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Heart failure: a cardiovascular outcome in diabetes that can no longer be ignored
John J V McMurray1, Hertzel C Gerstein2, Rury R Holman3
1BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.
Insights
New diabetes drugs should be tested for heart failure risk. Current trials often omit this crucial cardiovascular outcome, despite its importance in diabetic patients.
Area of Science:
- Endocrinology
- Cardiology
- Clinical Trials
Background:
- Glycemic control, measured by HbA1c, strongly correlates with microvascular and macrovascular complications in diabetes.
- Lowering HbA1c with new drugs was previously used as a surrogate for cardiovascular risk reduction.
- Regulatory bodies now mandate cardiovascular safety demonstration for new glucose-lowering drugs.
Purpose of the Study:
- To highlight the critical need for evaluating heart failure hospital admissions in cardiovascular outcome trials for new glucose-lowering drugs.
- To address the current omission of heart failure as a primary endpoint in large-scale trials of novel diabetes medications.
Main Methods:
- Review of current regulatory requirements for cardiovascular safety in diabetes drug development.
- Analysis of the significance of heart failure as a cardiovascular complication in diabetic patients.
- Assessment of the impact of existing glucose-lowering therapies on heart failure risk.
Main Results:
- Hospital admission for heart failure is a common and prognostically significant complication of diabetes.
- Some glucose-lowering therapies have unequivocally increased the risk of heart failure.
- Current large-scale trials for new glucose-lowering drugs often lack heart failure as a prespecified primary outcome.
Conclusions:
- Heart failure should be systematically evaluated in all cardiovascular outcome trials for new glucose-lowering drugs.
- Relying solely on HbA1c reduction as a surrogate for cardiovascular benefit is no longer acceptable.
- Ensuring heart failure safety is paramount for new diabetes medications due to its prevalence and association with specific therapies.
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.
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