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AB0860 A New Safety Meta-Analysis of Ketoprofen VS Ibuprofen and Diclofenac: Risk and Benefit of NON Steroidal Anti-Inflammatory Drugs beyond Efficacy Meta-Analysis
  1. P. Sarzi-Puttini1,
  2. F. Atzeni1,
  3. L. Lanata2,
  4. A. Monguzzi2,
  5. M. Bagnasco2
  1. 1Rheumatology Unit, L.Sacco University Hospital
  2. 2Medical Department, Dompé S.P.A,, Milan, Italy


Background Over the last decades, ketoprofen, ibuprofen and diclofenac have been the most often prescribed drugs in the management of mild-to-moderate pain, chronic inflammatory and degenerative joint diseases.

Objectives The aim of this study was to perform a new meta-analysis of randomised controlled trials (RCTs) in order to compare the safety of oral ketoprofen with that of ibuprofen and/or diclofenac therefore obtaining complete risk/benefit profiles of these drugs.

Methods A systematic literature search was performed on main databases (Medline, Cochrane Central and Embase) until July 2013 to identify RCTs comparing directly therapeutic doses of oral ketoprofen (50-200 mg/day) vs ibuprofen (600-1800 mg/day) or diclofenac (75-150 mg/day). in accordance with the Cochrane Collaboration guideline, two rheumatologists carried out independently study selection.

Results A total of 10 RCTs involving 843 patients met the inclusion criteria: six comparing ketoprofen vs ibuprofen and four comparing ketoprofen vs diclofenac. 6 of the 10 RCTs included 493 patients with systemic rheumatic diseases such as RA, OA, ankylosing spondylitis (AS), low back pain or painful shoulder. Treatments based on oral administration of ketoprofen showed a RR (Risk Ratio) of 1.02 of developing an adverse event (AE) vs treatments based on diclofenac or ibuprofen, even though there was no statistical significance in this result (P=0.91, 95% CI 0.78, 1.33). The difference between rates of AEs (Risk difference) with the three molecules was equal to 0 (P=0.91, 95% CI -0.05, 0.05), and no serious AE was observed. Moreover, there was no difference across the studies in the heterogeneity test for the safety outcome (χ2=9.07 - df=9 - P=0.43, I2 =1%), demonstrating homogeneity of trials and reliability of meta-analysis results.

Conclusions Taken together, the results of this meta-analysis show that ketoprofen is well tolerated and its safety profile is comparable to ibuprofen and diclofenac, with no serious AE observed. Therefore, these data on oral ketoprofen support its recommendation in clinical practice.


  1. Sarzi-Puttini P, et al. Efficacy of ketoprofen vs ibuprofen and diclofenac: a systematic review of the literature and meta-analysis. Clin Exp Rheumatol. 2013;31:731-8

Disclosure of Interest P. Sarzi-Puttini Grant/research support: He received a restritcted grant for study, F. Atzeni: None declared, L. Lanata Employee of: Dompe'SpA, A. Monguzzi Employee of: Dompe' SpA, M. Bagnasco Employee of: Dompe' SpA

DOI 10.1136/annrheumdis-2014-eular.3690

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