title: Heart failure: a cardiovascular outcome in diabetes that can no longer be ignored.
abstract: In patients with type 1 or type 2 diabetes, glycaemic exposure assessed as HbA1c correlates strongly with risk of future microvascular and macrovascular complications. Improved glucose control substantially reduces the risk of microvascular complications and, with extended follow-up, modestly reduces the risk of atherosclerotic events. The lowering of HbA1c concentrations by newly developed glucose-lowering drugs (alone or when added to other glucose-lowering drugs) has been used, until recently, as a surrogate measure of their potential to lower cardiovascular risk. This assumption is no longer acceptable, and now demonstration of cardiovascular safety has been mandated by regulatory authorities. A major concern, however, is the universal absence in any large-scale trials of new glucose-lowering drugs of hospital admission for heart failure as a prespecified component of the primary composite cardiovascular outcomes. This omission is important because hospital admission for heart failure is a common and prognostically important cardiovascular complication of diabetes. Moreover, it is the one cardiovascular outcome for which the risk has been shown unequivocally to be increased by some glucose-lowering therapies. As such, we believe that heart failure should be systematically evaluated in cardiovascular outcome trials of all new glucose-lowering drugs.
authors.affiliation: BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK. Electronic address: john.mcmurray@glasgow.ac.uk.
authors.forename: John J V
authors.initials: JJ
authors.lastname: McMurray
authors.affiliation: Department of Medicine and Department of Clinical Epidemiology and Biostatistics, McMaster University and Population Health Research Institute, Hamilton, ON, Canada.
authors.forename: Hertzel C
authors.initials: HC
authors.lastname: Gerstein
authors.affiliation: Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford, UK.
authors.forename: Rury R
authors.initials: RR
authors.lastname: Holman
authors.affiliation: Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: Marc A
authors.initials: MA
authors.lastname: Pfeffer
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003922:Diabetes Mellitus, Type 1 / Q000150:complications* / Q000188:drug therapy; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000188:drug therapy; D006333:Heart Failure / Q000139:chemically induced / Q000453:epidemiology* / Q000209:etiology*; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects; D008875:Middle Aged; D012307:Risk Factors; D055815:Young Adult
chemical_list: D007004:Hypoglycemic Agents