European Journal of Heart Failure Advance Access originally published online on April 19, 2009
European Journal of Heart Failure 2009 11(6):542-550; doi:10.1093/eurjhf/hfp054
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Baseline factors associated with congestive heart failure in patients receiving etoricoxib or diclofenac: multivariate analysis of the MEDAL program
1 Department of Epidemiology and Preventive Medicine, NHMRC Centre of Clinical Research Excellence in Therapeutics, Monash University, Alfred Hospital, Melbourne Vic 3004, Australia
2 Merck Research Laboratories, Rahway, NJ, USA
3 Division of Nephrology, University of Maryland School of Medicine, Baltimore, MD, USA
4 Department of Medicine, University of Southern California, Keck School of Medicine, Los Angeles, CA, USA
5 Indiana University School of Medicine, Indianapolis, IN, USA
6 TIMI Study Group, Brigham and Women’s Hospital, Boston, MA, USA
* Corresponding author. Tel: +61 3 9903 0042, Fax: +61 3 9903 0556, Email: henry.krum{at}med.monash.edu.au
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Abstract |
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Aims: Non-steroidal anti-inflammatory drugs have been associated with increased risk of congestive heart failure (CHF). We aimed to assess the impact of treatment with etoricoxib or diclofenac on risk of CHF relative to baseline risk factors.
Methods and results: We performed a multivariate analysis of 34 701 patients with arthritis receiving etoricoxib 60 or 90 mg, or diclofenac 150 mg, daily for a mean of 18 months, to assess the incidence of confirmed, adjudicated CHF events resulting in emergency room visit or hospitalization. Analyses were performed using a Cox proportional hazard model to evaluate the hazard ratio (HR) between the levels of each risk marker for the incidence of CHF. Significant risk markers included history of CHF (HR: 6.69, 95% CI 3.59–12.47; P <0.0001), age 
65 years (2.56, 1.65–3.98; P <0.0001), and history of hypertension (1.83, 1.16–2.89; P = 0.0094) or diabetes (1.83, 1.15–2.94; P = 0.0116). Etoricoxib vs. diclofenac was a significant risk factor only when pooling the etoricoxib 90 mg cohorts (1.88; 1.13–3.10; P = 0.0143). Etoricoxib 60 mg did not significantly increase risk vs. diclofenac.
Conclusion: History of CHF was highly associated with risk for CHF hospitalization. Hypertension, diabetes, and older age also increased risk modestly. There appeared to be a dose-related increase in CHF with etoricoxib compared with diclofenac, which reached statistical significance when the etoricoxib 90 mg groups (osteoarthritis and rheumatoid arthritis) were pooled.
(Clinicaltrials.gov: NCT00092703 [ClinicalTrials.gov] , NCT00092742 [ClinicalTrials.gov] , NCT00250445 [ClinicalTrials.gov] ).
Key Words: Congestive heart failure • Diclofenac • Etoricoxib • Non-steroidal anti-inflammatory drugs • NSAIDs • Risk
Received October 23, 2008; Revised February 20, 2009; Accepted March 9, 2009