Riera-Guardia N, Hirst C, Castellsague J, Varas-Lorenzo C, Pariente A, Sturkenboom MCJM, Perez-Gutthann S. The SOS project: cardiovascular and gastrointestinal safety of NSAIDS. Preliminary results of a systematic review of epidemiological studies. Poster presented at the 25th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 2009. Providence, RI. [abstract] Pharmacoepidemiol Drug Saf. 2009 Aug 16; 18(Suppl 1):S207.

BACKGROUND: In 2008 the European Commission funded the Safety Of non-Steroidal anti-inflammatory drugs (SOS) collaborative project to develop a population-based decision model for treatment and regulatory decision-making regarding the use of NSAIDs.

OBJECTIVES: To review published meta-analyses and individual epidemiological studies on the use of individual NSAIDs and the risk of CV and GI events to identify gaps in research.

METHODS: Systematic search of epidemiological studies included in Medline and manual review of references from articles retrieved. Articles for inclusion were restricted to English language and published between 1980 and 2008. As a first stage, all meta-analyses reporting data on individual NSAIDs were identified and reviewed.

RESULTS: We identified five meta-analyses on CV events and individual NSAIDs. Four were focused on myocardial infarction (MI), and one on the combination of MI and stroke. Selective COX-2 inhibitors were included in three meta-analyses. The pooled effect of dose was assessed for rofecoxib in one meta-analysis. None provided pooled estimates for duration of use. No meta-analyses were identified for stroke or heart failure. We identified four meta-analysis on the risk of GI events and individual NSAIDs. The NSAIDs with the largest number of studies included in the meta-analyses were indomethacin, ibuprofen, piroxicam, naproxen, and diclofenac. The pooled effect of dose was only available for these NSAIDs. No summary results were identified for individual NSAIDs for duration of use and for groups at high risk of GI events. No meta-analyses were identified for COX-2 inhibitors.

CONCLUSIONS: These results support the need for further data and meta-analyses to assess the CV and GI safety of individual NSAIDs. The meta-analysis of observational studies is ongoing.

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