Thirugnanam Subarna, Pinto Ruxandra, Cook Deborah J, Geerts William H, Fowler Robert A
Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
Crit Care. 2012 Mar 9;16(2):R43. doi: 10.1186/cc11241.
Despite evidence-based guidelines for venous thromboembolism prevention, substantial variability is found in practice. Many economic evaluations of new drugs for thromboembolism prevention do not occur prospectively with efficacy studies and are sponsored by the manufacturers, raising the possibility of bias. We performed a systematic review of economic analyses of venous thromboembolism prevention in hospitalized patients to inform clinicians and policy makers about cost-effectiveness and the potential influence of sponsorship.
We searched MEDLINE, EMBASE, Cochrane Databases, ACP Journal Club, and Database of Abstracts of Reviews of Effects, from 1946 to September 2011. We extracted data on study characteristics, quality, costs, and efficacy.
From 5,180 identified studies, 39 met eligibility and quality criteria. Each addressed pharmacologic prevention: low-molecular-weight heparins versus placebo (five), unfractionated heparin (12), warfarin (eight), one or another agents (five); fondaparinux versus enoxaparin (11); and rivaroxaban and dabigatran versus enoxaparin (two). Low-molecular-weight heparins were most economically attractive among most medical and surgical patients, whereas fondaparinux was favored for orthopedic patients. Fondaparinux was associated with increased bleeding events. Newer agents rivaroxaban and dabigatran may offer additional value. Of all economic evaluations, 64% were supported by manufacturers of a "new" agent. The new agent had a favorable outcome in 38 (97.4%) of 39 evaluations [95% confidence interval [CI] (86.5 to 99.9)]. Among studies supported by a pharmaceutical company, the sponsored medication was economically attractive in 24 (96.0%) of 25 [95% CI, 80.0 to 99.9)]. We could not detect a consistent bias in outcome based on sponsorship; however, only a minority of studies were unsponsored.
Low-molecular-weight heparins and fondaparinux are the most economically attractive drugs for venous thromboembolism prevention in hospitalized patients. Approximately two thirds of evaluations were supported by the manufacturer of the new agent; such drugs were likely to be reported as economically favorable.
尽管有基于证据的静脉血栓栓塞预防指南,但在实际应用中仍存在很大差异。许多用于血栓栓塞预防的新药的经济评估并非与疗效研究同时进行前瞻性研究,且由制造商赞助,这增加了偏倚的可能性。我们对住院患者静脉血栓栓塞预防的经济分析进行了系统综述,以向临床医生和政策制定者提供有关成本效益以及赞助潜在影响的信息。
我们检索了1946年至2011年9月的MEDLINE、EMBASE、Cochrane数据库、美国内科医师学会杂志俱乐部以及循证医学数据库。我们提取了关于研究特征、质量、成本和疗效的数据。
在5180项已识别的研究中,39项符合纳入标准和质量标准。每项研究都涉及药物预防:低分子量肝素与安慰剂对比(5项)、普通肝素(12项)、华法林(8项)、一种或其他药物(5项);磺达肝癸钠与依诺肝素对比(11项);利伐沙班和达比加群与依诺肝素对比(2项)。在大多数内科和外科患者中,低分子量肝素在经济上最具吸引力,而磺达肝癸钠在骨科患者中更受青睐。磺达肝癸钠与出血事件增加相关。新型药物利伐沙班和达比加群可能具有额外价值。在所有经济评估中,64%得到了“新型”药物制造商的支持。在39项评估中的38项(97.4%)中,新型药物有良好结局[95%置信区间(CI)(86.5至99.9)]。在由制药公司支持的研究中,在25项研究中的24项(96.0%)中,受赞助药物在经济上具有吸引力[95%CI,80.0至99.9]。我们无法检测到基于赞助的结局存在一致的偏倚;然而,只有少数研究没有得到赞助。
低分子量肝素和磺达肝癸钠是住院患者静脉血栓栓塞预防中最具经济吸引力的药物。大约三分之二的评估得到了新型药物制造商的支持;这类药物可能被报告为在经济上有利。