More patients with type 2 diabetes reach target lipid levels with combination therapy

June 9, 2009

A significantly greater proportion of patients with type 2 diabetes with mixed dyslipidemia treated with a combination of fenofibric acid and rosuvastatin achieved American Diabetes Association (ADA) target lipid levels compared to those taking rosuvastatin alone, reports Robert S. Rosenson, MD, State University of New York, Brooklyn, NY. "Because diabetes is a risk factor for heart disease, it is particularly important that patients with diabetes and mixed dyslipidemia manage all three key lipid parameters," he says.

A significantly greater proportion of patients with type 2 diabetes with mixeddyslipidemia treated with a combination of fenofibric acid and rosuvastatin achievedAmerican Diabetes Association (ADA) target lipid levels compared to those takingrosuvastatin alone, reports Robert S. Rosenson, MD, State University of New York,Brooklyn, NY (pictured left). "Because diabetes is a risk factor for heart disease, it isparticularly important that patients with diabetes and mixed dyslipidemia manage allthree key lipid parameters," he says.

Researchers studied 480 patients with type 2 diabetes who were included in twophase 3 studies, treated with 135 mg fenofibric acid plus 5 mg, 10 mg, or 20 mgrosuvastatin daily for 12 weeks. Control groups were treated with 135 mg fenofibricacid monotherapy or rosuvastatin monotherapy at doses of 10 mg, 20 mg, or 40 mg.

Mean patient age was 58.8 years; 11% had coronary artery disease, 75.7% werehypertensive, 87.8% had metabolic syndrome according to National CholesterolEducation Program-Adult Treatment Panel III guidelines, and 38.2% had a history ofobesity. All patients had a baseline low-density lipoprotein (LDL) level of at least130 mg/dL, baseline triglycerides of 150 mg/dL, and a baseline high-densitylipoprotein (HDL) level of less than 40 mg/dL.

An increase in HDL cholesterol was a notable finding, Dr. Rosenson says. Patientsreceiving combination treatment with 5 mg rosuvastatin had a 25.5% increase in HDLcompared to 17% of those taking rosuvastatin alone (p=0.02) and 19% of thosetaking fenofibric acid alone. Patients taking the combination with 10 mgrosuvastatin had a 19.6% increase in HDL compared with a 5.7% increase forrosuvastatin alone (p=0.002).

Dr. Rosenson notes that in 52-week clinical trials using a fixed-dose combinationof fenofibric acid and rosuvastatin, HDL increases occur early and continueincrementally. "We see this with both niacin and fibrates. I think there are twodifferent sets of genes being activated; one set is activated early to raise HDL andanother set is activated long-term," he says.

Elevated triglycerides were also effectively treated with combination therapy andwere lowered 39.9% in the group taking the combination with 5 mg rosuvastatin versus23.6% in the rosuvastatin-alone group (p<0.001); 44.8% in the group takingthe combination with 10 mg rosuvastatin versus 28.6% in the rosuvastatin-alone group(p=0.002); and 42.6% in the group taking the combination with 20 mgrosuvastatin versus 28.6% in the rosuvastatin-alone group (p=0.002).

LDL was lowered in 32.8% of patients taking the combination with 5 mgrosuvastatin compared with 28.1% for those taking 5 mg rosuvastatin alone; 36.8%versus 43.3% for those taking the 10 mg rosuvastatin combination versus 10 mgrosuvastatin alone; and 37.0% versus 44.3% for those taking the 20 mg rosuvastatincombination versus 20 mg alone.

The combination of rosuvastatin 10 mg with fenofibric acid was associated withthe greatest percentage of patients reaching all three ADA lipid targets (LDL<100 mg/dL; triglycerides <150 mg/dL; HDL >40 mg/dL for men and >50mg/dL for women) during the 12-week treatment period. In this treatment group, 28.3%of patients reached target lipid levels compared to 8.3% receiving a comparable doseof rosuvastatin monotherapy (p=0.012). Among those taking the combinationwith 20 mg rosuvastatin, 19.1% of patients versus 5.9% of monotherapy patientsreached all three targets (p=0.045). There was not a significant differencein the percentage of patients reaching lipid targets between the 5 mg combinationand monotherapy groups.

Two-year data on a fixed-dose combination of fenofibric acid and rosuvastatin areyet to be presented. "Our diabetic patients complain to us frequently that they taketoo many medications," says Dr. Rosenson. "This combination will mean one less theywill have to take."