There is a significantly increased risk of heart attack associated with the widely prescribed class of non-steroidal anti-inflammatory drugs, according to data published in the current edition of the British Medical Journal.
Although lead researcher, Professor Julia Hippisley-Cox of the University of Nottingham, argued that the report could have “considerable implications” for public health, she said that more research into these treatments would be needed. An accompanying editorial in the BMJ said that “the results should be interpreted with caution.”
The study in question assessed some 9,218 patients who had suffered a first heart attack over a four-year period from 2000 to 2004 and found that NSAID use was associated with a 24% to 55% increase in risk of suffering a heart attack. For ibuprofen, the risk increased by almost a quarter (24%), and for diclofenac it rose by more than half (55%). The newer generation of anti-inflammatories – the COX-2 inhibitors – was also associated with increased rates of first-time heart attack. Those taking Pfizer’s Celebrex (celecoxib) were at a 21% higher risk of heart attack, while Merck & Co’s withdrawn drug, Vioxx (rofecoxib) [[01/10/04a]], was associated with a 32% increased risk.
The British Heart Foundation said that while existing heart patients should avoid the drug, the increased incidence of heart attack among others taking ibuprofen was low. Professor Peter Weissberg, the BHF’s medical director, said: “The link between Cox-2 inhibitors and increased risk of heart attack is now well established and doctors know that prescribing these drugs should be avoided in people with poor heart health. The question that has not yet been answered satisfactorily by this study or others, is whether regular use of other types of NSAID can increase the risk of heart problems. It would be wrong to change clinical practice on the basis of current evidence, but it is important that we build on this work and address the question in properly constructed and controlled trials.” He added: “For now, any patients who are prescribed NSAIDs should be reassured that the results indicated a very low incidence of heart attack.”
David Pruce, director of practice and quality improvement at the Royal Pharmaceutical Society of Great Britain said: “The conclusions that [the study] draws from this data are that there is a significantly increased risk of a myocardial infarction associated with the use of these medicines. We do not believe that the evidence presented in the BMJ study justifies this conclusion."
However, there can be no doubt that the data cast another shadow over the already controversial class of drugs. The COX-2 class has been dogged by concerns over both GI and cardiovascular problems – worries over a cardiovascular risk resurfaced last year when Merck withdrew Vioxx after data linked it to a doubling of heart attack risk [[01/10/04a]]. Safety worries have since abounded concerning other products in the class [[20/12/04a]], [[08/04/05a]], and the UK regulator has already said that patients with heart disease currently taking the products should be switched to alternative treatment as soon as convenient [[22/12/04c]].