Study says Vioxx danger begins earlier than stated

By Bill Berkrot

NEW YORK (Reuters) - The increased heart risk from Vioxx, Merck & Co's withdrawn arthritis medicine, begins much earlier than after 18 months of use, according to a study that contradicts assertions by the drug maker and its scientists.

The 2,434-patient study, published on Wednesday in the New England Journal of Medicine, was halted early when the medicine was pulled from the market in September 2004.

Although the median duration of treatment was only 7.4 months, the researchers concluded that Vioxx, known generically as rofecoxib, was still associated with an increased frequency of adverse cardiovascular events.

Adverse events included fatal and nonfatal heart attacks, strokes, sudden death from cardiac causes, blood clots and chest pain, the study said.

Merck said the study in the Journal was just a small piece of the Vioxx story, and said it was not conclusive.

The study was limited by a relatively small number of adverse heart events -- 15 in the Vioxx group and 6 in the placebo group -- and its shorter-than-planned duration, the researchers said.

"However, our findings suggest an increased risk of cardiovascular thrombotic events in patients randomly assigned to receive rofecoxib" during or within 14 days after the treatment period, the researchers said.

Dr. David Kerr of Britain's University of Oxford was the lead author of the study.