Insulin resistance is one of the characteristics of the metabolic syndrome, which is a collection of health risks that increase a person's chance of developing heart disease, stroke, and diabetes. Research shows that insulin resistance is also an independent risk factor for cardiovascular disease. "The role that insulin resistance plays in the development of cardiovascular disease makes insulin sensitizers an attractive consideration when treating type 2 diabetes patients," said Dr. Weissman.

Important Safety Information About the Products Studied

The combination of rosiglitazone maleate and metformin HCl along with diet and exercise helps improve blood sugar control. A small number of people who have taken metformin have developed a rare yet serious condition called lactic acidosis (a buildup of lactic acid in the blood).

Lactic acidosis occurs most often in people with kidney problems and can be fatal in up to one half of the cases. Rosiglitazone and metformin combination therapy should not be used in people with kidney problems or in people 80 years of age and older whose kidneys are not functioning properly. Rosiglitazone and metformin combination therapy should not be used by people who drink alcohol excessively or by those taking medication for heart failure. It is not approved for use with insulin.

Some people may experience tiredness or weight gain with rosiglitazone and metformin combination therapy. Rosiglitazone and metformin combination therapy may also cause swelling, which, if left unchecked, could lead to or worsen heart failure. If you experience an unusually rapid increase in weight, swelling, shortness of breath, or have a history of these conditions, talk to your doctor immediately.

Rosiglitazone and metformin combination therapy is not recommended for people with liver disease. Also, blood tests to check for serious liver problems should be conducted before therapy, and periodically thereafter as determined by your doctor. If you experience unexplained tiredness, stomach problems, dark urine or yellowing of the skin, talk to your doctor immediately. Women who are nursing, pregnant, thinking about becoming pregnant or premenopausal should talk to their doctor before taking rosiglitazone and metformin combination therapy.

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