GOAL: multicenter, open-label, post-marketing study of flavocoxid, a novel dual pathway inhibitor anti-inflammatory agent of botanical origin
GOAL: multicenter, open-label, post-marketing study of flavocoxid, a novel dual pathway inhibitor anti-inflammatory agent of botanical origin
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DOI：
10.1185/03007991003694522
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发表时间：
2010-05-01
影响因子：
2.3
通讯作者：
Levy, Robert M.
中科院分区：
文献类型：
--
作者：
Pillai, Lakshmi;Burnett, Bruce P.;Levy, Robert M.
目的：我们开展了一项开放标签的上市后研究--Goal(用Limbrel*测量骨关节炎)，以确定黄曲霉毒素的总体疗效和胃肠道(GI)耐受性，这是一种新型的植物性抗炎药物，在“真实世界”的临床实践环境中。为此，这项研究招募了几种独特的患者类型，包括非类固醇抗炎药(NSAID)的幼稚患者，那些过去曾使用非类固醇抗炎药的患者，无论结果是阳性还是阴性，以及那些以前服用过胃保护药物以改善GI耐受性或继续服用它作为预防措施以防止NSAID相关的GI损害的患者。方法：总共有1067名患者在41个风湿科诊所接受了为期60天的黄曲霉毒素500 mg，每天2次的处方。使用医生全球疾病评估量表(PGAD)视觉模拟评分(VAS)作为评估关节不适、功能僵硬、功能活动度和生活质量的指标。此外，总体耐受性和上消化道耐受性通过5部分Likert量表上的个别问题评分来评估。医生还监测了由于胃肠道问题而导致的黄曲霉毒素的任何中断或停止使用，以及胃保护药物的使用变化。结果：在完成所有随访的1005例患者中，医生记录的VAS评分从基线的60.1+/-18.8分平均改善到8周时的42.5+/-21.9分(P
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