Lower Risk of Heart Failure and Death in Patients Initiated on Sodium-Glucose Cotransporter-2 Inhibitors Versus Other Glucose-Lowering Drugs: The CVD-REAL Study (Comparative Effectiveness of Cardiovascular Outcomes in New Users of Sodium-Glucose Cotransporter-2 Inhibitors).
Lower Risk of Heart Failure and Death in Patients Initiated on Sodium-Glucose Cotransporter-2 Inhibitors Versus Other Glucose-Lowering Drugs: The CVD-REAL Study (Comparative Effectiveness of Cardiovascular Outcomes in New Users of Sodium-Glucose Cotransporter-2 Inhibitors).
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DOI：
10.1161/circulationaha.117.029190
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发表时间：
2017-07-18
期刊：
影响因子：
37.8
通讯作者：
CVD-REAL Investigators and Study Group*
中科院分区：
文献类型：
--
作者：
Kosiborod M;Cavender MA;Fu AZ;Wilding JP;Khunti K;Holl RW;Norhammar A;Birkeland KI;Jørgensen ME;Thuresson M;Arya N;Bodegård J;Hammar N;Fenici P;CVD-REAL Investigators and Study Group*
补充数字内容可在文本中找到。最近报告了钠-葡萄糖协同转运蛋白-2抑制剂（SGLT-2 i）恩格列净在患有动脉粥样硬化性心血管疾病的2型糖尿病患者中减少心血管死亡和心力衰竭（HHF）住院治疗。我们比较了6个国家中新开始使用任何SGLT-2 i与其他降糖药物的患者的HHF和死亡，以确定这些获益是否在现实世界实践中和SGLT-2 i类别中观察到。通过美国、挪威、丹麦、瑞典、德国和英国的医疗索赔、初级保健/医院记录和国家登记处收集数据。使用SGLT-2 i启动倾向评分匹配治疗组。按国家估计HHF、死亡及其组合的风险比，并汇总以确定加权效应量。德国的死亡数据不可用。倾向匹配后，有309 056例患者新开始接受SGLT-2 i或其他降糖药物治疗（每个治疗组154 528例患者）。卡格列净、达格列净和恩格列净分别占SGLT-2 i类中总暴露时间的53%、42%和5%。两组之间的基线特征平衡。在190 164人年的随访中，有961例HHF病例（发病率为0.51/100人年）。在美国、挪威、丹麦、瑞典和英国的215622例患者中，1334例发生死亡（发病率为0.87/100人-年），1983年发生HHF或死亡（发病率为1.38/100人-年）。与其他降糖药物相比，SGLT-2 i的使用与HHF发生率较低相关（风险比，0.61; 95%置信区间，0.51-0.73; P<0.001）;死亡（风险比，0.49; 95%置信区间，0.41-0.57; P<0.001）; HHF或死亡（风险比，0.54; 95%置信区间，0.48-0.60; P<0.001），各国之间无显著异质性。在这项大型多国研究中，SGLT-2 i治疗与其他降糖药物相比，HHF和死亡风险较低，这表明在随机试验中观察到的恩格列净获益可能是一种类效应，适用于现实世界实践中的广泛2型糖尿病患者人群。URL：http://www.clinicaltrials.gov。唯一标识符：NCT 02993614。
Supplemental Digital Content is available in the text. Reduction in cardiovascular death and hospitalization for heart failure (HHF) was recently reported with the sodium-glucose cotransporter-2 inhibitor (SGLT-2i) empagliflozin in patients with type 2 diabetes mellitus who have atherosclerotic cardiovascular disease. We compared HHF and death in patients newly initiated on any SGLT-2i versus other glucose-lowering drugs in 6 countries to determine if these benefits are seen in real-world practice and across SGLT-2i class. Data were collected via medical claims, primary care/hospital records, and national registries from the United States, Norway, Denmark, Sweden, Germany, and the United Kingdom. Propensity score for SGLT-2i initiation was used to match treatment groups. Hazard ratios for HHF, death, and their combination were estimated by country and pooled to determine weighted effect size. Death data were not available for Germany. After propensity matching, there were 309 056 patients newly initiated on either SGLT-2i or other glucose-lowering drugs (154 528 patients in each treatment group). Canagliflozin, dapagliflozin, and empagliflozin accounted for 53%, 42%, and 5% of the total exposure time in the SGLT-2i class, respectively. Baseline characteristics were balanced between the 2 groups. There were 961 HHF cases during 190 164 person-years follow-up (incidence rate, 0.51/100 person-years). Of 215 622 patients in the United States, Norway, Denmark, Sweden, and the United Kingdom, death occurred in 1334 (incidence rate, 0.87/100 person-years), and HHF or death in 1983 (incidence rate, 1.38/100 person-years). Use of SGLT-2i, versus other glucose-lowering drugs, was associated with lower rates of HHF (hazard ratio, 0.61; 95% confidence interval, 0.51–0.73; P<0.001); death (hazard ratio, 0.49; 95% confidence interval, 0.41–0.57; P<0.001); and HHF or death (hazard ratio, 0.54; 95% confidence interval, 0.48–0.60; P<0.001) with no significant heterogeneity by country. In this large multinational study, treatment with SGLT-2i versus other glucose-lowering drugs was associated with a lower risk of HHF and death, suggesting that the benefits seen with empagliflozin in a randomized trial may be a class effect applicable to a broad population of patients with type 2 diabetes mellitus in real-world practice. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02993614.