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1. Incorporation of a Stress Reducing Mobile App in the Care of Patients With Type 2 Diabetes: A Prospective Study

Author

Munster-Segev, Maya, Fuerst, Oren, Kaplan, Steven A, and Cahn, Avivit

Subjects
Information technology, T58.5-58.64, Public aspects of medicine, RA1-1270
Abstract

BackgroundSevere and sustained emotional stress creates a physiological burden through increased sympathetic activity and higher energy demand. This may lead to increased oxidative stress and development of the metabolic syndrome. Emotional stress has been shown to contribute to the onset, progression, and control of type 2 diabetes (T2D). Stress management and biofeedback assisted relaxation have been shown to improve glycemic control. Use of a mobile app for stress management may enhance the scalability of such an approach. ObjectiveThe aim of this study was to assess the effect of using a mobile app of biofeedback-assisted relaxation on weight, blood pressure (BP), and glycemic measures of patients with T2D. MethodsAdult patients with T2D and inadequate glycemic control (hemoglobin A1c [HbA1c]>7.5%) were recruited from the outpatient diabetes clinic. Baseline weight, BP, HbA1c, fasting plasma glucose (FPG), triglycerides (TG), and 7-point self-monitoring of blood glucose were measured. Patients were provided with a stress reducing biofeedback mobile app and instructed to use it 3 times a day. The mobile app—Serenita—is an interactive relaxation app based on acquiring a photoplethysmography signal from the mobile phone’s camera lens, where the user places his finger. The app collects information regarding the user’s blood flow, heart rate, and heart rate variability and provides real-time feedback and individualized breathing instructions in order to modulate the stress level. All clinical and biochemical measures were repeated at 8 and 16 weeks of the study. The primary outcome was changes in measures at 8 weeks. ResultsSeven patients completed 8 weeks of the study and 4 completed 16 weeks. At week 8, weight dropped by an average of 4.0 Kg (SD 4.3), systolic BP by 8.6 mmHg (SD 18.6), HbA1c by 1.3% (SD 1.6), FPG by 4.3 mmol/l (4.2), and serum TG were unchanged. ConclusionsStress reduction using a mobile app based on biofeedback may improve glycemic control, weight, and BP.

Published
2017
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7. Effects of dapagliflozin on hospitalisations in people with type 2 diabetes: post-hoc analyses of the DECLARE-TIMI 58 trial

Author

Schechter, Meir, Wiviott, Stephen D., Raz, Itamar, Goodrich, Erica L., Rozenberg, Aliza, Yanuv, Ilan, Murphy, Sabina, Zelniker, Thomas A., Fredriksson, Martin, Johansson, Peter A, Leiter, Lawrence A., Bhatt, Deepak, McGuire, Darren K, Wilding, John P. H., Gause-Nilson, Ingrid A. M., Cahn, Avivit, Langkilde, Anna Maria, Sabatine, Marc S., and Mosenzon, Ofri

Subjects
Endocrinology, Endocrinology, Diabetes and Metabolism, Internal Medicine
Abstract

BackgroundIn people with type 2 diabetes at high risk of cardiovascular or kidney disease, sodium-glucose co-transporter 2 (SGLT2) inhibitors consistently reduce the risk of hospitalisations for heart failure. Less is known about their effects on hospitalisation from any cause, especially in people with type 2 diabetes without atherosclerotic cardiovascular disease, which includes most of the global population of people with type 2 diabetes. We aimed to assess the effect of the SGLT2 inhibitor, dapagliflozin, on the risks of hospitalisations for any cause and for specific causes in people with type 2 diabetes with and without atherosclerotic cardiovascular disease.MethodsThe DECLARE-TIMI 58 trial was a double-blind, multicentre, randomised, placebo-controlled study. People with type 2 diabetes and either risk factors for or established atherosclerotic cardiovascular disease were randomly assigned (1:1) to receive oral dapagliflozin 10 mg or placebo once daily. In these post-hoc analyses, the effects of dapagliflozin on risks of first non-elective any-cause and cause-specific hospitalisation were assessed with Cox proportional hazards regression models overall and in the subset of participants without prevalent atherosclerotic cardiovascular disease. The risk of total (first plus subsequent) non-elective hospitalisations was assessed with Lin-Wei-Ying-Yang model. Investigator-reported System Organ Class terms were used to classify cause-specific hospitalisations. The trial is registered with ClinicalTrials.gov, NCT01730534.FindingsBetween April 25, 2013, and Sept 18, 2018, 17 160 people (6422 [37·4%] women, 10 738 [62·6%] men; mean age 63·9 years [SD 6·8]) were enrolled in the original trial, of whom 10186 (59·4%) had multiple risk factors for but did not have established atherosclerotic cardiovascular disease, and 6835 (39·8%) had both no evidence of atherosclerotic cardiovascular disease and low KDIGO risk. Over a median follow-up of 4·2 years (IQR 3·9–4·4), dapagliflozin was associated with a lower risk of first non-elective hospitalisation for any cause (2779 [32·4%] of 8582 people in the dapagliflozin group vs 3036 [35·4%] of 8578 people in the placebo group; hazard ratio [HR] 0·89 [95% CI 0·85–0·94]) and total (first plus subsequent) non-elective hospitalisations for any cause (risk ratio 0·92 [95% CI 0·86–0·97]). The association between dapagliflozin use and the risk of first non-elective hospitalisation for any cause was consistent in subgroups of participants with (HR 0·92 [95% CI 0·85–0·99] and without (0·87 [0·81–0·94]) atherosclerotic cardiovascular disease at baseline (p interaction=0·31). Compared with the placebo group, the dapagliflozin group had lower risk of first hospitalisations due to cardiac disorders (HR 0·91 [95% CI 0·84–1·00]), metabolism and nutrition disorders (0·73 [0·60–0·89]), renal and urinary disorders (0·61 [0·49–0·77]), and due to any other cause excluding these three causes (0·90 [0·85–0·96]). Treatment with dapagliflozin was also associated with a lower risk of hospitalisations due to musculoskeletal and connective tissue disorders (HR 0·81 [0·67–0·99]) and infections and infastations (HR 0·86 [0·78–0·96]).InterpretationDapagliflozin reduced the risk of first and total non-elective hospitalisations for any cause in people with type 2 diabetes, regardless of the presence of atherosclerotic cardiovascular disease, including hospitalisations not directly attributed to cardiac, kidney, or metabolic causes. These findings might have implications on health-related quality of life for people with type 2 diabetes and on health-care costs attributable this condition.

Published
2023

9. Abstract 16139: A Targeted Proteomic Approach to Identify Circulating Biomarkers of Heart Failure Risk in Patients With Type 2 Diabetes Mellitus in DECLARE-TIMI 58

Author

Berg, David, Wiviott, Stephen D, RAZ, Itamar, Kamanu, Frederick, Im, KyungAh, Cahn, Avivit, Mosenzon, ofri, Bhatt, Deepak L, Jarolim, Petr, Leiter, Lawrence A, McGuire, Darren K, WILDING, JOHN, Huo, Yong, Lopez-sendon, Jose L, Ardissino, Diego, Gause-nilsson, Ingrid A, Sabatine, Marc S, and Morrow, David A

Published
2020
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10. Abstract 15701: Relationship Between Cardiac Biomarkers and Major Adverse Cardiovascular Events in DECLARE-TIMI 58

Author

Zelniker, Thomas A, Morrow, David A, Mosenzon, ofri, Goodrich, Erica, Jarolim, Petr, Cahn, Avivit, Bhatt, Deepak L, Leiter, Lawrence A, McGuire, Darren K, WILDING, JOHN, Averkov, Oleg V, Budaj, Andrzej, Parkhomenko, Alexander, Ray, Kausik K, Gause-nilsson, Ingrid A, Langkilde, Anna Maria, Fredriksson, Martin, RAZ, Itamar, Sabatine, Marc S, and Wiviott, Stephen D

Published
2020
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12. Dapagliflozin and Cardiac, Kidney, and Limb Outcomes in Patients With and Without Peripheral Artery Disease in DECLARE-TIMI 58

Author

Bonaca, Marc P., Wiviott, Stephen D., Zelniker, Thomas A., Mosenzon, Ofri, Bhatt, Deepak L., Leiter, Lawrence A., McGuire, Darren K., Goodrich, Erica L., De Mendonca Furtado, Remo Holanda, Wilding, John P.H., Cahn, Avivit, Gause-Nilsson, Ingrid A.M., Johanson, Per, Fredriksson, Martin, Johansson, Peter A., Langkilde, Anna Maria, Raz, Itamar, and Sabatine, Marc S.

Published
2020
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13. RELATIONSHIP BETWEEN CYSTATIN C, CREATININE-BASED EGFR, CARDIOVASCULAR EVENTS AND KIDNEY OUTCOMES IN DECLARETIMI 58

Author

Small, Andre M., primary, Berg, David, additional, Raz, Itamar, additional, Goodrich, Erica L., additional, Moura, Filipe, additional, Mosenzon, Ofri, additional, Cahn, Avivit, additional, Bhatt, Deepak L., additional, Leiter, Lawrence A., additional, McGuire, Darren K., additional, Wilding, John, additional, Gause-Nilsson, Ingrid, additional, Sabatine, Marc Steven, additional, Morrow, David A., additional, and Wiviott, Stephen D., additional

Published
2023
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15. Effect of Dapagliflozin on Heart Failure and Mortality in Type 2 Diabetes Mellitus

Author

Kato, Eri T., Silverman, Michael G., Mosenzon, Ofri, Zelniker, Thomas A., Cahn, Avivit, Furtado, Remo H.M., Kuder, Julia, Murphy, Sabina A., Bhatt, Deepak L., Leiter, Lawrence A., McGuire, Darren K., Wilding, John P.H., Bonaca, Marc P., Ruff, Christian T., Desai, Akshay S., Goto, Shinya, Johansson, Peter A., Gause-Nilsson, Ingrid, Johanson, Per, Langkilde, Anna Maria, Raz, Itamar, Sabatine, Marc S., and Wiviott, Stephen D.

Published
2019
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16. Dapagliflozin and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus and Previous Myocardial Infarction: Subanalysis From the DECLARE-TIMI 58 Trial

Author

Furtado, Remo H.M., Bonaca, Marc P., Raz, Itamar, Zelniker, Thomas A., Mosenzon, Ofri, Cahn, Avivit, Kuder, Julia, Murphy, Sabina A., Bhatt, Deepak L., Leiter, Lawrence A., McGuire, Darren K., Wilding, John P.H., Ruff, Christian T., Nicolau, Jose C., Gause-Nilsson, Ingrid A.M., Fredriksson, Martin, Langkilde, Anna Maria, Sabatine, Marc S., and Wiviott, Stephen D.

Published
2019
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17. Comparison of the Effects of Glucagon-Like Peptide Receptor Agonists and Sodium-Glucose Cotransporter 2 Inhibitors for Prevention of Major Adverse Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus: Systematic Review and Meta-Analysis of Cardiovascular Outcomes Trials

Author

Zelniker, Thomas A., Wiviott, Stephen D., Raz, Itamar, Im, KyungAh, Goodrich, Erica L., Furtado, Remo H.M., Bonaca, Marc P., Mosenzon, Ofri, Kato, Eri T., Cahn, Avivit, Bhatt, Deepak L., Leiter, Lawrence A., McGuire, Darren K., Wilding, John P.H., and Sabatine, Marc S.

Published
2019
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18. Efficacy and Safety of Dapagliflozin by Baseline Insulin Regimen and Dose: Post Hoc Analyses From DECLARE-TIMI 58

Author

Pollack, Rena, primary, Raz, Itamar, additional, Wiviott, Stephen D., additional, Goodrich, Erica L., additional, Murphy, Sabina A., additional, Yanuv, Ilan, additional, Rozenberg, Aliza, additional, Mosenzon, Ofri, additional, Langkilde, Anna Maria, additional, Gause-Nilsson, Ingrid A.M., additional, Bhatt, Deepak L., additional, Leiter, Lawrence A., additional, McGuire, Darren K., additional, Wilding, John P.H., additional, Sabatine, Marc S., additional, and Cahn, Avivit, additional

Published
2022
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19. Dapagliflozin and Prevention of Kidney Disease Among Patients With Type 2 Diabetes: Post Hoc Analyses From the DECLARE-TIMI 58 Trial

Author

Mosenzon, Ofri, primary, Raz, Itamar, additional, Wiviott, Stephen D., additional, Schechter, Meir, additional, Goodrich, Erica L., additional, Yanuv, Ilan, additional, Rozenberg, Aliza, additional, Murphy, Sabina A., additional, Zelniker, Thomas A., additional, Langkilde, Anna Maria, additional, Gause-Nilsson, Ingrid A.M., additional, Fredriksson, Martin, additional, Johansson, Peter A., additional, Wilding, John P.H., additional, McGuire, Darren K., additional, Bhatt, Deepak L., additional, Leiter, Lawrence A., additional, Cahn, Avivit, additional, Dwyer, Jamie P., additional, Heerspink, Hiddo J.L., additional, and Sabatine, Marc S., additional

Published
2022
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20. Efficacy and Safety of Dapagliflozin in Type 2 Diabetes According to Baseline Blood Pressure: Observations From DECLARE-TIMI 58 Trial

Author

Furtado, Remo H.M., primary, Raz, Itamar, additional, Goodrich, Erica L., additional, Murphy, Sabina A., additional, Bhatt, Deepak L., additional, Leiter, Lawrence A., additional, McGuire, Darren K., additional, Wilding, John P.H., additional, Aylward, Philip, additional, Dalby, Anthony J, additional, Dellborg, Mikael, additional, Dimulescu, Doina, additional, Nicolau, José C., additional, Oude Ophuis, Anthonius J.M., additional, Cahn, Avivit, additional, Mosenzon, Ofri, additional, Gause-Nilsson, Ingrid, additional, Langkilde, Anna Maria, additional, Sabatine, Marc S., additional, and Wiviott, Stephen D., additional

Published
2022
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21. FIBROBLAST GROWTH FACTOR-23, CARDIORENAL OUTCOMES, AND EFFICACY OF DAPAGLIFLOZIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS: AN ANALYSIS FROM DECLARE-TIMI 58

Author

Berg, David, primary, Wiviott, Stephen D., additional, Raz, Itamar, additional, Jarolim, Petr, additional, Goodrich, Erica L., additional, Mosenzon, Ofri, additional, Cahn, Avivit, additional, Bhatt, Deepak L., additional, Leiter, Lawrence A., additional, McGuire, Darren K., additional, Wilding, John PH, additional, Gause-Nilsson, Ingrid, additional, Hammarstedt, Ann, additional, Oscarsson, Jan, additional, Sabatine, Marc Steven, additional, and Morrow, David A., additional

Published
2022
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22. Association of Baseline HbA1c With Cardiovascular and Renal Outcomes: Analyses From DECLARE-TIMI 58

Author

Cahn, Avivit, primary, Wiviott, Stephen D., additional, Mosenzon, Ofri, additional, Goodrich, Erica L., additional, Murphy, Sabina A., additional, Yanuv, Ilan, additional, Rozenberg, Aliza, additional, Bhatt, Deepak L., additional, Leiter, Lawrence A., additional, McGuire, Darren K., additional, Wilding, John P.H., additional, Gause-Nilsson, Ingrid A.M., additional, Langkilde, Anna Maria, additional, Sabatine, Marc S., additional, and Raz, Itamar, additional

Published
2022
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23. Abstract 13182: Dapagliflozin and Changes in Metabolic Syndrome in Patients With Type 2 Diabetes: A DECLARE TIMI 58 Sub-Analysis

Author

Moura, Filipe A, primary, RAZ, Itamar, additional, Cahn, Avivit, additional, Goodrich, Erica, additional, Bhatt, Deepak L, additional, Leiter, Lawrence A, additional, WILDING, JOHN, additional, Gause-nilsson, Ingrid A, additional, Mosenzon, Ofri, additional, Sabatine, Marc S, additional, and Wiviott, Stephen D, additional

Published
2021
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24. Efficacy and Safety of Dapagliflozin by Baseline Insulin Regimen and Dose: Post Hoc Analyses From DECLARE-TIMI 58.

Author

Pollack, Rena, Raz, Itamar, Wiviott, Stephen D., Goodrich, Erica L., Murphy, Sabina A., Yanuv, Ilan, Rozenberg, Aliza, Mosenzon, Ofri, Langkilde, Anna Maria, Gause-Nilsson, Ingrid A.M., Bhatt, Deepak L., Leiter, Lawrence A., McGuire, Darren K., Wilding, John P.H., Sabatine, Marc S., and Cahn, Avivit

Subjects
INSULIN therapy, DAPAGLIFLOZIN, SODIUM-glucose cotransporter 2 inhibitors, SYSTOLIC blood pressure, SALT-free diet, DIABETIC acidosis, INSULIN pumps
Abstract

Objective: The cardiorenal benefits of adding sodium-glucose cotransporter 2 (SGLT2) inhibitor therapy for patients on insulin, particularly those on intensive regimens that include short-acting (SA) insulin, have not been explored.Research Design and Methods: In Dapagliflozin Effect on Cardiovascular Events trial (DECLARE-TIMI 58), 17,160 patients with type 2 diabetes were randomized to dapagliflozin or placebo for a median follow-up of 4.2 years. Cardiovascular (CV), renal, metabolic, and safety outcomes with dapagliflozin versus placebo by insulin dose and regimen were studied with Cox regression models.Results: The study included 7,013 insulin users at baseline, with 4,650 (66.3%) patients on regimens including SA insulin. Insulin doses varied, with 2,443 (34.8%) patients receiving <0.5 IU/kg, 2,795 (39.9%) 0.5 to ≤1 IU/kg, and 1,339 (19.1%) >1 IU/kg. Dapagliflozin reduced CV death/hospitalization for heart failure among overall insulin users (hazard ratio [HR] 0.82 [95% CI 0.69-0.97]) and consistently in patients on insulin regimens with or without SA insulin (0.83 [0.67-1.03] and 0.78 [0.57-1.07], respectively, Pinteraction = 0.75). No heterogeneity was observed by insulin dose (Pinteraction = 0.43). The HR for major adverse CV events with dapagliflozin among insulin users (0.84 [0.74-0.97]) was similar irrespective of regimen or dose (Pinteraction = 0.75 and 0.07). Dapagliflozin reduced the rate of adverse renal outcomes overall and consistently across subgroups of insulin users. Decreases in HbA1c, weight, and systolic blood pressure with dapagliflozin were seen regardless of insulin dose or regimen. The known safety profile of dapagliflozin was unchanged in patients on intensive insulin regimens.Conclusions: The benefits and safety of dapagliflozin were maintained in high-risk patients receiving high-dose or intensive insulin regimens including SA insulin.Article Highlights: Limited data exist regarding the cardiorenal, metabolic, and safety outcomes of SGLT2 inhibitors in patients on high-dose or intensive insulin regimens including short-acting insulin. In DECLARE-TIMI 58, 17,160 patients including 7,013 baseline insulin users were randomized to dapagliflozin versus placebo. Outcomes among insulin users by insulin dose and regimen were studied. Our results suggest that use of dapagliflozin by patients with type 2 diabetes managed with insulin, including high-dose or intensive insulin regimens, provided significant cardiovascular, renal, and metabolic benefits, in line with overall trial results. Adverse events associated with dapagliflozin, including hypoglycemia and diabetic ketoacidosis, were rare in this cohort. [ABSTRACT FROM AUTHOR]

Published
2023
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27. A Biomarker-Based Score for Risk of Hospitalization for Heart Failure in Patients With Diabetes

Author

Berg, David D., primary, Wiviott, Stephen D., additional, Scirica, Benjamin M., additional, Zelniker, Thomas A., additional, Goodrich, Erica L., additional, Jarolim, Petr, additional, Mosenzon, Ofri, additional, Cahn, Avivit, additional, Bhatt, Deepak L., additional, Leiter, Lawrence A., additional, McGuire, Darren K., additional, Wilding, John P.H., additional, Johanson, Per, additional, Langkilde, Anna Maria, additional, Raz, Itamar, additional, Braunwald, Eugene, additional, Sabatine, Marc S., additional, and Morrow, David A., additional

Published
2021
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28. Obesity and effects of dapagliflozin on cardiovascular and renal outcomes in patients with type 2 diabetes mellitus in the DECLARE–TIMI 58 trial

Author

Oyama, Kazuma, primary, Raz, Itamar, additional, Cahn, Avivit, additional, Kuder, Julia, additional, Murphy, Sabina A, additional, Bhatt, Deepak L, additional, Leiter, Lawrence A, additional, McGuire, Darren K, additional, Wilding, John P H, additional, Park, Kyong Soo, additional, Goudev, Assen, additional, Diaz, Rafael, additional, Špinar, Jindřich, additional, Gause-Nilsson, Ingrid A M, additional, Mosenzon, Ofri, additional, Sabatine, Marc S, additional, and Wiviott, Stephen D, additional

Published
2021
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29. The Effect of Dapagliflozin on Albuminuria in DECLARE-TIMI 58

Author

Mosenzon, Ofri, primary, Wiviott, Stephen D., additional, Heerspink, Hiddo J.L., additional, Dwyer, Jamie P., additional, Cahn, Avivit, additional, Goodrich, Erica L., additional, Rozenberg, Aliza, additional, Schechter, Meir, additional, Yanuv, Ilan, additional, Murphy, Sabina A., additional, Zelniker, Thomas A., additional, Gause-Nilsson, Ingrid A.M., additional, Langkilde, Anna Maria, additional, Fredriksson, Martin, additional, Johansson, Peter A., additional, Bhatt, Deepak L., additional, Leiter, Lawrence A., additional, McGuire, Darren K., additional, Wilding, John P.H., additional, Sabatine, Marc S., additional, and Raz, Itamar, additional

Published
2021
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31. Obesity and effects of dapagliflozin on cardiovascular and renal outcomes in patients with type 2 diabetes mellitus in the DECLARE–TIMI 58 trial.

Author

Oyama, Kazuma, Raz, Itamar, Cahn, Avivit, Kuder, Julia, Murphy, Sabina A, Bhatt, Deepak L, Leiter, Lawrence A, McGuire, Darren K, Wilding, John P H, Park, Kyong Soo, Goudev, Assen, Diaz, Rafael, Špinar, Jindřich, Gause-Nilsson, Ingrid A M, Mosenzon, Ofri, Sabatine, Marc S, and Wiviott, Stephen D

Subjects
TYPE 2 diabetes, SODIUM-glucose cotransporter 2 inhibitors, DAPAGLIFLOZIN, ATRIAL flutter, DISEASE risk factors
Abstract

Aims  We investigated the associations between obesity, cardiorenal events, and benefits of dapagliflozin in patients with type 2 diabetes mellitus (T2DM). Methods and results  DECLARE–TIMI 58 randomized patients with T2DM and either atherosclerotic cardiovascular (CV) disease or multiple risk factors to dapagliflozin vs. placebo. Patients were stratified by body mass index (BMI, kg/m2): normal (18.5 to <25), overweight (25 to <30), moderately obese (30 to <35), severely obese (35 to <40), and very-severely obese (≥40). Outcomes analysed were CV death, hospitalization for heart failure (HHF), renal-specific composite outcome, and atrial fibrillation or flutter (AF/AFL). Of 17 134 patients, 9.0% had a normal BMI, 31.5% were overweight, 32.4% were moderately, 17.2% severely, and 9.8% were very-severely obese. Higher BMI was associated with a higher adjusted risk of HHF and AF/AFL (hazard ratio 1.30 and 1.28, respectively, per 5 kg/m2; P  < 0.001 for all). Dapagliflozin reduced body weight by similar relative amounts consistently across BMI categories (percent difference: −1.9 to −2.4%). Although relative risk reductions in CV and renal-specific composite outcomes with dapagliflozin did not significantly differ across the range of BMI (P for interaction ≥0.20 for all outcomes), obese patients (BMI ≥ 30 kg/m2) tended to derive greater absolute risk reduction in HHF and AF/AFL (P for interaction 0.02 and 0.09, respectively) than non-obese patients. Conclusions  In DECLARE–TIMI 58, patients with T2DM and higher BMI were more likely to have HHF and AF/AFL. Whereas relative risk reductions in CV and renal outcomes with dapagliflozin were generally consistent across the range of BMI, absolute risk reduction in obesity-related outcomes including HHF and AF/AFL tended to be larger in obese patients with T2DM. Clinical trial registration URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01730534. [ABSTRACT FROM AUTHOR]

Published
2022
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32. 788-P: The Cardiovascular and Renal Benefits of Dapagliflozin Are Independent of Baseline HbA1c: Analyses from DECLARE-TIMI 58

Author

CAHN, AVIVIT, primary, WIVIOTT, STEPHEN D., additional, MOSENZON, OFRI, additional, MURPHY, SABINA, additional, GOODRICH, ERICA L., additional, BHATT, DEEPAK L., additional, LEITER, LAWRENCE A., additional, MCGUIRE, DARREN K., additional, WILDING, JOHN, additional, GAUSE-NILSSON, INGRID A., additional, LANGKILDE, ANNA MARIA, additional, SABATINE, MARC S., additional, and RAZ, ITAMAR, additional

Published
2021
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33. MEDIATION ANALYSIS FOR DAPAGLIFLOZIN AND THE REDUCTION IN HOSPITALIZATION FOR HEART FAILURE IN DECLARE-TIMI 58

Author

Berg, David, primary, Wiviott, Stephen, additional, Goodrich, Erica, additional, Murphy, Sabina, additional, Mosenzon, Ofri, additional, Bhatt, Deepak, additional, Cahn, Avivit, additional, Leiter, Lawrence, additional, McGuire, Darren, additional, Wilding, John, additional, Gause-Nilsson, Ingrid, additional, Hammarstedt, Ann, additional, Karlsson, Cecilia, additional, Johansson, Peter, additional, Langkilde, Anna-Maria, additional, Raz, Itamar, additional, and Sabatine, Marc, additional

Published
2021
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34. Hypoglycaemia and its management in primary care setting

Author

Ibrahim, Mahmoud, Baker, Jason, Cahn, Avivit, Eckel, Robert H., Sayed, Nuha Ali El, Fischl, Amy Hess, Gaede, Peter, Leslie, R. David, Pieralice, Silvia, Tuccinardi, Dario, Pozzilli, Paolo, Richelsen, Bjørn, Roitman, Eytan, Standl, Eberhard, Toledano, Yoel, Tuomilehto, Jaakko, Weber, Sandra L., Umpierrez, Guillermo E., and Clinicum

Subjects
Continuous glucose monitoring (CGM), Technology, COGNITIVE DYSFUNCTION, diabetes self-management education, endocrine system diseases, diabetes, REAL-TIME, GLUCOSE-SENSING TECHNOLOGY, AUTONOMIC FAILURE, nutritional and metabolic diseases, INTENSIVE INSULIN THERAPY, DEPENDENT DIABETES-MELLITUS, OPEN-LABEL, IMPAIRED AWARENESS, Hypoglycemia, hypoglycaemia unawareness pregnancy, 3121 General medicine, internal medicine and other clinical medicine, GLYCEMIC CONTROL, continuous glucose monitoring, hypoglycemia unawareness Pregnancy, PREGNANT-WOMEN, hypoglycaemia
Abstract

Hypoglycemia is common in patients with type 1 diabetes (T1D) and type 2 diabetes (T2D) and constitutes a major limiting factor in achieving glycemic control among people with diabetes. While hypoglycemia is defined as a blood glucose level under 70 mg/dL (3.9?mmol/L), symptoms may occur at higher blood glucose levels in individuals with poor glycemic control. Severe hypoglycemia is defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions to assure neurologic recovery. Hypoglycemia is the most important safety outcome in clinical studies of glucose lowering agents. The ADA Standards of Medical Care recommends that a management protocol for hypoglycemia should be designed and implemented by every hospital, along with a clear prevention and treatment plan. A tailored approach, using clinical and pathophysiologic disease stratification, can help individualize glycemic goals and promote new therapies to improve quality of life of patients. Data from recent large clinical trials reported low risk of hypoglycemic events with the use of newer antidiabetic drugs. Increased hypoglycemia risk is observed with the use of insulin and/or sulfonylureas. Vulnerable patients with T2D at dual risk of severe hypoglycemia and Cardiovascular (CV) outcomes show features of ?frailty?. Many of such patients may be better treated by the use of GLP-1 receptor agonists or SGLT2 inhibitors rather than insulin. CGM should be considered for all individuals with increased risk for hypoglycemia, impaired hypoglycemia awareness, frequent nocturnal hypoglycemia and with history of severe hypoglycemia. Patients with impaired awareness of hypoglycemia (IAH) benefit from real-time continuous glucose monitoring (CGM). The diabetes educator is an invaluable resource and can devote the time needed to thoroughly educate the individual to reduce the risk of hypoglycemia and integrate the information within the entire construct of diabetes self-management. Conversations about hypoglycemia facilitated by a healthcare professional may reduce the burden and fear of hypoglycemia among patients with diabetes and their family members. Optimizing insulin doses and carbohydrate intake, in addition to a short warm up before or after the physical activity sessions may help avoiding hypoglycemia. Several therapeutic considerations are important to reduce hypoglycemia risk during pregnancy including administration of rapid-acting insulin analogs rather than human insulin, pre-conception initiation of insulin analogs, and immediate postpartum insulin dose reduction. This article is protected by copyright. All rights reserved.

Published
2020

35. Cardiovascular, Renal, and Metabolic Outcomes of Dapagliflozin Versus Placebo in a Primary Cardiovascular Prevention Cohort: Analyses From DECLARE-TIMI 58

Author

Cahn, Avivit, primary, Raz, Itamar, additional, Leiter, Lawrence A., additional, Mosenzon, Ofri, additional, Murphy, Sabina A., additional, Goodrich, Erica L., additional, Yanuv, Ilan, additional, Rozenberg, Aliza, additional, Bhatt, Deepak L., additional, McGuire, Darren K., additional, Wilding, John P.H., additional, Gause-Nilsson, Ingrid A.M., additional, Langkilde, Anna Maria, additional, Sabatine, Marc S., additional, and Wiviott, Stephen D., additional

Published
2021
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38. 303-OR: Effect of Dapagliflozin on Risk for Fast Decline in EGFR: Analyses from the DECLARE-TIMI 58 Trial

Author

RAZ, ITAMAR, primary, WIVIOTT, STEPHEN D., additional, HEERSPINK, HIDDO L., additional, DWYER, JAMIE P., additional, CAHN, AVIVIT, additional, GOODRICH, ERICA L., additional, MURPHY, SABINA, additional, ROZENBERG, ALIZA, additional, YANUV, ILAN, additional, WILDING, JOHN, additional, LEITER, LAWRENCE A., additional, BHATT, DEEPAK L., additional, MCGUIRE, DARREN K., additional, MA, RONALD C., additional, TANKOVA, TSVETALINA, additional, FREDRIKSSON, MARTIN, additional, GAUSE-NILSSON, INGRID A., additional, LANGKILDE, ANNA MARIA, additional, SABATINE, MARC S., additional, and MOSENZON, OFRI, additional

Published
2020
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39. 1101-P: Cardiorenal Outcomes with Dapagliflozin by Baseline Glucose Lowering Agents: Analyses from DECLARE-TIMI 58

Author

CAHN, AVIVIT, primary, WIVIOTT, STEPHEN D., additional, MOSENZON, OFRI, additional, MURPHY, SABINA, additional, GOODRICH, ERICA L., additional, YANUV, ILAN, additional, ROZENBERG, ALIZA, additional, WILDING, JOHN, additional, LEITER, LAWRENCE A., additional, BHATT, DEEPAK L., additional, MCGUIRE, DARREN K., additional, LITWAK, LEON, additional, KOOY, ADRIAAN, additional, GAUSE-NILSSON, INGRID A., additional, FREDRIKSSON, MARTIN, additional, LANGKILDE, ANNA MARIA, additional, SABATINE, MARC S., additional, and RAZ, ITAMAR, additional

Published
2020
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41. EFFECTS OF DAPAGLIFLOZIN ON CARDIOVASCULAR OUTCOMES ACROSS BODY MASS INDEX CATEGORIES IN PATIENTS WITH TYPE 2 DIABETES MELLITUS IN THE DECLARE TIMI 58 TRIAL

Author

Oyama, Kazuma, primary, Raz, Itamar, additional, Cahn, Avivit, additional, Kuder, Julia, additional, Murphy, Sabina, additional, Bhatt, Deepak, additional, Leiter, Lawrence A., additional, McGuire, Darren K., additional, Wilding, John, additional, Park, Kyong-Soo, additional, Goudev, Assen, additional, Diaz, Rafael, additional, Špinar, Jindřich, additional, Gause-Nilsson, Ingrid, additional, Mosenzon, Ofri, additional, Sabatine, Marc, additional, and Wiviott, Stephen D., additional

Published
2020
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43. Efficacy and Safety of Dapagliflozin in the Elderly: Analysis From the DECLARE–TIMI 58 Study

Author

Cahn, Avivit, primary, Mosenzon, Ofri, additional, Wiviott, Stephen D., additional, Rozenberg, Aliza, additional, Yanuv, Ilan, additional, Goodrich, Erica L., additional, Murphy, Sabina A., additional, Bhatt, Deepak L., additional, Leiter, Lawrence A., additional, McGuire, Darren K., additional, Wilding, John P.H., additional, Gause-Nilsson, Ingrid A.M., additional, Fredriksson, Martin, additional, Johansson, Peter A., additional, Langkilde, Anna Maria, additional, Sabatine, Marc S., additional, and Raz, Itamar, additional

Published
2019
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46. Imported melioidosis, Israel, 2008

Author

Cahn, Avivit, Koslowsky, Benjamin, Nir-Paz, Ran, Temper, Violeta, Hiller, Nurit, Karlinsky, Alla, Gur, Itzhak, Hidalgo-Grass, Carlos, Heyman, Samuel N., Moses, Allon E., and Block, Colin

Subjects
Infection -- Health aspects, Pseudomonas infections -- Health aspects, Diabetes -- Health aspects
Abstract

Melioidosis, which is caused by Burkholderia pseudomallei, is endemic to some areas of Southeast Asia and northern Australia (1,2). Recent data indicate that it is now endemic to most of [...]

Published
2009
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47. The efficacy and safety of dapagliflozin in women and men with type 2 diabetes mellitus.

Author

O'Donoghue, Michelle L., Kato, Eri T., Mosenzon, Ofri, Murphy, Sabina A., Cahn, Avivit, Herrera, Marisol, Tankova, Tsvetalina, Šmahelová, Alena, Merlini, Piera, Gause-Nilsson, Ingrid, Langkilde, Anna Maria, McGuire, Darren K., Wilding, John P. H., Leiter, Larry A., Bhatt, Deepak L., Raz, Itamar, Sabatine, Marc S., and Wiviott, Stephen D.

Abstract

Aims/hypothesis: Women remain underrepresented in clinical trials and those with type 2 diabetes mellitus are at high risk for cardiovascular (CV) events. The sodium–glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin reduces the risk of CV death or heart failure hospitalisations in individuals with type 2 diabetes. Here, we performed a pre-specified analysis to examine whether sex modifies these effects. Methods: The DECLARE-TIMI 58 trial randomised 17,160 patients with type 2 diabetes with or at risk for atherosclerotic disease to dapagliflozin or placebo (median follow-up 4.2 years). The dual efficacy outcomes were CV death or heart failure hospitalisations, and major adverse cardiovascular events (MACE; CV death, myocardial infarction or ischaemic stroke). The renal-specific composite outcome was a sustained ≥40% drop in eGFR to <60 ml min−1 [1.73 m]−2, new end-stage renal disease or renal death. Cox models were run separately by sex with treatment-by-sex interaction testing for each outcome. Results: At baseline, women (n = 6422, 37.4%) had higher HbA1c, longer type 2 diabetes duration, and were on fewer glucose-lowering medications. There was no evidence of modification of the effect of dapagliflozin by sex for (1) CV death or heart failure hospitalisations: women (3.8% vs 4.5%; HR 0.84, 95% CI 0.66, 1.07) and men (5.3% vs 6.4%; HR 0.83, 95% CI 0.71, 0.96; pinteraction = 0.90); (2) MACE: women (6.3% vs 6.8%; HR 0.93, 95% CI 0.77, 1.12) and men (10.0% vs 10.7%; HR 0.93, 95% CI 0.83, 1.05; pinteraction = 0.99); or (3) renal-specific composite: women (1.4% vs 2.8%; HR 0.50, 95% CI 0.35, 0.70) and men (1.5% vs 2.5%; HR 0.55, 95% CI 0.42, 0.73; pinteraction = 0.64). The overall safety profile of dapagliflozin was similar for women and men. Conclusions/interpretation: Dapagliflozin offers comparable CV and renal benefits and a comparable safety profile in women and men. Funding: AstraZeneca. Trial registration: clinicaltrials.gov NCT01730534. [ABSTRACT FROM AUTHOR]

Published
2021
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49. 244-OR: Effects of Dapagliflozin on the Urinary Albumin-to-Creatinine Ratio in Patients with Type 2 Diabetes: A Predefined Analysis from the DECLARE-TIMI 58 Randomised, Placebo-Controlled Trial

Author

RAZ, ITAMAR, primary, WIVIOTT, STEPHEN D., additional, YANUV, ILAN, additional, ROZENBERG, ALIZA, additional, ZELNIKER, THOMAS A., additional, CAHN, AVIVIT, additional, HEERSPINK, HIDDO L., additional, DWYER, JAMIE P., additional, GOODRICH, ERICA, additional, BHATT, DEEPAK L., additional, LEITER, LAWRENCE A., additional, MCGUIRE, DARREN K., additional, WILDING, JOHN P., additional, GAUSE-NILSSON, INGRID ANNA, additional, FREDRIKSSON, MARTIN, additional, JOHANSSON, PETER A., additional, LANGKILDE, ANNA MARIA, additional, SABATINE, MARC S., additional, and MOSENZON, OFRI, additional

Published
2019
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50. Cardiac and Inflammatory Biomarkers Are Associated with Worsening Renal Outcomes in Patients with Type 2 Diabetes Mellitus: Observations from SAVOR-TIMI 53

Author

Zelniker, Thomas A, primary, Morrow, David A, primary, Mosenzon, Ofri, primary, Gurmu, Yared, primary, Im, Kyungah, primary, Cahn, Avivit, primary, Raz, Itamar, primary, Steg, Philippe Gabriel, primary, Leiter, Lawrence A, primary, Braunwald, Eugene, primary, Bhatt, Deepak L, primary, and Scirica, Benjamin M, primary

Published
2019
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