PMID- 20845002
OWN - NLM
STAT- MEDLINE
DCOM- 20110128
LR  - 20240109
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Linking)
VI  - 27
IP  - 10
DP  - 2010 Oct
TI  - Efficacy and safety of flavocoxid, a novel therapeutic, compared with naproxen: a 
      randomized multicenter controlled trial in subjects with osteoarthritis of the 
      knee.
PG  - 731-42
LID - 10.1007/s12325-010-0064-z [doi]
AB  - 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.
FAU - Levy, Robert M
AU  - Levy RM
AD  - Primus Pharmaceuticals, Inc., Scottsdale, AZ 85251, USA. rlevy@primusrx.com
FAU - Khokhlov, Alexander
AU  - Khokhlov A
FAU - Kopenkin, Sergey
AU  - Kopenkin S
FAU - Bart, Boris
AU  - Bart B
FAU - Ermolova, Tatiana
AU  - Ermolova T
FAU - Kantemirova, Raiasa
AU  - Kantemirova R
FAU - Mazurov, Vadim
AU  - Mazurov V
FAU - Bell, Marjorie
AU  - Bell M
FAU - Caldron, Paul
AU  - Caldron P
FAU - Pillai, Lakshmi
AU  - Pillai L
FAU - Burnett, Bruce P
AU  - Burnett BP
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20100915
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Cyclooxygenase Inhibitors)
RN  - 0 (Drug Combinations)
RN  - 0 (Lipoxygenase Inhibitors)
RN  - 0 (flavocoxid)
RN  - 57Y76R9ATQ (Naproxen)
RN  - 8R1V1STN48 (Catechin)
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anti-Inflammatory Agents, Non-Steroidal/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Catechin/administration & dosage/adverse effects/*therapeutic use
MH  - Cyclooxygenase Inhibitors/therapeutic use
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Female
MH  - Gastrointestinal Diseases/chemically induced
MH  - Humans
MH  - Lipoxygenase Inhibitors/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Naproxen/administration & dosage/adverse effects/*therapeutic use
MH  - Osteoarthritis, Knee/*drug therapy
MH  - Respiratory Tract Diseases/chemically induced
EDAT- 2010/09/17 06:00
MHDA- 2011/02/01 06:00
CRDT- 2010/09/17 06:00
PHST- 2010/07/09 00:00 [received]
PHST- 2010/09/17 06:00 [entrez]
PHST- 2010/09/17 06:00 [pubmed]
PHST- 2011/02/01 06:00 [medline]
AID - 10.1007/s12325-010-0064-z [doi]
PST - ppublish
SO  - Adv Ther. 2010 Oct;27(10):731-42. doi: 10.1007/s12325-010-0064-z. Epub 2010 Sep 
      15.