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

Moon Soo Park, Chang Nam Kang, Woo Suk Lee, Ho Joong Kim, Sahnghoon Lee, Jin Hwan Kim, Sang Jin Shin, Seong Hwan Moon

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Article numbere0226184
JournalPloS one
Volume15
Issue number1
DOIs
Publication statusPublished - 2020 Jan 1

Bibliographical note

Funding Information:
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], but did not have any additional role in the study design, data collection, and analysis, decision to publish, or preparation of the manuscript. The funder was not involved in any part of the trial implementation or data analysis. The specific roles of these authors are articulated in the ?author contributions? section. Competing Interests: 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. Financial Disclosure: This study was supported by a research fund from Hanmi Pharmaceutical Co., Ltd (grant number HM-IIT-NAX-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], but did not have any additional role in the study design, data collection, and analysis, decision to publish, or preparation of the manuscript. The funder was not involved in any part of the trial implementation or data analysis. The specific roles of these authors are articulated in the ?author contributions? section. The authors wish to thank Dr. Young-Hoon Kim (Department of Orthopedic Surgery, Seoul St. Mary?s Hospital, Catholic University of Korea College of Medicine), Dr. Ho Seong Lee (Department of Orthopedic Surgery, Asan Medical Center, Ulsan University College of Medicine), Dr. Sung Shik Kang (Department of Orthopaedic Surgery, Busan Bumin Hospital, Affiliation Hospital of Catholic Kwandong University College of Medicine) and Dr. Hyuk-Soo Han (Department of Orthopedic Surgery, Seoul National University College of Medicine) for their assistance in obtaining the research data.

Publisher Copyright:
© 2020 Park et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

All Science Journal Classification (ASJC) codes

  • General

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