American College of Cardiology conference: The cardiac side-effects of commonly prescribed arthritis drugs have been underestimated and could affect a larger number of patients, a major medical conference has been told.
In a session specifically arranged to discuss the implications of the recent withdrawal of the drug Vioxx and to address questions over the safety of other cox- 2 inhibitor drugs, doctors at the American College of Cardiology Scientific meeting in Orlando, Florida, were told they must be more selective in prescribing anti- inflammatory therapy.
The meeting also heard that the system of drug-development must be changed so that questions important to patients and doctors are answered.
Cox 2 inhibitors were introduced in 1999 as an improvement on the first generation of non-steroidal anti-inflammatory drugs (NSAIDs).
These drugs, which block the action of the enzyme cycooxygenase thereby inhibiting joint inflammation, are licensed for use in people with osteoarthritis and rheumatoid arthritis.
Research suggested they were effective in reducing pain and were marketed as being less likely to cause gastrointestinal problems.
Dr Peter Juni of the department of rheumatology and social and preventive medicine at the University of Berne, Switzerland said an analysis of trials of Vioxx, (Rofecoxib) suggested that for every 70 patients prescribed the drug, one would experience a significant side-effect.
This risk is greater than the two to threefold increased risk of a major cardiac side effect found in clinical trials of Vioxx.
"We need a systematic review of all clinical trials of cox-2 inhibitors to determine whether the increased cardiovascular risk seen with Vioxx applies to all cox 2 inhibitors," Dr Juni said.
He called for new research trials to be carried out in large groups of patients who are typical of the patients likely to use the arthritis drugs in practice.
"Based on a proper determination of risk profiles, doctors will then be able to decide what is best for an individual patient", he said, adding that in his opinion the risk of cox-2 drugs had been underestimated up to now.
Dr Robert Califf, vice-chancellor for clinical research at the Duke University Medical Centre in North Carolina, who chaired the session, said he was disappointed that one no one from the pharmaceutical industry or the Food and Drug Administration (the US drugs regulatory agency) had made themselves available to speak at the symposium.
Dr Califf noted that most people over the age of 40 had a reason to take non-steroidal anti-inflammatory drugs for either arthritis or muscular aches.
"Many of us have cardiovascular disease already but our systems of drug-development have failed to produce a solid estimate of the balance of risks and benefits for cox 2 drugs."
He called for new research which would include at least 10,000 patients and with a mix of people considered to be at high risk of side-effects.
Dr Califf advised patients with arthritis to first use low-dose aspirin and to then consider other alternatives to NSAIDs such as paracetemol.
If an NSAID was necessary, he advised people to take Naproxen, an older-type NSAID combined with a drug which reduces stomach acid secretion (to prevent gastric side effects).
Dr Califf was also highly critical of the US system of direct-to-consumer advertising saying it was dangerous to public health.