说明:该文章为国外近期的文献报道。但国内外国情不同,药物价格也不相同,因此仅供同行和病友参考。
背景:慢性肾脏病病人存在较高的罹患痛风及难治疾病的风险。降尿酸药物的应用,如别嘌醇和非布司他,对于治疗痛风极为重要,但对于合并中重度慢性肾脏病的患者,临床治疗时需考虑相关并发症的风险,而且目前缺乏真实世界关于该病治疗的效价研究。
目的:研究对于痛风伴中重度慢性肾脏病患者,应用别嘌醇与非布司他治疗的费用情况。
方法:回顾性研究痛风伴慢性肾脏病3-4期患者应用别嘌醇或非布司他的月平均费用。主要研究终点为总的月平均费用,次级研究终点为特定疾病的治疗费用情况,如痛风、糖尿病、肾脏疾病及心血管疾病。将2009年1月至2012年6月应用别嘌醇或非布司他的大于18岁的痛风伴慢性肾脏病3-4期的患者从MarketScan数据库中选择出来,进行分组、入组及筛选。将应用别嘌醇的病人以1:1的模式与应用非布司他的患者进行配比。建立5种线性评分工具,每个工具均进行倾向性评分,以此评估应用别嘌醇及非布司他的费用情况。
结果:共入组1486病人,64.6%为男性,平均年龄67.4岁。74.6%的病人存在慢性肾脏病3期,82.9%的病人存在心血管疾病,42.1%的病人存在糖尿病。其中应用别嘌醇组的病人,在首选别嘌醇治疗后,有4.2%的病人再次给予了非布司他治疗。非校正月平均费用比较如下:别嘌醇组1490美元,非布司他组1525美元,两组比较无统计学差异,P=0.809。校正后数据显示,首选非布司他组1299美元,别嘌醇1487美元,非布司他组明显低于别嘌醇组,P=0.009,。但是,首选别嘌醇后再次选用非布司他治疗的费用为1751美元,较别嘌醇组明显高,P=0.001。对于单纯治疗痛风的亚组病人,非布司他组费用明显高,这是因为非布司他的成本本身就高的缘故。对于存在心血管疾病的病人,首选非布司他组费用较别嘌醇组明显降低,分别为288美元及459美元,P<0.001.对于肾脏疾病相关费用,非布司他及别嘌醇组也明显降低,分别为86及216美元。对于首选别嘌醇治疗后改用非布司他治疗的病人,与单纯首选别嘌醇治疗组相比,肾脏及心血管疾病费用均无明显差别。
结论:对于痛风伴慢性肾脏病的病人,首选非布司他明显比首选别嘌醇治疗费用降低。相反,首选别嘌醇而后改用非布司他治疗,费用明显高于单用别嘌醇。尽管该研究显示,应用非布司他治疗痛风,有降低该类病人心血管疾病及肾脏疾病相关治疗费用的潜力,以此弥补该药本身成本高的不足,但是,这只是关于该问题的第一个回顾性研究的结果。未来会进行更多研究,可以更清楚的分析及阐述该问题。
附原文:BACKGROUND: Patients with chronic kidney disease (CKD) are at increased risk for developing gout and having refractory disease. Gout flare prevention relies heavily on urate-lowering therapies such as allopurinol and febuxostat, but clinical decision making in patients with moderate-to-severe CKD is complicated by significant comorbidity and the scarcity of real-world cost-effectiveness studies.OBJECTIVE: To compare total and disease-specific health care expenditures by line of therapy in allopurinol and febuxostat initiators after diagnosis with gout and moderate-to-severe CKD.METHODS: A retrospective observational cohort study was conducted to compare mean monthly health care cost (in 2012 U.S. dollars) among gout patients with CKD (stage 3 or 4) who initiated allopurinol or febuxostat. The primary outcome was total mean monthly health care expenditures, and the secondary outcome was disease-specific (gout, diabetes, renal, and cardiovascular disease [CVD]) expenditures. Gout patients (ICD-9-CM 274.xx) aged ≥ 18 years with concurrent CKD (stage 3 or 4) were selected from the MarketScan databases (January 2009-June 2012) upon allopurinol or febuxostat initiation. Patients were followed until disenrollment, discontinuation of the qualifying study agent, or use of the alternate study agent. Patients initiating allopurinol were subsequently propensity score-matched (1:1) to patients initiating febuxostat. Five generalized linear models (GLMs) were developed, each controlling for propensity score, to identify the incremental costs (vs. allopurinol) associated with febuxostat initiation in first-line (without prior allopurinol exposure) and second-line (with prior allopurinol exposure) settings.RESULTS: Propensity score matching yielded 2 cohorts, each with 1,486 patients (64.6% male, mean [SD] age 67.4 [12.8] years). Post-match, 74.6% of patients had stage 3 CKD; 82.9% had CVD; and 42.1% had diabetes. The post-match sample was well balanced on numerous comorbidities and medication exposures with the following exception: 50.0% of febuxo-stat initiators were treated in the second-line setting; that is, they had baseline exposure to allopurinol, whereas only 4.2% of allopurinol initiators had baseline exposure to febuxostat. Unadjusted mean monthly cost was $1,490 allopurinol and $1,525 febuxostat (P = 0.809). GLM results suggest that first-line febuxostat users incurred significantly (P = 0.009) lower cost than allopurinol users ($1,299 vs. $1,487), whereas second-line febuxostat initiators incurred significantly (P = 0.001) higher cost ($1,751 vs. $1,487). Febuxostat initiators in both settings had significantly (P < 0.001) higher gout-specific cost, due to higher febuxostat acquisition cost. increased gout-specific cost in the first-line febuxostat cohort was offset by significantly (p < 0.001) lower cvd ($288 vs. $459) and renal-related cost ($86 vs. $216). there were no significant differences in either renal or cvd costs (adjusted) between allopurinol initiators treated almost exclusively in the first-line setting and second-line febuxostat patients.conclusions: gout patients with concurrent ckd, initiating treatment with febuxostat in a first-line setting, incurred significantly less total cost than patients initiating allopurinol during the first exposure to each agent. conversely, patients treated with second-line febuxostat following allopu-rinol incurred significantly higher total cost than patients initiating allopurinol. there was no significant difference in total cost between the agents across line of therapy. although study findings suggest the potential for cvd and renal-related savings to offset febuxostat's higher acquisition cost in gout patients with moderate-to-severe ckd, this is the first such retrospective evaluation. future research is warranted to both demonstrate the durability of study findings and to better elucidate the mechanism by which associated cost offsets occur.
引自:Mitri G1, Wittbrodt ET2, Turpin RS3, Tidwell BA4, Schulman KL.Cost Comparison of Urate-Lowering Therapies in Patients with Gout and Moderate-to-Severe Chronic Kidney Disease. J Manag Care Spec Pharm. 2016 Apr;22(4):326-36. doi: 10.18553/jmcp.2016.22.4.326.