Combination of | |
---|---|
Ezetimibe | Hypolipidemic agent |
Atorvastatin | Statin |
Clinical data | |
Trade names | Liptruzet, Atozet |
Routes of administration | By mouth |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
PubChem CID | |
KEGG |
Ezetimibe/atorvastatin (trade names Liptruzet, Atozet) is a cholesterol lowering combination drug. In the United States, it was approved in May 2013, by the Food and Drug Administration for the treatment of elevated low-density lipoprotein (LDL) in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet.[1] It has also been approved to reduce elevated total cholesterol and elevated LDL in patients diagnosed with homozygous familial hypercholesterolemia as an adjunctive treatment to other hyperlipidemia treatments.[2]
Some cardiologists opposed the approval, because the combination reduced LDL cholesterol in a clinical trial, but it did not reduce heart disease. A clinical trial studying the endpoints of heart attacks, strokes and heart-related deaths is scheduled to conclude in 2014.[3]
Liptruzet was withdrawn from sale by its manufacturer in June 2015, but not for reasons of safety or effectiveness.[4]
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Transcription
Hi. I’m Doctor Chaudhry. I’m going to talk about the double jeopardy of high cholesterol and the side effects of cholesterol drugs. The cholesterol drugs which are being used to lower cholesterol are called statins. This group includes Lipitor, which is probably the most popular drug all over the world. By the way, it produces approximately 12 to 14 billion dollars for Pfizer every year. The next popular statin is Crestor. There is the Zocor, Prevachol, and the very first statin called Mevacor which was developed approximately 25 or 30 year ago. So these drugs work by interfering with the synthesis or the production of cholesterol by the liver. And when they do that they do it threw a mechanism which interferes with the production of some essential proteins which we need. And because of that they cause side effects. The major side effects include myalgias, which is defined as muscle soreness, muscle weakness, pains, sometimes joint pains. They cause headache, constipation and other GI disorders. Some of which can be quite serious. And according to the recently published Jupiter Study, now they are known to cause mental confusion, type 2 diabetes. And the GI disorders actually are reported to cause even death. And we know from the previous experience the statins can cause muscle damage which can lead to kidney failure which can also be fatal. So, the number of people who are experiencing significant side effects is increasing because the number of people who are using these statin drugs is also increasing gradually. Approximately 104 million of the American adult population is known to have high cholesterol. So you can think that even if 50% of them are on drug therapy about 10-15% of them are experiencing side effects. So what do we do? So you’re not alone frankly, if you are having side effects. Having high cholesterol is bad enough so why put up with the side effects? Fortunately there are natural alternatives available now which are effective to lower cholesterol. They are Tocotrienols, which are natural, quite effective. Red Yeast Rice, which is also natural and very effective, can lower cholesterol anywhere from 30-45%. Then the other natural alternatives are plant based and the most effective among them is Beta Sitosterol which works through the absorption mechanism of cholesterol. And the last one is the group of probiotics discovered to lower cholesterol. So these agents can be combined with each other and the first two actually their combination is as effective as any statin to lower cholesterol. So because these ingredients are available, they are based on research and scientific studies. So when you go to see your doctor, ask him if he would like to use one of these natural remedies to help you get to your cholesterol goal.
Mechanism of action
This combination drug works to reduce cholesterol levels through two different pathways. The ezetimibe component of the medication works by inhibiting cholesterol absorption from food while the atorvastatin component inhibits intrinsic cholesterol production in the liver.[5]
Safety
- The drug is not safe to use in patients with active liver disease or unexplained persistent elevations in hepatic transaminase.
- Women that are pregnant or may become pregnant should not use the drug. It is a teratogenic agent that may disrupt the growth and development of a fetus. Immediate discontinuation is recommended in patients that become pregnant while taking this drug.
Adverse effects
Commonly reported adverse effects include:[6]
- Musculoskeletal pain
- Elevated liver enzymes (AST and ALT)
- Gastrointestinal problems such as abdominal pain and nausea
See also
References
- ^ "FDA Approves Merck's LIPTRUZET (ezetimibe and atorvastatin), a New Product That Can Help Powerfully Lower LDL Cholesterol". Business Wire. May 6, 2013. Retrieved May 6, 2013.
- ^ "Liptruzet." CenterWatch. Web. 28 Oct. 2014.
- ^ Drug to Cut Cholesterol Is Approved by the F.D.A. By Katie Thomas, New York Times, May 3, 2013
- ^ Determination That LIPTRUZET (Ezetimibe and Atorvastatin) Tablets, 10 Milligrams/10 Milligrams, 10 Milligrams/20 Milligrams, 10 Milligrams/40 Milligrams, and 10 Milligrams/80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Federal Register: Notice by the Food and Drug Administration on 11/20/2015.
- ^ Liptruzet [package insert]. Whitehouse Station, NJ: Merck & Co.; 2013
- ^ Clinical trial number NCT00418834 for "Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)" at ClinicalTrials.gov
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