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Efficacy and safety of flavocoxid, a novel therapeutic, compared with naproxen: a randomized multicenter controlled trial in subjects with osteoarthritis of the knee

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Abstract

Introduction

Flavocoxid is a novel flavonoid-based “dual inhibitor” of the 5-lipoxygenase (5-LOX) enzyme and the cyclooxygenase (COX) enzymes. This study was designed to compare the effectiveness and safety of flavocoxid to naproxen in subjects with moderate to severe osteoarthritis (OA) of the knee.

Methods

In this randomized, multicenter, double-blind study, 220 subjects were assigned to receive either flavocoxid (500 mg twice daily) or naproxen (500 mg twice daily) for 12 weeks. The trial was structured to show noninferiority of flavocoxid to naproxen. Primary outcome measures included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and subscales and a timed walk.

Results

More than 90% of the subjects in both groups noted significant reduction in the signs and symptoms of knee OA. There were no statistically significant differences in efficacy between the flavocoxid and naproxen groups when the entire intent-to-treat population was analyzed. The flavocoxid group had significantly fewer upper gastrointestinal (UGI) and renal (edema) adverse events (AEs) as well as a strong trend toward fewer respiratory AEs.

Conclusion

Flavocoxid, a first-in-class flavonoid-based therapeutic that inhibits COX-1 and COX-2 as well as 5-LOX, was as effective as naproxen in managing the signs and symptoms of OA of the knee. Flavocoxid demonstrated better UGI, renal (edema), and respiratory safety profiles than naproxen.

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Authors and Affiliations

  1. Primus Pharmaceuticals, Inc., 4725 N. Scottsdale Road, Suite 200, Scottsdale, AZ, 85251, USA

    Robert M. Levy, Lakshmi Pillai & Bruce P. Burnett

  2. Yaraslavl State Medical Academy, Yaraslavl, Russia

    Alexander Khokhlov

  3. Russian State Medical University, Moscow, Russia

    Sergey Kopenkin

  4. Russian State Medical University Federal Agency of Health Care and Social Development, Moscow, Russia

    Boris Bart

  5. St. Petersburg Medical Academy of Postgraduate Studies, St. Petersburg, Russia

    Tatiana Ermolova

  6. Federal State Institute St. Petersburg Scientific and Practical Center of Medical and Social Expertise, St. Petersburg, Russia

    Raiasa Kantemirova

  7. St. Petersburg Medical Academy of Postgraduate Studies, St. Petersburg, Russia

    Vadim Mazurov

  8. ClinDataServices, Bloomington, IN, USA

    Marjorie Bell

  9. Arizona Arthritis and Rheumatology Research, Scottsdale, AZ, USA

    Paul Caldron

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  1. Robert M. Levy
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  10. Lakshmi Pillai
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Correspondence to Robert M. Levy.

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Levy, R.M., Khokhlov, A., Kopenkin, S. et al. Efficacy and safety of flavocoxid, a novel therapeutic, compared with naproxen: a randomized multicenter controlled trial in subjects with osteoarthritis of the knee. Adv Therapy 27, 731–742 (2010). https://doi.org/10.1007/s12325-010-0064-z

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  • DOI: https://doi.org/10.1007/s12325-010-0064-z

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