New Formulation of Cholesterol-Lowering Medication Now Available
  Contributed by: Michael Denning, Pharm.D. Candidate
                        Drake School of Pharmacy

The FDA recently approved a new formulation of fenofibrate called TriLipix, a medication used to lower cholesterol.  TriLipix is a once daily capsule that can be taken with or without food.  The active component in TriLipix is the same as is in TriCor.  Both of these products are made by the same company.  The only major differences between these two products are that TriLipix is a delayed-release product and is FDA approved for use with statin medications: Lipitor (atorvastatin), Crestor (rosuvastatin), Zocor (simvastatin) and Pravachol (pravastatin), for example.  TriCor is often used by physicians in combination with statins in patients who need further reductions in triglycerides or LDL (bad) cholesterol or who need increases in HDL (good) cholesterol.  The FDA, however, has not approved the use of these two medications together.  The potential risk in using fibric acid derivatives - TriCor/TriLipix (fenofibrate) or Lopid (gemfibrozil) - with a statin is an increased risk of muscle pain or weakness, which can lead to a serious condition known as rhabdomyolysis, resulting in kidney problems.  This is rare but is a condition for which every patient on a statin, especially those on a statin and fi

bric acid derivative combination, should watch.  TriLipix has specifically been studied with statin medications and the results of these trials showed that 3.1% to 3.5% of patients on this combination will experience muscle pain or weakness, similar to the rates for each medication individually.  The other main side effects (=3%) include headache, back pain, inflammation of the nose or throat, upset stomach, diarrhea and upper respiratory tract infections.  Overall, TriLipix was generally well tolerated by most patients.

TriLipix can also be used by itself for lowing cholesterol, usually for patients who cannot tolerate a statin or for those who specifically need reductions in triglycerides and/or a beneficial increase in HDL cholesterol.  Patients should not use TriLipix if they have poor kidney function, active liver disease, gallbladder disease or if they are nursing.


TriLipix and other cholesterol lowering medications should always be accompanied with a low fat and low cholesterol diet, along with regular exercise.  The American Heart Association recommends a minimum of 30 minutes of exercise 5 days of

the week for all healthy adults.  They also recommend eating a variety of fruits, vegetables, whole grain foods, fat-free or low-fat dairy products, and fish twice a week.

TriLipix is just one cholesterol lowering option, talk with your pharmacist or doctor about other options that may be right for you.  Some of these options include the statin medications listed previously, Niaspan (niacin), Welchol (colesevelam), fish oil - over-the-counter or prescription Lovaza, Zetia (ezetimibe) or Vytorin (Ezetimibe and simvastatin).  You may also visit www.trilipix.com.

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