Heart Failure Clinical Trials in East and Southeast Asia

Mentz, Robert J.; Roessig, Lothar; Greenberg, Barry; Sato, Naoki; Shinagawa, Kaori; Yeo, Daniel; Kwok, Bernard W.K.; Reyes, Eugenio B.; Krum, Henry; Pieske, Burkert; Greene, Stephen J.; Ambrosy, Andrew P.; Kelly, Jacob P.; Zannad, Faı̈ez; Pitt, Bertram; Lam, Carolyn S.P.

doi:10.1016/j.jchf.2016.01.013

Cited by 49 publications

(24 citation statements)

References 67 publications

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“…Despite acknowledgement of the large and growing global public health burden of HF, substantial knowledge and care gaps exist, especially among low- and middle-income regions of Asia, where resources are particularly limited. 23, 24 In this study, we show that—independent of clinical covariates—HRQoL as defined by the patient’s KCCQ score is significantly different among White, Black or African American, Indian, Chinese, Malay, or Japanese/Korean patients with HF across Asia, North America, and France. In general, ethnic Malay participants reported the worst health status, with the most physical limitations and highest quantity of symptoms.…”

Section: Discussionmentioning

confidence: 61%

Multinational and multiethnic variations in health-related quality of life in patients with chronic heart failure

Luo

Teng

Tay

et al. 2017

American Heart Journal

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Background Assessing health-related quality of life (HRQoL) in patients with heart failure (HF) are important goals of clinical care and HF research. We sought to investigate ethnic differences in perceived HRQoL and its association with mortality among patients with HF and left ventricular ejection fraction ≤35%, controlling for demographic characteristics and HF severity. Methods and results We compared 5,697 chronic HF patients of Indian (26%), White (23%), Chinese (17%), Japanese/Koreans (12%), Black (12%), and Malay (10%) ethnicities from the HF-ACTION and ASIAN-HF multinational studies using the Kansas City Cardiomyopathy Questionnaire (KCCQ; range 0–100; higher scores reflect better health status). KCCQ scores were lowest in Malay (58±22) and Chinese (60±23), intermediate in Black (64±21) and Indian (65±23), and highest in White (67±20) and Japanese or Korean patients (67±22), after adjusting for age, sex, educational status, HF severity and risk factors. Self-efficacy, which measures confidence in the ability to manage symptoms, was lower in all Asian ethnicities (especially Japanese/Koreans [60±26], Malay [66±23] and Chinese [64±28]) compared to Black (80±21) and White (82±19) patients, even after multivariable adjustment (p<0.001). In all ethnicities, KCCQ strongly predicted 1-year mortality (HR 0.45, 95% CI 0.30–0.67 for highest vs lowest quintile of KCCQ; p for interaction by ethnicity 0.101). Conclusions Overall, HRQoL is inversely and independently related to mortality in chronic HF, but is not modified by ethnicity. Nevertheless, ethnic differences exist independent of HF severity and comorbidities. These data may have important implications for future global clinical HF trials that use patient-reported outcomes as endpoints. Clinical Trial Registration NCT00047437 and NCT01633398

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Section: Discussionmentioning

confidence: 61%

Multinational and multiethnic variations in health-related quality of life in patients with chronic heart failure

Luo

Teng

Tay

et al. 2017

American Heart Journal

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“…Although LOHS decreased dramatically during the study period, it remains higher in Japan than in other countries,5 even among other Asian countries 15. One reason for the extremely long LOHS in Japan might be the inpatient management program.…”

Section: Discussionmentioning

confidence: 84%

9‐Year Trend in the Management of Acute Heart Failure in Japan: A Report From the National Consortium of Acute Heart Failure Registries

Shiraishi

Kohsaka

Sato

et al. 2018

JAHA

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BackgroundAcute heart failure (AHF) is a heterogeneous condition, and its characteristics and management patterns differ by region. Furthermore, limited evidence is available on AHF outside of Western countries. A project by the National Consortium of Acute Heart Failure Registries was designed to evaluate the trends over time in patient backgrounds, in‐hospital management patterns, and long‐term outcomes of patients with AHF over 9 years in Japan.Methods and ResultsBetween 2007 and 2015, registry data for patients with AHF were collected from 3 large‐scale quality AHF registries (ATTEND/WET‐HF/REALITY‐AHF). Predefined end points were trends over time in age, sex, and clinical outcomes, including short‐ and long‐term mortality and readmission for heart failure. The final data set consisted of 9075 patients with AHF. No significant differences in patient backgrounds and laboratory findings (eg, anemia or renal function) were observed, with the exception of patient age; mean age became substantially higher over 9 years (71.6–77.0 years; P for trend, <0.001). On the contrary, length of hospital stay became shorter (mean, 26–16 days). These changes were not associated with in‐hospital mortality (4.7–7.5%) or 30‐day heart failure readmission rate (4.8–5.4%), as well as 1‐year mortality and heart failure readmission rate (20.1–23.3% and 23.6–26.2%, respectively).ConclusionsLength of hospital stay in patients with AHF shortened over the 9‐year period despite the increasing age of the patients. However, short‐ and long‐term outcomes do not seem to be affected; continuous efforts to monitor clinical outcomes in patients with AHF are needed.

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“…Guidelines for management of HF vary across different Asian regions 53). We reviewed the most up to date HF management guidelines in the Asian countries in PARADIGM-HF to see if there were any recommendations pertaining to sacubitril/valsartan.…”

Section: Implementation Of Sacubitril/valsartan In Asian Guidelinesmentioning

confidence: 99%

Sacubitril/Valsartan in Asian Patients with Heart Failure with Reduced Ejection Fraction

2019

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The Prospective comparison of Angiotensin Receptor-neprilysin inhibitor (ARNI) with Angiotensin converting enzyme inhibitor (ACEI) to Determine Impact on Global Mortality and morbidity in Heart Failure (HF) trial (PARADIGM-HF) showed that adding a neprilysin inhibitor (sacubitril) to a renin-angiotensin system blocker (and other standard therapy) reduced morbidity and mortality in ambulatory patients with chronic HF with reduced ejection fraction (HFrEF). In PARADIGM-HF, valsartan combined with sacubitril (a socalled ARNI) was superior to the current gold standard of an ACEI, specifically enalapril, reducing the risk of the primary composite outcome of cardiovascular (CV) death or first HF hospitalization by 20% and all-cause death by 16%. Following the results of PARADIGM-HF, sacubitril/valsartan was approved by American and European regulatory authorities for the treatment of HFrEF. The burden of HF in Asia is substantial, both due to the huge population of the region and as a result of increasing CV risk factors and disease. Both the prevalence and mortality associated with HF are high in Asia. In the following review, we discuss the development of sacubitril/valsartan, the prototype ARNI, and the available evidence for its efficacy and safety in Asian patients with HFrEF.

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Heart Failure Clinical Trials in East and Southeast Asia

Cited by 49 publications

References 67 publications

Multinational and multiethnic variations in health-related quality of life in patients with chronic heart failure

Multinational and multiethnic variations in health-related quality of life in patients with chronic heart failure

9‐Year Trend in the Management of Acute Heart Failure in Japan: A Report From the National Consortium of Acute Heart Failure Registries

Sacubitril/Valsartan in Asian Patients with Heart Failure with Reduced Ejection Fraction

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