Kowa Pharmaceuticals America Inc. announced data assessing the effect of Livalo (pitavastatin) compared with Crestor (rosuvastatin) on steady-state pharmacodynamics (PD) of warfarin by measuring international normalized ratio (INR) in healthy adult subjects. The study, published in Current Medical Research & Opinion, showed INR during stable warfarin treatment did not change significantly when Livalo was added to the regimen, while a significant increase was observed when Crestor was added to warfarin. INR is a laboratory test that measures the time it takes for blood to clot and compares it to an average. Warfarin is a widely used anticoagulant that inhibits vitamin K-dependent clotting factors to prevent blood clot formation.
It is not uncommon for patients on chronic warfarin therapy to have high cholesterol that requires lipid modifying agents, particularly statins. The concomitant use of statins and warfarin has been studied, and a large database outcomes study reported that the initiation of certain statins was associated with an increased risk of hospitalization for gastrointestinal bleeding. Livalo and Crestor have not been studied in this context. Given there may be potential differences among statins and their effect on warfarin, the purpose of the study was to assess the effect of Livalo compared with Crestor on steady-state INR when coadministered with warfarin.
Results showed that, in healthy subjects taking Livalo 4 mg, mean INR changed from 1.73+/-0.18 (n=42) on day 14 before starting statin dosing, to 1.78+/-0.29 (n=42) on day 22 at treatment end; the difference in INR was not significant. For Crestor 40 mg, mean INR increased significantly from 1.74+/-0.20 (n=43) at baseline to 1.90+/-0.30 (n=43) at treatment end (p<0.001). There were no severe adverse events, serious adverse events, or deaths. Patients receiving warfarin should have their prothrombin time (PT) and INR monitored when Livalo is added to their therapy.
"These data are important as this is the first study to investigate differences in steady-state pharmacodynamic response and effect on anticoagulation between two statins when each are independently added to warfarin," said Craig Sponseller, MD, Vice President of Medical Affairs, Kowa Pharmaceuticals America, Inc. "Physicians now have additional information to reference with this pharmacodynamic data when considering statin options for patients with high cholesterol who are on chronic warfarin treatment."
Date: February 13, 2012
Source: Kowa Pharmaceuticals America Inc.