Pitavastatin–ezetimibe combo affords large LDL-C reductions in dyslipidaemia

Treatment with the combination of pitavastatin plus ezetimibe effectively lowers low-density lipoprotein cholesterol (LDL-C) levels by more than 50 percent, with a safety profile comparable to that of pitavastatin monotherapy, according to the results of a phase III study.

The study included 283 Korean adults with primary hypercholesterolaemia requiring medical treatment. They were instructed to make therapeutic lifestyle changes during the 8-week screening period, which consisted of a 4-week washout period and a 4-week placebo run-in period (4–8 weeks).

During treatment period I, patients were randomized to receive one of following treatments: pitavastatin 2 mg plus ezetimibe 10 mg, pitavastatin 2 mg, pitavastatin 4 mg plus ezetimibe 10 mg, or pitavastatin 4 mg. The 8-week double-blind treatment period then commenced. Researchers evaluated adverse events (AEs), clinical laboratory data, and vital signs.

Eight weeks of double-blind treatment led to a significant reduction in LDL-C from baseline both in the pooled pitavastatin/ezetimibe (–52.8 percent) and pooled pitavastatin (–37.1 percent) groups. However, pitavastatin/ezetimibe exerted a significantly greater LDL-C–lowering effect than did pitavastatin (difference, –15.8 mg/dL, 95 percent confidence interval [CI], –18.7 to –12.9; p<0.001).

Finally, more patients in the pooled pitavastatin/ezetimibe vs pooled pitavastatin groups achieved their LDL-C goal (94.2 percent vs 69.1 percent; p<0.001).

There were no significant differences in the frequency of overall adverse events (AEs) and adverse drug reactions, with serious AEs being comparable between the treatment groups.