Pitavastatin - results from phase III & IV.

The pitavastatin Phase III and IV studies assessed the efficacy and safety of standard dose pitavastatin vs. comparable doses of alternative statins in a broad range of patients with hypercholesterolaemia. Phase III studies conducted in Europe included five 12-week, randomised, double-blind trials evaluating the non-inferiority of pitavastatin 1-4mg vs. atorvastatin 10-20mg, simvastatin 20-40 mg and/or pravastatin 10-40mg in patients with primary hypercholesterolaemia and combined dyslipidaemia, including patients with high cardiovascular risk, type II diabetes, and age ≥65 years. The primary endpoint was the adjusted mean percent change from baseline in low-density lipoprotein-cholesterol (LDL-C); secondary endpoints included changes from baseline in lipid and lipoprotein profiles, LDL-C-target attainment rates and safety parameters. For each study, treatment was continued in open-label, long-term extension studies. Phase IV Japanese studies included CHIBA - a 12-week, open-label active control, non-inferiority investigator-led trial comparing the efficacy and safety of pitavastatin 2mg and atorvastatin 10 mg in patients with hypercholesterolaemia; PIAT - a 52-week open-label, investigator-led, randomised, parallel-group study comparing the efficacy and tolerability of pitavastatin 2mg and atorvastatin 10 mg in patients with hypercholesterolaemia and glucose intolerance; and LIVES - a 2-year prospective post-marketing surveillance of pitavastatin in 20,279 patients with hypercholesterolaemia. The primary endpoint for the first two studies was the percent change from baseline in non-high-density lipoprotein-C (non-HDL-C) and HDL-C, respectively; secondary endpoints included % changes from baseline in other lipid/lipoprotein parameters, safety and tolerability. Overall, Phase III and IV studies demonstrate that pitavastatin 1-4mg is well tolerated, improves atherogenic lipid profile and increases LDL-C target attainment rates with a similar or greater efficacy to comparable doses of atorvastatin, simvastatin and pravastatin in most patient groups. In each of these studies, improvements in lipid profile were sustained or improved during the long term suggesting benefits for continued treatment with pitavastatin.