Major side-effects from anti-inflammation drug
Tuesday October 14th, 2008
Follow-up data confirms the anti-inflammatory drug rofecoxib substantially increases the risk of stroke, heart attack and death, researchers warned today.
The findings in The Lancet have raised concern that a much wider range of drugs may share the same side-effects.
Using data from the APPROVe trial, which looked at 2587 patients worldwide taking rofecoxib, (Vioxx), for cancerous polyps in the bowel, researchers attempted to follow-up for one year all patients that had to stop treatment because of cardiovascular toxicity.
They looked for combined incidence of non-fatal heart attack, non-fatal stroke and death from cardiovascular, haemorrhagic or unknown causes (known as the Antiplatelet Trialists' Collaboration (APTC) combined endpoint).
They found that the relative risk of reaching APTC was increased by 79 per cent in the rofecoxib group compared with placebo.
After one-year follow up, the risk of heart attack or stroke was roughly doubled for rofecoxib patients compared with placebo, while the relative risk of death increased by 31 per cent.
The authors said the data was compatible with an early increase in risk that seemed to persist for about one year after three years of treatment.
"The cardiovascular toxicity seems to be a class effect; indeed, studies of other selective COX-2 inhibitors have reported similar findings," they said.
"Conventional non-aspirin NSAIDs may share the same toxicity to the extent that they are COX-2 selective.
"All these drugs are effective analgesic and anti-inflammatory agents, and seem to reduce risks of colorectal neoplasia.
"However, these benefits will have to be weighed against their proven or possible cardiovascular risks in assessing their suitability in various clinical settings."
The authors were Professor John Baron, Dartmouth Medical School, New Hampshire, USA, Dr Robert Bresalier, MD Anderson Cancer Center, University of Texas, USA and Professor Dion Morton, University of Birmingham, UK and colleagues.
The Lancet on-line October 14 2008
Tags: Cancer | Gastroenterology | Pharmaceuticals | Rheumatology | UK News | North America
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