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The safety and efficacy of Guluronic acid (G2013) in ankylosing spondylitis: A randomized controlled parallel clinical trial

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Abstract

Background

To assess the therapeutic efficacy, safety and tolerability of Guluronic acid (G2013) in patients with ankylosing spondylitis (AS) patients.

Methods

This investigation was a 12-week randomized, placebo-controlled, phase I/II clinical trial involving 75 AS patients that were randomly divided into 3 groups: 25 as placebo, 25 Guluronic acid and 25 naproxen groups. Patients who had AS with active disease at baseline according to the modified New York criteria were considered for this trial. The primary consequence measure was the Appraisement of Spondyloarthritis International Society (ASAS) 20 response-rate at week 12.

Results

There were no statistically significant differences between groups at the entry. ASAS20 response at week 12 was achieved (60.8%) in patients receiving Guluronic acid compared with — (68.4% of) — patients in the naproxen group (p > 0.05) and (21.0%) of patients in the placebo group. In comparison with the placebo group from the baseline to week 12, patients who received Guluronic acid and naproxen showed significantly greater improvement in all secondary endpoints. Moreover, Guluronic acid decreased some inflammatory parameters more dramatically than naproxen and placebo group. Patients in the naproxen group had more incidence of gastrointestinal and others adverse events in comparison with Guluronic acid and placebo groups.

Conclusion

The present research indicated that Guluronic acid and naproxen are similar in terms of efficacy. However, Guluronic acid had more notable safety characteristics identifying information than naproxen. Accordingly, it is proposed that Guluronic acid could be appropriate for management of AS.

Clinical trial identifier; IRCT2016091813739N4.

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Authors and Affiliations

  1. Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran

    Sepideh Nazeri, Shahin Khadem Azarian, Sanaz Afraei & Abbas Mirshafiey

  2. Rheumatology Research Center, Shariati Hospital, Tehran University of Medical Science, Tehran, Iran

    Ahmad Reza Jamshidi, Mahdi Mahmoudi, Mahdi Vojdanian & Shayan Mostafaei

  3. Department of Community Medicine, Faculty of Medicine, Kermanshah University of medical Sciences, Kermanshah, Iran

    Shayan Mostafaei

  4. Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran

    Mostafa Hosseini

Authors
  1. Sepideh Nazeri
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  2. Ahmad Reza Jamshidi
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  3. Mahdi Mahmoudi
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  4. Mahdi Vojdanian
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  5. Shahin Khadem Azarian
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  6. Sanaz Afraei
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  7. Shayan Mostafaei
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  8. Mostafa Hosseini
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  9. Abbas Mirshafiey
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Corresponding authors

Correspondence to Ahmad Reza Jamshidi or Abbas Mirshafiey.

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Nazeri, S., Jamshidi, A.R., Mahmoudi, M. et al. The safety and efficacy of Guluronic acid (G2013) in ankylosing spondylitis: A randomized controlled parallel clinical trial. Pharmacol. Rep 71, 393–398 (2019). https://doi.org/10.1016/j.pharep.2019.02.002

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  • DOI: https://doi.org/10.1016/j.pharep.2019.02.002

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