Coleman Craig I, Kalus James S, White C Michael, Spencer Anne P, Tsikouris James P, Chung Jenny O, Kenyon Kenneth W, Ziska Martin, Kluger Jeffrey, Reddy Prabashni
Department of Drug Information, Hartford Hospital, Hartford, Connecticut, USA.
Pharmacoeconomics. 2004;22(13):877-83. doi: 10.2165/00019053-200422130-00005.
In the Treatment with Ibutilide and Magnesium Evaluation (TIME) study, a retrospective multicentre cohort trial, prophylactic magnesium was found to improve the antiarrhythmic efficacy of ibutilide as demonstrated by an increase in the rate of successful chemical conversion and reduction in the need for direct current cardioversion (DCC).
The primary objective of this piggyback cost-effectiveness analysis of the TIME study was to compare the cost per successful conversion of atrial fibrillation (AF) for ibutilide in the presence and absence of magnesium prophylaxis. A secondary objective was to determine whether specific factors predict costs in the conversion of AF.
The study was conducted from the US hospital-payer perspective. Direct medical costs (USD, 2002 values) including drugs, intravenous admixture and administration, DCC, electrocardiographs and physicians' fees were obtained directly from the provider. Nonparametric bootstrapping was conducted to calculate confidence intervals for the incremental cost-effectiveness ratios. One-way sensitivity analysis was conducted varying efficacy, and drug, hospital and physician costs. Multivariate analysis was conducted to determine whether specific baseline factors were predictors of total cost.
Total costs per patient were lower in the ibutilide plus magnesium group compared with ibutilide alone (USD1075 vs USD1201); however, the difference was not statistically significant (p = 0.116). Patients receiving ibutilide plus magnesium had lower DCC costs compared with those receiving ibutilide alone (USD261 vs USD399; p = 0.036), but higher magnesium-associated costs (USD0.50 vs USD0; p < 0.001). Bootstrapping revealed that the ibutilide plus magnesium strategy would result in lower costs and greater efficacy 93.4% of the time. These results remained robust to changes in both cost and efficacy. No baseline factors were found to be independent predictors of total costs.
Our data suggest that adding prophylactic magnesium to ibutilide may be cost effective, from a US hospital-payer perspective, for the acute conversion of patients in AF or flutter compared with ibutilide alone.
在伊布利特与镁联合治疗评估（TIME）研究中，一项回顾性多中心队列试验发现，预防性使用镁可提高伊布利特的抗心律失常疗效，表现为成功化学复律率增加以及直流电复律（DCC）需求减少。
这项对TIME研究进行的附带成本效益分析的主要目的是比较在有和没有镁预防的情况下，伊布利特转复心房颤动（AF）每成功转复一次的成本。次要目的是确定特定因素是否可预测AF转复的成本。
该研究从美国医院支付方的角度进行。直接医疗成本（2002年美元价值）包括药物、静脉混合液及给药、DCC、心电图检查和医生费用，直接从提供者处获取。采用非参数自抽样法计算增量成本效益比的置信区间。进行单因素敏感性分析，改变疗效、药物、医院和医生成本。进行多因素分析以确定特定基线因素是否为总成本的预测因素。
与单独使用伊布利特相比，伊布利特加镁组每位患者的总成本更低（1075美元对1201美元）；然而，差异无统计学意义（p = 0.116）。与单独使用伊布利特的患者相比，接受伊布利特加镁的患者DCC成本更低（261美元对399美元；p = 0.036），但与镁相关的成本更高（0.50美元对0美元；p < 0.001）。自抽样法显示，93.4%的情况下，伊布利特加镁策略会带来更低成本和更高疗效。这些结果在成本和疗效变化时均保持稳健。未发现基线因素是总成本的独立预测因素。
我们的数据表明，从美国医院支付方的角度来看，与单独使用伊布利特相比，在伊布利特中添加预防性镁对于AF或心房扑动患者的急性转复可能具有成本效益。
