Vytorin for the Treatment of Hyperlipidemia

Vytorin is a combination therapy comprised of two drugs already separately approved for the treatment of hyperlipidemia. Zocor (simvistatin) and Zetia (ezetimibe) are combined in this oral medication currently awaiting an FDA decision on approval. Results released by Merck and Schering-Plough in March 2004 from Phase III clinical trials demonstrated that patients taking Zocor and Zetia had significantly greater reductions in LDL cholesterol compared to those patients taking only Lipitor or Zocor. In the 24-week, 788 patient study, patients taking Zetia 10 mg with Zocor 10 mg experienced greater LDL-C reductions (46%) compared to Lipitor 10 mg (37% p <0.01). The companies also reported that the Zocor/Zetia combination produced a greater mean HDL-C increase compared to patients taking Lipitor alone.

Zocor is a so-called ‘statin’ lipid lowering agent that exerts its action by inhibiting an enzyme known as HMG-CoA., which plays a critical role in cholesterol synthesis. The clinical benefit of Zocor in reducing death due to CHD, MI, and decreasing the need for invasive coronary procedures in patients with elevated cholesterol levels is well established. Unlike Zocor, Zetia works by inhibiting the absorption of dietary cholesterol from the small intestine. Data demonstrating Zetia’s ability to significantly decrease morbidity and mortality from coronary artery disease has not been produced.

According to the American Heart Association, in excess of 100 million Americans presently have total blood cholesterol levels above 200 mg/dl. In addition, fewer than 50% of patients who would benefit from cholesterol lowering treatments are actually receiving them. Some analysts expect Vytorin to eventually attain annual sales of up to $8 billion.

Given that Vytorin is comprised of two already approved drugs, a positive FDA decision is anticipated. Combination therapies are almost always less expensive than the cost of their constituents purchased separately, so potentially Vytorin would not drive up cost of per patient treatment. However, Vytorin will most certainly be more costly than the individual statin drugs that in some cases it is likely to replace. Clinicians might choose Vytorin when they are striving for more aggressive lipid control or when patients are inadequately controlled on a statin alone. Both of these scenarios would see the cost of treatment significantly increase on a per patient basis and forms the underlying rationale for our recommendation that clients should begin preliminary assessment activities for Vytorin in anticipation of FDA approval.

Technology Details
Target Disease / Indication: Hyperlipidemia
Technology Classification: Drug
Body System: Cardiovascular System
Program Area: Medicine/Cardiology
Regulatory Status: Phase III
BioHorizon Impact Score: 81/100 – High