2008年12月15日美国FDA批准雅培公司出品的最新的心血管的新药Trilipix（非诺贝酸），该药为缓释胶囊剂，该药可以联合饮食调理降低患者血清甘油三酯和LDL胆固醇的水平，同时可以升高HDL胆固醇水平。Trilipix是首个被批准可与statin类药物联用的fibrate类降血脂药物。为了调节某些患者的血脂水平，治疗指南推荐采用statin类和fibrate类降血脂药物联用的治疗方法。目前为止，尚未观察到Trilipix可以预防心脏病发生和心脏病发作。delayed-release capsules 是缓释胶囊吗?应是肠溶胶囊.应该是缓释胶囊哦请看看USP/BP的delayed-release是什么?翻译成肠溶比较合适。
缓释应该为extended release其实肠溶也不是很确切，一说肠溶就会让人想到是包了肠溶衣的。个人认为“迟释”最接近原意，比如国外新上市的Lodotra制剂，推迟4小时后释放，但处方中没有一点肠溶成分。有没有专利问题？当然有专利个人也认为“迟释”最接近“delayed-release”原意，其实“肠溶”也应该是“迟释”的一种；但在国内也有人会将此归入“脉冲”，如按ChP2005。
其实，在美国，肠溶、迟释、缓释、脉冲 都是调(控)释的一种，当然，人家的控释不等于在体外零级释药。
雅培表示，这种药物可作为单用治疗药，并且它是第一种也是唯一一种获准可与Statin类药物联用的Fibrate类降脂药。
此次TriLipix获准的依据是一项为期12周的III期临床实验结果，这项实验主要评估该药与三种最常用的Statin类药物联用的治疗效果，受试者人数达2698人，均为伴有混合性血脂异常的患者。实验数据显示，在所有的实验项目中，与单用Statin类药相比较，TriLipix联合疗法都能更显著地改善患者体内的HDL、甘油三酸酯和LDL的水平。

Trilipix
Generic Name: fenofibric acid (FEN oh FYE brik AS id)
Brand Names: Fibricor, Trilipix

What is Trilipix?
Trilipix (fenofibric acid) helps reduce cholesterol and triglycerides (fatty acids) in the blood. High levels of these types of fat in the blood are associated with an increased risk of atherosclerosis (clogged arteries).

Trilipix is used to treat high cholesterol and high triglyceride levels. It is sometimes given together with other cholesterol-lowering medications.

Trilipix may also be used for other purposes not listed in this medication guide.

Important information about Trilipix
You should not take Trilipix if you are allergic to fenofibric acid, or if you have liver disease, gallbladder disease, severe kidney disease (or if you are on dialysis), or if you are breast-feeding a baby.

Before you take Trilipix, tell your doctor if you have kidney disease, diabetes, or underactive thyroid.

Trilipix is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.

Avoid drinking alcohol while taking Trilipix. It can raise triglyceride levels and may increase your risk of liver damage.

Avoid eating foods that are high in fat or cholesterol. Trilipix will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

In rare cases, Trilipix can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Before taking Trilipix
If you have any of these conditions, you may need a dose adjustment or special tests to safely take Trilipix:
severe kidney disease (or if you are on dialysis);
liver disease;
gallbladder disease; or
if you are breast-feeding a baby.

If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before you take Trilipix, tell your doctor if you have:
kidney disease;
diabetes; or
underactive thyroid.

FDA pregnancy category C. It is not known whether Trilipix will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Do not breast-feed while you are taking Trilipix.

How should I take Trilipix?
Take Trilipix exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take the medicine with a full glass of water.

You may take Trilipix with or without food.

If you also take cholestyramine (Questran), colesevelam (Welchol), or colestipol (Colestid), take these medicines at least 1 hour after taking Trilipix, or 4 to 6 hours before taking Trilipix. Do not take any of these medicines at the same time you take fenofibric acid.

"Statin" cholesterol-lowering medications may be taken at the same time as Trilipix.

Trilipix is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.

To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor.

To be sure Trilipix is helping your condition and not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney, liver, and gallbladder function may also need to be tested. Visit your doctor regularly.

Store Trilipix at room temperature away from moisture and heat.

What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Symptoms of a Trilipix overdose are not known.
What should I avoid while taking Trilipix?
Avoid eating foods that are high in fat or cholesterol. Trilipix will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Avoid drinking alcohol while taking Trilipix. Alcohol can raise triglyceride levels, and may also damage your liver while you are taking Trilipix.

Trilipix side effects
In rare cases, Trilipix can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Stop taking Trilipix and call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Get emergency medical help if you have any of these signs of an allergic reaction to Trilipix: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking Trilipix and call your doctor at once if you have any of these other serious side effects:
sharp stomach pain spreading to your back or shoulder blade;
stomach pain just after eating a meal;
nausea, vomiting, fever, clay-colored stools, jaundice (yellowing of the skin or eyes);
pain, swelling, warmth, or redness in one or both legs; or
chest pain, sudden cough, wheezing, rapid breathing, fast heart rate.

Less serious Trilipix side effects may include:
headache, dizziness;
back pain;
joint pain, mild back pain;
diarrhea, upset stomach; or
cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Trilipix?
Tell your doctor about all other medications you use, especially:
cyclosporine (Neoral, Sandimmune, Gengraf);
a blood thinner such as warfarin (Coumadin);
a diuretic (water pill);
birth control pills or hormone replacement therapy; or
a beta-blocker such as atenolol (Tenormin), carvedilol (Coreg), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), and others.

This list is not complete and other drugs may interact with Trilipix. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?
Your pharmacist can provide more information about Trilipix.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.