Effect of sacubitril/valsartan versus enalapril on glycaemic control in patients with heart failure and diabetes: a post-hoc analysis from the PARADIGM-HF trial

Seferović, Jelena P.; Claggett, Brian; Seidelmann, Sara B.; Seely, Ellen W.; Packer, Milton; Zile, Michael R.; Rouleau, Jean L.; Swedberg, Karl; Lefkowitz, Martin; Shi, Victor; Desai, Akshay S.; McMurray, John J.V.; Solomon, Scott D.

doi:10.1016/s2213-8587(17)30087-6

Cited by 281 publications

(241 citation statements)

References 40 publications

(42 reference statements)

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“…Sacubitril/valsartan is safe and effective in a broad spectrum of patients with HFrEF . Its safety is similar in ACE‐I/ARB naïve patients and thus its initiation may be considered also in these patients.…”

Section: Pharmacotherapymentioning

confidence: 99%

Clinical practice update on heart failure 2019: pharmacotherapy, procedures, devices and patient management. An expert consensus meeting report of the Heart Failure Association of the European Society of Cardiology

Seferović

Ponikowski

Anker

et al. 2019

European J of Heart Fail

521

422

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The European Society of Cardiology (ESC) has published a series of guidelines on heart failure (HF) over the last 25 years, most recently in 2016. Given the amount of new information that has become available since then, the Heart Failure Association (HFA) of the ESC recognized the need to review and summarise recent developments in a consensus document. Here we report from the HFA workshop that was held

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Section: Pharmacotherapymentioning

confidence: 99%

Clinical practice update on heart failure 2019: pharmacotherapy, procedures, devices and patient management. An expert consensus meeting report of the Heart Failure Association of the European Society of Cardiology

Seferović

Ponikowski

Anker

et al. 2019

European J of Heart Fail

521

422

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“…81 In addition, initiation of insulin therapy was significantly lowered by 29% and the initiation of oral anti-hyperglycaemic therapy by 23%. 81 In addition, initiation of insulin therapy was significantly lowered by 29% and the initiation of oral anti-hyperglycaemic therapy by 23%.…”

Section: Diagnosis Screening and Therapymentioning

confidence: 99%

Heart failure in the patient with diabetes: Epidemiology, aetiology, prognosis, therapy and the effect of glucose‐lowering medications

Bell¹,

Goncalves

2019

Diabetes Obesity Metabolism

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In people with type 2 diabetes the frequency of heart failure (HF) is increased and mortality from HF is higher than with non-diabetic HF. The increased frequency of HF is attributable to the cardiotoxic tetrad of ischaemic heart disease, left ventricular hypertrophy, diabetic cardiomyopathy and an extracellular volume expansion resistant to atrial natriuretic peptides. Activation of the renin-angiotensin-aldosterone system and sympathetic nervous systems results in cardiac remodelling, which worsens cardiac function. Reversal of remodelling can be achieved, and cardiac function improved in people with HF with reduced ejection fraction (HFrEF) by treatment with angiotensin-converting enzyme inhibitors and β-blockers. However, with HF with preserved ejection fraction (HFpEF), only therapy for the underlying risk factors helps.Blockers of mineralocorticoid receptors may be beneficial in both HFrEF and HFpEF. Glucoselowering drugs can have a negative effect (insulin, sulphonylureas, dipeptidyl peptidase-4 inhibitors and thiazolidinediones), a neutral effect (α-glucosidase inhibitors and glucagon-like peptide-1 receptor agonists) or a positive effect (sodium-glucose co-transporter-2 inhibitors and metformin).antidiabetic drug, GLP-1 analogue, heart failure, insulin therapy, SGLT2 inhibitor, thiazolidinediones 1 | INTRODUCTION Heart failure (HF) results from structural and/or functional impairment of ventricular filling and/or ejection 1 and it is a common and serious comorbidity of type 2 diabetes. 2 In the present review we document the increased incidence of HF, and the reasons for this increase, as well as its poor prognosis in patients with diabetes.The potential therapies to both prevent and treat HF are discussed, in addition to the positive and negative effects of glucoselowering medications.Several reviews on this important subject have been recently published 3-7 ; however, this is a rapidly evolving field. An important limitation has been that HF was not a primary endpoint in most cardiovascular (CV) outcome trials, and it has been the most heterogeneously distributed outcome. | EPIDEMIOLOGYAs long ago as the Framingham Heart Study, HF was shown to be twice as common in men with diabetes and five times more common in women with diabetes between the ages of 45 and 74 years when compared with age-matched non-diabetic controls, and, in those aged ≤65 years, there was a fourfold increase in the prevalence of HF in men with diabetes and an eightfold increase in women with diabetes. 8In almost 10 000 patients with type 2 diabetes enrolled in a Health Maintenance Organization, 12% had HF at entry. Independent risk factors for the presence of HF were older age, longer duration of diabetes, use of insulin and lower body mass index (BMI). 9 In addition, those with type 2 diabetes who did not have HF at entry developed HF at a rate of 3.3% per year. The Reykjavik Study reported a 12% prevalence of HF in people with diabetes compared with 3% in people

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“…The pre‐specified exploratory outcome of new‐onset diabetes was not reduced, likely due to a very small number of new‐onset diabetes cases. An additional limitation of this same endpoint was that it was clinical and not routinely assessed . Another similar secondary analysis evaluated the impact of diabetes on the trial outcomes .…”

Section: Tolerabilitymentioning

confidence: 99%

PARADIGM‐HF Trial: Secondary Analyses Address Unanswered Questions

et al. 2018

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Our aim was to summarize published secondary analyses of the PARADIGM-HF trial. In the original trial, published in September 2014, sacubitril/valsartan significantly reduced the primary composite outcome of cardiovascular death or heart failure hospitalization compared to enalapril. This summary provides a resource for clinicians to review subsequent analyses of the landmark trial evaluating the benefit of sacubitril/valsartan in various subgroups and providing information regarding optimal use of this new therapy in the broader heart failure population. A full list of publications of the existing PARDADIGM-HF post hoc analyses was obtained and summarized, grouped by focus (e.g., severity of illness, tolerability). Twenty-six publications and one abstract analyzing the PARADIGM-HF trial were reviewed, summarizing the most important results that compared the benefits of sacubitril/valsartan to enalapril, including pertinent subgroup information from each analysis. Key publications evaluated the treatment effect of sacubitril/valsartan based on heart failure severity (i.e., ejection fraction or heart failure risk scores), impact on alternate outcomes, influence of additional therapies, tolerability in patients with comorbidities (i.e., diabetes), long-term benefits, and cost-effectiveness. In addition, nine ongoing phase III and phase IV clinical trials with sacubitril/valsartan were briefly summarized to address potential future uses in more extensive heart failure settings. The benefit of sacubitril/valsartan over enalapril for the primary endpoint in the PARADIGM-HF trial is maintained throughout numerous secondary analyses. Though the subgroups analyzed are based on participants from a single clinical trial, clinicians can more confidently incorporate this novel therapy into practice with expanded knowledge of these existing analyses as well as ongoing prospective trials.

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Effect of sacubitril/valsartan versus enalapril on glycaemic control in patients with heart failure and diabetes: a post-hoc analysis from the PARADIGM-HF trial

Cited by 281 publications

References 40 publications

Clinical practice update on heart failure 2019: pharmacotherapy, procedures, devices and patient management. An expert consensus meeting report of the Heart Failure Association of the European Society of Cardiology

Clinical practice update on heart failure 2019: pharmacotherapy, procedures, devices and patient management. An expert consensus meeting report of the Heart Failure Association of the European Society of Cardiology

Heart failure in the patient with diabetes: Epidemiology, aetiology, prognosis, therapy and the effect of glucose‐lowering medications

PARADIGM‐HF Trial: Secondary Analyses Address Unanswered Questions

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