Livalo pitavastatin: Extension study data

In the open-label, 52-week extension of a pair of double-blind, active-controlled, European Phase III trials in 1,353 patients, the proportion of patients treated with 4 mg daily Livalo that achieved NCEP and EAS LDL-C targets at week 52 was 74% and 73.5%, respectively. Changes in triglycerides, total cholesterol, non-HDL-C, apolipoprotein A-1 (APOA1), apolipoprotein B (APOB), high-sensitivity C-reactive protein (hsCRP) and oxidized LDL were sustained during the extension study compared with the end of the double-blind studies. Furthermore, levels of HDL-C increased an additional 8.7% from the end of the double-blind studies. Livalo was well tolerated to week 52 with no serious drug-related adverse events. Data were published in Atherosclerosis.

Kowa previously reported data from the Phase III trials in 857 and 830 patients, respectively, showing that Livalo met the primary endpoint of non-inferiority to simvastatin and Lipitor atorvastatin, respectively, as measured by a reduction of LDL-C from baseline at 12 weeks (see BioCentury, Sept. 7, 2009). Lipitor is marketed by Pfizer Inc. (NYSE:PFE; New York, N.Y.). ...