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news.New research has shown that First Horizon Pharmaceutical's fibric cholesterol-lowering product Triglide does not work more effectively in conjunction with the statin-based drugs Zocor and Lipitor.
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The study evaluated the effects of a single dose of Merck & Co’s Zocor (simvastatin), Pfizer’s Lipitor (atorvastatin calcium), and Kos Pharmaceuticals’ Niaspan (niacin) on the pharmacokinetics and safety of a single dose of Triglide (fenofibrate) tablets.
Results showed that there were no significant effects on the pharmacokinetics of Triglide when taken alone or in combination with simvastatin or atorvastatin, although there was evidence of some drug interaction between Triglide and niacin.
Triglide, a fibric acid derivative, is an adjunctive therapy to diet for people with heightened cholesterol levels. A combination of statins and fibrates are known to improve the overall lipoprotein profile of patients. This finding has led to a movement for considering use of fibrates in combination with statins in high-risk individuals whose triglyceride levels are still elevated.
The study was a four-treatment, four-period crossover examination of 20 healthy male and female volunteers to determine the effect of a single dose of atorvastatin (10mg), simvastatin (10mg), or extended-release niacin (500mg) on the pharmacokinetics and safety of a single dose of Triglide 160mg tablet.
US rights to Triglide were licensed to First Horizon Pharmaceuticals in May 2004 by SkyePharma. FDA approval of the product was received in May 2005, triggering a $15 million milestone payment from First Horizon to SkyePharma.