- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Common NSAIDs May Increase Risk of Heart Attacks
Researchers find small but significant risk with high-dose diclofenac and ibuprofen (May 30)
Prolonged use of some widely used painkillers increases the risk of heart attacks by a small but significant amount, an international study led by Oxford University researchers has found.
Professor Colin Baigent helmed the research on nonsteroidal anti-inflammatory drugs (NSAIDs). He said: “The research shows that, when used in high doses, diclofenac and ibuprofen increase the risk of cardiovascular disease, on average causing about three extra heart attacks a year in every 1,000 patients treated, one of which would be fatal.
“We would emphasize that the risks are mainly relevant to people with arthritis who need to take high doses over a long period. A short course of lower-dose tablets purchased without a prescription — for example, for a muscle sprain — is not likely to be hazardous.”
The new research was published in The Lancet.
The study found that high doses of diclofenac and ibuprofen increased the risk of a major vascular event (i.e., heart attack, stroke, or dying from cardiovascular disease) by about one-third. Most of this additional risk was due to an increased risk of heart attacks.
In contrast, high doses of naproxen did not appear to increase the risk of heart attacks. The researchers say this may be because naproxen also has protective effects that balance out any extra risk of heart attacks.
The researchers gathered the results of 639 randomized trials involving more than 350,000 subjects, and re-analyzed the data to predict the magnitude of the adverse effects of NSAIDs in particular types of patients.
The availability of detailed data from so many studies allowed the researchers to predict accurately the size of any increased risk of heart attacks and ulcer bleeding in certain patients, including those at increased risk of such adverse effects.
Importantly, the increased risk of heart attacks from individual NSAIDs seemed to be proportional to a patient’s underlying risk of such heart attacks, so that the risk was highest in those with a previous history of heart disease or in those with cardiac risk factors, such as hypertension or high cholesterol.
The research also showed that the risks of ulcer bleeding were increased by two- to four-fold, depending on the NSAID regimen, but the consequences of such bleeding were not usually serious.
Source: Oxford University; May 30, 2013.