New Meta-Analysis On Pitavastatin Demonstrates No Adverse Effect Compared With Placebo Or Other Statins On New-Onset Diabetes In Non-Diabetic Patients At Risk For Cardiovascular Disease

MONTGOMERY, Ala., May 4, 2015 /PRNewswire/ -- Kowa Pharmaceuticals America, Inc., announced that the results of a meta-analysis of 15 randomized, controlled clinical trials, to assess the effects of LIVALO^® (pitavastatin) on glycemic parameters and new-onset diabetes (NOD) in non-diabetic individuals were presented as a late-breaking abstract at the 83^rd European Atherosclerosis Society (EAS) Congress held in Glasgow, UK. The analysis was performed by Professor Kausik Ray, now of Imperial College London, and a team at St George's, University of London, UK. This first-ever meta-analysis of pitavastatin data showed that pitavastatin had no significant adverse effect on parameters of glucose metabolism [fasting blood glucose (FBG) or HbA1c] or NOD.

A total of 15 randomized controlled studies (including four unpublished studies), involving 4,815 non-diabetic patients, were included in the meta-analysis. The weighted mean follow-up overall (n=15 studies) was 17.3 ± 17.7 weeks (approx. 1,600 person-years). Most studies had a follow-up time of 12 weeks (n=11 studies). For those with a longer follow-up (n=4 studies), this time ranged from 32 to 120 weeks with a weighted mean follow-up of 59.5 ± 28.5 weeks. Overall results confirmed no significant differences associated with pitavastatin versus placebo/other statins were observed for FBG [mean difference (95% CI): -0.01(-0.77-0.74); for HbA1c: -0.03 (-0.11-0.05)] or for NOD [risk ratio: 0.70 (0.30-1.61); risk difference: -0.00 (-0.00-0.00)].

"This new meta-analysis confirms the results of our previously presented retrospective and prospective, prespecified data on glucose parameters for pitavastatin from our phase 3 and phase 4 clinical studies," said Dr. Craig Sponseller, Vice President of Medical Affairs at Kowa Pharmaceuticals America, Inc. "Importantly, this analysis included doses ranging from 1 mg to as high as 8 mg, and the results suggest there is no dose-dependent relationship."

"Current guidelines emphasize appropriate statin selection for patients with hypercholesterolemia," said Ben Stakely, CEO and President, Kowa Pharmaceuticals America, Inc. "It is important for healthcare providers and patients to discuss therapeutic options and relevant clinical data like this to best approach individual treatment and patient-centric care, particularly for those at risk for cardiovascular disease."

About LIVALO

LIVALO is a HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hyperlipidemia or mixed dyslipidemia.

Limitations of Use:

• Doses of LIVALO greater than 4 mg once daily were associated with an increased risk for severe myopathy in premarketing clinical studies. Do not exceed 4 mg once daily dosing of LIVALO.
• The effect of LIVALO on cardiovascular morbidity and mortality has not been determined.
• LIVALO has not been studied in Fredrickson Type I, III, and V dyslipidemias.

LIVALO was launched in the U.S. in June 2010.

Primary Hyperlipidemia and Mixed Dyslipidemia

Primary hyperlipidemia is defined as an elevation of cholesterol, particularly "bad" cholesterol (LDL-C), triglycerides (TG), or both. Mixed dyslipidemia is usually characterized by an elevation of LDL-C, TG, and a decrease in the "good" cholesterol (HDL-C) in the blood.

Important Safety Information for LIVALO^® (pitavastatin) tablets

Who should NOT take LIVALO?

LIVALO is not right for everyone. Do not take LIVALO if:

• You have a known allergy to LIVALO or any of its ingredients.
• You have active liver problems, including some abnormal liver test results.
• You are nursing, pregnant or may become pregnant, as it may harm the baby.
• You are currently taking cyclosporine or gemfibrozil.

What is the most important information I should know and talk to my doctor about?

• Call your healthcare provider or get help right away if you experience any symptoms of an allergic reaction, such as rash, itching, or hives.
• Muscle problems may be an early sign of rare, serious conditions. Tell your doctor right away if you have any unexplained muscle pain, weakness, or tenderness, particularly if accompanied by malaise or fever, or if these muscle signs or symptoms persist after discontinuing LIVALO.
• Serious liver problems have been reported rarely in patients taking statins, including LIVALO. Your doctor should do liver tests before you start, and if you have symptoms of liver problems while you are taking LIVALO. Tell your healthcare provider right away if you feel more tired than usual, have a loss of appetite, upper belly pain, dark-colored urine, or yellowing of the skin or eyes.
• Tell your doctor about all your medical conditions and medications you take including nonprescription medicines, vitamins, or herbal supplements.
• Increases in blood sugar levels have been reported with statins, including LIVALO.
• Tell your doctor about your alcohol use.

What are the most common side effects of LIVALO?

The most common side effects of LIVALO in clinical studies were:

• Back pain
• Constipation
• Diarrhea
• Muscle pain
• Pain in the legs or arms

This is not a complete list of side effects. Talk to your healthcare provider for more information.

You are encouraged to report negative side effects of all drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

How should I store and take LIVALO?

• Store LIVALO tablets at room temperature, in a dry place, and out of the reach of children.
• LIVALO can be taken at any time of day, with or without food.
• Swallow the tablet whole. Do not split, crush, dissolve, or chew.

Other important information I should know about LIVALO.

• LIVALO has not been studied to evaluate its effect on reducing heart-related disease or death.
• LIVALO is available by prescription only.

For additional information please see the full Prescribing Information.

© Kowa Pharmaceuticals America, Inc. (2013) - LIV-RA-0086 10/2013

About Kowa Company, Ltd. and Kowa Pharmaceuticals America, Inc.

Kowa Company, Ltd. (Kowa) is a privately held multinational company headquartered in Nagoya, Japan. Established in 1894, Kowa is actively engaged in various manufacturing and trading activities in the fields of pharmaceuticals, life science, information technology, textiles, machinery and various consumer products. Kowa's pharmaceutical division is focused on research and development for cardiovascular therapeutics (dyslipidemia, type 2 diabetes and atherosclerosis), ophthalmology and anti-inflammatory agents. The company's flagship product, LIVALO^® (pitavastatin), is approved in 45 countries around the world.

Kowa Pharmaceuticals America, Inc., headquartered in Montgomery, AL, is focused primarily in the area of cardiometabolic diseases. Established in September 2008, Kowa Pharmaceuticals America focuses its efforts on the successful commercialization of its current and near-term portfolio of pharmaceutical products, and business development activities. For more information about Kowa Pharmaceuticals America, visit www.kowapharma.com.

LIVALO is a registered trademark of the Kowa group of companies.

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SOURCE Kowa Pharmaceuticals America, Inc.

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