the end of the study, 25 percent of the people who had taken a placebo had developed diabetes, compared with 10.6 percent who took rosiglitazone. Half of those who took rosiglitazone saw their blood sugar return to normal levels, compared to 30 percent of the placebo group, while the other participants continued to show elevated sugar levels, but did not progress to diabetes.
Another part of the study that was released by the New England Journal of Medicine found that ramipril, a blood pressure drug, did not prevent diabetes. Previous studies suggested that ramipril might prevent diabetes. "