Effects of empagliflozin on insulin initiation or intensification in patients with type 2 diabetes and cardiovascular disease: Findings from the EMPA-REG OUTCOME trial.
Effects of empagliflozin on insulin initiation or intensification in patients with type 2 diabetes and cardiovascular disease: Findings from the EMPA-REG OUTCOME trial.
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DOI：
10.1111/dom.14535
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发表时间：
2021-12
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影响因子：
--
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在一项大型心血管结局试验中，评价恩格列净与安慰剂相比对后续胰岛素治疗开始或剂量变化的影响。在EMPA‐REG OUTCOME中，7020例2型糖尿病和心血管疾病患者接受恩格列净10 mg、25 mg或安慰剂治疗。中位随访时间为3.1年。治疗12周后，允许改变背景抗高血压治疗。在胰岛素初治患者中，我们评估了汇总恩格列净组与安慰剂组对至开始胰岛素治疗时间的影响。在接受胰岛素治疗的患者中，我们评估了对胰岛素剂量增加或减少超过20%的时间的影响。在3633例（52%）基线时未接受胰岛素治疗的受试者中，与安慰剂相比，恩格列净使胰岛素的新使用减少了60%（7.1% vs. 16.4%;校正HR 0.40 [95% CI 0.32 - 0.49]; P < .0001）。在3387例（48%）基线时使用胰岛素的患者中，恩格列净使胰岛素剂量增加20%以上的需求降低了58%（14.4% vs. 29.3%;校正HR 0.42 [95% CI 0.36 - 0.49]; P < .0001），并且与安慰剂相比，达到持续大于20%胰岛素剂量降低而随后HbA 1c未升高的比例增加（9.2% vs. 4.9%;校正HR 1.87 [95% CI：1.39 - 2.51]; P < .0001）。敏感性分析证实，当胰岛素剂量变化超过10%或超过30%时，结果一致。在2型糖尿病和心血管疾病患者中，恩格列净显著且持久地延迟胰岛素启动和胰岛素剂量的大幅增加，同时促进胰岛素需求随时间的持续降低。
To evaluate the effects of empagliflozin versus placebo on subsequent insulin initiation or dosing changes in a large cardiovascular outcomes trial. In EMPA‐REG OUTCOME, 7020 patients with type 2 diabetes and cardiovascular disease received empagliflozin 10 mg, 25 mg, or placebo. Median follow‐up was 3.1 years. After 12 weeks of treatment, changes in background antihyperglycaemic therapy were permitted. Among insulin‐naïve patients, we assessed the effects of pooled empagliflozin arms versus placebo on time to initiation of insulin. Among insulin‐treated patients, we assessed effects on time to an increase or decrease in insulin dose of more than 20%. In 3633 (52%) participants not treated with insulin at baseline, empagliflozin reduced new use of insulin versus placebo by 60% (7.1% vs. 16.4%; adjusted HR 0.40 [95% CI 0.32‐0.49]; P < .0001). In 3387 (48%) patients using insulin at baseline, empagliflozin reduced the need for a greater than 20% insulin dose increase by 58% (14.4% vs. 29.3%; adjusted HR 0.42 [95% CI 0.36‐0.49]; P < .0001) and increased the proportion achieving sustained greater than 20% insulin dose reductions without subsequent increases in HbA1c compared with placebo (9.2% vs. 4.9%; adjusted HR 1.87 [95% CI: 1.39‐2.51]; P < .0001). Sensitivity analyses confirmed consistent findings when insulin dose changes of more than 10% or more than 30% were considered. In patients with type 2 diabetes and cardiovascular disease, empagliflozin markedly and durably delays insulin initiation and substantial increases in insulin dose, while facilitating sustained reductions in insulin requirements over time.
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影响因子：
8.2
作者：
Sattar N;Fitchett D;Hantel S;George JT;Zinman B
通讯作者：
Zinman B
DOI：
10.1111/dom.14143
发表时间：
2020-11
期刊：
Diabetes, obesity & metabolism
影响因子：
--
作者：
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通讯作者：
Neal B
影响因子：
18.2
作者：
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通讯作者：
Latini, Roberto
影响因子：
16.2
作者：
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通讯作者：
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影响因子：
37.8
作者：
Bethel, M. Angelyn;Stevens, Susanna R.;Holman, Rury R.
通讯作者：
Holman, Rury R.