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  1. Aschenbrenner, Diane S. MS, RN


* The Food and Drug Administration is requiring the manufacturer of fenofibric acid (Trilipix), also called fenofibrate, to complete a clinical trial to determine the drug's efficacy in reducing cardiovascular events in patients with type 2 diabetes who are already taking a statin.


* This decision follows the outcome of a clinical trial that found that the combination of fenofibric acid and simvastatin (Zocor) was no better than simvastatin alone in minimizing cardiovascular risk.



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Patients with type 2 diabetes are at increased risk for adverse cardiovascular events such as myocardial infarction and stroke. And that risk remains despite lowering of low-density lipoprotein (LDL) cholesterol levels through the use of statins. Fenofibric acid (Trilipix), or fenofibrate, is an anticholesterol drug used to lower triglyceride and LDL cholesterol levels and increase high-density lipoprotein cholesterol levels. It works by speeding up the natural process that removes cholesterol from the body.


In the large Action to Control Cardiovascular Risk in Diabetes Lipid trial, patients with type 2 diabetes received simvastatin and either a placebo (n = 2,753) or fenofibrate (n = 2,765) in an effort to determine the effectiveness of the combination in reducing cardio-vascular risk. The mean duration of follow up in the randomized, double-blind, placebo-controlled trial was 4.7 years. Analysis of study data (published in a May 2011 supplement to Diabetes Care) showed that the combination of the two drugs didn't decrease the risk of cardiovascular events more than simvastatin alone. In a subgroup analysis, the addition of fenofibric acid actually increased the risk of cardiovascular events in women, although not in men. That finding hasn't yet been confirmed in other clinical trials. Based on these data, the Food and Drug Administration (FDA) has decided to require the manufacturer of fenofibrate to conduct a clinical trial evaluating the cardiovascular effectiveness of fenofibrate when it's added to statin therapy.


At this time there is no mandate that patients discontinue therapy with fenofibric acid, although primary care providers should use caution and consider the risks and benefits of fenofibrate therapy in each patient. Like all drugs, fenofibric acid can have adverse effects. Like statins, it can produce myopathies and rhabdomyolysis, and the risk increases if the patient is also taking a statin. An increase in liver-enzyme levels is also possible, as is an increase in serum creatinine levels. Patients with severe renal disease shouldn't receive fenofibric acid. Nurses should monitor liver enzymes while a patient receives fenofibric acid; if the enzymes persistently remain elevated above three times the upper limit of normal, the drug should be discontinued. Nurses should instruct patients taking fenofibric acid to read the medication guide that accompanies each filled prescription for the most recent information on the drug. To read the FDA Drug Safety Communication regarding fenofibrate, go to http://1.usa.gov/vdjzXH.