Merck & Co. (MRK)s cholesterol drug Tredaptive, pulled from the market earlier this year, increased side effects like bleeding and infections and didnt help patients, according to results of a clinical trial. The study of 25,673 patients found Tredaptive failed to reduce the risk of stroke, death, heart attack or the need for surgery in people with vascular diseases. The drug combines the vitamin niacin, which studies suggest can help raise levels of good cholesterol, with the experimental medicine laropiprant, added to reduce a face-flushing effect of the vitamin. The results of the study, called HPS2-THRIVE, could change the use of niacin, which is often used to supplement cholesterol-lowering drugs, said the studys lead investigator. Niacin has been used for many years in the belief that it would help patients and prevent heart attack and stroke, but we know now that its adverse side effects outweigh the benefits when used with current treatments, Jane Armitage, the studys lead investigator and a professor of clinical trials and epidemiology at the University of Oxford, said in a statement announcing the results. The data were presented today at the American College of Cardiology meeting in San Francisco. Patients in the trial were also … Continue reading →

By Bill Berkrot March 9 (Reuters) - Unexpected serious side effects arose in a huge study of a Merck & Co long-acting niacin drug aimed at raising good HDL cholesterol, according to data released on Saturday, possibly adding a final nail to the coffin of niacin therapy for heart patients. Merck (Other OTC: MKGAY - news) has already given up on the drug that combines extended-release niacin with an experimental agent called laropiprant, designed to prevent the uncomfortable facial flushing associated with niacin. When it was announced that the drug called Tredaptive had failed to show benefit in preventing heart attacks, strokes, death and other complications in heart patients also taking statins to lower bad LDL cholesterol, Merck said it would not seek U.S. approval and stop selling it in the dozens of other countries where it was already available. A European medical journal last week said the drug caused concerning muscle weakness, especially in Asian patients. But the final results presented on Saturday at the American College of Cardiology scientific meeting in San Francisco painted an even more troubling picture of the medicine. Researchers found patients taking the Merck drug had significantly higher rates of bleeding - 2.5 percent … Continue reading →

Scientists acknowledge that an individual's search data doesn't always reflect an accurate picture. STORY HIGHLIGHTS (TIME.com) -- Researchers looking for previously undiscovered drug side effects are turning to web searches for answers. When drugs are approved by the Food and Drug Administration, they are vetted for potential side effects, and drug makers are required to divulge these on their products' labels. But not all side effects emerge in the short term studies that manufacturers conduct, so many only come to light when hundreds of thousands, and even millions of people start using a medication. And what better way, a group of researchers from the Stanford University School of Medicine and Microsoft Research decided, to suss out some of these unexpected side effects than to turn to where people are most likely to report, share and ask about them -- the internet. The researchers combed through a year of web search history from 6 million Internet user volunteers. Using automated tools, the scientists were able to to mine anonymous data from 82 million drug-symptom and condition searches made by the participants who agreed to let the users install a Microsoft plug-in to monitor their history. The team was rewarded with a … Continue reading →

By Bill Berkrot SAN FRANCISCO, March 9 (Reuters) - Unexpected serious side effects arose in a huge study of a Merck & Co long-acting niacin drug aimed at raising good HDL cholesterol, according to data released on Saturday, possibly adding another nail to the coffin of niacin therapy for heart patients. Merck (Other OTC: MKGAY - news) has already given up on the drug that combines extended-release niacin with an experimental agent called laropiprant, designed to prevent the uncomfortable facial flushing associated with niacin. When it was announced that the drug called Tredaptive had failed to prevent heart attacks, strokes, death and other complications in heart patients also taking drugs to lower bad LDL cholesterol, Merck said it would not seek U.S. approval and would stop selling it in the dozens of other countries where it was already available. A European medical journal last week said the drug caused concerning muscle weakness, especially in Asian patients. But the results presented on Saturday at the American College of Cardiology scientific meeting in San Francisco painted an even more troubling picture of the medicine. Researchers found patients taking the Merck drug had significantly higher rates of bleeding - 2.5 percent vs 1.9 … Continue reading →

SAN FRANCISCO (Reuters) - Unexpected serious side effects arose in a huge study of a Merck & Co long-acting niacin drug aimed at raising good HDL cholesterol, according to data released on Saturday, possibly adding another nail to the coffin of niacin therapy for heart patients. Merck has already given up on the drug that combines extended-release niacin with an experimental agent called laropiprant, designed to prevent the uncomfortable facial flushing associated with niacin. When it was announced that the drug called Tredaptive had failed to prevent heart attacks, strokes, death and other complications in heart patients also taking drugs to lower bad LDL cholesterol, Merck said it would not seek U.S. approval and would stop selling it in the dozens of other countries where it was already available. A European medical journal last week said the drug caused concerning muscle weakness, especially in Asian patients. But the results presented on Saturday at the American College of Cardiology scientific meeting in San Francisco painted an even more troubling picture of the medicine. Researchers found patients taking the Merck drug had significantly higher rates of bleeding - 2.5 percent vs. 1.9 percent - and infections - 8.0 percent vs. 6.6 percent … Continue reading →