Fenofibrate added to pravastatin could help control mixed hyperlipidemia
MedWire News: Adding 160 mg fenofibrate daily to 40 mg pravastatin can significantly improve the lipid profile of high-risk patients whose mixed hyperlipidemia is not controlled by the statin alone, trial findings suggest.
Combination therapy resulted in significantly greater decrease in the primary endpoint of non-high-density lipoprotein (non-HDL) cholesterol compared with 40-mg pravastatin monotherapy.
Significantly more patients receiving the fibrate-statin combination also achieved the LDL cholesterol (<100 mg/dl; 2.6 mmol/l) and non-HDL cholesterol (<130 mg/dl; 3.4 mmol/l) National Cholesterol Education Program Adult Treatment Panel (NCEP-ATP) III treatment goals.
The significantly greater decreases in low-density lipoprotein (LDL) and non-HDL cholesterol with fenofibrate plus pravastatin also enabled more patients in this group to achieve NCEP-ATP III treatment goals.
After an 8-week run-in with pravastatin 40 mg daily, 248 participants who still had LDL cholesterol levels of at least 100 mg/dl and fasting triglycerides between 150 mg/dl and 400 mg/dl (1.7 to 4.5 mmol/l) inclusive were randomly assigned to receive 160 mg fenofibrate plus 40 mg pravastatin or the pravastatin dose alone for 12 weeks.
Combination therapy produced significantly greater complementary decreases in non-HDL cholesterol than pravastatin monotherapy (-14.1% versus -6.1% respectively).
The fibrate-statin combination also resulted in significantly greater reductions in LDL cholesterol (-11.7% vs -5.9%), triglycerides (-22.6% vs -2.0%), and apolipoprotein B (-12.6% vs -3.8%) compared with pravastatin alone.
Increases in HDL cholesterol were also significantly higher with the combination versus monotherapy (6.5% vs 2.3%).
In addition to improving atherogenic lipid profile, combination therapy also induced significantly greater decreases in fibrinogen and high-sensitivity C-reactive protein.
Michel Farnier (Point Medical, Dijon, France) and colleagues say both treatments were generally well tolerated and the frequency and type of adverse events were similar in the two groups.
Reporting in the American Journal of Cardiology, they say: "The fenofibrate/pravastatin combination therapy produced robust beneficial effects across lipid and lipoprotein profiles."
Participants who completed the 12-week study have been offered entry into a 52-week open-label extension study, which the authors plan for future publication.
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By Anita Wilkinson