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01.09.2009 – 14:12

Kowa Company, Ltd.

Pitavastatin is Non-Inferior to Atorvastatin and Simvastatin and Demonstrates Sustained Efficacy and Tolerability Over 52 Weeks

Barcelona, Spain (ots/PRNewswire)

- Pitavastatin Represents Long-Term Treatment Option for Patients
With  Primary Hypercholesterolaemia or Combined Dyslipidaemia
New phase III data presented at the European Society of
Cardiology congress (ESC) demonstrated that pitavastatin is
non-inferior to atorvastatin and simvastatin at usual therapeutic
doses in patients with primary hypercholesterolemia or combined
dyslipidemia, as measured by reduction of low density lipoprotein
cholesterol (LDL-C) from baseline.
LDL-C target attainment data was similar when comparing
pitavastatin to first-line drugs atorvastatin and simvastatin,
although pitavastatin demonstrated significantly higher LDL-C target
attainment compared to simvastatin in the lower dose study-arm
(pitavastatin 2 mg vs simvastatin  20 mg) (p=0.047). Furthermore,
continued gradual increases in high density lipoprotein cholesterol
(HDL-C) were observed over the long-term, supported by data from a 52
week extension study. Pitavastatin also demonstrated a favourable
safety and tolerability profile to 52 weeks, the latter exemplified
by a low rate of discontinuations due to adverse events, which were
comparable to those with simvastatin or atorvastatin.
"This study confirms that pitavastatin is an effective and well
tolerated long-term treatment option for patients with
hypercholesterolemia or combined dyslipidemia," commented Dr. Leiv
Ose, MD PhD, Rikshospitalet, Oslo University Hospital, Norway, and
Study Investigator. "Many patients do not reach LDL-C targets with
current therapies due to a number of factors, especially
non-compliance, and a statin which has the potential to improve
long-term treatment compliance is welcomed."
The primary objective of the two phase III, double blind,
active-controlled studies was to demonstrate non-inferiority of
pitavastatin to atorvastatin and simvastatin, as measured by the
reduction of LDL-C. After a 6-8 week wash-out period, patients with
primary hypercholesterolemia or combined dyslipidemia who had an
average LDL-C greater than or equal to  4.2 mmol/L (160 mg/dL) and
less than or equal to 5.7 mmol/L (220 mg/dL) and  a triglycerides
(TG) level of less than or equal to 4.6 mmol/L (400 mg/dL)  were
treated for 12-week duration as follows:
- Study 1: 830 patients (46% males; mean 58 years) were randomised to one
      of four treatment groups, pitavastatin 2 mg, pitavastatin 4 mg,
      atorvastatin 10 mg or atorvastatin 20 mg (all doses QD) using
      up-titration for higher doses.
    - Study 2: 857 patients (39% males; mean 58 years) were randomised to one
      of four treatment groups, pitavastatin 2 mg, pitavastatin 4 mg,
      simvastatin 20 mg or simvastatin 40 mg (all doses QD) using
      up-titration for higher doses.
Secondary objectives 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.
1355 patients (42.5% males; mean age 58.6 years) who completed
the two initial studies took part in an open-label extension to
assess the long-term safety and tolerability of pitavastatin 4 mg
(QD) for up to 52 weeks. Secondary objectives were to assess NCEP and
EAS LDL-C target attainment, other lipid and lipoprotein fractions.
Pitavastatin was well tolerated to 52 weeks; no serious
treatment-emergent adverse event (TEAE) was related to pitavastatin,
with the most commonly reported TEAEs being increased blood
creatinine kinase (5.8%), nasopharyngitis (5.4%) and myalgia (4.1%).
Additionally, there were no clinically significant abnormalities in
routine laboratory variables, urinalysis, vital signs or 12-lead ECG.
Continued gradual increases in HDL-C were observed over 52 weeks and
reductions in LDL-C were sustained over 52 weeks thus demonstrating
sustained efficacy of pitavastatin over the long-term.
"Data from these pivotal, phase III studies show that
pitavastatin has a robust efficacy, safety and tolerability profile,
and in terms of LDL-C reduction, stands up to atorvastatin and
simvastatin at usual therapeutic doses," said Dr Neil Hounslow, Vice
President of scientific affairs, Kowa Research Europe. "With
sustained efficacy, low rates of discontinuations due to adverse
events and continued increases in HDL-C observed over 52 weeks,
pitavastatin shows great promise for the long-term treatment of
patients with hypercholesterolemia or combined dyslipidemia."
    Notes to editors
    Methodology:
    - In the two 12-week studies, pitavastatin was considered non-inferior if
      the lower bound on the 95% confidence limit for the percent change in
      low density lipoprotein cholesterol (LDL-C) from baseline was >-6%, for
      all doses.
    Results:
    - Pitavastatin (PIT) was non-inferior to atorvastatin (ATO) in terms of
      the reduction in LDL-C (PIT 2 mg -37.9%; ATO 10 mg -37.8%: PIT 4 mg
      -44.6%; ATO 20 mg -43.5%).
    - The LDL-C reduction was greater with pitavastatin 2 mg than simvastatin
      20 mg (PIT 2 mg -38.99%; SIM 20 mg -34.97%). PIT 4 mg was non-inferior
      to SIM 40 mg in terms of the LDL-C reduction (PIT 4mg -43.97%; SIM 40mg
      -42.84%)
    - The proportion of patients that met the EAS LDL-C target was
      significantly greater with pitavastatin 2 mg; 62.9% compared with
      simvastatin 20 mg; 52.1% (p=0.047). Total cholesterol (TC), and
      non-HDL-C showed significant decreases with pitavastatin 2 mg
      compared with simvastatin 20 mg (p=<0.05).
    - Continued gradual increases in HDL-C were observed over 52 weeks (57.0
      mg/dL at week 52 compared with 52.9 mg/dL at the end of the
      double-blind phase). Non-HDL-C, hs-CRP and oxidised LDL showed a
      sustained decrease at week 52.
    - The number of patients who achieved NCEP and EAS LDL-C at 52 weeks was
      74.0% and 73.5% respectively, up from 71.5% and 69.4% at the end of the
      double-blind phase. Similarly, reductions in LDL-C were sustained over
      52 weeks (104.3 mg/dL at week 52 compared with 105.6 mg/dL at the end
      of the double-blind phase).
    Lipid and lipoprotein fractions assessed:
    - Total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C),
      non-HDL-C, TC:HDL-C ratio, non HDL-C:HDL-C ratio, triglycerides (TG),
      apolipoprotein B (Apo-B) and apolipoprotein A1 (Apo-A1), Apo-B:Apo-A1
      ratio, high sensitivity C-reactive protein (hs-CRP), oxidised LDL.
About pitavastatin
Pitavastatin (a statin) is a fully synthetic and highly potent
inhibitor of HMG-CoA reductase used for primary hypercholesterolaemia
and combined dyslipidaemia. Pitavastatin has a unique 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 comorbidities
and are taking multiple medications. Kowa received FDA approval of
pitavastatin for the primary treatment of hypercholesterolemia and
combined dyslipidemia in August 2009, and is expected to launch in
the U.S. during Q1 of 2010. Additionally, Kowa filed in Europe in
August 2008 using the decentralised authorisation procedure. In
Europe, pitavastatin will be marketed by Recordati SpA. Pitavastatin
will be available in three dosage strengths (1, 2 and 4 mg).
About Kowa
Since its establishment in 1894, Kowa has grown into a
multinational Japanese company actively engaged in various
manufacturing and trading activities in the fields of pharmaceutical,
life science and information technology, textiles, machinery and
various consumer products. Kowa focuses its efforts on the
acquisition, development, licensing and marketing of pharmaceutical
products. During its long history, Kowa has consistently strived to
meet the changing needs of the global market, and with its continuing
entrepreneurial initiative, is determined to meet the needs of future
generations. It is this commitment to consistency and initiative in
an ever-changing world that Kowa vows to carry forward through each
generation.
For more information about Kowa, please visit
http://www.kowa.com.

Contact:

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