| Two top cholesterol drugs 'may have no benefits' |
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The Straits Times, April 1, 2008 Vytorin and a related drug, Zetia, did not reduce fatty plaque in arteries any more than a generic, researchers at a cardiology conference in Chicago said on Sunday. Plaque is a buildup of cholesterol in the arteries and is believed to play a key role in heart attacks and strokes. The two drugs should be used only as a last resort, a panel of four cardiologists told the conference. Instead, doctors and patients should rely more heavily on older cholesterol-lowering drugs called statins, which have proven benefits and can be cheaper, the panel said. 'The strongest recommendation we can make on this panel is to go back to statins,' said Dr Harlan Krumholz, a cardiologist at Yale. Statins include drugs like Lipitor and Simvastatin. But other lesser-known drugs and the vitamin niacin should also be tried before Vytorin and Zetia, the panel said. Vytorin and Zetia are among the top-selling drugs in the world, with combined sales of US$5 billion (S$6.9 billion) last year. About five million people, including four million Americans, take the medicines, which have been heavily advertised to consumers in the United States. In an online editorial, the New England Journal of Medicine recommended that until more research is available, patients should forgo using the drugs unless other medications such as statins or a better diet and more exercise fail to lower cholesterol levels in their blood. Doctors have advised that patients should not stop using the medicines without consulting their physicians. But specialists estimated that as many as two-thirds of people on the drugs eventually might be switched to other therapies. 'What this tells us is that we have had far too many patients on these drugs than the science supports,' said Dr W. Douglas Weaver, a cardiologist and president-elect of the American College of Cardiology. The medicines are jointly sold by Merck & Co and Schering-Plough. The trial, known as Enhance, was finished in 2006 but the full results were not released until now. The results probably will fuel an already fevered debate over why it took so long for the drugs' two manufacturers to release the findings. In a joint statement on Sunday, the two companies said the drugs are effective and they plan to continue marketing them as primary treatments for heart disease. Schering-Plough's Zetia came on to the market in 2002, and Vytorin, which combines Zetia with an older statin, became available in 2004. Zetia is marketed as Ezetrol in Singapore, and is prescribed to reduce cholesterol levels along with Vytorim. The drugs are still available in Singapore and the health authorities here have deemed them as not dangerous. The drugs, however, have not been shown to prevent heart attacks. The Food and Drug Administration (FDA) approved the medicines on the basis that they reduce levels of LDL, or bad cholesterol. Doctors have long believed that lowering LDL levels helps slow heart disease. In the Enhance trial, the drugs did lower cholesterol levels more than a statin but neither helped reduce thickening of a neck artery in the trial's subjects. The FDA recently said it was reviewing the Enhance data and could take up to six months to decide if any regulatory action was needed. LOS ANGELES TIMES, NEW YORK TIMES
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