Vytorin 10/40 |
Ezetimibe/simvastatin is a drug combination used for the treatment of dyslipidemia.
It is a combination of ezetimibe (best known as Zetia in the United States)
and the statin drug simvastatin (best known as Zocor in the U.S.). The combination
preparation is marketed by Merck & Co./Schering-Plough Pharmaceuticals (joint
venture) under the trade names Vytorin and Inegy. Ezetimibe is prescribed to reduce the amount of cholesterol that the body absorbs from the food ingested. But a recent study by the drug's manufacturers revealed that it did not reduce the buildup of plaque in the coronary arteries -- a key indicator of progression toward heart disease. Simvastatin is an HMG-CoA reductase inhibitor or statin. It works by blocking an enzyme that is necessary for the body to make cholesterol. Pharmacology The combination of Ezetimibe and Simvastatin is the only product to treat both sources of cholesterol; absorption in the intestine of both biliary and dietary cholesterol, and production in the liver and peripheral tissues. It is thought that the treatment of high cholestrol from both sources is likely to result in lower cholesterol levels, particularly LDL cholesterol. In a clinical study, it was shown that the combination of Ezetimibe and Simvastatin was superior to Lipitor in lowering LDL cholestrol. ENHANCE Trial Data The two year ENHANCE Study, released by the manufacturer as an abstract, recently failed to provide evidence that ezetimibe/simvastatin was better than simvastatin (a generic medication) in terms of achieving a lower change from baseline in carotid intima-media thickness despite lower LDL levels. Clinical events such as heart attack and stroke were not measured as primary or secondary endpoints of the study making it impossible to determine Vytorin's effect on these events. Data from studies specifically designed to answer this question are expected within the next few years. Subsequent debate and enquiries The American College of Cardiology released a statement indicating that given the small and unique patient population, 720 patients in an Amsterdam hospital with heterozygous familial hypercholesterolemia, "major clinical decisions not be made on the basis of the ENHANCE study alone". Merck and Schering Plough have reported that they have three trials underway to focus on outcomes, measuring the drug's effect on heart attacks and strokes in patients. The results of the ENHANCE study have been long anticipated as the House Committee on Energy and Commerce began an inquiry into the delayed disclosure of the study data; which is expected to be released in full at the American College of Cardiology meeting in March 2008. In addition there is an an ongoing investigation into Carrie Smith Cox, Schering-Plough’s president, selling 900,000 shares of company stock last April and May worth an estimated $28 million. This massive sell off comes after the ENHANCE trial was complete. Finally there is an inquiry into the popular Vytorin brand direct to consumer (DTC) ads because while withholding the ENHANCE results, the companies continued spending at least $155 million a year on clever TV ads that heralded Vytorin’s supposed superiority over statins alone. Advertising campaign In the United States, the Vytorin brand has become rather well known for its television advertising campaign showing a series of split-screen images of a person and a food item to make the point that cholesterol comes from two sources and can be absorbed from food or manufactured by the body, and that heredity plays a role in the latter. This point is a departure from the commonly held belief that high cholestrol only comes from the food that you eat. In each commercial, the person is dressed, and the food plated, to emphasize the resemblance between the person and the food. Some examples include: A woman wearing a yellow shirt with a red and green pin intended to look like a taco. A man wearing a white shirt with a green bow tie intended to look like a plate of pasta topped with peas. A woman wearing a yellow blouse with a decorative white fringe around the neck line intended to look like some sort of lemon pie surrounded with whipped cream and cookies (the cookies being the same yellow as the blouse) An older gentleman with rather spiky white hair intended to look like a lamb chop (with the bones of the lamb chop resembling the spiky white hair) A woman in a red diving suit carrying large flippers, intended to look like a lobster. A woman in a suit with red and white swirls, intended to look like cheese cake topped with a red swirled topping. A man in a brown jacket and helmet of some kind, with bright yellow goggles, intended to resemble pancakes with a similarly yellow topping of butter or margarine. Contraindications Acute liver disease Pregnancy and breast feeding Vytorin is currently undergoing drug trials on patients with extremely high cardiovascular risk who have been in hospital with cardiac problems in the past 10 days. It is not being tested on the lower risk patients with raised cholesterol even though these represent the overwhelming majority of patients said to benefit from this kind of therapy. Side effects Myopathy Rhabdomyolysis Myalgia Pain in extremities, abdomen, Angioedema Hepatitis Eczema Fatigue Headache Influenza, Pharyngitis, sinusitis and upper respiratory tract infection Depression. Interactions Cyclosporine Danazol Protease inhibitors Verapamil Amiodarone Large amounts of niacin (nicotinic acid), grapefruit juice Erythromycin, telithromycin, clarithromycin Nefazodone |