NEW YORK (Reuters Health) – When target cholesterol levels are not achieved with statin monotherapy in patients with mixed dyslipidemia, adding fenofibrate can tip the scales favorably.
Dr. Michel Farnier of Point Medical in Dijon, France and colleagues describe those findings in the American Journal of Cardiology issued online August 2.
The investigators compared treatment with 40 mg pravastatin to a fixed-dose combination of 40 mg pravastatin plus 160 mg fenofibrate in a double-blind, double-dummy trial involving 248 high-risk patients with mixed dyslipidemia not at their LDL cholesterol goal; i.e., baseline LDL cholesterol levels were at least 100 mg/dL and fasting triglyceride concentrations were between 150 and 400 mg/dL.
“Coadministration of fenofibrate 160 mg with pravastatin 40 mg produced a significantly greater decrease in non-HDL cholesterol after 12 weeks of treatment compared to pravastatin 40 mg, with a between-treatment difference of -8% (p=0.002),” the authors report.
Specifically, mean non-HDL cholesterol dropped from 183 to 156 mg/dL (-14.1%) in the combination arm and from 187 to 174 mg/dL (-6.1%) in the monotherapy arm.
LDL cholesterol dropped from 138 to 121 mg/dL (-11.7%) and from 141 to 131 mg/dL (5.9%) in the two arms, respectively.
During the 12-week study, 36.6% of patients on combination therapy reported 1 or more adverse event compared with 32.0% of patients given pravastatin alone, the researchers found. The frequency and type of adverse events — musculoskeletal, GI or nervous system — were very similar in the two treatment groups.
Summing up, Dr. Farnier and colleagues write: “The significantly greater decreases in LDL cholesterol and non-HDL cholesterol enabled more patients in the combination therapy group to achieve Adult Treatment Panel III LDL cholesterol and non- HDL cholesterol goals.”