Merck Touts New Vioxx Study

Merck & Co. said Thursday that patients who stopped taking arthritis drug Vioxx for one year after taking it in an earlier trial had no greater risk of heart attacks and strokes than patients who took placebos during the same study.

Vioxx was withdrawn from the market in September 2004, after the three-year study, called Approve, showed Vioxx doubled the risk of heart attacks and strokes in those who took it for at least 18 months. More than 11,500 lawsuits have been filed against Merck by people, or their survivors, claiming to have been harmed by Vioxx.

Merck General Counsel Kenneth C. Frazier said the follow-up results should supply a defense against those who blame Vioxx for heart attacks or strokes suffered after they stopped taking the drug. “We believe the data does not provide a valid basis for claims after patients stopped taking the medicine,” he said.

The company followed patients for another year, as part of the original Approve study design, to assess health consequences for those no longer taking the drug.

Merck said 28 Vioxx patients had adverse heart events compared with 16 in the placebo group, a gap seen as statistically insignificant. “The data were insufficient to conclude that there was an increased relative risk of confirmed thrombotic cardiovascular events following discontinuation of therapy,” Merck said.

During the one-year review period after the dosing stopped, even those who had taken Vioxx the full three years had no statistically higher risk of heart attack and stroke than those who took placebos, Merck said.

But a statistically higher risk of heart attacks and strokes remained in the Vioxx group when taking into consideration the full four-year period that included the trial itself and the subsequent yearlong follow-up review.

Shares of Whitehouse Station, N.J.-based Merck edged up 5 cents to $34.56 in after-hours trading after closing at $34.51.