Painkiller research confirms heart risk – experts respond

New research confirms and clarifies the link between high doses of commonly prescribed painkillers and adverse cardiovascular events such as heart attacks.

Painkillers a heart breakerNon-steroidal anti-inflammatory drugs (NASIDs) —  such as diclofenac and ibuprofen — have been the cornerstone in managing pain in people with inflammatory disorders like rheumatoid arthritis, and are some of the most commonly used drugs worldwide. However, NASID use has been linked to heart attacks and gastrointestinal bleeding.

Now a new study has drawn on data from hundreds of trials to clarify the association between NASID use and vascular complications identified in previous research.

The study, published this week in the Lancet, reviewed data from 639 previous randomised controlled trials of NASIDs covering over 353 000 patients. In addition to identifying specific risks for different NSAIDs and doses, the review found that overall NSAIDs approximately double the risk of heart failure and produce an increased risk of serious upper gastrointestinal complications such as bleeding ulcers. The study also identified the types of patients most at risk of adverse events, information which will help doctors prescribe the best NSAID regime for patients based on a risk profile.

Read more about the study in a Lancet media release.

In commentary article for the journal, Marie Griffin from Vanderbilt University Medical Center in the USA says, “The meta-analysis offers considerable certainty about relative and absolute major vascular risks of high doses of the most commonly prescribed NSAIDs, but leaves large gaps about risks associated with lower NSAID doses, longer durations of use, and residual effects after stopping treatment.”

She adds, “Identification of safe and effective strategies for chronic pain is sorely needed. In the meantime, long-term use of high dose NSAIDs should be reserved for those who receive considerable symptomatic benefit from the treatment and understand the risks.”

Our colleagues at the UK SMC collected the following expert commentary. Feel free to use these quotes in your reporting. If you would like to contact a New Zealand expert, please contact the SMC (04 499 5476;

Professor Simon Maxwell, member of the British Pharmacological Society and Professor of Student Learning/Clinical Pharmacology, University of Edinburgh, said:

“This study adds further information by confirming that commonly used standard NSAIDs such as diclofenac and ibuprofen appear to carry the same excess risk as the newer and more selective coxibs. The interesting finding is that a rather less commonly used NSAID, naproxen, appears to carry no excess risk of heart attack or stroke compared to placebo. This might lead to a review of prescribing advice by some NHS organisations who currently advocate the use of diclofenac and ibuprofen.”

Professor Donald Singer, member of the British Pharmacological Society and Professor of Clinical Pharmacology and Therapeutics at the University of Warwick, said:

“These findings confirm previous reports that newer painkillers – coxibs – are associated with a clinically important increase in risk of coronary disease. A major new finding is that among traditional non-steroidal anti-inflammatory painkiller drugs (tNSAIDs) – diclofenac, and possibly ibuprofen, but not naproxen – appear to be associated with a similar increase in fatal and non-fatal coronary heart events to the coxibs. However naproxen, like all coxibs and tNSAIDs studied, was associated with an increased risk of heart failure and gastro-intestinal complications such as bleeding. The authors themselves acknowledge they cannot be sure whether the reported risks would persist in patients on longer term treatment or on lower doses of these medicines. In addition, the extent of adjustments across treatment groups for different cardiovascular risk factors (e.g. smoking as a source of bias) is not revealed. Despite this, the findings underscore a key point for patients and prescribers: powerful drugs may have serious harmful effects. It is therefore important for prescribers to take into account these risks and ensure patients are fully-informed about the medicines they are taking.”