BARCELONA, Spain, Sept. 1 /PRNewswire/ -- New data presented today showed that in patients treated with LIVALO (pitavastatin), high-density lipoprotein cholesterol (HDL-C) concentrations increased, and nearly three-fourths of patients attained low-density lipoprotein cholesterol (LDL-C) targets, with results sustained over 52 weeks. Additionally, LIVALO was found to have comparable efficacy to atorvastatin and simvastatin, as measured by reduction in LDL-C from baseline. The Phase III data were presented at the European Society of Cardiology Congress (ESC) in Barcelona, Spain.
The primary objective of the two Phase III, double-blind, active-controlled studies was to demonstrate non-inferiority of LIVALO to atorvastatin and simvastatin, as measured by the reduction of LDL-C. Secondary objectives of the study were to assess National Cholesterol Education Program (NCEP) and European Atherosclerosis Society (EAS) LDL-C target attainment, other lipid and lipoprotein fractions, safety and tolerability. An open-label extension study was also conducted to assess the long-term safety and tolerability of LIVALO 4 mg once daily for up to 52 weeks.
Study 1
Study 2
Extension Study
About LIVALO
LIVALO is a fully synthetic and highly potent statin that differs from other, currently available statins in the United States in that it has a unique cyclopropyl group on the base structure. This cyclopropyl group contributes to a more effective inhibition of the HMG-CoA reductase enzyme to inhibit cholesterol production, and potentially affords greater LDL-C clearance and reduction of plasma cholesterol. Importantly, LIVALO is only minimally metabolized by the liver through the cytochrome P450 pathway, a common pathway for the metabolism of many other medications.
Since its launch in Japan, South Korea, Thailand and China, LIVALO has been successfully used in these countries to treat primary hypercholesterolemia and combined dyslipidemia, and has accumulated millions of patient-years of exposure. It is frequently prescribed in these countries as first-line therapy for a broad range of patients, including the elderly, patients with diabetes and those whose treatment is complicated by concurrent disease and concomitant medications. Kowa also filed for approval of LIVALO in Europe in August 2008, using the decentralized authorization procedure.
Dyslipidemia is well established as one of the strongest independent predictors of cardiovascular morbidity and mortality. Despite the availability of treatments in the United States, there is still a need for better control of and treatment for dyslipidemia. According to the American Heart Association, approximately one out of every three American adults has an LDL-C level of 130 mg/dL or higher, which is a major risk factor for coronary heart disease (CHD) and stroke. In addition, less than half of patients who qualify for any kind of lipid-modifying treatment( )for CHD risk reduction are receiving it, and only about( )one-third of patients who are on treatment are achieving their LDL-C ( )goals.
Kowa Company, Ltd. (KCL) is a privately held multinational company headquartered in Nagoya, Japan. Established in 1894, KCL is actively engaged in various manufacturing and commercial activities in the fields of pharmaceutical, life science, information technology, textiles, machinery and various consumer products. KCL’s pharmaceutical division is focused on cardiovascular therapeutics, with sales of the company’s flagship product, LIVALO, totaling $340 million (12% market share) in Japan during the 2008 fiscal year and expected to exceed $500 million in the near future.
Kowa Research Institute, Inc. (KRI), a division of KCL located in the Research Triangle Park area of North Carolina, is responsible for the clinical development of drug candidates in the United States for KCL. KRI was established in California in 1997 and began operations at its current location in 2003.
SOURCE Kowa Company Ltd., Kowa Pharmaceuticals America, Inc., and Kowa Research Institute, Inc.
CONTACT: Lauren Curren, +1-215-238-8500, lcurren@voxmedica.com
Web site: http://www.kowapharma.com/
