Abstract 16353: Effects of Dapagliflozin on Physical and Social Activity Limitations in Patients With Heart Failure and Reduced Ejection Fraction: An Analysis of DAPA-HF

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Kieran Docherty ◽  
Mikhail N Kosiborod ◽  
Silvio E Inzucchi ◽  
Lars Kober ◽  
Anna Maria Langkilde ◽  
...  
Keyword(s):  
Heart Failure ◽  
Ejection Fraction ◽  
Kansas City ◽  
Social Activity ◽  
Sglt2 Inhibitor ◽  
Sexual Relationships ◽  
Reduced Ejection Fraction ◽  
Patients With Heart Failure ◽  
Individual Domain ◽  
Physical Limitations

Background: Patients with heart failure and reduced ejection fraction (HFrEF) suffer limitations in physical and social activities. We examined whether the SGLT2 inhibitor dapagliflozin improved the degree of physical and social activity limitation measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) in DAPA-HF. Hypothesis: Dapagliflozin, compared with placebo, would reduce the limitations of physical and social activity experienced by patients with HFrEF. Methods: We examined the effect of dapagliflozin on the physical and social limitation domains of the KCCQ at 8 months (prespecified analysis time point). Mean change from baseline was calculated using a linear regression model adjusted for baseline values with no imputation for missing data. Scores range from 0-100, with higher scores indicating better health status. Findings: At baseline, 4443 (94%) patients had available KCCQ data. Mean baseline physical limitations and social limitations scores were 66.0±24.0 and 65.5±27.4, respectively. Of the 10 individual domains that constitute these scores, the greatest limitations reported by patients at baseline were in doing gardening or housework or carrying groceries, hurrying/jogging and sexual relationships. Dapagliflozin improved physical and social limitations scores at 8 months (placebo-corrected mean difference +1.88 [95%CI 0.66,3.10] and +1.60 [0.18,3.01], respectively). Each individual domain reflecting physical and social limitations improved with dapagliflozin with the exception of sexual relationships (Table); the greatest improvements were seen in doing gardening or housework or carrying groceries (+2.48 [0.63,4.33]), hobbies and recreational activities (+2.46 [0.75-4.17]), and walking 100yd on level ground (+2.29 [0.62,3.96]). Interpretation: In DAPA-HF, dapagliflozin, compared with placebo, improved physical and social limitations as measured by the KCCQ in patients with HFrEF.

scholarly journals Towards quadruple therapy for heart failure with reduced ejection fraction: DAPA-HF secondary analysis data

2020 ◽  
Vol 25 (5) ◽  
pp. 3870
Author(s):  
Zh. D. Kobalava ◽  
V. V. Medovchshikov ◽  
N. B. Yeshniyazov
Keyword(s):  
Heart Failure ◽  
Ejection Fraction ◽  
Sglt2 Inhibitor ◽  
Secondary Analysis ◽  
Analysis Data ◽  
Adverse Outcomes ◽  
Reduced Ejection Fraction ◽  
Sodium Glucose Cotransporter ◽  
Patients With Heart Failure ◽  
First Time

Patients with heart failure with reduced ejection fraction (HFrEF), despite optimal evidence-based treatment, have a high residual risk of adverse outcomes. The favorable results of studies on cardiovascular safety and the effectiveness of sodium-glucose cotransporter 2 (SGLT2) inhibitors in patients with type 2 diabetes (T2D), including outcomes associated with heart failure, were the reason for studying the effectiveness in patients with HFrEF regardless of the T2D status. For the first time in the DAPA-HF study, the SGLT2 inhibitor dapagliflozin in patients with HFrEF showed a positive effect on hard endpoints. Data of the secondary analysis confirmed the effectiveness of dapagliflozin regardless of the T2D status, therapy, age, and quality of life. The results of DAPA-HF have become a serious statement for changing the standards of the guideline-recommended therapy of HFrEF.

scholarly journals Dapagliflozin and the Incidence of Type 2 Diabetes in Patients With Heart Failure and Reduced Ejection Fraction: An Exploratory Analysis From DAPA-HF

2020 ◽  
Author(s):  
Silvio E Inzucchi ◽  
Kieran F Docherty ◽  
Lars Køber ◽  
Mikhail N Kosiborod ◽  
Felipe A Martinez ◽  
...  
Keyword(s):  
Heart Failure ◽  
Type 2 Diabetes ◽  
Ejection Fraction ◽  
Sglt2 Inhibitor ◽  
Adverse Outcomes ◽  
Exploratory Analysis ◽  
Diabetes Incidence ◽  
Reduced Ejection Fraction ◽  
Patients With Heart Failure

<b>Objective </b> <p>The SGLT2 inhibitor dapagliflozin reduced the risk of cardiovascular mortality and worsening heart failure in the <a>Dapagliflozin and Prevention of Adverse-Outcomes in Heart Failure </a>trial (DAPA-HF). This report explores the effect of dapagliflozin on incident type 2 diabetes in the non-diabetic cohort enrolled in the trial.</p> <p><b> </b></p> <p><b>Research Design/Methods</b></p> <p>The subgroup of 2605 patients with heart failure and reduced ejection fraction (HFrEF), no prior history of diabetes, and a HbA1c of <6.5% at baseline was randomized to dapagliflozin 10 mg daily or placebo. In this exploratory analysis, surveillance for new onset diabetes was accomplished through periodic HbA1c testing as part of the study protocol and comparison between the treatment groups assessed through a Cox proportional hazards model.</p> <p><b> </b></p> <p><b>Results</b></p> <p>At baseline, the mean HbA1c was 5.8%. At 8 months, there were minimal changes, with a placebo-adjusted change in the dapagliflozin group of -0.04%. Over a median follow-up of 18 months, diabetes developed in 93/1307 patients (7.1%) in the placebo group and 64/1298 (4.9%) in the dapagliflozin group. Dapagliflozin led to a 32% reduction in diabetes incidence (HR 0.68, 95% CI, 0.50-0.94; p=0.019.) More than 95% of the participants who developed type 2 diabetes had prediabetes at baseline (HbA1c 5.7-6.4%.) Participants who developed diabetes in DAPA-HF had a higher subsequent mortality than those who did not.</p> <p><b>Conclusions</b></p> <p>In this exploratory analysis among patients with HFrEF, treatment with dapagliflozin reduced the incidence of new diabetes. This potential benefit needs confirmation in trials of longer duration and in people without heart failure.</p>

scholarly journals Dapagliflozin and the Incidence of Type 2 Diabetes in Patients With Heart Failure and Reduced Ejection Fraction: An Exploratory Analysis From DAPA-HF

2020 ◽  
Author(s):  
Silvio E Inzucchi ◽  
Kieran F Docherty ◽  
Lars Køber ◽  
Mikhail N Kosiborod ◽  
Felipe A Martinez ◽  
...  
Keyword(s):  
Heart Failure ◽  
Type 2 Diabetes ◽  
Ejection Fraction ◽  
Sglt2 Inhibitor ◽  
Adverse Outcomes ◽  
Exploratory Analysis ◽  
Diabetes Incidence ◽  
Reduced Ejection Fraction ◽  
Patients With Heart Failure

<b>Objective </b> <p>The SGLT2 inhibitor dapagliflozin reduced the risk of cardiovascular mortality and worsening heart failure in the <a>Dapagliflozin and Prevention of Adverse-Outcomes in Heart Failure </a>trial (DAPA-HF). This report explores the effect of dapagliflozin on incident type 2 diabetes in the non-diabetic cohort enrolled in the trial.</p> <p><b> </b></p> <p><b>Research Design/Methods</b></p> <p>The subgroup of 2605 patients with heart failure and reduced ejection fraction (HFrEF), no prior history of diabetes, and a HbA1c of <6.5% at baseline was randomized to dapagliflozin 10 mg daily or placebo. In this exploratory analysis, surveillance for new onset diabetes was accomplished through periodic HbA1c testing as part of the study protocol and comparison between the treatment groups assessed through a Cox proportional hazards model.</p> <p><b> </b></p> <p><b>Results</b></p> <p>At baseline, the mean HbA1c was 5.8%. At 8 months, there were minimal changes, with a placebo-adjusted change in the dapagliflozin group of -0.04%. Over a median follow-up of 18 months, diabetes developed in 93/1307 patients (7.1%) in the placebo group and 64/1298 (4.9%) in the dapagliflozin group. Dapagliflozin led to a 32% reduction in diabetes incidence (HR 0.68, 95% CI, 0.50-0.94; p=0.019.) More than 95% of the participants who developed type 2 diabetes had prediabetes at baseline (HbA1c 5.7-6.4%.) Participants who developed diabetes in DAPA-HF had a higher subsequent mortality than those who did not.</p> <p><b>Conclusions</b></p> <p>In this exploratory analysis among patients with HFrEF, treatment with dapagliflozin reduced the incidence of new diabetes. This potential benefit needs confirmation in trials of longer duration and in people without heart failure.</p>

scholarly journals Quality of life and disease experience in patients with heart failure with reduced ejection fraction in Spain: a mixed-methods study

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e053216
Author(s):  
Raül Rubio ◽  
Beatriz Palacios ◽  
Luis Varela ◽  
Raquel Fernández ◽  
Selene Camargo Correa ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Ejection Fraction ◽  
Kansas City ◽  
Mixed Methods Study ◽  
Kansas City Cardiomyopathy Questionnaire ◽  
Reduced Ejection Fraction ◽  
Patients With Heart Failure ◽  
Disease Experience

ObjectivesTo gather insights on the disease experience of patients with heart failure (HF) with reduced ejection fraction (HFrEF), and assess how patients’ experiences and narratives related to the disease complement data collected through standardised patient-reported outcome measures (PROMs). Also, to explore new ways of evaluating the burden experienced by patients and caregivers.DesignObservational, descriptive, multicentre, cross-sectional, mixed-methods study.SettingSecondary care, patient’s homes.ParticipantsTwenty patients with HFrEF (New York Heart Association (NYHA) classification I–III) aged 38–85 years.MeasuresPROMs EuroQoL 5D-5L (EQ-5D-5L) and Kansas City Cardiomyopathy Questionnaire and patient interview and observation.ResultsA total of 20 patients with HFrEF participated in the study. The patients’ mean (SD) age was 72.5 (11.4) years, 65% were male and were classified inNYHA functional classes I (n=4), II (n=7) and III (n=9). The study showed a strong impact of HF in the patients’ quality of life (QoL) and disease experience, as revealed by the standardised PROMs (EQ-5D-5L global index=0.64 (0.36); Kansas City Cardiomyopathy Questionnaire total symptom score=71.56 (20.55)) and the in-depth interviews. Patients and caregivers often disagreed describing and evaluating perceived QoL, as patients downplayed their limitations and caregivers overemphasised the poor QoL of the patients. Patients related current QoL to distant life experiences or to critical moments in their disease, such as hospitalisations. Anxiety over the disease progression is apparent in both patients and caregivers, suggesting that caregiver-specific tools should be developed.ConclusionsPROMs are an effective way of assessing symptoms over the most recent time period. However, especially in chronic diseases such as HFrEF, PROM scores could be complemented with additional tools to gain a better understanding of the patient’s status. New PROMs designed to evaluate and compare specific points in the life of the patient could be clinically more useful to assess changes in health status.

scholarly journals Effects of SGLT2 inhibitor dapagliflozin in patients with heart failure with reduced ejection fraction

2020 ◽  
Vol 25 (8) ◽  
pp. 4049
Author(s):  
N. R. Khasanov
Keyword(s):  
Heart Failure ◽  
Ejection Fraction ◽  
Drug Class ◽  
Sglt2 Inhibitor ◽  
Cardiovascular Death ◽  
Sglt2 Inhibitors ◽  
Reduced Ejection Fraction ◽  
Patients With Heart Failure ◽  
Recommended Therapy

SGLT2 inhibitors have been shown to reduce the risk of cardiovascular events and the development and decompensation of heart failure (HF) in patients with type 2 diabetes (T2D). The improved prognosis in HF may be related not only to the hypoglycemic effect of this drug class. The DAPA-HF study, which included patients with HF with reduced ejection fraction, demonstrated the benefit of dapagliflozin in reducing the risk of cardiovascular death and worsening HF, as well as improving HF symptoms compared to placebo, regardless of the presence of T2D and the recommended therapy for HF.

The Role of Sodium-Glucose Cotransporter-2 Inhibitors in Patients With Heart Failure, Regardless of Diabetes Status: Focus on Cardiovascular Disease

2021 ◽  
pp. 106002802098511
Author(s):  
Filipe Ferrari ◽  
Vítor M. Martins ◽  
Rafael S. Scheffel ◽  
Anderson D. da Silveira ◽  
Marcelo Trotte Motta ◽  
...  
Keyword(s):  
Heart Failure ◽  
Ejection Fraction ◽  
Data Extraction ◽  
Sglt2 Inhibitor ◽  
Sglt2 Inhibitors ◽  
Reduced Ejection Fraction ◽  
Sodium Glucose Cotransporter ◽  
Diabetes Status ◽  
Neprilysin Inhibitor ◽  
Patients With Heart Failure

Objective: To provide clinical guidance and an overview of the available data on the use of sodium-glucose cotransporter-2 (SGLT2) inhibitors in patients with heart failure with reduced ejection fraction (HFrEF), regardless of the presence of type 2 diabetes mellitus (T2DM). Data Sources: We searched the MEDLINE database via PubMed (from January 2015 to November 2020) for the following key terms: SGLT2 inhibitors, sodium-glucose co-transporter-2 inhibitors, SGLT2i, heart failure, and heart failure with reduced ejection fraction. Study Selection and Data Extraction: To be included in the review, the articles needed to assess the effects of SGLT2 inhibitors in the heart failure (HF) scenario. Data Synthesis: There is consistent evidence that SGLT2 inhibitors reduce the risk of major adverse cardiovascular (CV) events and hospitalization in patients with HFrEF, even in the absence of T2DM. On May 5, 2020, the U.S. Food and Drug Administration approved dapagliflozin for adults with HFrEF, regardless of the presence of T2DM, even in those patients on standard therapy, including an angiotensin receptor/neprilysin inhibitor. Relevance to Patient Care and Clinical Practice: The SGLT2 inhibitors are well tolerated, and their once-daily dosing without the need for adjustments is convenient. These drugs can be considered a major breakthrough in pharmacotherapy for HF, providing physicians with a new treatment approach to reduce major clinical outcomes. Conclusions: SGLT2 inhibitor therapy reduces CV death and hospitalizations in HFrEF patients regardless of T2DM. The decision to prescribe this class of drugs should not be determined by glycemic status.

Sign in / Sign up

Export Citation Format

Share Document