Dapagliflozin for inpatient hyperglycemia in cardiac surgery patients with type 2 diabetes: randomised controlled trial (Dapa-Hospital trial)

IF 3.1 3区医学 Q2 ENDOCRINOLOGY & METABOLISM Acta Diabetologica Pub Date : 2023-06-29 DOI:10.1007/s00592-023-02138-4

Mohammad Shafi Kuchay, Pushpender Khatana, Mitali Mishra, Parvathi Surendran, Parjeet Kaur, Jasjeet Singh Wasir, Harmandeep Kaur Gill, Apanshu Singh, Rujul Jain, Chhavi Kohli, Gazal Bakshi, Vishnupriya Radhika, Sumayya Saheer, Manish Kumar Singh, Sunil Kumar Mishra

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Abstract

Aims

To examine the efficacy and safety of dapagliflozin in the treatment of hyperglycemia in cardiac surgery patients with type 2 diabetes (T2D).

Methods

Cardiac surgery patients with T2D (n = 250) were randomly assigned (1:1) to receive dapagliflozin plus basal-bolus insulin (DAPA group) or basal-bolus insulin alone (INSULIN group) in the early postoperative period. The primary outcome was mean difference in daily blood glucose (BG) concentrations between groups. The major safety outcomes were the occurrence of severe ketonemia/diabetic ketoacidosis (DKA) and hypoglycemia. All analyses were performed according to the intention-to-treat principle.

Results

The median age of the patients was 61 years (range, 55–61), and 219 (87.6%) were men. Overall, the randomization blood glucose was 165 mg/dL (SD, 37) and glycated hemoglobin was 7.7% (SD, 1.4). There were no differences in mean daily BG concentrations (149 vs. 150 mg/dL), mean percentage of readings within target BG of 70–180 mg/dL (82.7% vs. 82.5%), total daily insulin dose (mean, 39 vs. 40 units/day), number of daily insulin injections (median, 3.9 vs. 4), length of hospital stay (median, 10 vs. 10 days), or hospital complications (21.6% vs. 24.8%) between the DAPA and INSULIN groups. The mean plasma ketone levels were significantly higher in the DAPA group than in the INSULIN group at day 3 (0.71 vs. 0.30 mmol/L) and day 5 (0.42 vs. 0.19 mmol/L) of randomization. Six patients in the DAPA group developed severe ketonemia, but no patient developed DKA. There were no differences in the proportion of patients with BG < 70 mg/dL (9.6% vs. 7.2%) between the two groups.

Conclusion

Dapagliflozin complementary to basal-bolus insulin does not improve glycemia further over and above the basal-bolus insulin alone in hospitalized cardiac surgery patients. Dapagliflozin significantly increases plasma ketones levels. Safety of dapagliflozin in hospitalized patients needs further investigation.

Trial registration ClinicalTrials.gov NCT05457933.

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达格列嗪治疗2型糖尿病心脏手术患者住院高血糖：随机对照试验（达帕医院试验）

目的观察达格列嗪治疗2型糖尿病（T2D）心脏手术患者高血糖的疗效和安全性 = 250）被随机分配（1:1）在术后早期接受达格列嗪加基础推注胰岛素（DAPA组）或单独基础推注的胰岛素（胰岛素组）。主要结果是各组间每日血糖（BG）浓度的平均差异。主要的安全性结果是发生严重酮症酸中毒/糖尿病酮症酸血症（DKA）和低血糖。所有分析均按照意向治疗原则进行。结果患者中位年龄为61岁（55-61岁），男性219人（87.6%）。总体而言，随机分组的血糖为165 mg/dL（SD，37），糖化血红蛋白为7.7%（SD，1.4）。在平均每日血糖浓度（149 vs.150 mg/dL）、目标血糖范围内读数的平均百分比（70–180 mg/dL，82.7%vs.82.5%）、总每日胰岛素剂量（平均39 vs.40单位/天）、每日胰岛素注射次数（中位数3.9 vs.4）、，DAPA和胰岛素组的住院时间（中位数为10天对10天）或住院并发症（21.6%对24.8%）。在随机化的第3天（0.71 vs.0.30 mmol/L）和第5天（0.42 vs.0.19 mmol/L），DAPA组的平均血浆酮水平显著高于胰岛素组。DAPA组中有6名患者出现严重酮症酸中毒，但没有一名患者出现DKA。BG患者的比例没有差异 <； 70 mg/dL（9.6%对7.2%）。结论在住院的心脏手术患者中，补充基础推注胰岛素的达格列嗪并不能比单独基础推注的胰岛素进一步改善血糖。达格列嗪显著提高血浆酮体水平。达格列嗪在住院患者中的安全性需要进一步研究。试验注册ClinicalTrials.gov NCT05457933。

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来源期刊

Acta Diabetologica 医学-内分泌学与代谢

CiteScore

7.30

自引率

2.60%

发文量

180

审稿时长

2 months

期刊介绍： Acta Diabetologica is a journal that publishes reports of experimental and clinical research on diabetes mellitus and related metabolic diseases. Original contributions on biochemical, physiological, pathophysiological and clinical aspects of research on diabetes and metabolic diseases are welcome. Reports are published in the form of original articles, short communications and letters to the editor. Invited reviews and editorials are also published. A Methodology forum, which publishes contributions on methodological aspects of diabetes in vivo and in vitro, is also available. The Editor-in-chief will be pleased to consider articles describing new techniques (e.g., new transplantation methods, metabolic models), of innovative importance in the field of diabetes/metabolism. Finally, workshop reports are also welcome in Acta Diabetologica.