Pitavastatin Consistently Demonstrates Sustained Increases in HDL-C and Offers Atheroprotective Benefits

WOKINGHAM, England, June 27, 2011 /PRNewswire/ --

Today, at the European Atherosclerosis Society (EAS) congress, Kowa Pharmaceutical Europe announced results from a post marketing surveillance study showing pitavastatin provides consistent long-term increases in high-density lipoprotein cholesterol (HDL-C) in a broad range of patients with hypercholesterolaemia.^[1]

The data from the Livalo Effectiveness and Safety (LIVES) Study Extension showed a relationship between on-treatment serum HDL-C levels and cardiovascular risk, and that pitavastatin consistently provided clinically relevant elevations in HDL-C that continued to increase over five years. ^[1]

"The results of the LIVES Study Extension highlight the benefits of pitavastatin in patients at risk of cardiovascular disease (CVD). Not only does pitavastatin consistently increase HDL-C levels, but it also has additional patient benefits that help to reduce CVD. We very much look forward to seeing the full results anticipated at a later date," said Professor Tamio Teramoto, Dean and Chairman of Internal Medicine, Teikyo University School of Medicine, Japan.

Recently published guidance from the EAS recommends that physicians target elevated LDL-C and decreased HDL-C, both of which are recognised as risk factors for CVD.  Study results have shown that pitavastatin could be beneficial to patients as it reduces LDL-C and consistently raises HDL-C over long-term treatment. ^[1]  

In addition, further Kowa data is being announced at EAS, which demonstrates that pitavastatin has beneficial anti-oxidative and anti-inflammatory effects, in addition to its direct effects on cholesterol levels. The additional benefits of pitavastatin include consistently decreasing levels of oxidized low-density lipoprotein (Ox-LDL) and high sensitivity C-reactive protein (hs-CRP) in at-risk patients during long-term treatment. Both of these are associated with atherosclerosis.^[2]

About Livazo®

Pitavastatin (a statin) is a fully synthetic and highly potent inhibitor of HMG-CoA reductase used for primary hypercholesterolemia and combined dyslipidemia. Pitavastatin has a novel cyclopropyl group on the base structure common to the statin class.  Since its 2003 launch in Japan, pitavastatin has accumulated millions of patient-years of exposure. Many of these patients have co-morbidities and are taking multiple medications. Kowa received FDA approval of pitavastatin (Livalo®) for the treatment of primary hyperlipidemia or mixed dyslipidemia in August 2009 and it was launched in the U.S. in June 2010. Additionally, Kowa filed in Europe in August 2008 using the decentralised authorisation procedure and received regulatory approval in mid 2010. In much of Europe, pitavastatin will be marketed by Recordati as Livazo. Pitavastatin will be available in three dosage strengths (1 mg, 2 mg and 4 mg).

Pitavastatin launched in Lebanon and Spain in 2011; other European and Middle Eastern launches are planned for 2011 and 2012.  For more information about the geographical availability of pitavastatin and marketing companies please visit the Kowa Pharmaceutical Europe website http://www.kowapharmaceuticals.eu

About Kowa

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 was founded in 1947, and is focused on cardiovascular therapeutics, with sales of the company's flagship product, Livalo, totalling $520 million (14.3% market share) in Japan during 2010 and expected to exceed $700 million in the near future.

Kowa Research Europe Ltd. (KRE), established in 1999 in the United Kingdom, is responsible for European clinical trials for Kowa's strategic global pharmaceutical development.

Kowa Pharmaceutical Europe (KPE) Co. Ltd, established in 2000, is a specialty pharmaceutical company located in Wokingham, UK, focused primarily on cardiometabolic therapeutics. Working in harmony with KRE, these European pharmaceutical divisions of Japanese Kowa Company, Ltd. are committed to ground-breaking research, development and marketing to ensure quality products are made available to people around the world, enabling them to enjoy a better standard of health and a more comfortable life.

1. Hounslow, N. Pitavastatin provides long-term improvements in HDL-cholesterol in a range of patients with dyslipidaemia:results from a phase III study programme. Abstract presented at EAS. June, 2011

2. Hounslow, N. Pitavastatin has pleiotropic antioxidative and anti-inflammatory benefits in patients with dyslipidaemia:results from a phase III study programme. Abstract presented at EAS. June, 2011