Approve trial rofecoxib

Overview Fingerprint. Abstract Background Selective inhibition of cyclo-oxygenase-2 has been associated with an increased risk of cardiovascular events in several clinical trials. Access to Document Together they form a unique fingerprint. View full fingerprint. Lancet , , In: Lancet. In: Lancet , Vol. External committees blindly assessed potential serious cardiovascular events.

The focus of the analysis was the combined incidence of non-fatal myocardial infarction, non-fatal stroke, and death from cardiovascular, haemorrhagic, and unknown causes Antiplatelet Trialists' Collaboration [APTC] combined endpoint. We used Cox proportional hazards regression to calculate endpoint hazard ratios. The study is registered with ClinicalTrials. In total, 59 individuals had an APTC endpoint in the rofecoxib group and 34 in the placebo group hazard ratio 1.

It was not stopped earlier because the results for the first 18 months of the trial did not show any increased risk of confirmed cardiovascular events on Vioxx. What did FDA know about the risk of heart attack and stroke when it approved Vioxx? FDA originally approved Vioxx in May The original safety database included approximately patients on Vioxx and did not show an increased risk of heart attack or stroke.

The study showed that patients taking Vioxx had fewer stomach ulcers and bleeding than patients taking naproxen, another NSAID, however, the study also showed a greater number of heart attacks in patients taking Vioxx. Merck then began to conduct longer-term trials to obtain more data on the risk for heart attack and stroke with chronic use of Vioxx.

Vioxx received a six-month priority review because the drug potentially provided a significant therapeutic advantage over existing approved drugs due to fewer gastrointestinal side effects, including bleeding. A product undergoing a priority review is held to the same rigorous standards for safety, efficacy, and quality that FDA expects from all drugs submitted for approval.

You should consult your physician to determine which treatment is right for you. The results of clinical studies with one drug in a given class do not necessarily apply to other drugs in the same class. All of the NSAIDs have risks when taken chronically, especially of gastrointestinal stomach bleeding, but also liver and kidney toxicity. Patients using these drugs for a long period of time longer than two weeks should be under the care of a physician.

FDA did not request a recall of Vioxx. This product is being voluntarily withdrawn from the market by Merck.