PMID- 20225990
OWN - NLM
STAT- MEDLINE
DCOM- 20100730
LR  - 20131121
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 26
IP  - 5
DP  - 2010 May
TI  - GOAL: multicenter, open-label, post-marketing study of flavocoxid, a novel dual 
      pathway inhibitor anti-inflammatory agent of botanical origin.
PG  - 1055-63
LID - 10.1185/03007991003694522 [doi]
AB  - OBJECTIVES: GOAL (Gauging Osteoarthritis [OA] with Limbrel*), an open-label, 
      post-marketing study was performed to determine the overall efficacy and 
      gastrointestinal (GI) tolerability of flavocoxid, a novel, plant-based, 
      anti-inflammatory medication, in a 'real world' clinical practice setting. To 
      this end, the study enrolled several unique patient types including nonsteroidal 
      anti-inflammatory drug (NSAID) naive patients, those who had used NSAIDs in the 
      past, regardless of outcome (positive or negative), and those who had previously 
      taken a gastroprotective medication to improve GI tolerability or continued to 
      take it as a precautionary measure to prevent NSAID-associated GI damage. 
      METHODS: A total of 1067 individuals at 41 rheumatology practices were enrolled 
      and prescribed flavocoxid, 500 mg b.i.d., for 60 days. The Physician Global 
      Assessment of Disease (PGAD) visual analog scale (VAS) was used as a global 
      measure to assess the signs and symptoms of OA, including joint discomfort, 
      functional stiffness, functional mobility and quality of life. In addition, 
      overall tolerability and upper GI tolerability were assessed by individual 
      questions scored on a 5-part Likert scale. The physicians also monitored any 
      interruption in, or cessation of use of flavocoxid due to a GI issue as well as 
      changes in the use of gastroprotective medications. Adverse event (AE) monitoring 
      was also conducted. RESULTS: Of the 1005 patients who completed all follow-up 
      visits, physicians recorded an average improvement in VAS scores from 60.1 +/- 
      18.8 at baseline to 42.5 +/- 21.9 at 8 weeks (p < 0.001) in 65.8% of patients. 
      The PGAD VAS noted the most significant improvement in those patients with 
      moderate to severe OA (baseline VAS [0 = least severe, 100 = most severe]: 0-25 
      mm, -3.5 +/- 6.9; 26-50 mm, -10.1 +/- 17.0; 51-75 mm, -19.3 +/- 19.5; 76-100 mm, 
      -29.6 +/- 23.6; p < 0.001) and in those patients who were historically 
      non-responders to NSAIDs (40.3 +/- 21.1 vs. 66.3 +/- 17.7 at baseline; p < 
      0.001). Patients who had previously responded well to NSAIDs had VAS scores of 
      42.6 +/- 19.8 vs. 58.0 +/- 18.0 (p < 0.001) and NSAID naive subjects showed 
      improvement in VAS scores from 60.5 +/- 18.0 at baseline to 46.3 +/- 23.7 (p < 
      0.001). The study recorded a low incidence ( approximately 10%) of AEs reported 
      to physicians and good overall tolerability to flavocoxid. Flavocoxid showed 
      improved upper GI tolerability in almost 50% of previous NSAID users (p < 0.001) 
      and reduced therapy interruption in approximately 90% of previous NSAID users 
      with a history of GI-related therapy interruptions (p < 0.0001). Finally, the use 
      of flavocoxid resulted in a >30% reduction in or cessation of the use of 
      gastroprotective medications such as proton pump inhibitors (PPI) or histamine-2 
      receptor antagonists (H2s) in subjects (p < 0.001). CONCLUSIONS: Within a 'real 
      world' clinical rheumatology practice setting, flavocoxid demonstrated 
      significant efficacy in the management of OA in multiple patient types and 
      displayed significant potential for reducing the possibility of adverse GI 
      side-effects and use of gastroprotective agents associated with more traditional 
      OA medications. A limitation of this study was that it was open-label and not 
      rigorously controlled. The large population may compensate for this lack of 
      control.
FAU - Pillai, Lakshmi
AU  - Pillai L
AD  - Primus Pharmaceuticals, Inc., Scottsdale, AZ85251, USA. pillai@primusrx.com
FAU - Burnett, Bruce P
AU  - Burnett BP
FAU - Levy, Robert M
AU  - Levy RM
CN  - GOAL Study Cooperative Group
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Drug Combinations)
RN  - 0 (flavocoxid)
RN  - 8R1V1STN48 (Catechin)
SB  - IM
MH  - Anti-Inflammatory Agents, Non-Steroidal/adverse effects/*therapeutic use
MH  - Catechin/adverse effects/*therapeutic use
MH  - Drug Combinations
MH  - Gastrointestinal Tract/drug effects
MH  - Humans
MH  - Movement
MH  - Osteoarthritis/*drug therapy/physiopathology
MH  - *Product Surveillance, Postmarketing
MH  - Quality of Life
EDAT- 2010/03/17 06:00
MHDA- 2010/07/31 06:00
CRDT- 2010/03/16 06:00
PHST- 2010/03/16 06:00 [entrez]
PHST- 2010/03/17 06:00 [pubmed]
PHST- 2010/07/31 06:00 [medline]
AID - 10.1185/03007991003694522 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2010 May;26(5):1055-63. doi: 10.1185/03007991003694522.