No proof of increase heart-related problems associated with rofecoxib- Circulation report shows

An extensive report and analysis which was published recently in the on-line edition of "Circulation," one of the leading and respected journals, showed that there was no significant evidence to prove that the arthritic drug rofecoxib increases the incidence of cardiovascular problems when compared to a placebo (sugar pill) and to traditional non-naproxen non-steroidal anti-inflammatory drugs (NSAIDs).

The investigative report by Dr. Marvin Konstam and colleagues, which was a combined analysis of more than 28,000 patients representing >14,000 patient-years at risk, was derived from 23 various rofecoxib studies that lasted at least 4 weeks dealing with osteoarthritis, rheumatoid arthritis, chronic low back pains and even Alzheimer's disease.

According to Konstam and colleagues, the outcome measure that was used in their investigation was the combined endpoint defined by the Antiplatelet Trialist's Collaboration (APTC). The APTC endpoint consists of the combined incidence of cardiovascular (CV), hemorrhagic (heavy bleeding), and unknown death; non-fatal myocardial infarctions (heart attacks); and non-fatal strokes. This endpoint is the most common and widely accepted endpoint in quantifying the overall CV impact of antithrombotic compounds in clinical trials. When rofecoxib was compared to placebo, the results showed a comparable risk of APTC events in both groups. Because placebo was given for a limited duration in the osteoarthritis, rheumatoid arthritis, and chronic low back pain studies, the majority of patient-years came from the Alzheimer's trials, whose populations included predominantly elderly, male patients. These data reassure that there is no evidence for any increased risk of CV events with rofecoxib.

When rofecoxib was compared to non-naproxen NSAIDs, the results also demonstrated comparable risks of APTC events in both groups. Non-naproxen NSAIDs were only studied in osteoarthritis patients.