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Efficacy of Ketoprofen Vs. Ibuprofen and Diclofenac: a Systematic Review of the Literature and Meta-Analysis P

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Efficacy of Ketoprofen Vs. Ibuprofen and Diclofenac: a Systematic Review of the Literature and Meta-Analysis P Efficacy of ketoprofen vs. ibuprofen and diclofenac: a systematic review of the literature and meta-analysis P. Sarzi-Puttini1, F. Atzeni1, L. Lanata2, M. Bagnasco2 1Rheumatology Unit, L. Sacco University Hospital, Milan, Italy; 2Medical Department, Dompé SpA, Milan, Italy. Abstract Objective The aim of this systematic review of the literature and meta-analysis of randomised controlled trials (RCTs) was to compare the efficacy of orally administered ketoprofen with that of ibuprofen and/or diclofenac. Methods The literature was systematically reviewed in accordance with the Cochrane Collaboration guidelines. The search was restricted to randomised clinical trials published in the Medline and Embase databases up to June 2011, and comparing the efficacy of oral ketoprofen (50–200 mg/day) with ibuprofen (600-1800 mg/day) or diclofenac (75–150 mg/day). Results A total of 13 RCTs involving 898 patients met the inclusion criteria: eight comparing ketoprofen with ibuprofen, and five comparing ketoprofen with diclofenac. The results of the meta-analysis showed a statistically significant difference in efficacy in favour of ketoprofen. The difference between ketoprofen and the pooled ibuprofen/diclofenac data was also statistically significant (0.459, 95% CI 0.33-0.58; p=0.00) at all point-estimates of the mean weighted size effect. Ketoprofen was significantly superior to both diclofenac (mean = 0.422; 95% CI 0.19-0.65; p=0.0007) and ibuprofen (mean = 0.475; 95% CI 0.32-0.62; p=0.0000) at all point-estimates. Heterogeneity for the analysed efficacy outcome was not statisically significant in any of the meta-analyses. Conclusion The efficacy of orally administered ketoprofen in relieving moderate-severe pain and improving functional status and general condition was significantly better than that of ibuprofen and/or diclofenac. Key words ketoprofen, diclofenac, ibuprofen, efficacy Clinical and Experimental Rheumatology 2013; 31: 731-738. Meta-analysis of ketoprofen efficacy / P. Sarzi-Puttini et al. Piercarlo Sarzi-Puttini, MD, Introduction followed to guarantee the homogeneity Fabiola Atzeni, MD, PhD, The management of mild-to-moderate between studies and to lower the risk of Luigi Lanata, MD, pain has traditionally been based on the bias. Michela Bagnasco, PhD use of non-steroidal anti-inflammatory The aim of this systematic literature re- Please address correspondence to: Pier- drugs (NSAIDs) and the synthetic non- view and meta-analysis of RCTs was to carlo Sarzi-Puttini, MD, opioid analgesic paracetamol (acetami- compare the pain relieving efficacy of Dipartimento di Reumatologia, Ospedale Universitario L. Sacco, nophen), both of which are effective, ketoprofen with that of ibuprofen and Via G.B. Grassi 74, widely recommended, and extensively diclofenac. 20127 Milano, Italy. used (1). Among the NSAIDs, keto- E-mail: [email protected] profen, ibuprofen and diclofenac have Methods Received on December 7, 2012; accepted been used for the last 30 years (1-3). The meta-analysis was designed and in revised form on March 18, 2013. Ketoprofen is potent and effective in performed in accordance to the PRIS- © Copyright CLINICAL AND relieving pain due to traumatic, ortho- MA (Preferred Reporting Items for EXPERIMENTAL RHEUMATOLOGY 2013. pedic and rheumatic disorders because Systematic Reviews and Meta-Analy- of its anti-inflammatory and analgesic ses) statement (10). properties (1). Its main mechanism of analgesic action is the inhibition of cy- Literature search clo-oxygenase (COX), which decreas- A systematic search was made of the es the production of prostaglandin E2 Medline and Embase electronic data- (PGE2), but it also inhibits the lipoxy- bases up to June 2011 in order to iden- genase pathway of the arachidonic acid tify clinical trials comparing ketoprofen cascade (4), thus decreasing leukot- with ibuprofen or diclofenac following riene synthesis. Furthermore, like other a previously defined protocol. No geo- NSAIDs, it has both peripheral and graphical neither language limits were central sites of activity (5) as a result of applied. The search was extended to inhibiting central prostaglandin biosyn- grey literature sources, such as abstract thesis (6, 7) by inhibiting brain COX from Annual Scientific Meetings of and nitric oxide synthase. It has been the American College od Rheumatol- shown that the analgesic efficacy of ogy (ACR) congress, European League its oral administration to patients with Against Rheumatism (EULAR) con- chronic rheumatic diseases such as os- gress from 2009 to 2011, non peer re- teoarthritis (OA) and rheumatoid arthri- view or unpublished randomised trials. tis (RA) is greater than that of naproxen The databases were searched using or acetylisalycilic acid. A comparative various combinations of the key words: multicentre study evaluating the ef- “clinical trial”, “ibuprofen”, “Brufen”, ficacy and tolerability of ketoprofen “diclofenac” “Voltaren”, “Orudis”, and diclofenac sodium in subjects with “OKi” and “ketoprofen”. acute rheumatic and traumatic condi- We applied inclusion and exclusion cri- tions showed an improvement in pain teria by subquestions and designs. All symptoms, with complete pain relief PRISMA steps were followed, includ- being observed in 25% of the patients ing checklist (data not shown). treated with ketoprofen as against 10% of those treated with diclofenac (8). An Study selection interesting multicentre, double-blind All selected titles and abstracts were study of 165 patients with traumatic independently reviewed by two rheu- pain-related sports injuries compared matologists (PCSP and FA) in accord- the analgesic efficacy of one week’s ance with the Cochrane Collaboration treatment with ketoprofen (50 mg/b.i.d. guidelines (11). per os) or ibuprofen (600 mg/b.i.d per The inclusion criteria used to select the os), and found that 50% pain relief was studies were established a priori and in- Funding: this study was supported by an achieved by more of the patients treated cluded prospective RCTs involving pa- unrestricted grant from Dompé SpA, Italy. Dompé SpA played had no role in the study with ketoprofen (76% vs. 58%; p<0.05) tients aged >18 years that compared the design, literature search, data collection, and in a shorter time (9). clinical efficacy of oral ketoprofen in data analysis, or data interpretation. In our meta-analysis we decided to in- treating moderate-severe pain with that Competing interests: All the authors have clude only trials comparing directly of oral ibuprofen or diclofenac, with or received consultancy fees or Congress ketoprofen with ibuprofen and/or di- without a placebo control group. invitations from Dompé. clofenac; this approach was actually Furthermore, in order to guarantee the 732 Meta-analysis of ketoprofen efficacy / P. Sarzi-Puttini et al. adherence to therapeutic doses and the homogeneity of the effect sizes, we only included trials in which ketopro- fen, ibuprofen and diclofenac were used at daily doses within the respec- tive therapeutical ranges of 50-200 mg/ day, 600-1800 mg/day, and 75-150 mg/ day. These doses are in accordance with the posology recommended in clinical practice for the treatment of moderate to severe pain. The clinical trials that did not concen- trate on efficacy were excluded, as were those that did not directly compare ke- toprofen with diclofenac or ibuprofen, those which compared ketoprofen with diclofenac or ibuprofen combined with a narcotic or non-narcotic agent, those in which the NSAIDs were not admin- istered orally or administred at daily doses outside the specified therapeuti- cal ranges. Retrospective studies were excluded to minimise heterogeneity, and no consideration was given to re- Fig. 1. Flow chart of the selection process. views, letters, editorials, conference pa- pers, case reports, basic science papers tion, allocation concealment, incom- (0–4 point scale), pain (0-20 point or clinical practice guidelines. plete outcome data, selective outcome scale), pain (1-5 point scale), pain re- Initially, the titles and/or abstracts of all reporting, blinding of participants and lief (0–4 point scale), responders (pain of the identified trials were reviewed personnel and blinding of outcome as- relief score >2: i.e. 50% pain relief), independently by two of the authors. sessment (11). These items were con- total symptom rating score (0–4 point This was followed by a second review sidered as key domains for RoB assess- scale), joint index, and the percentage of the eligible full-text publications ment and classified as ‘‘adequate’’ (low of improved patients vs. the percentage using a recognised method of positive risk of bias), ‘‘inadequate’’ (high risk of unimproved patients. inclusion. Disagreements regarding the of bias), or ‘‘unclear’’. Studies with ad- inclusion of articles were resolved by equate procedures in all domains were Statistical analysis discussions involving all of the authors. considered to have a low risk of bias; The meta-analysis was made using the ones with inadequate procedures in standardised mean differences (SMD) Study quality assessment and one or more key domain(s) were con- of each RCT. The weighted mean dif- risk of bias in included studies sidered to have a high risk of bias; and ference and the 95% confidence interval The quality of the selected publica- ones with unclear procedures in one or (95% CI) were obtained by the combin- tions was assessed using Jadad’s RCT more key domain(s) were considered ing standardised mean differences us- assessment scale (12), which assesses to have an unclear risk of bias. ing a fixed effects model. The statisti- blinding, randomisation and dropouts/ cal heterogeneity of the standardised withdrawn patients. The scale scores Data extraction and outcome mean differences was assessed using range from 0 to 5, with higher scores definition Cochrane’s Q statistic, which shows the indicating less likelihood of bias in The data were extracted using a pre- variation across studies due to hetero- the results and a score of ≥3 indicat- defined data extraction form. The ex- geneity and can be used to assess the ing high quality. However, we also tracted information included first au- consistency of the evidence (13-15).
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