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Study Demonstrates Efficacy of Pitavastatin in Elderly Patients
Date:6/16/2009

Pitavastatin represents important treatment option for more vulnerable populations

BOSTON, June 16 /PRNewswire/ -- 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 populations."

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 more 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 (
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SOURCE Kowa Company Ltd. and Kowa Pharmaceuticals America, Inc.
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