Evaluation of the population safety of nonsteroidal anti-inflammatory drugs in the framework of the Pan-European SOS program: focus on aceclofenac

Abstract

Since 2008, a group of international experts has been studying the population risk of serious complications of NSAIDs (the Safety Of nonSteroidal anti-inflammatory drugs (SOS) project) as part of the Seventh Framework Program of the European Union for Research and Technological Development (2007–2013). Four large-scale studies assessing the individual risk of gastrointestinal bleeding, heart failure (HF), ischemic stroke (IS), and myocardial infarction (MI) while taking various NSAIDs have been published over the past time. Meta-analysis of 28 population studies has shown that the risk of bleeding is minimal for aceclofenac: the relative risk is 1.43 (95% confidence interval (CI), 0.65–3.15). Analysis of national databases in the Netherlands, Italy, Germany, and the UK has indicated that aceclofenac does not increase the risk of hospitalization for heart failure (odds ratio (OR), 1.03; 95% CI, 0.91–1.15) and MI (OR, 1.04; 95% CI, 0.90–1.19). The risk of IS from the use of aceclofenac is slightly increased (OR, 1.17; 95% CI, 0.98–1.39), but is not statistically significant. Thus, according to the Pan-European SOS program, aceclofenac is characterized by a very low risk of gastrointestinal and cardiovascular events.

Keywords

• nonsteroidal anti-inflammatory drugs
• aceclofenac
• risk of complications
• gastrointestinal bleeding
• heart failure
• ischemic stroke
• myocardial infarction