Vytorin (ezetimibe/simvastatin) was significantly more effective at reducing LDL cholesterol than Crestor (rosuvastatin) in a clinical trial evaluating patients with high cholesterol, according to Merck and Schering-Plough.

The companies presented the positive findings during the International Symposium on Atherosclerosis June 18 in Rome.

Ezetimibe/simvastatin resulted in a 52%-61% reduction in LDL cholesterol among patients treated with 10/20 mg to 10/80 mg of the combination, compared to a reduction of 46%-57% among patients treated with 10 mg to 40 mg of AstraZeneca's Crestor.

Both Vytorin and Crestor raised HDL cholesterol by 8% averaged across all doses studied, according to the research.

The latest results are among a series of trials that the Merck/Schering-Plough joint venture has been using to bolster data around Vytorin. Earlier this month, the companies released data supporting Vytorin's efficacy over Pfizer's Lipitor (atorvastatin) at reducing LDL cholesterol (¹ Also see "Vytorin Bolsters LDL-Lowering Claim Over Lipitor With New Study" - Pink Sheet, 12 June, 2006.).

A data analysis presented in March found that hypercholesteremia patients on Vytorin achieved greater reductions in LDL-C and apoliproprotein B compared to atorvastatin. That analysis led to the addition of a superiority claim over Lipitor to Vytorin's labeling (² Also see "Vytorin Data Showing Superiority Over Lipitor Added To Labeling" - Pink Sheet, 23 March, 2006.).

The latest trial involving Crestor was a six-week, double-blind, parallel-group study involving 2,855 patients who were randomized to one of six treatment groups. Vytorin demonstrated greater LDL lowering when averaged across all dose comparisons (56% versus 52%) and at all individual dose comparisons.

The reductions for the different treatment groups were: 52% Vytorin 10/20 mg versus 46% Crestor 10 mg; 55% Vytorin 10/40 mg versus 52% Crestor 20 mg; 61% Vytorin 10/80 mg versus 57% Crestor 40 mg.

The companies would not comment on plans to submit the data to FDA.

In an AstraZeneca study announced June 19, treatment with Crestor plus Merck/Schering-Plough's Zetia (ezetimibe) showed an unprecedented 70% reduction in LDL-C (see related ³ Also see "Crestor Combination Treatment Shows Unprecedented 70% LDL-C Reduction" - Pink Sheet, 19 June, 2006.).

A report issued by Decision Resources in May predicted that Vytorin would stand up to the introduction of generic Zocor (simvastatin) in June better than Lipitor because the drug's distinct therapeutic profile offers inhibition of both cholesterol synthesis and absorption (⁴ Also see "Pfizer Could Expect Major Lipitor Sales Decline By 2007, Report Says" - Pink Sheet, 17 May, 2006.).

- Jessica Merrill

Vytorin Outpaces Crestor In Comparison Study

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