ADA 2009: Fenofibric Acid Plus Rosuvastatin Lowers LDL, Raises HDL Cholesterol in Type 2 Diabetics

Martha Kerr

June 12, 2009

June 12, 2009 (New Orleans, Louisiana) — Type 2 diabetics with mixed dyslipidemia reach target lipid levels, including raising high-density lipoprotein (HDL) cholesterol and well as lowering low-density lipoprotein (LDL) cholesterol and triglycerides 3 times more often with a combination of fenofibric acid (Trilipix, Abbott) and rosuvastatin (Crestor, AstraZeneca) 20 mg than with either component alone.

Results of a composite analysis of 2 studies of fenofibric acid plus rosuvastatin were announced here this week at the 69th Scientific Sessions of the American Diabetes Association by Robert Rosenson, MD, chief of the Division of Endocrinology and senior cardiologist at the State University of New York, Brooklyn.

The 2 phase 3 studies involved 480 patients with type 2 diabetes and mixed dyslipidemia randomized to rosuvastatin 5 mg, 10 mg or 20 mg, fenofibric acid, or any combination of the 2 agents.

At baseline, patients had a LDL cholesterol levels of 130 mg/dL or greater, triglyceride levels of 150 mg/dL or greater, and HDL cholesterol levels of less than 40 mg/dL for men and less than 50 mg/dL for women.

HDL cholesterol and triglyceride levels were significantly improved with the combination compared with rosuvastatin alone. LDL cholesterol levels were significantly improved with the combination compared with fenofibric acid alone.

According to ADA guidelines, lipid targets were an LDL cholesterol level of less than 100 mg/dL, a triglyceride level less than 150 mg/dL, and an HDL cholesterol level greater than 40 mg/dL for men and greater than 50 mg/dL for women.

Dr. Rosenson reported that 28.3% of patients achieved all 3 lipid targets with fenofibric acid plus rosuvastatin 10 mg (P = .012 compared with fenofibric acid alone), 19.1% achieved the 3 targets with fenofibric acid plus rosuvastatin 20 mg (P = .045), and 21.7% achieved the 3 targets when rosuvastatin 5 mg was added to fenofibric acid (P = .007 compared with fenofibric acid alone).

"The combination allows more patients to achieve LDL and HDL targets," Dr. Rosenson told Medscape Diabetes & Endocrinology.

"It's important to get to targets with type 2 diabetes," he commented. "Risk remains high even with LDL levels below 100 mg/dL. The optimal LDL target is really below 70 mg/dL. We should at least try for this.

"This combination is very well tolerated, with no additional toxicity with the 2 agents together, " Dr. Rosenson pointed out. "Our main concerns are rhabdomylolitis, which we did not see at all.

"These agents mobilize triglycerides in the liver, which can cause liver abnormalities. There can be a risk of creatinine elevations with the increase in tubular secretion, but we didn't observe this. There was no potentiation of these effects with the combination," Dr. Rosenson commented.

"Diabetes is a multisystem disease and it is very important to treat the risk factors," he explained. Fenofibrates have been shown to have microvascular benefits, with reduced progression of retinopathy and nephropathy. Statins have proven benefits with macrovascular disease. The combination just make it easier for the patient to maintain compliance."

"Type 2 diabetics should be treated early and aggressively, reducing risk factors as much as possible," said R. Paul Robertson, MD, the American Diabetes Association's president of medicine and science. He is an endocrinologist at Swedish Medical Center in Seattle, Washington.

He echoed Dr. Rosenson's exhortation about treating diabetes as a multisystem disease.

"We have to be much more aggressive abut treating all the risk factors. We can't just focus on the hyperglycemia — that's just the tip of the iceberg. It's the other systems that are much more likely to lead to morbidity and mortality."

Dr. Rosenson is a consultant with Novo Nordisk, Roche Pharmaceuticals, Abbott Laboratories, AstraZeneca, and Daiichi-Sankyo. Dr. Robertson receives research support from Merck & Co, Inc.

American Diabetes Association (ADA) 69th Scientific Sessions: Abstract 966-P. Presented June 8, 2009.


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