NEW YORK (Reuters Health) – The combination of fibrate and statin therapy is a safe and efficacious treatment option for women with multiple lipid abnormalities, a multicenter team reports in the January 20 online issue of the American Journal of Cardiology.
That conclusion comes from a post hoc analysis of pooled data from three large, multicenter, randomized, double-blind, controlled studies that evaluated fenofibric acid (Trilipix; Abbott) combined with rosuvastatin, simvastatin, or atorvastatin. The 1393 women in the studies had LDL cholesterol levels of at least 130 mg/dL, triglyceride levels at least 150 mg/dL and HDL cholesterol levels less than 50 mg/dL.
“The eligible women were randomized to receive fenofibric acid plus a low- or moderate-dose statin (combination treatment); or low-, moderate-, or high-dose statin monotherapy; or fenofibric acid monotherapy,” Dr. Anne C. Goldberg, at Washington University School of Medicine in St. Louis, Missouri, and colleagues explain.
They found that the combination approach gave the best overall results. Specifically, the low-dose combination treatment increased HDL cholesterol 20% and decreased triglycerides 46%. Corresponding changes with low-dose statins alone were an 8% HDL increase and 20% triglyceride decrease.
“With the moderate-dose combination, the baseline HDL cholesterol increased 21% and TG (triglycerides) decreased 44% compared to an 8% HDL cholesterol increase and 26% TG decrease with moderate-dose statins alone,” the investigators report.
The reduction in LDL cholesterol with the combination treatments (37%-39%) was about the same as with the corresponding statin doses alone (36%-43%).
High-dose statin therapy lowered LDL by 47%, but changes in HDL and triglycerides were similar to those seen with lower statin doses, the team reports.
The incidence of serious treatment-related adverse event was similar in each treatment group, ranging from 2% to 4%.
Mean changes in serum creatinine values were significantly greater in the combination arms than in the statin monotherapy arms, according to the report, but none of the women discontinued treatment because of an increase in creatinine.
The end-of-study lipid levels achieved with combination therapy “were comparable to, or better than, those attained using high-dose statins,” Dr. Goldberg and colleagues conclude. “A clinical decision to treat with high-dose statins in women must reasonably weigh their tolerability and efficacy against those of combination therapies using low- to moderate-dose statins plus fenofibric acid.”
Reference:
Efficacy of Fenofibric Acid Plus Statins on Multiple Lipid Parameters and Its Safety in Women With Mixed Dyslipidemia
Am J Cardiol 2011.
