Study Demonstrates Efficacy of Pitavastatin in Elderly Patients

    Pitavastatin Represents Important Treatment Option for More Vulnerable

    BOSTON, June 16 /CNW/ - New data presented today showed that pitavastatin
is an effective treatment for the management of dyslipidemia in elderly
patients, with a similar safety and tolerability profile to low-dose
pravastatin. The Phase III data were presented today by Kowa, at the XV
International Symposium on Atherosclerosis in Boston.
    "This study shows the effectiveness of pitavastatin to lower LDL
(low-density lipoprotein) cholesterol in a group of elderly patients with
primary hypercholesterolemia or combined dyslipidemia," said Professor Steen
Stender, M.D., Ph.D., Gentofte University Hospital, Denmark, and an
investigator for the study. "When compared to the usual daily dosage of 40 mg
pravastatin, a 4-mg dosage of pitavastatin demonstrated greater
LDL-cholesterol lowering with no significant safety difference across all
doses, and may represent a more favorable treatment option for such target
    The Phase III, active-controlled study was conducted for 12 weeks to
compare the safety and efficacy of pitavastatin (1 mg, 2 mg and 4 mg) and
pravastatin (10 mg, 20 mg and 40 mg) in patients aged greater than or equal to
65 years with primary hypercholesterolemia or combined dyslipidemia. About
half of the patients had hypertension, 5 percent had diabetes and about 80
percent were taking concomitant medications. A 60-week, open-label extension
to this core study was conducted to assess the long-term safety of
pitavastatin at the recommended starting dose of 2 mg once daily, and the need
for up-titration to 4 mg once daily in consenting completers from the
pitavastatin treatment groups of the core study.
    The results of the core study demonstrated that pitavastatin was
statistically superior to pravastatin across all three dose comparisons as
measured by percent change from baseline in LDL-C (P(less than).001), and that
a higher percentage of patients achieved LDL-C goal with pitavastatin 2 mg and
4 mg than in any other treatment group. All three doses of pitavastatin
demonstrated a comparable safety profile to low-dose pravastatin. In addition,
results from the extension study showed maintenance of the efficacy and safety
of pitavastatin 2 mg and 4 mg through 60 weeks.
    "The results of this study show that pitavastatin has a robust efficacy,
safety and tolerability profile at the proposed starting dose and offers a
low-dose alternative for vulnerable populations, such as the elderly," said
Neil Hounslow, vice president of scientific affairs, Kowa Research Europe. "It
may be difficult to choose a suitable statin for elderly patients with primary
hypercholesterolemia or combined dyslipidemia who are taking other
medications, and this study demonstrates that the majority of these patients
can achieve and sustain goal with the starting dose of 2 mg of pitavastatin
once daily."

    About pitavastatin

    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 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
has filed a New Drug Application for pitavastatin with the U.S. Food and Drug
Administration and has filed in Europe in August 2008, using the decentralized
authorization procedure. Once approved, 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

For further information:

For further information: Carrie Fernandez, (215) 238-8500 ext. 1402,

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