Baseline Characteristics of Patients With Heart Failure and Preserved Ejection Fraction in the PARAGON-HF Trial

Solomon, Scott D.; Rizkala, Adel R.; Lefkowitz, Martin; Shi, Victor; Gong, Jianjian; Anavekar, Nagesh S.; Anker, Stefan D.; Arango, Juan Luis; Arenas, Juan D.; Atar, Dan; Ben-Gal, T; Boytsov, S. А.; Chen, Chen Huan; Chopra, Vijay; Cleland, John G.F.; Comín‐Colet, Josep; Duengen, Hans Dirk; Correa, Luis Eduardo Echeverría; Filippatos, Gerasimos; Flammer, Andreas J.; Galinier, Michel; Godoy, Armando; Gonçalvesová, Eva; Janssens, Stefan; Katova, Tzvetana; Køber, Lars; Lelonek, Małgorzata; Linssen, Gerard C.M.; Lund, Lars H.; O’Meara, Eileen; Merkely, Béla; Miličić, Davor; Oh, Byung Hee; Perrone, Sergio V.; Ranjith, Naresh; Saito, Yoshihiko; Saraiva, José Francisco Kerr; Shah, Sanjiv J.; Seferović, Petar; Senni, Michele; Sibulo, Antonio S.; Sim, David; Sweitzer, Nancy K.; Taurio, Jyrki; Vinereanu, Dragoş; Vrtovec, Bojan; Widimský, Jiří; Yilmaz, Mehmet Birhan; Zhou, Jingmin; Zweiker, Robert; Anand, Inder S.; Ge, Junbo; Lam, Carolyn S.P.; Maggioni, Aldo P.; Martinez, Felipe; Packer, Milton; Pfeffer, Marc A.; Pieske, Burkert; Redfield, Margaret M.; Rouleau, Jean L.; Veldhuisen, Dirk J. van; Zannad, Faı̈ez; Zile, Michael R.; McMurray, John J.V.

doi:10.1161/circheartfailure.118.004962

Cited by 123 publications

(87 citation statements)

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“…Type 2 diabetes mellitus is common in patients with heart failure and preserved ejection fraction (HFpEF), with a reported prevalence of around 30–40% . It has been suggested that diabetes plays a key pathophysiological role in the development of HFpEF, and is an independent predictor of adverse outcomes in HFpEF . The importance of better understanding the safety and possible benefits of anti‐diabetes agents in patients with established heart failure (HF) is underscored by recent cardiovascular (CV) outcome trials in diabetes mellitus.…”

Section: Introductionmentioning

confidence: 99%

Insulin treatment and clinical outcomes in patients with diabetes and heart failure with preserved ejection fraction

Shen

Rørth

Cosmi³

et al. 2019

European J of Heart Fail

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Aims Insulin causes sodium retention and hypoglycaemia and its use is associated with worse outcomes in heart failure (HF) with reduced ejection fraction. We have investigated whether this is also the case in HF with preserved ejection fraction (HFpEF). Methods and results We examined the association between diabetes/diabetes treatments and the risk of the primary composite of cardiovascular death or HF hospitalization, as well as other outcomes in adjusted analyses in CHARM‐Preserved (left ventricular ejection fraction ≥ 45%), I‐Preserve and TOPCAT (Americas) pooled. Of 8466 patients, 2653 (31%) had diabetes, including 979 (37%) receiving insulin. Patients receiving insulin were younger, had a higher body mass index, prevalence of ischaemic aetiology, N‐terminal pro‐B‐type natriuretic peptide and use of diuretics, worse New York Heart Association class and signs and symptoms, and worse quality of life and renal function, compared to patients with diabetes not on insulin. Among the 1398 patients with echocardiographic data, insulin use was associated with higher left ventricular end‐diastolic pressure and more diastolic dysfunction than in other participants. The primary outcome occurred at a rate of 6.3 per 100 patient‐years in patients without diabetes, and 10.2 and 17.1 per 100 patient‐years in diabetes patients without and with insulin use, respectively [fully adjusted hazard ratio (aHR) insulin‐treated diabetes vs. other diabetes: 1.41, 95% confidence interval (CI) 1.23–1.63, P < 0.001]. The adjusted HR is 1.67 (95% CI 1.20–2.32, p = 0.002) for sudden death (insulin‐treated diabetes vs. other diabetes). Conclusions Insulin use is associated with poor outcomes in HFpEF. Although we cannot conclude a causal association, the safety of insulin and alternative glucose‐lowering treatments in HF needs to be evaluated in clinical trials.

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Section: Introductionmentioning

confidence: 99%

Insulin treatment and clinical outcomes in patients with diabetes and heart failure with preserved ejection fraction

Shen

Rørth

Cosmi³

et al. 2019

European J of Heart Fail

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“…There are considerable regional differences in patient characteristics reported in global clinical registries and trials . In the following sections, we focused on studies published after 2010 to reduce time‐lag and increase comparability between studies and registries ( Tables ) . In the PARADIGM‐HF trial, patients from AP were almost a decade younger compared to patients from NA and WE .…”

Section: Regional Differences In Heart Failurementioning

confidence: 99%

“…Recent results from PARADIGM‐HF and the Prospective Comparison of Angiotensin Receptor Neprilysin Inhibitor With Angiotensin Receptor Blocker Global Outcomes in HFpEF (PARAGON‐HF) have shown that the combined usage of natriuretic peptides and requirements with regards to background therapy can considerably reduce regional heterogeneity . This is particularly striking in the PARAGON‐HF trial, where regional differences are smaller compared to earlier HFpEF trials . Having pre‐specified regional caps provides an important ‘check and balance’ on the enrolment of patients, but in practice is not universally supported yet, particularly when there is great emphasis on rapid enrolment.…”

Section: Implication Of Regional Differences and Recommendationsmentioning

confidence: 99%

Heart failure around the world

Tromp

Ferreira

Janwanishstaporn

et al. 2019

European J of Heart Fail

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With increasingly large sample sizes required to demonstrate event reduction, heart failure outcome trials are no longer being performed in a small group of selected patients and countries, but at a global scale with worldwide contribution of patients from countries with considerable differences in background therapy, socioeconomic status and healthcare practices. Recent studies have highlighted how socioeconomic determinants rather than geographical factors may underlie the heterogeneity of patient populations across the globe. Therefore, in this review, we evaluated (i) regional differences in patient characteristics and outcomes in recent epidemiologic studies; (ii) regional differences in worldwide representativeness of clinical trial populations; and (iii) the role of socioeconomic determinants in driving country differences in heart failure trial enrolment and clinical outcomes.

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“…Interestingly, in that study BP reduction was greater in the LCZ696 group than in the valsartan group after 12 weeks of treatment. Whether or not these effects may translate into improved outcomes in HFpEF is currently being tested in the Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction (PARAGON-HF) Trial [7].…”

Section: Editorialmentioning

confidence: 99%

Will we ever use angiotensin receptor neprilysin inhibition (ARNi) for the treatment of hypertension?

2019

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Baseline Characteristics of Patients With Heart Failure and Preserved Ejection Fraction in the PARAGON-HF Trial

Abstract: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01920711.

Cited by 123 publications

References 13 publications

Insulin treatment and clinical outcomes in patients with diabetes and heart failure with preserved ejection fraction

Insulin treatment and clinical outcomes in patients with diabetes and heart failure with preserved ejection fraction

Heart failure around the world

Will we ever use angiotensin receptor neprilysin inhibition (ARNi) for the treatment of hypertension?

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