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Randomized Controlled Trial
. 2020 Jan 27;15(1):e0226184.
doi: 10.1371/journal.pone.0226184. eCollection 2020.

A comparative study of the efficacy of NAXOZOL compared to celecoxib in patients with osteoarthritis

Moon Soo Park  1 , Chang-Nam Kang  2 , Woo-Suk Lee  3 , Ho-Joong Kim  4 , Sahnghoon Lee  5 , Jin Hwan Kim  6 , Sang-Jin Shin  7 , Seong-Hwan Moon  8
Affiliations
Randomized Controlled Trial

A comparative study of the efficacy of NAXOZOL compared to celecoxib in patients with osteoarthritis

Moon Soo Park et al. PLoS One. .

Abstract

Objective: Selective cyclooxygenase-2 inhibitors (celecoxib) can minimize the gastrointestinal complications related to non-steroidal anti-inflammatory drug (NSAID) use. NAXOZOL is a new combination formulation designed to provide sequential delivery of a non-enteric-coated, immediate-release esomeprazole strontium tetrahydrate 20 mg mantle followed by an enteric-coated naproxen 500 mg core. However, there have been no studies comparing NAXOZOL to celecoxib with respect to gastrointestinal tract protection and pain relief in patients with osteoarthritis. This study was undertaken to compare the effects of NAXOZOL and celecoxib with respect to gastrointestinal tract protection and pain relief in patients with osteoarthritis.

Methods: The randomized enrolled patients were divided into two treatment groups: a NAXOZOL group and a celecoxib group. All participants received treatments (NAXOZOL, 500/20 mg (naproxen 500 mg, esomeprazole strontium tetrahydrate 20 mg) twice per day versus celecoxib, 200 mg daily) on a 1:1 allocation basis for 12 weeks. The primary outcome was the Leeds Dyspepsia Questionnaire (LDQ) score used for non-inferiority testing. Secondary outcome measures included the Gastrointestinal Symptom Rating Scale (GSRS) score, Visual Analogue Scale (VAS) score, European Quality of Life-5 dimensions (EQ-5D) scale and the EQ-5D Visual Analogue Scale (EQ VAS). Other outcome measures included the use of supplementary or rescue drugs, and the incidence of adverse events.

Results: The baseline-adjusted LDQ scores immediately after 12 weeks of treatment in NAXOZOL group were not inferior to those in celecoxib group. The overall change in the baseline-adjusted GSRS score, VAS score, EQ-5D, and EQ VAS was not different between the two groups. The usage of supplementary drugs and the drug-related incidence of adverse events were not different. However, the days to use rescue drug were longer in celecoxib group than in NAXOZOL group.

Conclusion: NAXOZOL was not inferior to celecoxib in protecting the gastrointestinal tract and providing pain relief in patients with osteoarthritis.

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Conflict of interest statement

This study was supported by a research fund from Hanmi Pharmaceutical Co., Ltd (grant number HM-IITNAX-001). NAXOZOL(Naproxen, Esomeprazole strontium) was provided by Hanmi Pharmaceutical Co., Ltd. The funder provided support in the form of salaries for authors [MSP, CNK, WSL, HJK, SHL, JHK, SJS, SHM]. NAXOZOL is a combination drug of naproxen and esomeprazole strontium ("esomezol" proved in FDA) as a product marketed in only Korea currently. NAXOZOL was patented in 2013 as it contains esomeprazole strontium developed in Hanmi pharmaceutical company. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. CONSORT flow diagram: enrollment, randomization, assigned interventions, and follow-up of the study participants showing the safety analysis set (SAS), full analysis set (FAS), and per protocol set (PPS).
See this image and copyright information in PMC

References

    1. Patrignani P, Tacconelli S, Bruno A, Sostres C, Lanas A. Managing the adverse effects of nonsteroidal anti-inflammatory drugs. Expert Rev Clin Pharmacol. 2011;4(5):605–21. Epub 2011/11/26. 10.1586/ecp.11.36 . - DOI - PubMed
    1. Lanas A, Hirschowitz BI. Toxicity of NSAIDs in the stomach and duodenum. Eur J Gastroenterol Hepatol. 1999;11(4):375–81. Epub 1999/05/13. 10.1097/00042737-199904000-00003 . - DOI - PubMed
    1. Watson DJ, Harper SE, Zhao PL, Quan H, Bolognese JA, Simon TJ. Gastrointestinal tolerability of the selective cyclooxygenase-2 (COX-2) inhibitor rofecoxib compared with nonselective COX-1 and COX-2 inhibitors in osteoarthritis. Arch Intern Med. 2000;160(19):2998–3003. Epub 2000/10/21. ioi90757 [pii]. 10.1001/archinte.160.19.2998 . - DOI - PubMed
    1. Moore RA, Derry S, Makinson GT, McQuay HJ. Tolerability and adverse events in clinical trials of celecoxib in osteoarthritis and rheumatoid arthritis: systematic review and meta-analysis of information from company clinical trial reports. Arthritis Res Ther. 2005;7(3):R644–65. Epub 2005/05/19. ar1704 [pii] 10.1186/ar1704 - DOI - PMC - PubMed
    1. Hawkey CJ, Jones RH, Yeomans ND, Scheiman JM, Talley NJ, Goldstein JL, et al. Efficacy of esomeprazole for resolution of symptoms of heartburn and acid regurgitation in continuous users of non-steroidal anti-inflammatory drugs. Aliment Pharmacol Ther. 2007;25(7):813–21. Epub 2007/03/22. APT3210 [pii] 10.1111/j.1365-2036.2006.03210.x . - DOI - PubMed

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