Merck: Arcoxia Heart Risk Same As Voltaren

U.S. firm Merck said Monday its new COX 2 painkiller — in the same class as Vioxx — has a cardiac risk similar to Novartis’ Voltaren.

According to data from a large patient trial released Monday, Merck said its new arthritis treatment Arcoxia (etoricoxib), carries a comparable risk of heart attack and other cardiovascular events, compared to Voltaren (diclofenac), but showed a lower risk of gastrointestinal problems, like bleeding ulcers.

However, Merck said the data also revealed that a high dose of Arcoxia carries a higher risk of congestive heart failure, and a higher rate of patients discontinued Arcoxia due to high blood pressure, versus diclofenac.

Merck said late last week that, based on the new data, it would narrow the indication it is pursuing for Arcoxia to treat osteoarthritis at two dose levels, instead of a wider array of uses that had included treating rheumatoid arthritis.

The drug maker said it expects the Food and Drug Administration to complete review of Arcoxia in April.

The company presented the data — from the Multinational Etoricoxib and Diclofenac Arthritis Long-Term or Medal study — at the American Heart Association meeting in Chicago.

The 18-month study — which was also published online in The Lancet — involved 34,701 arthritis patients, about half of whom received Arcoxia, with the remaining patients taking diclofenac.

Arcoxia is sold in more than 60 countries worldwide. Merck first applied for U.S. approval in 2001, but the FDA’s nod has been delayed by the agency’s request for more safety and efficacy data, Merck said.