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Experimental Lipid Drug Does Not Interfere With Lipid Reduction in Combination With Rosuvastatin: Presented at ADA
By Ed Susman
SAN FRANCISCO -- June 8, 2008 -- Investigative fenofibrate acid molecule ABT-335, when used in conjunction with the cholesterol-lowering agent rosuvastatin, does not interfere with lipid reduction in diabetic patients who also have hyperlipidaemia, according to study data presented here at the American Diabetes Association (ADA) 68th Scientific Sessions.
"The treatment effect of … ABT-335 plus rosuvastatin was similar in diabetic and nondiabetic subjects," said lead investigator Peter H. Jones, MD, Methodist DeBakey Heart Center, Houston, Texas, in an oral presentation here on June 7.
Dr. Jones and colleagues reviewed data in a 1,400-patient, phase 3 study of ABT-335, identifying the 20% of subjects who were diagnosed with type 2 diabetes.
In the main study, patients were randomised to receive ABT-335 at a daily dose of 135 mg combined with either 10 or 20 mg of rosuvastatin or to rosuvastatin alone in doses of 10, 20, or 40 mg. The combination therapy proved to be more effective than ABT-335 alone or rosuvastatin alone, Dr. Jones said.
The outcomes in the 276 patients with diabetes mirrored the outcomes in the general patient population of the study, Dr. Jones added.
Focusing solely on the diabetic patients, Dr. Jones noted that the combination of ABT-335 and rosuvastatin 10 mg resulted in an increase of 21% in high-density lipoprotein (HDL) cholesterol; a decrease in triglycerides of 44.7%; and a decrease of 37.1% in low-density lipoprotein (LDL) cholesterol. The rosuvastatin 10-mg monotherapy arm demonstrated an increase of 6.6% in HDL cholesterol (P = .001); a 28.8% decrease in triglycerides (P = .002); and a 43.6% reduction in LDL cholesterol (P < .001).
Dr. Jones noted that, because many patients with diabetes also have hyperlipidaemia, "a comprehensive approach may be necessary to help these patients manage their lipids. Treatment guidelines recommend aggressive treatment of lipids in patients with mixed dyslipidaemia and type 2 diabetes."
A New Drug Application for ABT-335 for use as monotherapy and in combination with statins has been submitted to the US Food and Drug Administration (FDA).
Funding for this study was provided by Abbott Laboratories and AstraZeneca Pharmaceuticals LP. The 2 companies are working together to develop a fixed-dose combination of ABT-335 and rosuvastatin.
[Presentation title: Efficacy of ABT-335 in Combination With Rosuvastatin in Patients With Type 2 Diabetes Mellitus and Mixed Dyslipidemia. Abstract 335]
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