Fluvastatin sodium (Lescol) is now approved for an additional indication: reducing triglycerides and apolipoprotein B (Apo B) in patients with mixed dyslipidemia. Fluvastatin is a product of Novartis.
The Food and Drug Administration (FDA) based the approval on data from trials involving more than 1,600 patients with hypercholesterolemia and mixed dyslipidemia. Fluvastatin (40 mg and 80 mg) reduced triglycerides by 19.6% and 23.3%, respectively, and reduced Apo B by 18.3% and 28.1%, respectively, in patients with baseline triglycerides equal to or above 200 mg/dl.
The FDA also changed fluvastatin's labeling to reflect the need for fewer liver function tests (LFTs) for patients taking the drug. The new requirement is for LFT monitoring before starting therapy and at 12 weeks following treatment start or dose elevation. If results are normal, no further tests are required. Close monitoring of any LFT abnormality is still recommended.
Copyright Springhouse Corporation May 1999
Provided by ProQuest Information and Learning Company. All rights Reserved
Contact
Home
A
Captagon