Heart Disease Prevention Program, University of California-Irvine, Irvine, CA, USA.
Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
Diab Vasc Dis Res. 2020 Jul-Aug;17(4):1479164120945674. doi: 10.1177/1479164120945674.
We examined eligibility and preventable cardiovascular disease events in US adults with diabetes mellitus from the Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME).
We identified adults with diabetes mellitus eligible for EMPA-REG OUTCOME based on trial eligibility criteria available from the National Health and Nutrition Examination Surveys, 2007-2016. We estimated composite cardiovascular disease endpoints, as well as all-cause deaths, death from cardiovascular disease and hospitalizations for heart failure from trial treatment and placebo event rates, the difference indicating the preventable events.
Among 29,629 US adults aged ⩾18 years (representing 231.9 million), 4672 (27.3 million) had diabetes mellitus, with 342 (1.86 million) meeting eligibility criteria of EMPA-REG OUTCOME. We estimated from trial primary endpoint event rates of 10.5% and 12.1% in the empagliflozin and placebo groups, respectively, that based on the 'treatment' of our 1.86 million estimated EMPA-REG OUTCOME eligible subjects, 12,066 (95% confidence interval: 10,352-13,780) cardiovascular disease events could be prevented annually. Estimated annual preventable deaths from any cause, cardiovascular causes and hospitalizations from heart failure were 17,078 (95% confidence interval: 14,652-19,504), 14,479 (95% confidence interval: 12,422-16,536) and 9467 (95% confidence interval: 8122-10,812), respectively.
Empagliflozin, if provided to EMPA-REG OUTCOME eligible US adults, may prevent many cardiovascular disease events, cardiovascular and total deaths, as well as heart failure hospitalizations.
我们研究了来自 2 型糖尿病患者恩格列净心血管结局事件试验（EMPA-REG OUTCOME）的美国糖尿病成年人的资格和可预防的心血管疾病事件。
我们根据 2007-2016 年全国健康和营养调查中可用的试验资格标准，确定符合 EMPA-REG OUTCOME 资格的成年人患有糖尿病。我们估计了复合心血管疾病终点以及全因死亡率、心血管疾病死亡率和心力衰竭住院率，试验治疗和安慰剂的事件率差异表明可预防的事件。
在 29629 名年龄 ⩾18 岁的美国成年人（代表 23190 万人）中，有 4672 人（2730 万人）患有糖尿病，其中 342 人（1860 万人）符合 EMPA-REG OUTCOME 的资格标准。我们从试验主要终点的事件率估计，恩格列净组和安慰剂组分别为 10.5%和 12.1%，根据我们估计的 1860 万符合 EMPA-REG OUTCOME 标准的患者的“治疗”，每年可预防 12066 例（95%置信区间：10352-13780）心血管疾病事件。估计每年可预防的任何原因、心血管原因和心力衰竭导致的死亡人数分别为 17078 人（95%置信区间：14652-19504）、14479 人（95%置信区间：12422-16536）和 9467 人（95%置信区间：8122-10812）。
如果将恩格列净提供给符合 EMPA-REG OUTCOME 标准的美国成年人，可能会预防许多心血管疾病事件、心血管和总死亡以及心力衰竭住院。
