WelChol is a prescription drug indicated alone or in combination with a statin, as an adjunct to diet and exercise for the reduction of elevated LDL cholesterol in patients with primary hypercholesterolemia (Fredrickson Type IIa) when the response to diet and exercise has been inadequate. Liver- function monitoring is not required with WelChol when used as monotherapy, and in combination with a statin, no additional liver-function monitoring is required beyond that for the prescribed statin alone.
In clinical trials with patients with primary hypercholesterolemia, when WelChol was given alone in addition to a low-fat diet and exercise, it was shown to reduce LDL cholesterol by an average of 15% to 18%.
When WelChol is given in combination with a statin, the combination can lower cholesterol levels more effectively than using either therapy alone. In pivotal studies where WelChol was taken with a statin, WelChol 3.8g provided up to an additional mean 16% (32 mg/dL) reduction in LDL cholesterol. WelChol is the only non-systemic cholesterol-lowering agent approved by the FDA for combination with a statin. WelChol can be used in combination with any dose of any statin.
WelChol is engineered for affinity and high capacity bile acid binding.
It has been studied with our commonly prescribed statins -- Lipitor(R)
(atorvastatin calcium), Zocor(R) (simvastatin), Pravachol(R)4 (pravastatin
sodium) and Mevacor(R) (lovastatin). Additionally, WelChol has been studied
with fenofibrate and had no significant effect on the bioavailability of
|SOURCE Daiichi Sankyo, Inc.|
Copyright©2007 PR Newswire.
All rights reserved