Merck Sharp and Dohme touts safety of ‘Vioxx successor’

Merck Sharp & Dohme (MSD) has announced that the rate of cardiovascular events for Arcoxia – widely dubbed as its successor to Vioxx – is comparable to existing treatments.

Arcoxia is a nonsteroidal anti-inflammatory drug (NSAID) and a COX-2 inhibitor like Vioxx, the once best-selling drug that was withdrawn following reports of an increased incidence of cardiovascular events, resulting in thousands of lawsuits against MSD.

The new drug was tested in 60mg and 90mg doses in patients with osteoarthritis and rheumatoid arthritis and compared with diclofenac, a widely-used NSAID. The results of the trial programme – entitled Medal – showed that the relative risk of thrombotic cardiovascular events between Arcoxia and diclofenac was 0.95.

In an “intent to treat” analysis, the relative risk between Arcoxia and diclofenac was 1.05.

However, a significantly higher number of Arcoxia patients withdrew from treatment due to hypertension-related adverse events, although diclofenac patients experienced a larger number of gastrointestinal and hepatic side-effects.

Dr Peter S Kim, president of MSD research laboratories, commented: “After four years of conducting this arthritis study program in more than 34,000 patients, we are looking forward to sharing the full Medal programme results in the future.”

Preliminary analyses of Arcoxia – now available in 62 countries across the world – have been forwarded to the European Medicines Agency and the FDA.

MSD is currently battling over 11,000 lawsuits from Vioxx patients and the families of Vioxx patients who suffered cardiovascular events like heart attacks and strokes following use of the drug.

The company has said it acted appropriately at all times and that it will defend itself against all lawsuits because there is “no commonality” between cases.

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