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Rosiglitazone/Sulfonylurea Has Significant Advantages over Max

Jun 21, 2004

Early addition of the insulin sensitizer rosiglitazone (Avandia) in older type 2 diabetic patients previously on submaximal doses of a sulfonylurea reduces disease progression and provides superior glycemic control that is sustained over two years.

The study also demonstrated that adding rosiglitazone results in a greater likelihood of achieving glycemic targets than just maximizing sulfonylurea monotherapy.

Dr. Julio Rosenstock, with the Dallas Diabetes and Endocrine Center in Dallas, Texas, United States, presented results of 227 type 2 diabetics greater than 60 years of age initially on sub-maximal doses of the sulfonylurea glipizide. Subjects were randomised to rosiglitazone combined with glipizide or uptitration of glipizide monotherapy plus placebo. Treatments were individualized to encourage management to aggressive glycaemic targets.

Both groups were required to uptitrate the study medication when the fasting plasma glucose was greater than or equal to 10 mmol/L (180 mg/dL) to a maximum dose of 40 mg/d glipizide and 8 mg/d rosiglitazone or placebo.

The study found that 50% of patients who received combination treatment with rosiglitazone and glipizide achieved the goal hemoglobin A1c level of less than 7% versus 22% of patients on glipizide plus placebo.

Rosiglitazone added to the sulfonylurea achieved sustained improvements in hemoglobin A1c over 2 years’ treatment, with a mean hemoglobin A1c level less than 7% at the end of the study.

Only 1.7% of patients taking rosiglitazone added to the sulfonylurea had progression of their disease compared with 24.3% of patients on glipizide monotherapy.

Rosiglitazone added to the sulfonylurea significantly decreased insulin resistance and improved beta-cell function compared with the sulfonylurea plus placebo.

Patients taking the combination sulfonylurea plus rosiglitazone reported significantly fewer emergency room visits and hospitalizations compared with those on the sulfonylurea and placebo.

The insulin sensitizer was well tolerated in combination with the sulfonylurea and conferred no increased risk of hypoglycemia.

The results show that the early use of rosiglitazone reduces disease progression and provides sustained improvements in glycemic control, without compromising safety and tolerability, in combination with a sulfonylurea, titrated over two years in older type 2 diabetics in whom glycemic control is inadequate, Dr. Rosenstock said.

IDF: [Study title: Type 2 diabetes in the elderly: reaching durable glycemic goals with combination sulfonylurea and rosiglitazone. Abstract 2278. The investigation, known as the Rosiglitazone Early vs. SULfonylurea Titration (RESULT) study, was sponsored by GlaxoSmithKline in King of Prussia, Pennsylvania.


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