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New Study Indicates Pioglitazone HCl/Metformin Combination Therapy Enhances Glycemic Control in Patients With Type 2 Diabetes : Presented at SEL

Significant Improvement Seen in a Leading Indicator Of Cardiovascular Disease

SECAUCUS, NJ -- November 7, 2002 -- Diabetes patients taking the insulin sensitizer pioglitazone HCl in combination with metformin experienced significantly greater improvement in triglyceride levels than patients taking rosiglitazone maleate and metformin, according to the results of a new multi-center, retrospective study being presented this week at the 193^rd Meeting of the Society for Endocrinology in London. Patients with diabetes have an increased risk of morbidity and mortality due to heart disease and stroke, and an elevated triglyceride level is a leading risk factor associated with these conditions.

Results from this retrospective review -- Impact of Pioglitazone and Rosiglitazone on Risk Factors for Cardiovascular Disease, or IMPROVE -- showed that patients treated with pioglitazone and metformin experienced a statistically significant 19.8 percent decline from baseline in their triglyceride levels, while those taking the rosiglitazone/metformin combination had a 10.8 percent increase in triglyceride levels over the same period. Blood sugar levels decreased in a similar manner for both study groups.

"These findings are particularly significant because of the link between diabetes and cardiovascular disease," said Anne Peters Harmel, MD, one of the authors of the study and Professor of Clinical Medicine, Keck School of Medicine, University of Southern California. "Diabetes dramatically increases a person's risk for heart disease and stroke, and it is important that we learn which therapies can potentially minimize that risk by improving clinical risk factors for cardiovascular disease."

Approximately 17 million Americans have diabetes, and heart disease is the leading cause of diabetes-related deaths.(1) Adults with diabetes have heart disease death rates that are about two to four times higher than adults without diabetes.(2) Insulin resistance, a condition where the body does not respond efficiently to the insulin it produces, seems to predispose a person to both cardiovascular disease and diabetes.

Both pioglitazone HCl and rosiglitazone are members of a class of type 2 diabetes oral anti-diabetic agents called thiazolidinediones, or insulin sensitizers, which work by making the body more sensitive to insulin. Insulin sensitizers are sometimes prescribed in combination with metformin, a biguanide that decreases the amount of glucose made by the liver, to help lower blood glucose in patients with non-insulin dependent, or type 2, diabetes. In order to achieve glycemic target, more patients than at present will require combinations of oral agents and then, insulin therapy, according to the United Kingdom Prospective Diabetes Study (UKPDS), a pivotal 20-year study examining more than 5,000 patients with type 2 diabetes in 23 clinical centers in England, Northern Ireland and Scotland.

Study Findings
The IMPROVE study, conducted by Health Economics Research, was based on a national, multi-center, retrospective chart review of 193 similar patients with type 2 diabetes, drawn from 318 endocrinology practices across the U.S. Ninety-seven patients received the combination pioglitazone and metformin and 96 patients received the combination rosiglitazone and metformin.

Only patients in the pioglitazone-metformin group experienced a drop in triglyceride levels. Triglycerides dropped a statistically significant 19.8 percent from baseline in the pioglitazone-metformin group, while those in the rosiglitazone-metformin group increased by 10.8 percent. In addition, study results showed combination therapy with pioglitazone significantly improved lipid profiles by increasing mean HDL ("good") cholesterol by 7 percent from baseline. Among patients receiving combination therapy with rosiglitazone, the increase in mean HDL cholesterol was not significant. Declines in blood sugar did not differ between the study groups.

"It is vitally important to manage not only the blood sugar levels of diabetes patients, but clinical risk factors for cardiovascular disease as well, including high cholesterol and triglyceride levels," said Albert Marchetti, MD, Vice President and Director of Medical Research for the Professional Postgraduate Services division of Health Economics Research. "Pioglitazone in combination with metformin appears to help patients realize greater lipid improvement, which in turn, may help patients minimize their risk for cardiovascular disease."

Based in Secaucus, NJ, Health Economics Research (HER) is the medical technology assessment and health/pharmacoeconomic research division of Thomson Physicians World. For the past 11 years, HER has provided analytic support to the healthcare industry through consultation and clinical research programs that address the needs of patients, providers, and payers, as well as manufacturers of healthcare products.

Pioglitazone is manufactured as ACTOS by Takeda Pharmaceuticals North American and is co-promoted with Eli Lilly and Company. Rosiglitazone is manufactured as AVANDIA by GlaxoSmithKline.

(1) National Diabetes Information Clearinghouse. National diabetes statistics: general information and national estimates on diabetes in the United States, 2000. Available at: http://www.niddk.nih.gov/health/diabetes/pubs/dmstats/dmstats.htm.
[Accessed 10/28/02]

(2) National Diabetes Information Clearinghouse. National diabetes statistics: general information and national estimates on diabetes in the United States, 2000. Available at: http://www.niddk.nih.gov/health/diabetes/pubs/dmstats/dmstats.htm.
[Accessed 10/28/02]


SOURCE: Thomson Physicians World

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