Wolfe Frederick, Michaud Kaleb, Burke Thomas A, Zhao Sean Z
National Data Bank for Rheumatic Diseases-Arthritis Research Center Foundation, Wichita, Kansas 67214, USA.
J Rheumatol. 2004 Feb;31(2):355-8.
To compare COX-2-specific inhibitor therapy with conventional nonspecific nonsteroidal antiinflammatory drugs (NS NSAID), and investigate the effect of demographic and disease factors on NSAID duration of use.
A total of 3639 patients with rheumatoid arthritis (RA), osteoarthritis, and fibromyalgia starting therapy of celecoxib, rofecoxib, naproxen, or ibuprofen were surveyed at 6-month intervals for up to 2.5 years. Detailed demographic and disease severity variables were also measured. Time to discontinuation, discontinuation rates, and effect of covariates were determined by Weibull parametric survival analyses, controlling for a wide variety of demographic and disease severity factors.
The median duration of use for celecoxib, rofecoxib, naproxen, and ibuprofen was 15, 13, 10, and 10 months, respectively. Duration of use of celecoxib and rofecoxib, as measured by survival times, was significantly longer than those of naproxen and ibuprofen. The celecoxib survival time was significantly longer than the rofecoxib survival time (p = 0.005). Disease severity was not associated with survival times, but survival was related to younger age and male sex. In addition, ulcer diagnosis was a strong predictor of early termination. After adjustment for severity, survival times for RA and non-RA patients were the same.
COX-2-specific inhibitors have a longer duration of use than NS NSAID. Among the COX-2-specific inhibitors, celecoxib has a longer survival time than rofecoxib. In addition, COX-2-specific inhibitors also have longer survival times than noted in the literature of NS NSAID in RA community practice. Duration of use can be an indicator of treatment effectiveness and/or drug acceptability, and provides additional interpretation beyond the results of clinical trials.
比较COX-2特异性抑制剂疗法与传统非特异性非甾体抗炎药(NS NSAID),并研究人口统计学和疾病因素对NSAID使用时长的影响。
对总共3639例开始使用塞来昔布、罗非昔布、萘普生或布洛芬进行治疗的类风湿性关节炎(RA)、骨关节炎和纤维肌痛患者,每隔6个月进行一次调查,为期长达2.5年。还测量了详细的人口统计学和疾病严重程度变量。通过威布尔参数生存分析确定停药时间、停药率和协变量的影响,并控制多种人口统计学和疾病严重程度因素。
塞来昔布、罗非昔布、萘普生和布洛芬的中位使用时长分别为15个月、13个月、10个月和10个月。通过生存时间衡量,塞来昔布和罗非昔布的使用时长显著长于萘普生和布洛芬。塞来昔布的生存时间显著长于罗非昔布的生存时间(p = 0.005)。疾病严重程度与生存时间无关,但生存与年轻年龄和男性性别有关。此外,溃疡诊断是早期停药的有力预测因素。在对严重程度进行调整后,RA患者和非RA患者的生存时间相同。
COX-2特异性抑制剂的使用时长比NS NSAID更长。在COX-2特异性抑制剂中,塞来昔布的生存时间比罗非昔布更长。此外,在RA社区实践中,COX-2特异性抑制剂的生存时间也比NS NSAID文献中记载的更长。使用时长可以作为治疗效果和/或药物可接受性的一个指标,并能提供超出临床试验结果的额外解读。