Primus Pharmaceuticals, 4725 N. Scottsdale Road, Scottsdale, AZ 85251, USA.
Adv Ther. 2010 Dec;27(12):953-62. doi: 10.1007/s12325-010-0083-9. Epub 2010 Oct 21.
twice-daily flavocoxid, a cyclooxygenase and 5-lipoxygenase inhibitor with potent antioxidant activity of botanical origin, was evaluated for 12 weeks in a randomized, double-blind, active-comparator study against naproxen in 220 subjects with moderate-severe osteoarthritis (OA) of the knee. As previously reported, both groups noted a significant reduction in the signs and symptoms of OA with no detectable differences in efficacy between the groups when the entire intent-to-treat population was considered. This post-hoc analysis compares the efficacy of flavocoxid to naproxen in different subsets of patients, specifically those related to age, gender, and disease severity as reported at baseline for individual response parameters.
in the original randomized, double-blind study, 220 subjects were assigned to receive either flavocoxid (500 mg twice daily) or naproxen (500 mg twice daily) for 12 weeks. In this subgroup analysis, primary outcome measures including the Western Ontario and McMaster Universities OA index and subscales, timed walk, and secondary efficacy variables, including investigator global assessment for disease and global response to treatment, subject visual analog scale for discomfort, overall disease activity, global response to treatment, index joint tenderness and mobility, were evaluated for differing trends between the study groups.
subset analyses revealed some statistically significant differences and some notable trends in favor of the flavocoxid group. These trends became stronger the longer the subjects continued on therapy. These observations were specifically noted in older subjects (>60 years), males and in subjects with milder disease, particularly those with lower subject global assessment of disease activity and investigator global assessment for disease and faster walking times at baseline.
initial analysis of the entire intent-to-treat population revealed that flavocoxid was as effective as naproxen in managing the signs and symptoms of OA of the knee. Detailed analyses of subject subsets demonstrated distinct trends in favor of flavocoxid for specific groups of subjects.
每日两次使用 flavocoxid（一种具有强大抗氧化活性的植物源性环氧化酶和 5-脂氧合酶抑制剂），对 220 例中重度膝关节骨关节炎（OA）患者进行为期 12 周的随机、双盲、阳性对照研究，以评估其疗效。与萘普生相比，此前的研究结果显示，两组患者的 OA 体征和症状均显著减轻，当考虑整个意向治疗人群时，两组之间的疗效无明显差异。本事后分析比较了 flavocoxid 与萘普生在不同亚组患者中的疗效，特别是那些与基线时报告的年龄、性别和疾病严重程度相关的患者。
在原始的随机、双盲研究中，220 例患者被分配接受 flavocoxid（每日两次 500mg）或萘普生（每日两次 500mg）治疗 12 周。在本亚组分析中，主要疗效指标包括 Western Ontario 和 McMaster 大学骨关节炎指数和子量表、定时行走以及次要疗效变量，包括研究者对疾病的总体评估和对治疗的总体反应、患者对不适的视觉模拟量表评分、总体疾病活动、对治疗的总体反应、指数关节压痛和活动度，评估了研究组之间的不同趋势。
亚组分析显示，flavocoxid 组有一些统计学上显著的差异和一些明显的趋势。这些趋势随着患者继续治疗而变得更强。这些观察结果在年龄较大的患者（>60 岁）、男性和疾病较轻的患者中更为明显，尤其是那些疾病活动度自评较低和研究者对疾病的总体评估以及基线时行走速度较快的患者。
对整个意向治疗人群的初步分析显示，flavocoxid 与萘普生在管理膝关节 OA 的体征和症状方面同样有效。对患者亚组的详细分析显示，flavocoxid 对特定患者群体具有明显的优势趋势。
