Pitavastatin Demonstrates Sustained Efficacy, Tolerability and LDL-C Target Attainment Over 52 Weeks

Wokingham, England, April 28, 2010 (ots/PRNewswire) - New long-termphase III data published today in Atherosclerosis demonstrates that,of patients with primary hypercholesterolaemia or combineddyslipidaemia who received 4mg of pitavastatin, 74% and 73.5%achieved NCEP* and EAS* low-density lipoprotein cholesterol (LDL-C)targets at 52 weeks, respectively. At the end of this open-labelone-year extension study, reductions in LDL-C observed duringprevious 12-week double-blind phase III studies were maintained(104.3 mg/dL at week 52 compared with 105.6 mg/dL at the end of thedouble-blind phase). Furthermore, high-density lipoproteincholesterol (HDL-C) levels rose continually over 52 weeks, with anoverall increase of 14.3% from initial baseline, while changes inother efficacy parameters and ratios** were sustained during 52 weekstreatment compared with the end of the double-blind studies. Thesedata demonstrate sustained efficacy of pitavastatin over thelong-term.

Statins are considered the mainstay of dyslipidaemia treatment,however many patients do not reach clinically optimal lipidtargets.(1-4) Previous studies have demonstrated that around half ofpatients failed to reach LDL-C targets with the initially prescribeddose of statin, and that of these, 86% had still not reached LDL-Ctarget after six months, despite dose adjustment and use of theclinician's statin of choice.(5) Furthermore, 68.2% of patients in UKgeneral practice failed to reach optimal clinical levels of HDL-Cwithin a year of starting statin therapy;(6) these studies suggestthere is an unmet clinical need in the management of dyslipidaemia.

"This study confirms that pitavastatin is an effective and welltolerated long-term treatment option for patients withhypercholesterolaemia or combined dyslipidaemia," commented Dr. LeivOse, MD PhD, Rikshospitalet, Oslo University Hospital, Norway, andStudy Investigator. "Many patients do not reach LDL-C targets ontheir current treatment regimen, and this can be said for otherimportant lipid parameters including HDL-C. A statin which has thepotential to help healthcare professionals and patients alike achievelipid targets represents a welcome treatment option for the future."

Prior to this extension study, all patients had previously takenpart in one of two double-blind studies, and had receivedpitavastatin (2mg or 4mg QD), atorvastatin (10mg or 20mg QD) orsimvastatin (20mg or 40mg QD) for 12 weeks. On completion of the twostudies, 1353 patients (42.5% males / 57.5% females; mean age 58.6years) took part in this open-label extension study to assess thelong-term safety and tolerability of pitavastatin 4mg QD for up to 52weeks; secondary objectives were to assess NCEP and EAS LDL-C targetattainment, other lipid and lipoprotein fractions.

*National Cholesterol Education Program (NCEP) and European Atherosclerosis Society (EAS) **Efficacy parameters (Triglycerides, total cholesterol, non-HDL-C, Apo-A1 and Apo-B, high sensitivity C-reactive protein, oxidized LDL ) and ratios (total cholesterol: HDL-C, non-HDL-C:HDL-C and Apo-B:Apo-A1)

Pitavastatin was well tolerated to 52 weeks; no serioustreatment-emergent adverse event (TEAE) was related to pitavastatin,with the most commonly reported TEAEs being increased bloodcreatinine kinase (5.8%), nasopharyngitis (5.4%) and myalgia (4.1%).Additionally, there were no clinically significant abnormalities inroutine laboratory variables, urinalysis, vital signs or 12-lead ECG.Pitavastatin also demonstrated a favourable safety and tolerabilityprofile throughout the extension study, exemplified by a low rate ofdiscontinuations due to adverse events.

"Data from this pivotal, phase III study demonstratespitavastatin's sustained and robust efficacy, safety and tolerabilityprofile" said Dr Neil Hounslow, Vice President of scientific affairs,Kowa Research Europe. "With sustained efficacy, low rates ofdiscontinuations due to adverse events and continued increases inHDL-C observed over 52 weeks, pitavastatin could provide clinicianswith a new option in the long-term treatment of patients withhypercholesterolaemia or combined dyslipidaemia."

About pitavastatin

Pitavastatin (a statin) is a fully synthetic and highly potentinhibitor of HMG-CoA reductase used for primary hypercholesterolaemiaand combined dyslipidaemia. Pitavastatin has a unique cyclopropylgroup on the base structure common to the statin class. Since its2003 launch in Japan, pitavastatin has accumulated millions ofpatient-years of exposure. Many of these patients have comorbiditiesand are taking multiple medications. Kowa received FDA approval ofpitavastatin (LIVALO(R)) for the treatment of primaryhypercholesterolaemia and combined dyslipidaemia in August 2009 andit will be launched in the U.S. in June 2010. Additionally, Kowafiled in Europe in August 2008 using the decentralised authorisationprocedure and is due to receive a regulatory approval in mid 2010. Inmuch of Europe, pitavastatin will be marketed by Recordati.Pitavastatin will be available in three dosage strengths (1 mg, 2 mgand 4 mg).

About Kowa

Kowa Company, Ltd. (KCL) is a privately held multinationalcompany headquartered in Nagoya, Japan. Established in 1894, KCL isactively engaged in various manufacturing and commercial activitiesin the fields of pharmaceutical, life science, informationtechnology, textiles, machinery and various consumer products. KCL'spharmaceutical division was founded in 1946, and is focused oncardiovascular therapeutics, with sales of the company's flagshipproduct, LIVALO, totaling $440 million (14% market share) in Japanduring the last fiscal year and expected to exceed $600 million inthe near future.

Kowa Pharmaceuticals America, Inc. (KPA) is a specialtypharmaceutical company focused primarily in the area ofcardiometabolic therapeutics. The company, started in 2001 asProEthic Pharmaceuticals, Inc., was acquired by KCL in September of2008. A privately held company, KPA focuses its efforts on theacquisition, development, licensing and marketing of pharmaceuticalproducts. Its lead product, LIPOFEN(R) (fenofibrate capsules), isindicated as adjunctive therapy to diet to reduce elevated TG and toincrease HDL-C in adult patients with primary hypercholesterolemia ormixed dyslipidaemia.

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

About Recordati

Recordati, established in 1926, is a European pharmaceuticalgroup, listed on the Italian Stock Exchange (Reuters RECI.MI,Bloomberg REC IM, ISIN IT 0003828271),with a total staff of over2,950, dedicated to the research, development, manufacturing andmarketing of pharmaceuticals. It has headquarters in Milan, Italy,operations in the main European countries, and a growing presence inthe new markets of Central and Eastern Europe. A European field forceof over 1,450 medical representatives promotes a wide range ofinnovative pharmaceuticals, both proprietary and under license, in anumber of therapeutic areas including a specialized businessdedicated to treatments for rare diseases. Recordati's current andgrowing coverage of the European pharmaceutical market makes it apartner of choice for new product licenses from companies which donot have European marketing organizations.

Recordati is committed to the research and development of newdrug entities within the cardiovascular and urogenital therapeuticareas and of treatments for rare diseases. Consolidated revenue for2008 was EUR689.6 million, operating income was EUR144.7 million andnet income was EUR100.4 million.

For more information about Recordati please visithttp://www.recordati.com.


1. Phatak H et al Atherosclerosis 2009;202:225-33

2. Ferrières J et al Arch Cardiovasc Dis 2008;101:557-63

3. García Ruiz FJ et al Pharmacoeconomics 2004;22 Suppl 3:1-12

4. Hermans MP et al Acta Cardiol 2009;64:177-85

5. Foley KA, Simpson RJ Jr, Crouse JR III, et al., Effectivenessof statin titration on low-density lipoprotein cholesterol goalattainment in patients at high risk of atherogenic events Am JCardiol. 2003;92:79-81

6. Phatak H, Wentworth C, Sazonov V, et al., Prevalence andpredictors of lipid abnormalities in patients treated with statins inthe UK general practice Atherosclerosis 2009;202:225-33

ots Originaltext: KowaIm Internet recherchierbar: http://www.presseportal.de

Contact:CONTACT: CONTACT: Laura Anderson, +44(0)207-861-3033,l.anderson@bellpottingerhealth.com


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Pitavastatin Demonstrates Sustained Efficacy, Tolerability and LDL-C Target Attainment Over 52 Weeks