Sodium glucose cotransporter 2 inhibitors and risk of serious adverse events: nationwide register based cohort study

To assess the association between the use of sodium glucose cotransporter 2 (SGLT2) inhibitors and seven serious adverse events of current concern. Register based cohort study. Sweden and Denmark from July 2013 to December 2016. A propensity score matched cohort of 17 213 new users of SGLT2 inhibito...

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Veröffentlicht in:	BMJ (Online) Jg. 363; S. k4365
Hauptverfasser:	Ueda, Peter, Svanström, Henrik, Melbye, Mads, Eliasson, Björn, Svensson, Ann-Marie, Franzén, Stefan, Gudbjörnsdottir, Soffia, Hveem, Kristian, Jonasson, Christian, Pasternak, Björn
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	England BMJ Publishing Group LTD 14.11.2018 BMJ Publishing Group Ltd
Schlagworte:	Adult Amputation Amputation - statistics & numerical data Benzhydryl Compounds - adverse effects Bias Canagliflozin - adverse effects Cohort analysis Cohort Studies Denmark - epidemiology Diabetes Diabetes mellitus Diabetes Mellitus, Type 2 - drug therapy Diabetic ketoacidosis Diabetic Ketoacidosis - epidemiology Disease management Endocrinology and Diabetes Endokrinologi och diabetes Female Folkhälsovetenskap, global hälsa och socialmedicin Fractures Fractures, Bone - epidemiology Glucagon Glucagon-like peptide 1 Glucose Glucosides - adverse effects Health risk assessment Humans Hypoglycemic Agents - adverse effects Ketoacidosis Kidneys Logistic Models Male Middle Aged Na+/glucose cotransporter Pancreatitis Pancreatitis - epidemiology Patients Prescription drugs Propensity Score Public Health, Global Health and Social Medicine Sodium Sodium-Glucose Transporter 2 Inhibitors - adverse effects Substance abuse treatment Sweden - epidemiology Thromboembolism Urinary tract Urinary tract diseases Urinary tract infections Urinary Tract Infections - epidemiology Urogenital system Venous Thromboembolism - epidemiology Denmark Sweden United States > US
ISSN:	0959-8138, 1756-1833, 1756-1833
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Zusammenfassung:	To assess the association between the use of sodium glucose cotransporter 2 (SGLT2) inhibitors and seven serious adverse events of current concern. Register based cohort study. Sweden and Denmark from July 2013 to December 2016. A propensity score matched cohort of 17 213 new users of SGLT2 inhibitors (dapagliflozin, 61%; empagliflozin, 38%; canagliflozin, 1%) and 17 213 new users of the active comparator, glucagon-like peptide 1 (GLP1) receptor agonists. The primary outcomes were lower limb amputation, bone fracture, diabetic ketoacidosis, acute kidney injury, serious urinary tract infection, venous thromboembolism, and acute pancreatitis, as identified from hospital records. Hazard ratios and 95% confidence intervals were estimated by using Cox proportional hazards models. Use of SGLT2 inhibitors, as compared with GLP1 receptor agonists, was associated with an increased risk of lower limb amputation (incidence rate 2.7 1.1 events per 1000 person years, hazard ratio 2.32, 95% confidence interval 1.37 to 3.91) and diabetic ketoacidosis (1.3 0.6, 2.14, 1.01 to 4.52) but not with bone fracture (15.4 13.9, 1.11, 0.93 to 1.33), acute kidney injury (2.3 3.2, 0.69, 0.45 to 1.05), serious urinary tract infection (5.4 6.0, 0.89, 0.67 to 1.19), venous thromboembolism (4.2 4.1, 0.99, 0.71 to 1.38) or acute pancreatitis (1.3 1.2, 1.16, 0.64 to 2.12). In this analysis of nationwide registers from two countries, use of SGLT2 inhibitors, as compared with GLP1 receptor agonists, was associated with an increased risk of lower limb amputation and diabetic ketoacidosis, but not with other serious adverse events of current concern.
Bibliographie:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23
ISSN:	0959-8138 1756-1833 1756-1833
DOI:	10.1136/bmj.k4365