New Phase III data published today in "Current Medical Research and Opinion" highlight that the recommended starting dose of 2 mg of LIVALO (pitavastatin), a novel synthetic statin, was statistically superior to simvastatin at a dose of 20 mg over 12 weeks in reducing low-density lipoprotein cholesterol
(LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C) and total cholesterol (TC) in patients with primary hypercholesterolemia and combined dyslipidemia. With respect to LDL-C goal attainment, treatment with LIVALO was comparable to simvastatin according to the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III guidelines, but was superior based on European Atherosclerosis Society (EAS) guidelines.
Although statins are proven to reduce LDL-C levels, many patients treated with statins fail to reach or maintain recommended LDL-C goals. As many as six out of ten patients stop taking statins during the first twelve months, often due to poor compliance and/or side effects. Untreated and undertreated patients are at an increased risk for cardiovascular events, especially patients with a chronic condition such as diabetes.
"A need exists for an effective, well-tolerated statin that improves LDL-C and other lipid parameters while offering a low-dose regimen that may encourage patient compliance," said Leiv Ose, M.D., Ph.D., Rikshospitalet University Hospital, Norway. "The results of this study show that LIVALO is an efficacious, low-dose therapy that is comparable to the most commonly prescribed doses of simvastatin."
The prospective trial examined 857 subjects with primary hypercholesterolemia or combined dyslipidemia, comparing percent change in LDL-C in patients treated with LIVALO or simvastatin. Subjects were randomized to one of four treatment groups: LIVALO 2 mg, LIVALO 4 mg (2 mg for 4 weeks titrated to 4 mg for 8 weeks), simvastatin 20 mg and simvastatin 40 mg (20 mg for 4 weeks titrated to 40 mg for 8 weeks). The results showed that LIVALO 2 mg was statistically significantly superior to simvastatin 20 mg in lowering LDL-C, as well as non-HDL-C and TC. At the higher dose comparison across all lipid parameters, 4 mg of LIVALO was comparable to 40 mg of simvastatin.
Secondary endpoints included LDL-C target attainment, as defined by the NCEP ATP III and EAS guidelines. Although a greater percentage of patients treated with 2 mg or 4 mg of LIVALO achieved target LDL-C goals by NCEP criteria, results were comparable to simvastatin. However, by EAS criteria, low-dose LIVALO was statistically superior to low-dose simvastatin in percentage of patients achieving LDL-C goal. The safety and tolerability of both agents were comparable across low- and high-dose comparisons.
"This study demonstrated that when compared to an established first-line lipid-lowering agent, LIVALO is a clinically effective treatment choice for patients with primary hypercholesterolemia or combined dyslipidemia," said Dr. Neil Hounslow, vice president of scientific affairs, Kowa Research Europe. "LIVALO is poised to offer practical and clinical treatment advantages, which could encourage patient compliance and maintenance of treatment goals."
SOURCE Kowa Company, Ltd.