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ABSTRACT
Introduction
Heart failure (HF) is becoming a huge public health burden. New diabetes drugs for type 2 diabetes (T2D), sodium-glucose cotransporter type 2 inhibitors (SGLT2is), reduce the rate of hospitalization for HF in placebo-controlled trials.
Areas covered
Pharmacokinetics of dapagliflozin and empagliflozin (in presence of renal impairment and hepatic dysfunction, two comorbidities frequently associated with HF) and pharmacodynamic studies in patients with HF. Main HF outcomes in T2D patients with cardiovascular risk and in patients with reduced (HFrEF) or preserved (HFpEF) ejection fraction, with or without T2D, from DAPA-HF, EMPEROR-Reduced and EMPEROR-Preserved original findings and post hoc analyses.
Expert opinion
No clinically relevant changes are expected concerning SGLT2i pharmacokinetics in patients with HF while pharmacodynamic studies reported improvements in myocardium/vascular parameters, biomarkers, and functional status. All SGLT2is showed a remarkable reduction in hospitalization for HF in patients with T2D and high cardiovascular risk. Furthermore, both dapagliflozin and empagliflozin improved the prognosis of patients with HFrEF, independently of the presence of T2D. Similar results were reported with empagliflozin in patients with HFpEF, to be confirmed with dapagliflozin in an ongoing trial (DELIVER). Thus, SGLT2is offer a new opportunity for the prevention and management of HF in patients with or without T2D.
Article highlights
Heart failure (HF) represents a major concern not only in patients with T2D but also in the general elderly population.
While several pharmacological approaches have proven their efficacy in the management of patients with reduced ejection fraction (HFrEF), none succeeded to do so in patients with preserved ejection fraction (HFpEF) yet.
All SGLT2is showed a marked reduction in hospitalization for HF (alone or combined with CV mortality) in patients with T2D and high CV risk.
Dapagliflozin and empagliflozin, when added to standard care, were associated with a better clinical prognosis in patients with HFrEF, irrespective of the presence of T2D.
Empagliflozin showed a similar improvement in a composite of CV death or hospitalization for HF in patients with HFpEF, both in individuals with and without T2D (dapagliflozin is currently tested in this population in an ongoing trial).
PK/PD characteristics and safety issues of SGLT2is (dapagliflozin and empagliflozin in particular) are fundamentally not different in patients with HF compared to people without HF.
SGLT2is are currently considered as a major breakthrough in the management of patients with HF as emphasized in recent guidelines from diabetes and cardiology scientific societies.
This box summarizes key points contained in the article.
Declaration of interest
AJ Scheen has received lecturer/scientific advisor/clinical investigator fees from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Merck Sharp & Dohme, NovoNordisk and Sanofi-Aventis; and has worked as a clinical investigator in EMPA-REG OUTCOME, CANVAS-R, DECLARE-TIMI 58, LEADER and HARMONY Outcomes cardiovascular outcome trials. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Reviewer disclosures
A reviewer on this manuscript has disclosed being a consultant for Lexicon (sotagliflozin), Bayer, AstraZeneca (dapgliflozin), Merck and Boehringer Ingelheim/Lilly (empaglifozin). Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.
Supplementary material
Supplemental data for this article can be accessed here