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Advances in Therapy

, Volume 27, Issue 10, pp 731–742 | Cite as

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

  • Robert M. LevyEmail author
  • Alexander Khokhlov
  • Sergey Kopenkin
  • Boris Bart
  • Tatiana Ermolova
  • Raiasa Kantemirova
  • Vadim Mazurov
  • Marjorie Bell
  • Paul Caldron
  • Lakshmi Pillai
  • Bruce P. Burnett
Original Research

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.

Keywords

5-lipoxygenase clinical trial cyclooxygenase flavocoxid, flavonoids naproxen osteoarthritis 

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Copyright information

© Springer Healthcare 2010

Authors and Affiliations

  • Robert M. Levy
    • 1
    Email author
  • Alexander Khokhlov
    • 2
  • Sergey Kopenkin
    • 3
  • Boris Bart
    • 4
  • Tatiana Ermolova
    • 5
  • Raiasa Kantemirova
    • 6
  • Vadim Mazurov
    • 7
  • Marjorie Bell
    • 8
  • Paul Caldron
    • 9
  • Lakshmi Pillai
    • 1
  • Bruce P. Burnett
    • 1
  1. 1.Primus Pharmaceuticals, Inc.ScottsdaleUSA
  2. 2.Yaraslavl State Medical AcademyYaraslavlRussia
  3. 3.Russian State Medical UniversityMoscowRussia
  4. 4.Russian State Medical University Federal Agency of Health Care and Social DevelopmentMoscowRussia
  5. 5.St. Petersburg Medical Academy of Postgraduate StudiesSt. PetersburgRussia
  6. 6.Federal State Institute St. Petersburg Scientific and Practical Center of Medical and Social ExpertiseSt. PetersburgRussia
  7. 7.St. Petersburg Medical Academy of Postgraduate StudiesSt. PetersburgRussia
  8. 8.ClinDataServicesBloomingtonUSA
  9. 9.Arizona Arthritis and Rheumatology ResearchScottsdaleUSA

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