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When the FDA approved Vytorin, a medicine that lowers bad cholesterol in the blood and raises the good one, it did so on account of a few clinical trials in which almost 4,000 patients participated. They all took the drug for about three months, but the examinations didn’t show proof of the medicine’s properties to decrease heart attacks or cardiovascular disease.
In spite of failing to reach its goal, Vytorin is frequently prescribed. Due to massive advertising, sales of the drug have increased up to $5.2 billion in the previous year, propelling it to the top of the best sold medicines worldwide.
Although there is no evidence linking the drug to the benefits it is said to bring, the number of people taking it is staggering. This is why health officials strongly recommended patients to avoid the intake of the drug if possible. While failing to prove that Vytorin reduces cardiovascular disease and avoids heart attacks, makers Merck & Co and Schering-Plough Corp. confront with another problem of great magnitude: scientists are discussing about a link between the cholesterol fighting medicine and cancer.
According to editors of the New England Journal of Medicine, combined findings from three Vytorin studies could neither provide evidence nor refute the presumptive bond with an increased risk of cancer. The results of the research were published on the Web site of the journal on Tuesday. On the same day, they were presented at the European Society of Cardiology conference, which was held in Munich.
As written by Thomas Fleming of the University of Washington "there are clinically important increases in the risk of cancer-related death that are not ruled out by this data."
However, some claim the cholesterol-lowering drug, in a separate form sold as Zetia or as a combination medicine - Vytorin, shouldn’t be put on the market, The New York Times reported. “The only place people should be taking it is in a clinical trial,” Dr. Allen J. Taylor of the Walter Reed Army Medical Center, stated on the topic of Zetia.
As expected, the two makers of the medicines disagreed, strongly defending their products. Merck and Schering-Plough said that, in animal trials, ezetimibe (the generic name for the cholesterol drug), didn’t offer any evidence leading to cancer risk. The two companies are supported by several independent experts, who claim that ezetimibe has beneficial effects regardless of which brand it is sold under, according to the Times.
In order to determine which are the real benefits and how much safety the drug offers, a trial involving more than 10,000 patients should be carried out. Also, it should last several years, long enough to find the truth.
"If people read about this and it spurs them to call their physicians, we could see some decline in prescriptions or we could see docs decide not to start new patients on the drug," said Edward Jones analyst Linda Bannister, Reuters reported.
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