Combination therapy with fenofibrate and simvastatin does not provide additional protection against cardiovascular disease (CVD) in high-risk patients with Type 2 diabetes compared with simvastatin alone, according to findings from the ACCORD lipid trial.

Presenting the findings at the 59th Annual Scientific Session of the American College of Cardiology, in Atlanta, Georgia, USA, Henry Ginsberg (Columbia University College of Physicians and Surgeons, New York, USA) said that the findings “provide physicians with important new information regarding the treatment of a common lipid abnormality affecting many of their patients with Type 2 diabetes”.

The findings were also simultaneously published online in the New England Journal of Medicine.

For the ACCORD (Action to Control CardiOvascular Risk in Diabetes) lipid trial, 5518 people who had Type 2 diabetes and either pre-existing CVD or at least two additional CV risk factors and who were already taking simvastatin were randomly assigned to additional treatment with fenofibrate 54??”160 mg/day or placebo.

At baseline, the average total cholesterol level was 175 mg/dl (4.5 mmol/l), and the average high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglyceride levels were 101 mg/dl (2.6 mmol/l), 38 mg/dl (0.98 mmol/l), and 162 mg/dl (1.83 mol/l), respectively.

After a mean follow-up of 4.7 years, there was no significant difference between the two groups in the annual rate of the primary outcome (CV death, nonfatal heart attack, or nonfatal stroke) at 2.2% in patients taking fenofibrate and simvastatin and 2.4% in patients taking simvastatin and placebo. Annual rates of death were 1.5% in the fenofibrate group and 1.6% in the placebo group.

The researchers also compared rates of the primary outcome in 10 prespecified subgroups based on baseline characteristics. Of these, there appeared to be a difference between men and women taking combination therapy, “with the data for women suggesting potential harm and the data for men suggesting potential benefit,” Ginsberg reported. But the results did not reach statistical significance for either group.

There was also a trend toward benefit of fibrate treatment in a prespecified subgroup of patients with particularly high triglyceride levels of at least 204 mg/dl (2.30 mmol/l) and low HDL levels of 34 mg/dl (0.88 mmol/l). In these patients, the primary outcome rate was 12.4% in those taking fenofibrate plus simvastatin versus 17.3% in the simvastatin plus placebo arm. This compared with a rate of 10.1% in both study groups for all other participants.

“This dyslipidemia group outcome, which was prespecified, is concordant with several post hoc analyses from prior lipid trials,” Ginsberg noted.

He cited the Helsinki Heart Study (HHS) of gemfibrozil, which had a positive result for the primary outcome in the whole cohort and a greater benefit in a dyslipidemia subgroup, similar to that reported here. Other trials included the Bezafibrate Infarction Prevention (BIP) study and the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study, which despite having negative results for the whole cohort showed significant findings for subgroups with severe dyslipidemia.

Ginsberg concluded: “ACCORD lipid does not support use of the combination of fenofibrate and simvastatin compared to simvastatin alone, to reduce CV events in the majority of patients with Type 2 diabetes mellitus who are at high risk for CVD.”

He added: “Subgroup analyses suggesting heterogeneity in response to combination therapy by gender or by the presence of significant dyslipidemia require further investigation.”

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2010

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