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Is MerckÂ’'s new pain drug safer than Vioxx?

Merck & Co. recently said that its arthritis painkiller Arcoxia does not increase the risk of a heart attack, in a study emphasizing the difference between this drug and its blockbuster Vioxx, which was withdrawn from the market for such risks.

Arcoxia however, showed mixed results in preventing gastro-intestinal bleeding, a key factor in differentiating the drug from competitors' products.
Merk’s new study results, unveiled at the annual meeting of the American Heart Association, showed that Arcoxia is safer than Vioxx in terms of heart attack risk. The study proved Arcoxia had the same cardiovascular safety as the commonly prescribed NSAIDs, such as diclofenac, a member of the same drug class as naproxen and ibuprofen, said Merck.

This is an important significance, because Arcoxia is a member of the same drug class as Vioxx, which was pulled off the market on Sept. 30, 2004 after Merck released a study linking the drug to increased risk of heart attacks and strokes.

Not only did Merck lose its $2.5 billion in annual Vioxx sales, but more than 20,000 lawsuits have been filed against the company from plaintiffs who blame Vioxx for causing heart attacks. Essentially, Merck is trying to replace Vioxx with Arcoxia.

Arcoxia and other Cox-2 inhibitors, such as the Pfizer drug Celebrex, are anti-inflammatories that are used to kill arthritis-related pain. (Pfizer has also had Cox-2 troubles, having to pull its painkiller Bextra off the market in 2005 because of health risks.) The Cox-2s compete with NSAIDs, arthritis pain killers that have been linked to gastrointestinal bleeding.

When Vioxx was on the market, patients susceptible to stomach problems took that drug instead of NSAIDs. Merck was trying to show improvement in preventing gastro intestinal bleeding prevention with its new Arcoxia study, and therefore preferable to NSAIDs, but had mixed results.

The study showed that Arcoxia performed better than the NSAID diclofenac in preventing a common type of gastro-intestinal bleeding, but it failed at preventing a rarer but more serious type of gastrointestinal bleeding that can involve ulcers, bloody vomit and holes in the stomach lining.

Arcoxia is already available in 62 countries, with sales totaling $192 million in the first nine months of 2006. Merck has submitted an Arcoxia application to the FDA to try to get the drug approved as a once-daily treatment for the most common type of arthritis, called osteoarthritis.

Dr. Christopher Cannon, an independent investigator in the Merck-funded study, said that research in the field of Cox-2 inhibitors is "a heated area, with lots of emotion" and that further research is needed to weigh the Cox-2s against other NSAIDs, like ibuprofen and naproxen. Dr. Cannon there is an ongoing study comparing these NSAIDs to Pfizer's Celebrex.

Takeda Pharmaceuticals recently unveiled study results showing that its diabetes drug Actos does a better job at preventing heart attacks than the generic drug glimepiride.

Investigators in a Takeda-financed study measured the thickness of arteries in the neck in patients taking the company's diabetes drug Actos versus patients who took the generic drug glimepiride. Patients taking the generic drug had thicker neck arteries: an indication that they could be susceptible to heart attack, according to lead investigator, Dr. Theodore Mazzone of the University of Illinois in Chicago.

"The thicker the artery wall, the more likely you are to have a heart attack or stroke in the next five or 10 years," said Mazzone, an independent investigator in the Takeda financed study.

Takeda announced the results of this study just days after releasing its new drug, Duetact, into the market. Duetact is a combination of Actos and the generic drug glimepiride.


However, both of the drugs do the same thing - lower blood sugar levels in diabetics - but they work in different ways so combining them can be beneficial to the patient, said Dr. Robert Spanheimer, medical director for Takeda.

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