Creatine Kinase Foundation Amsterdam, PO Box 23639, 1100 EC, Amsterdam, The Netherlands.
ESC Heart Fail. 2019 Jun;6(3):487-498. doi: 10.1002/ehf2.12421. Epub 2019 Mar 20.
Population data indicate that one in 25 persons of African ancestry has heart failure, a condition with relatively high mortality of around 50% in 5 years. Combined hydralazine and isosorbide dinitrate added to conventional therapy in African ancestry patients with heart failure and reduced ejection fraction improves quality of life and reduces the rate of first hospitalization for heart failure by 33% and annual mortality by 43%. The objectives of this study were to quantify the use of this guideline-recommended therapy in Europe and the potential effect of implementation gaps on mortality.
Prescription drug registration and utilization databases and population statistics were analysed in a cross-European survey without language restriction. Main outcomes were the number of unique patients prescribed the fixed combination hydralazine-isosorbide dinitrate (primary) or both drugs (secondary) in Europe in 2015, and the excess mortality related to prescribing practices was estimated. The survey indicates that around 12 million persons of African ancestry live in Europe. It is estimated that 480 000 persons of this population group have heart failure, with 120 000 eligible for hydralazine and isosorbide dinitrate therapy. However, single-pill hydralazine-isosorbide dinitrate is not authorized and therefore not dispensed in Europe in 2015. Out of the 25 European nations surveyed, the UK and the Netherlands are the only countries with major African ancestry populations where both hydralazine and isosorbide dinitrate are available for oral use, aside Norway, Sweden, and Finland. Hydralazine and isosorbide dinitrate are prescribed to <500 European patients in 2015. Thus, despite the recommendations of the European Society of Cardiology, the large majority of African-European patients with heart failure do not receive this drug combination, potentially resulting in 4800 to 5800 excess deaths yearly.
The life-saving, guideline-recommended, adjunctive therapy for heart failure in African ancestry patients with hydralazine and isosorbide dinitrate is rarely used in Europe. This major evidence-practice gap should urgently be overcome to reduce excess mortality in African-European patients with heart failure.
人口数据表明，每 25 个非裔人群中就有 1 人患有心力衰竭，这种疾病的 5 年死亡率相对较高，约为 50%。在非裔心力衰竭和射血分数降低的患者中，将肼屈嗪和硝酸异山梨酯联合应用于常规治疗，可改善生活质量，使心力衰竭首次住院率降低 33%，年死亡率降低 43%。本研究的目的是量化该指南推荐的治疗方法在欧洲的使用情况，以及实施差距对死亡率的潜在影响。
本研究在一项无语言限制的跨欧调查中，分析了处方药注册和使用数据库以及人口统计数据。主要结果是 2015 年在欧洲开具固定剂量肼屈嗪-硝酸异山梨酯（主要）或两种药物（次要）的独特患者人数，以及与处方实践相关的超额死亡率。该调查表明，约有 1200 万非裔人群居住在欧洲。据估计，该人群中有 48 万人患有心力衰竭，其中 12 万人适合肼屈嗪和硝酸异山梨酯治疗。然而，单粒肼屈嗪-硝酸异山梨酯在 2015 年并未在欧洲获得授权，因此也未在欧洲配药。在所调查的 25 个欧洲国家中，英国和荷兰是仅有的两个拥有大量非裔人群的国家，除挪威、瑞典和芬兰外，这两个国家还可以口服使用肼屈嗪和硝酸异山梨酯。2015 年，欧洲有<500 名患者开具肼屈嗪和硝酸异山梨酯。因此，尽管欧洲心脏病学会有相关推荐，但绝大多数非裔欧洲心力衰竭患者并未接受这种药物联合治疗，这可能导致每年有 4800 至 5800 人死亡。
对于患有心力衰竭的非裔人群，肼屈嗪和硝酸异山梨酯是一种有救命作用的、推荐使用的辅助治疗方法，但在欧洲很少使用。这种主要的证据与实践之间的差距应尽快得到解决，以降低非裔欧洲心力衰竭患者的超额死亡率。
