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Vytorin Fails to Demonstrate Superiority to Simvastatin in New Study15 Jan 08Joint-venture (JV) partners Schering-Plough and Merck & Co. (both U.S.) dropped a bombshell yesterday with the announcement that Vytorin (ezetimibe/simvastatin) performed no better than simvastatin in a trial measuring artery blockage due to bad/low-density (LDL) cholesterol.
Vytorin Fails to Reach Endpoint in ENAHCE Trial Schering-Plough and Merck yesterday released results from the long-anticipated ENHANCE trial. In a nutshell, the results indicate that the companies' Vytorin was no better in terms of safety or efficacy compared with the off-patent statin that is one of its components—simvastatin (Zocor, Merck). In the trial of 720 patients with Heterozygous Familial Hypercholesterolemia (HeFH), Vytorin (10/90 mg) was compared with simvastatin (80 mg). The endpoint was to achieve higher mean reduction in intima-media thickness (IMT) measured at three sites in the carotid arteries (the right and left common carotid, internal carotid, and carotid bulb). The change from baseline in the mean carotid IMT was 0.0111 mm for Vytorin vs. 0.0058 mm for simvastatin, and the difference was not statistically significant. The overall incidence of serious adverse events between the Vytorin and simvastatin groups was similar. Outlook and Implications The question that industry observers and the companies themselves are pondering in light of these findings is why anyone would want to use the three-times-as-expensive Vytorin if the same level of effectiveness can be achieved with cheaper generic copies of simvastatin. It is disturbing question for the JV partners, which appear to have delayed the release of the results to consider the implications. In early December, the companies announced plans to change the study endpoint and measure IMT at one carotid point (the common carotid) instead of comparing the results for all three measurements. The move—explained by the need to simplify analysis and speed up results reporting—immediately drew criticism from as high up as Congress. Just a week later, the JV partners decided to revert to the original study endpoint and analysis plans, but the damage may already have been done (see United States: 20 November 2007: Merck, Schering-Plough to Change Primary Endpoint of ENHANCE Trial and United States:17 December 2007: Merck, Schering-Plough Revert to Original Endpoint in Vytorin Study). The ENHANCE trial results would have attracted attention upon their release regardless of this new development. This attention has now no doubt increased out of proportion due to concerns that there was something in the data Merck and Schering-Plough may have been attempting to hide. The fallout from this study could potentially be higher now that doctors, legislators, and insurers have been warned to watch out for the data. Global Insight expects a slowdown in Vytorin sales growth in the current quarter, and even a decline in sales thereafter would be unsurprising. Although the study has been limited to one group with exceptionally high cholesterol and therefore risk of cardiovascular events, doctors and insurers would be asking if patients in this group did not benefit from Vytorin compared with simvastatin. Vytorin would retain favour with at least some prescribers—partly depending on how successful Merck and Schering-Plough are in downplaying the results of the ENHANCE trial—but some would have doubts and could switch patients to cheaper simvastatin while waiting for more convincing data. Vytorin would continue to be used particularly for those patients for whom increasing the dose of a statin used alone poses substantial risks. For the majority of patients, though, this may not be the case and at least some switching to simvastatin is to be expected. Sales of Vytorin's sister drug, Zetia (ezetimibe), are not expected to be negatively affected. |
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