Ward R E, Gheorghiade M, Young J B, Uretsky B
Center for Clinical Effectiveness, Henry Ford Health System, Detroit, Michigan 48202, USA.
J Am Coll Cardiol. 1995 Jul;26(1):93-101. doi: 10.1016/0735-1097(95)00140-u.
This study sought to analyze the health and economic outcomes of withdrawal of digoxin therapy among U.S. adult patients with stable congestive heart failure.
New information regarding the outcomes of digoxin withdrawal has been provided by the Prospective Randomized Study of Ventricular Failure and Efficacy of Digoxin (PROVED) and Randomized Assessment of Digoxin and Inhibitors of Angiotensin-Converting Enzyme (RADIANCE) trials. We interpreted and extrapolated the results of these trials to describe implications on a national level.
We used a decision-analytic model to estimate the outcomes of two alternative strategies to 1) continue and 2) withdraw digoxin in patients with congestive heart failure with normal sinus rhythm, New York Heart Association functional class II or III and left ventricular ejection fraction < or = 35%. Epidemiologic assumptions were derived from published reports and expert opinion. Assumptions regarding the effectiveness of digoxin therapy were derived from the RADIANCE and PROVED digoxin withdrawal trials. Hospital and Medicare data were used for economic assumptions. Calculated outcomes included treatment failures, cases of digoxin toxicity and health care costs.
The continuation of digoxin therapy in these patients with congestive heart failure nationally would avoid an estimated 185,000 clinic visits, 27,000 emergency visits and 137,000 hospital admissions for congestive heart failure. After accounting for an estimated 12,500 cases of digoxin toxicity, the net annual savings would be $406 million, with a 90% range of uncertainty of $106 to $822 million. One-way sensitivity analysis indicated that digoxin therapy is cost-saving when the assumed annual incidence of digoxin toxicity is < or = 33%.
The continuation of digoxin therapy in patients with stable congestive heart failure should be strongly considered, because this strategy is likely to lead to both lower costs and greater health benefits on the basis of available information.
本研究旨在分析美国成年稳定型充血性心力衰竭患者停用洋地黄治疗后的健康和经济结局。
洋地黄撤出试验（PROVED）和地高辛与血管紧张素转换酶抑制剂随机评估试验（RADIANCE）提供了有关停用洋地黄结局的新信息。我们对这些试验的结果进行了解释和推断，以描述其在全国范围内的影响。
我们使用决策分析模型来估计两种替代策略的结局，即1）继续使用和2）停用洋地黄，用于窦性心律正常、纽约心脏协会功能分级为II或III级且左心室射血分数≤35%的充血性心力衰竭患者。流行病学假设来自已发表的报告和专家意见。关于洋地黄治疗有效性的假设来自RADIANCE和PROVED洋地黄撤出试验。医院和医疗保险数据用于经济假设。计算的结局包括治疗失败、洋地黄中毒病例和医疗保健成本。
在全国范围内，这些充血性心力衰竭患者继续使用洋地黄治疗估计可避免185,000次门诊就诊、27,000次急诊就诊和137,000次因充血性心力衰竭住院。在考虑了估计的12,500例洋地黄中毒病例后，每年净节省4.06亿美元，90%的不确定性范围为1.06亿至8.22亿美元。单向敏感性分析表明，当假设的洋地黄中毒年发病率≤33%时，洋地黄治疗具有成本节约效果。
应强烈考虑在稳定型充血性心力衰竭患者中继续使用洋地黄治疗，因为根据现有信息，该策略可能会降低成本并带来更大的健康益处。
