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Comparison of the clinical effect of empagliflozin on glycemic and non-glycemic parameters in Japanese patients with type 2 diabetes and cardiovascular disease treated with or without baseline metformin
Cardiovascular Diabetology ( IF 8.5 ) Pub Date : 2021-07-31 , DOI: 10.1186/s12933-021-01352-0
Atsushi Tanaka 1 , Michio Shimabukuro 2 , Hiroki Teragawa 3 , Yosuke Okada 4 , Toshinari Takamura 5 , Isao Taguchi 6 , Shigeru Toyoda 7 , Hirofumi Tomiyama 8 , Shinichiro Ueda 9 , Yukihito Higashi 10 , Koichi Node 1 ,
Affiliation  

The most recent treatment guidelines for type 2 diabetes (T2D) recommend sodium-glucose cotransporter 2 (SGLT2) inhibitors should be considered preferentially in patients with T2D with either a high cardiovascular risk or with cardiovascular disease (CVD), regardless of their diabetes status and prior use of conventional metformin therapy. Whether the therapeutic impact of SGLT2 inhibitors on clinical parameters differs according to the use of metformin therapy however remains unclear. The study was a post hoc analysis of the EMBLEM trial (UMIN000024502). All participants (n = 105; women 31.4%; mean age 64.8 years) had both T2D and CVD and were randomized to either 24 weeks of empagliflozin 10 mg daily or placebo. Analysis of the data assessed the effect of empagliflozin on changes from baseline to 24 weeks in glycemic and non-glycemic clinical parameters, according to the baseline use of metformin. Overall, 53 (50.5%) patients received baseline metformin. In the 52 patients treated with empagliflozin (48.1% with baseline metformin), the decrease in systolic blood pressure from baseline levels was greater in patients receiving metformin, compared to that observed in metformin-naïve patients (group difference − 8.5 [95% confidence interval (CI) − 17.7 to 0.6 mmHg], p = 0.066). Reduction in body mass index (BMI) was significantly greater in patients receiving baseline metformin, relative to nonusers (− 0.54 [95% CI − 1.07 to − 0.01] kg/m2, p = 0.047). The group ratio (baseline metformin users vs. nonusers) of proportional changes in the geometric mean of high-sensitivity Troponin-I (hs-TnI) was 0.74 (95% CI 0.59 to 0.92, p = 0.009). No obvious differences were observed in glycemic parameters (fasting plasma glucose, glycohemoglobin, and glycoalbumin) between the baseline metformin users and nonusers. Our findings suggest 24 weeks of empagliflozin treatment was associated with an improvement in glycemic control, irrespective of the baseline use of metformin therapy. The effects of empagliflozin on reductions in BMI and hs-TnI were more apparent in patients who received baseline metformin therapy, compared to that observed in metformin-naïve patients. Trial registration University Medical Information Network Clinical Trial Registry, number 000024502

中文翻译:

恩格列净对日本 2 型糖尿病合并心血管疾病患者使用或不使用基线二甲双胍治疗的血糖和非血糖参数的临床效果比较

最新的 2 型糖尿病 (T2D) 治疗指南建议,对于具有高心血管风险或心血管疾病 (CVD) 的 T2D 患者,无论其糖尿病状况如何,应优先考虑钠-葡萄糖协同转运蛋白 2 (SGLT2) 抑制剂之前使用过常规二甲双胍治疗。SGLT2 抑制剂对临床参数的治疗影响是否因二甲双胍治疗的使用而异,但仍不清楚。该研究是对 EMBLEM 试验 (UMIN000024502) 的事后分析。所有参与者(n = 105;女性 31.4%;平均年龄 64.8 岁)同时患有 T2D 和 CVD,并被随机分配至 24 周的 empagliflozin 10 mg 每日组或安慰剂组。根据二甲双胍的基线使用情况,数据分析评估了恩格列净对从基线到 24 周血糖和非血糖临床参数变化的影响。总体而言,53 名 (50.5%) 患者接受了基线二甲双胍治疗。在接受恩格列净治疗的 52 名患者中(48.1% 使用基线二甲双胍),与未使用二甲双胍的患者相比,接受二甲双胍治疗的患者收缩压从基线水平的下降幅度更大(组差异 - 8.5 [95% 置信区间) (CI) - 17.7 至 0.6 mmHg],p = 0.066)。与未服用二甲双胍的患者相比,接受基线二甲双胍治疗的患者的体重指数 (BMI) 降低显着更大(- 0.54 [95% CI - 1.07 至 - 0.01] kg/m2,p = 0.047)。组比(基线二甲双胍使用者与 非使用者)高敏肌钙蛋白-I (hs-TnI) 几何平均值的比例变化为 0.74(95% CI 0.59 至 0.92,p = 0.009)。基线二甲双胍使用者和非使用者之间的血糖参数(空腹血糖、糖化血红蛋白和糖清蛋白)未观察到明显差异。我们的研究结果表明,无论基线使用二甲双胍治疗如何,恩格列净治疗 24 周与血糖控制改善相关。与未接受二甲双胍治疗的患者相比,恩格列净对降低 BMI 和 hs-TnI 的影响在接受基线二甲双胍治疗的患者中更为明显。试验注册大学医学信息网临床试验注册号000024502 基线二甲双胍使用者和非使用者之间的血糖参数(空腹血糖、糖化血红蛋白和糖清蛋白)未观察到明显差异。我们的研究结果表明,无论基线使用二甲双胍治疗如何,恩格列净治疗 24 周与血糖控制改善相关。与未接受二甲双胍治疗的患者相比,恩格列净对降低 BMI 和 hs-TnI 的影响在接受基线二甲双胍治疗的患者中更为明显。试验注册大学医学信息网临床试验注册号000024502 基线二甲双胍使用者和非使用者之间的血糖参数(空腹血糖、糖化血红蛋白和糖清蛋白)未观察到明显差异。我们的研究结果表明,无论基线使用二甲双胍治疗如何,恩格列净治疗 24 周与血糖控制改善相关。与未接受二甲双胍治疗的患者相比,恩格列净对降低 BMI 和 hs-TnI 的影响在接受基线二甲双胍治疗的患者中更为明显。试验注册大学医学信息网临床试验注册号000024502 我们的研究结果表明,无论基线使用二甲双胍治疗如何,恩格列净治疗 24 周与血糖控制改善相关。与未接受二甲双胍治疗的患者相比,恩格列净对降低 BMI 和 hs-TnI 的影响在接受基线二甲双胍治疗的患者中更为明显。试验注册大学医学信息网临床试验注册号000024502 我们的研究结果表明,无论基线使用二甲双胍治疗如何,恩格列净治疗 24 周与血糖控制改善相关。与未接受二甲双胍治疗的患者相比,恩格列净对降低 BMI 和 hs-TnI 的影响在接受基线二甲双胍治疗的患者中更为明显。试验注册大学医学信息网临床试验注册号000024502
更新日期:2021-08-01
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