Merck and Schering- Plough, the makers of the popular cholesterol drug, Zetia, announced that Zetia and Vytorin, a pill containing Zetia and Zocor, had failed to benefit patients of a two-year trial which was completed in April of 2006. Merck and Schering-Plough’s press release stated that Zetia not only failed to slow down the accumulation of fatty plaque in the arteries, it contributed to the formation of plaque. Patients taking Vytorin to reduce the growth of fatty plaque in the arteries actually experienced a growth of plaque in their arteries twice as fast as those taking Zetia alone.
This was the second time in just over a year that a clinical trial found that LDL reduction did not translate into measurable medical benefits. The first time involved Pfizer’s experimental cholesterol drug torcetrapib, whose development was stopped in December of 2006, when a trial involving 15,000 patients showed that the medicine caused heart attacks and strokes.
Merck and Schering repeatedly missed their own deadlines for reporting the results of the test, known as Enhance, leading cardiologists worldwide to wonder what the study would show.
The House Energy and Commerce Committee is investigating the delay in reporting the Enhance Study’s results. The committee believes that the negative results adds to suspicions that Merck and Schering-Plough purposely kept their findings to themselves.
However, the drug companies claim that the late release of the findings of the Enhance study were not related to the fact that the findings were negative and that the findings were not known to the companies until two weeks ago.
Dr. Steven E. Nissen, Cleveland Clinics chairman of cardiology stated that Millions of patients may be taking a drug that does not benefit them, raising their risk of heart attacks and exposing them to potential side effects. Patients should not be given prescriptions for Zetia unless all other cholesterol drugs have failed, he said.
Merck and Schering-Plough have begun two large clinical studies, so-called outcome or events trials, that they say will test whether or not taking Zetia with side statins like Lipitor, Crestor or Zocor actually reduces the risks of strokes and heart attacks in comparison to taking a statin alone. This data will not be available until 2011 at the earliest. Without data from events trials for Zetia and Vytorin, no one can be certain if the drugs help or hurt patients.
Cholesterol-lowering medicines, taken by tens of millions of patients daily, are the largest drug category worldwide, with annual sales of $40 billion. Sales of Zetia and Vytorin amounted to $5 billion in 2007. The drugs contribute a significant amount to the drug companies’ profits. Every week, about one million prescriptions for Zetia and Vytorin are written world-wide, and there are about five million patients taking Zetia and Vytorin. Merck has asked the F.D.A. to approve its drug Cordaptive, which raises HDL cholesterol and lowers LDL, without waiting for the results of an events trial that has begun but whose data will not be available until 2013.
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