Merck releases preliminary analyses of off-drug extension of Vioxx study

By Lisa Kerner

Erie, Pa., May 11 - Merck & Co., Inc. said it continued to follow patients in its Approve clinical study for one year after treatment in accordance with study protocol, although base study results released in 2004 led to the company voluntarily withdrawing Vioxx worldwide.

Approve (Adenomatous Polyp Prevention on Vioxx) was a multi-center, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy of three years of treatment with Vioxx 25 mg in preventing recurrence of colorectal polyps.

The one-year off-drug extension of the study addressed recurrence of polyps, thrombotic cardiovascular events and mortality.

Preliminary analyses of the off-drug extension showed there was not a statistically significant difference in the risk of confirmed thrombotic cardiovascular events in patients who had previously taken Vioxx compared to those who had previously taken placebo.

The analysis was the same in the one-year off-drug follow-up period for patients who completed approximately three years of therapy in the Approve study.

Four-year data showed an increased risk of confirmed heart attacks in the Vioxx group compared to the placebo group and an increased relative risk of confirmed ischemic strokes in the Vioxx group compared to the placebo group.

"Our preliminary analyses of the off-drug period did not demonstrate a statistically significant increased risk of confirmed cardiovascular thrombotic events after patients in the Approve study stopped taking Vioxx," president of Merck Research Laboratories Peter S. Kim said in the release.

"The limited data in the Approve study on stroke have to be interpreted in the context of the extensive data we have previously published, which consistently showed no increased risk of strokes in patients taking Vioxx."

Merck, located in Whitehouse Station, N.J., discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs.

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