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Back to Pharmacology Articles

Wednesday, 28th July 2004

Studies show that Vytorin can lower LDL or "bad" cholesterol more effectively than a statin alone.

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Diabetics should receive statins, new study says

The Food and Drug Administration has approved a new cholesterol-lowering drug called Vytorin, offering millions of patients and their doctors a potentially new way to reduce the risk of heart disease. Vytorin was approved on July 23, 2004.

Vytorin, combines a popular drug, Zocor (simvastatin), from a class known as statins, with a non-statin medication, Zetia (ezetimibe), in a single pill. Studies show that it can lower LDL or "bad" cholesterol more effectively than a statin alone.

About Vytorin

The starting dose of Vytorin contains 10 mg of Zetia and 10 mg of Zocor. Zocor is from the class of drugs known as statins, and lowers cholesterol by cutting its production in the liver. Zetia, meanwhile, limits the absorption of cholesterol in the intestines.

The drug is being marketed by a joint venture between Zocor maker Merck & Co. and Schering-Plough, which manufactures Zetia in a bid to compete against market leader Lipitor, which holds a 55 percent share of prescriptions and 49 percent of sales.

The potential market for the new drug is huge. According to the CDC, approximately a fifth of U.S. adults over 20 years of age have elevated cholesterol, and 23 million suffer from heart disease. Heart disease and strokes are two of the three leading causes of death.

New guidelines for lowering cholesterol

The main goal of cholesterol-lowering treatment is to lower 'the bad cholesterol", LDL level enough to reduce the risk of developing heart disease or having a heart attack.

Guidelines for cholesterol lowering include

  • Therapeutic Lifestyle Changes (TLC): includes a cholesterol-lowering diet (called the TLC diet), physical activity, and weight management. TLC is for anyone whose LDL is above goal.
  • Drug Treatment: if cholesterol-lowering drugs are needed, they are used together with TLC treatment to help lower your LDL.

Vytorin's approval coincides with the release last week of new guidelines issued by The National Cholesterol Education Program that call for high-risk heart patients to lower their so-called bad cholesterol, or LDL, to 70 instead of 100 as previously recommended. The guidelines also greatly expanded the number of Americans who may be candidates for cholesterol-lowering medications.

A trial published in The New England Journal of Medicine in April suggested that lowering cholesterol as far as possible with statins helps prevent repeat heart attacks and death in heart disease patients. Patients who had their LDL lowered by 50% reduced their risk of a heart attack by 18% and their chances of dying by 30% two years later. That could spur a lot of doctors and patients to use Vytorin since it appears to cut cholesterol more effectively than statins alone.

Further, a consumer group is asking the FDA to remove the cholesterol-lowering drug Crestor (AstraZeneca) from the market, claiming that it has killed one person and injured close to two dozen others since its approval late last summer The 39 year old woman taking the drug died from kidney damage caused by a muscle-destroying disease that is a rare, but recognized, side effect seen with all cholesterol-lowering medications. AstraZeneca spokesman commented that the drug's safety profile continues to mirror the other approved statins and the drug has been effective in lowering cholesterol for patients who are unable to get to goal on other statins.

The studies

In a multi-center, double-blind, placebo-controlled clinical study of 1,528 patients with LDL cholesterol levels of 145 mg/dL to 250 mg/dL, Vytorin provided LDL cholesterol reductions of 52 percent at the recommended starting dose (10/20 mg), 55 percent at the 10/40 mg dose and 60 percent at the maximum dose (10/80 mg).

Vytorin has been shown in studies to lower cholesterol better than market leader atorvastatin (Lipitor) and simvastatin (Zocor). In a multi-center, randomized, double-blind study of 788 patients, Vytorin (doses ranging from 10/10 mg to 10/80 mg) was compared to atorvastatin monotherapy (doses ranging from 10 mg to 80 mg). At the recommended usual starting doses, Vytorin 10/20 mg lowered LDL cholesterol by 50 percent vs. 37 percent for atorvastatin 10 mg and 44 percent for atorvastatin 20 mg. The impact on clinical outcomes of these differences in lipid altering effects is unknown.

In another study of 1,528 patients with LDL cholesterol levels of 145 mg/dL to 250 mg/dL, those taking Vytorin experienced significantly greater LDL cholesterol reductions compared to simvastatin. Vytorin 10/20 mg achieved a 52 percent LDL cholesterol reduction compared to reductions of 34 percent and 41 percent, respectively, for simvastatin 20 mg and 40 mg (typical starting doses for simvastatin). No incremental benefit of Vytorin on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established.

Results from a phase III, multi-center, randomized, double-blind controlled study of 710 patients showed that, Vytorin 10/20 mg lowered LDL cholesterol by 53 percent compared to a 38 percent reduction with simvastatin 20 mg. This greater LDL cholesterol reduction resulted in 83 percent of patients treated with Vytorin 10/20 mg achieving the study LDL cholesterol goal of less than 100 mg/dL as compared to 46 percent of patients taking simvastatin 20 mg.

Side effects

Vytorin was well tolerated with a low incidence of adverse events. In clinical trials, the most commonly reported side effects, regardless of cause, included headache (6.8 percent), upper respiratory tract infection (3.9 percent), myalgia (3.5 percent), influenza (2.6 percent), and extremity pain (2.3 percent).

Words of caution

Some caution that manufacturers have not proven that the drug actually prevents more cardiovascular events or deaths than currently available drugs just that it lowers LDL more effectively. A Merck/Schering-Plough joint venture representative says they are working to conduct a study to find out whether Vytorin actually prevents more heart attacks or saves more lives than a statin alone.

Another point is that the two-drug combination contains half the regular starting dose of the normal 20 mg of Zocor. Statins can also raise HDL, the so-called "good" cholesterol, and have been shown to reduce the markers of inflammation associated with heart disease. At 10 mg, the benefits of statins, which go beyond the drugs' LDL lowering effects, could be lost. However, it can be argued that though the starting dose of Vytorin contains 10 mg of Zetia and 10 mg of Zocor, Vytorin also comes in other combinations with higher dose of Zocor. The amount of Zetia remains the same, but the dose can be increased as needed, based on desired cholesterol, up to include 20 mg, 40 mg, or 80 mg of Zocor.

Article reviewed by:

Dr. Tamer Fouad, M.D.


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