Anti-diabetes drug slows progressive loss of sugar control in
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The anti-diabetes drug, rosiglitazone, significantly slowed the increase of blood sugar levels in patients with recently diagnosed type 2 diabetes, thus delaying the need to add a second medication, according to a new study. The results were published in the Dec. 7 New England Journal of Medicine and presented at the International Diabetes Federation s 19th World Diabetes Congress in Cape Town, South Africa, on Dec. 4.
The findings are from A Diabetes Outcome Progression Trial, or ADOPT. In this double-blind, randomized, controlled clinical trial, researchers compared rosiglitazone with metformin andglyburide over an average of four years of treatment. ADOPT involved more than 4,360 patients at 488 medical centers in the United States, Canada and 15 European countries. Study participants were 30 to 75 years old and diagnosed with type 2 diabetes for less than three years.
This is the first study to show that the progressive loss of glucose (sugar) control in early type 2 diabetes can be slowed and that, early in the course of the disease, rosiglitazone is preferable to glyburide, said Dr. Steven E. Kahn, an associate chief of staff for research at the Veterans Affairs Puget Sound Health Care System and professor of medicine at the University of Washington in Seattle.
Rosiglitazone s greater positive result was probably due to how effectively it improved the way the muscle, fat and liver respond to insulin, and how the ß-cell in the pancreas releases insulin, Kahn said.
The research team compared the three drugs and evaluated the time it would take before increasing blood sugar levels would necessitate adding an additional medication. They examined this using the current clinical standard for measuring glycemic (presence of sugar in the blood) control as defined by a glycated hemoglobin greater than 7 percent. The researchers found that rosiglitazone delayed the need for additional drug therapy by 60 months, while the delay with metformin and glyburide was 45 and 33 months, respectively.
In assessing when single drug therapy was no longer effective, Kahn and colleagues used the criteria that were in place for plasma glucose concentration when the study was originally designed (a fasting glucose less than 180 mg/dl) and today s more stringent standards for glucose control (a fasting plasma glucose less than 140 mg/dl or glycated hemoglobin less than 7 percent). Glycated hemoglobin is a measure of blood sugar level in the past two to three months.
All criteria demonstrated the greater efficacy of rosiglitazone, which reduces the amount of sugar in the blood. It is in a class of anti-diabetic drugs called thiazolidinediones, which are used in the treatment of type 2 diabetes.
Thiazolidinediones reduce insulin resistance by sensitizing muscle, liver and adipose (fatty) tissue to insulin and delay the progression to type 2 diabetes in patients with glucose intolerance.
Glyburide is a sugar-lowering drug in a class of medicines called sulfonylureas. It lowers the sugar level by stimulating insulin secretion in the pancreas. Insulin is a hormone that lowers the blood sugar level. Metformin also lowers blood sugar and belongs to a class of drugs called biguanides.
But unlike glyburide, rosiglitazone and metformin do not increase the concentration of insulin in the blood and, therefore, do not cause excessively low blood sugar levels when used alone. Metformin, however, is less expensive than risiglitazone and one of the most prescribed medications for diabetes treatment.
One finding that surprised the researchers was the study s safety data, which indicated an increased risk of fractures in women who were on rosiglitazone, but the same was not found in men. Interestingly, these fractures occurred predominantly in the hands and feet, and not in the hip or spine where fractures most commonly occur.
Glyburide was found to offer a lower risk of cardiovascular events (including congestive heart failure) than rosiglitazone, and the risk associated with metformin was similar to that found with rosiglitazone. Rosiglitazone was linked to more weight gain and edema (excessive accumulation of serous fluid in tissue) than either metformin or glyburide, but with fewer gastrointestinal events than metformin and with less hypoglycemia (low blood sugar) than glyburide. The researchers caution that the choice of rosiglitazone as the initial treatment for type 2 diabetes requires a full appreciation of its effectiveness in lowering sugar, the drug s side effects and its cost.
What needs to be considered is the risk-benefit ratio of each medication, as all three are known to have certain side effects, said Kahn. Patients and their physicians need to make an informed decision as to which drug they would want to use. Included in their assessment has to be consideration of the cost, as rosiglitazone is more expensive than either metformin or glyburide, both of which are now generic.
According to the International Diabetes Federation, there are an estimated 140 million people in the world with type 2 diabetes. In type 2 diabetes, the body makes too little insulin or uses the hormone inefficiently. Type 2 diabetes is the most common type of diabetes and accounts for about 95 percent of all people with the disease. In addition to medical therapy, some people with this type of diabetes can control their blood sugar with diet and weight loss.
The ADOPT study was supported by GlaxoSmithKline, the maker of rosiglitazone. Kahn has served as a consultant and speaker for GlaxoSmithKline and has received grant support from the company.
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