Pitavastatin compared with atorvastatin in primary hypercholesterolemia or combined dyslipidemia

Aims: To demonstrate the equivalence of pitavastatin compared with the most commonly used doses of atorvastatin in the reduction of LDL-C in primary hypercholesterolemia or combined dyslipidemia. Secondary objectives included the comparison of pitavastatin against the most commonly used doses of atorvastatin in achieving National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III and European Atherosclerosis Society (EAS) LDL-C goals, changes in other lipid parameters and safety. Method: An 18- to 20-week, prospective, randomized, double-blind, double-dummy, controlled trial assessing noninferiority of presumed equipotent doses of pitavastatin and atorvastatin in 821 patients with primary hypercholesterolemia or combined dyslipidemia. After a 6- to 8-week dietary lead-in period, randomized patients received one of four treatment regimens for 12 weeks. Two groups received pitavastatin (2 mg/day) or atorvastatin (10 mg/day) and two groups received pitavastatin (2 mg/day) or atorvastatin (10 mg/day) for 4 weeks followed by forced titration to pitavastatin (4 mg/day) or atorvastatin (20 mg/day). Results: The primary efficacy analysis showed pitavastatin was comparable to atorvastatin in percent change of LDL-C from baseline to end point (week 12 or last observation carried forward). The majority of patients achieved NCEP and EAS LDL-C goals at all doses, and more patients reached NCEP targets at the higher doses (pitavastatin: 78%; atorvastatin: 71%) than at the lower doses (pitavastatin: 57%; atorvastatin: 66%). There were some interesting differences between treatments in the other lipid parameters but none were statistically significant. Adverse event profiles were similar in all groups, with no apparent dose-related adverse events. Conclusion: Pitavastatin is equivalent to atorvastatin in reducing LDL-C in primary hypercholesterolemia or combined dyslipidemia, in both the lower-dose (pitavastatin 2 mg vs atorvastatin 10 mg) and higher-dose (pitavastatin 4 mg vs atorvastatin 20 mg) comparisons. Pitavastatin can be considered an effective, first-line therapy for these patients and offers an alternative, simple treatment regimen in the long-term care of primary hypercholesterolemia and combined dyslipidemia.