_:n6fcf7284c29b4a60bf18789dc2861725xb0
<http://schema.org/articleBody>
"ABBOTT PARK, Ill., Dec. 16 -- The FDA has approved fenofibric acid (Trilipix) delayed release tablets for use with a statin for dyslipidemia, according to an announcement from Abbott.               Although fibrates are frequently used with statins, the FDA action makes fenofibric acid the first in this class to receive a label indication for use with a statin. The drug was also approved for use with diet and life-style interventions aimed at lowering LDL and triglycerides and increasing HDL.              The FDA&#039;s approval was on the basis of a trial that enrolled 2,698 patients and randomized them to combination therapy with fenofibric acid and rosuvastatin (Crestor), atorvastatin (Lipitor), simvastatin (Zocor) or monotherapy with a statins or the fibrate.              The combination significantly improved HDL and triglycerides compared with statin monotherapy and significantly improved LDL compared with fenofibric acid alone.              Abbott said it was collaborating with AstraZeneca to develop a fixed dose combination of fenofibric acid and rousvastatin and planned to submit an NDA in 2009.              Fenofibric acid should not be taken by those with liver, gallbladder, or severe kidney disease, or nursing mothers.              The most common side effects reported in trials included  headache, heartburn, nausea, muscle aches and increases in muscle or liver enzymes."
<https://www.medpagetoday.com/Cardiology/Dyslipidemia/12190>