BACKGROUND: The European Commission funded the Safety Of non-Steroidal anti-inflammatory drugs (SOS) project to assess the cardiovascular and gastrointestinal safety of individual nonsteroidal anti-inflammatory drugs (NSAIDs).
OBJECTIVES: To perform a systematic review of observational studies evaluating the use of individual NSAIDs and the risk of heart failure (HF).
METHODS: A systematic search of studies published from 1990 to 2012 identified 8 observational studies of the risk of HF associated with individual NSAID use. Relative risks (RRs) of current use compared with nonuse were estimated using fixed- and random-effects models.
RESULTS: Six studies evaluated the risk of incident HF, mainly identified by hospitalizations, and 1 study included all types of HF hospitalizations; of these, six studies provided RRs associated with current use for our main analysis. For NSAIDs with at least three independent estimates, the summary RRs (95% confidence intervals [CIs]) were 0.91 (0.71–1.16) for celecoxib, 1.53 (1.09–2.15) for naproxen, and 1.73 (1.45–2.06) for rofecoxib. For NSAIDs with two independent estimates, the RRs (95% CIs) were 1.09 (0.83–1.44) for diclofenac, 1.46 (1.12–1.90) for ibuprofen, 1.57 (0.79– 3.11) for piroxicam, 1.73 (0.81–3.71) for ketoprofen, and 3.39 (1.89–6.09) for indometacin. Fixed and random estimates were almost identical. No data were available on dose or duration. In a single study estimating the risk of recurrent HF hospitalization and all-cause mortality associated with current use compared with nonuse of individual NSAIDs, naproxen, © 2013 The Authors Pharmacoepidemiology and Drug Safety © 2013 John Wiley & Sons, Ltd. ABSTRACTS OF THE 29TH ICPE 2013 67 ibuprofen, diclofenac, celecoxib, and rofecoxib were associated with a high risk of recurrent HF and death. Only rofecoxib was associated with a dose-dependent increase in HF risk, with RRs (95% CIs) of 1.33 (1.20–1.49) for doses of ≤ 25 mg/day and 1.86 (1.46– 2.35) for doses > 25 mg/day.
CONCLUSIONS: Summary estimates from few published observational studies suggest variability in the risk of HF for the most frequently used NSAIDs, with the lowest estimate for current use of celecoxib and the highest for indometacin as compared with nonuse of NSAIDs.
