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

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 basa...

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Veröffentlicht in:Acta diabetologica 2023-11, Vol.60 (11), p.1481-1490
Hauptverfasser: Kuchay, Mohammad Shafi, Khatana, Pushpender, Mishra, Mitali, Surendran, Parvathi, Kaur, Parjeet, Wasir, Jasjeet Singh, Gill, Harmandeep Kaur, Singh, Apanshu, Jain, Rujul, Kohli, Chhavi, Bakshi, Gazal, Radhika, Vishnupriya, Saheer, Sumayya, Singh, Manish Kumar, Mishra, Sunil Kumar
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container_issue 11
container_start_page 1481
container_title Acta diabetologica
container_volume 60
creator Kuchay, Mohammad Shafi
Khatana, Pushpender
Mishra, Mitali
Surendran, Parvathi
Kaur, Parjeet
Wasir, Jasjeet Singh
Gill, Harmandeep Kaur
Singh, Apanshu
Jain, Rujul
Kohli, Chhavi
Bakshi, Gazal
Radhika, Vishnupriya
Saheer, Sumayya
Singh, Manish Kumar
Mishra, Sunil Kumar
description 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 
doi_str_mv 10.1007/s00592-023-02138-4
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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 &lt; 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. 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Springer-Verlag Italia S.r.l., part of Springer Nature.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c375t-c00930fbb5708c8bb9670518e0fed59ec066cb1a5e23f98663645b49bca1d4c93</citedby><cites>FETCH-LOGICAL-c375t-c00930fbb5708c8bb9670518e0fed59ec066cb1a5e23f98663645b49bca1d4c93</cites><orcidid>0000-0003-3933-6137</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00592-023-02138-4$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00592-023-02138-4$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>315,782,786,27931,27932,41495,42564,51326</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37380728$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kuchay, Mohammad Shafi</creatorcontrib><creatorcontrib>Khatana, Pushpender</creatorcontrib><creatorcontrib>Mishra, Mitali</creatorcontrib><creatorcontrib>Surendran, Parvathi</creatorcontrib><creatorcontrib>Kaur, Parjeet</creatorcontrib><creatorcontrib>Wasir, Jasjeet Singh</creatorcontrib><creatorcontrib>Gill, Harmandeep Kaur</creatorcontrib><creatorcontrib>Singh, Apanshu</creatorcontrib><creatorcontrib>Jain, Rujul</creatorcontrib><creatorcontrib>Kohli, Chhavi</creatorcontrib><creatorcontrib>Bakshi, Gazal</creatorcontrib><creatorcontrib>Radhika, Vishnupriya</creatorcontrib><creatorcontrib>Saheer, Sumayya</creatorcontrib><creatorcontrib>Singh, Manish Kumar</creatorcontrib><creatorcontrib>Mishra, Sunil Kumar</creatorcontrib><title>Dapagliflozin for inpatient hyperglycemia in cardiac surgery patients with type 2 diabetes: randomised controlled trial (Dapa-Hospital trial)</title><title>Acta diabetologica</title><addtitle>Acta Diabetol</addtitle><addtitle>Acta Diabetol</addtitle><description>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 &lt; 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. 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Khatana, Pushpender ; Mishra, Mitali ; Surendran, Parvathi ; Kaur, Parjeet ; Wasir, Jasjeet Singh ; Gill, Harmandeep Kaur ; Singh, Apanshu ; Jain, Rujul ; Kohli, Chhavi ; Bakshi, Gazal ; Radhika, Vishnupriya ; Saheer, Sumayya ; Singh, Manish Kumar ; Mishra, Sunil Kumar</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c375t-c00930fbb5708c8bb9670518e0fed59ec066cb1a5e23f98663645b49bca1d4c93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Antidiabetics</topic><topic>Blood Glucose</topic><topic>Cardiac Surgical Procedures</topic><topic>Diabetes</topic><topic>Diabetes mellitus (non-insulin dependent)</topic><topic>Diabetes Mellitus, Type 2 - complications</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Diabetes Mellitus, Type 2 - surgery</topic><topic>Diabetic Ketoacidosis - drug therapy</topic><topic>Female</topic><topic>Heart</topic><topic>Heart surgery</topic><topic>Hemoglobin</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Hyperglycemia</topic><topic>Hyperglycemia - drug therapy</topic><topic>Hyperglycemia - etiology</topic><topic>Hypoglycemia</topic><topic>Hypoglycemic Agents - therapeutic use</topic><topic>Inpatients</topic><topic>Insulin</topic><topic>Insulin - therapeutic use</topic><topic>Internal Medicine</topic><topic>Ketoacidosis</topic><topic>Ketones</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine &amp; 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Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Acta diabetologica</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kuchay, Mohammad Shafi</au><au>Khatana, Pushpender</au><au>Mishra, Mitali</au><au>Surendran, Parvathi</au><au>Kaur, Parjeet</au><au>Wasir, Jasjeet Singh</au><au>Gill, Harmandeep Kaur</au><au>Singh, Apanshu</au><au>Jain, Rujul</au><au>Kohli, Chhavi</au><au>Bakshi, Gazal</au><au>Radhika, Vishnupriya</au><au>Saheer, Sumayya</au><au>Singh, Manish Kumar</au><au>Mishra, Sunil Kumar</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Dapagliflozin for inpatient hyperglycemia in cardiac surgery patients with type 2 diabetes: randomised controlled trial (Dapa-Hospital trial)</atitle><jtitle>Acta diabetologica</jtitle><stitle>Acta Diabetol</stitle><addtitle>Acta Diabetol</addtitle><date>2023-11-01</date><risdate>2023</risdate><volume>60</volume><issue>11</issue><spage>1481</spage><epage>1490</epage><pages>1481-1490</pages><issn>1432-5233</issn><issn>0940-5429</issn><eissn>1432-5233</eissn><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 &lt; 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.</abstract><cop>Milan</cop><pub>Springer Milan</pub><pmid>37380728</pmid><doi>10.1007/s00592-023-02138-4</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0003-3933-6137</orcidid></addata></record>
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subjects Antidiabetics
Blood Glucose
Cardiac Surgical Procedures
Diabetes
Diabetes mellitus (non-insulin dependent)
Diabetes Mellitus, Type 2 - complications
Diabetes Mellitus, Type 2 - drug therapy
Diabetes Mellitus, Type 2 - surgery
Diabetic Ketoacidosis - drug therapy
Female
Heart
Heart surgery
Hemoglobin
Hospitals
Humans
Hyperglycemia
Hyperglycemia - drug therapy
Hyperglycemia - etiology
Hypoglycemia
Hypoglycemic Agents - therapeutic use
Inpatients
Insulin
Insulin - therapeutic use
Internal Medicine
Ketoacidosis
Ketones
Male
Medicine
Medicine & Public Health
Metabolic Diseases
Middle Aged
Original Article
Patients
Safety
Treatment Outcome
title Dapagliflozin for inpatient hyperglycemia in cardiac surgery patients with type 2 diabetes: randomised controlled trial (Dapa-Hospital trial)
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