Heart failure, chronic obstructive pulmonary disease and efficacy and safety of dapagliflozin in heart failure with mildly reduced or preserved ejection fraction: Insights from DELIVER

Jawad H Butt; Henri Lu; Toru Kondo; Erasmus Bachus; Rudolf A de Boer; Silvio E Inzucchi; Pardeep S Jhund; Mikhail N Kosiborod; Carolyn S P Lam; Felipe A Martinez; Muthiah Vaduganathan; Scott D Solomon; John J V McMurray

doi:10.1002/ejhf.3000

Heart failure, chronic obstructive pulmonary disease and efficacy and safety of dapagliflozin in heart failure with mildly reduced or preserved ejection fraction: Insights from DELIVER

Jawad H Butt, Henri Lu, Toru Kondo, Erasmus Bachus, Rudolf A de Boer, Silvio E Inzucchi, Pardeep S Jhund, Mikhail N Kosiborod, Carolyn S P Lam, Felipe A Martinez, Muthiah Vaduganathan, Scott D Solomon, John J V McMurray^*

^*Corresponding author af dette arbejde

Afdeling for Hjertesygdomme

13 Citationer (Scopus)

Abstract

AIM: Chronic obstructive pulmonary disease (COPD) is common in heart failure with a mildly reduced or preserved ejection fraction (HFmrEF/HFpEF) and is associated with worse outcomes. In a pre-specified analysis of DELIVER, we investigated the relationship between COPD status and outcomes, and the efficacy and safety of dapagliflozin, compared with placebo, according to COPD status.

METHODS AND RESULTS: Patients with severe pulmonary disease (including COPD) were excluded from the trial. The primary outcome was a composite of cardiovascular death or worsening heart failure. Of the 6261 patients with data on baseline COPD status, 694 (11.1%) had a known history of this condition. The risk of the primary endpoint was higher in patients with mild-to-moderate COPD compared with those without COPD (adjusted hazard ratio [HR] 1.28, 95% confidence interval [CI] 1.08-1.51). The benefit of dapagliflozin on the primary outcome was consistent irrespective of COPD status (no COPD: HR 0.82 [95% CI 0.72-0.93]; COPD: HR 0.82 [95% CI 0.62-1.10]; p interaction = 0.98). Consistent effects were observed for heart failure, cardiovascular, and all-cause hospitalization, and deaths, and composites of these. Dapagliflozin, as compared with placebo, improved the Kansas City Cardiomyopathy Questionnaire scores from baseline to 8 months to a similar extent in patients with and without mild-to-moderate COPD (p interaction ≥ 0.63). Adverse events and treatment discontinuation were not more frequent with dapagliflozin than with placebo irrespective of COPD status.

CONCLUSIONS: Mild-to-moderate COPD is common in patients with HFmrEF/HFpEF and is associated with worse outcomes. The beneficial effects of dapagliflozin compared with placebo on clinical events and symptoms were consistent, regardless of COPD status.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT03619213.

Originalsprog	Engelsk
Tidsskrift	European Journal of Heart Failure
Vol/bind	25
Udgave nummer	11
Sider (fra-til)	2078-2090
Antal sider	13
ISSN	1388-9842
DOI	https://doi.org/10.1002/ejhf.3000
Status	Udgivet - nov. 2023

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Butt, J. H., Lu, H., Kondo, T., Bachus, E., de Boer, R. A., Inzucchi, S. E., Jhund, P. S., Kosiborod, M. N., Lam, C. S. P., Martinez, F. A., Vaduganathan, M., Solomon, S. D., & McMurray, J. J. V. (2023). Heart failure, chronic obstructive pulmonary disease and efficacy and safety of dapagliflozin in heart failure with mildly reduced or preserved ejection fraction: Insights from DELIVER. European Journal of Heart Failure, 25(11), 2078-2090. https://doi.org/10.1002/ejhf.3000

Heart failure, chronic obstructive pulmonary disease and efficacy and safety of dapagliflozin in heart failure with mildly reduced or preserved ejection fraction: Insights from DELIVER. / Butt, Jawad H; Lu, Henri; Kondo, Toru et al.
I: European Journal of Heart Failure, Bind 25, Nr. 11, 11.2023, s. 2078-2090.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Butt, JH, Lu, H, Kondo, T, Bachus, E, de Boer, RA, Inzucchi, SE, Jhund, PS, Kosiborod, MN, Lam, CSP, Martinez, FA, Vaduganathan, M, Solomon, SD & McMurray, JJV 2023, 'Heart failure, chronic obstructive pulmonary disease and efficacy and safety of dapagliflozin in heart failure with mildly reduced or preserved ejection fraction: Insights from DELIVER', European Journal of Heart Failure, bind 25, nr. 11, s. 2078-2090. https://doi.org/10.1002/ejhf.3000

@article{919438a0b3c34c209c6d3934c6b55126,

title = "Heart failure, chronic obstructive pulmonary disease and efficacy and safety of dapagliflozin in heart failure with mildly reduced or preserved ejection fraction: Insights from DELIVER",

abstract = "AIM: Chronic obstructive pulmonary disease (COPD) is common in heart failure with a mildly reduced or preserved ejection fraction (HFmrEF/HFpEF) and is associated with worse outcomes. In a pre-specified analysis of DELIVER, we investigated the relationship between COPD status and outcomes, and the efficacy and safety of dapagliflozin, compared with placebo, according to COPD status.METHODS AND RESULTS: Patients with severe pulmonary disease (including COPD) were excluded from the trial. The primary outcome was a composite of cardiovascular death or worsening heart failure. Of the 6261 patients with data on baseline COPD status, 694 (11.1%) had a known history of this condition. The risk of the primary endpoint was higher in patients with mild-to-moderate COPD compared with those without COPD (adjusted hazard ratio [HR] 1.28, 95% confidence interval [CI] 1.08-1.51). The benefit of dapagliflozin on the primary outcome was consistent irrespective of COPD status (no COPD: HR 0.82 [95% CI 0.72-0.93]; COPD: HR 0.82 [95% CI 0.62-1.10]; p interaction = 0.98). Consistent effects were observed for heart failure, cardiovascular, and all-cause hospitalization, and deaths, and composites of these. Dapagliflozin, as compared with placebo, improved the Kansas City Cardiomyopathy Questionnaire scores from baseline to 8 months to a similar extent in patients with and without mild-to-moderate COPD (p interaction ≥ 0.63). Adverse events and treatment discontinuation were not more frequent with dapagliflozin than with placebo irrespective of COPD status. CONCLUSIONS: Mild-to-moderate COPD is common in patients with HFmrEF/HFpEF and is associated with worse outcomes. The beneficial effects of dapagliflozin compared with placebo on clinical events and symptoms were consistent, regardless of COPD status.CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT03619213.",

keywords = "Chronic obstructive pulmonary disease, Clinical trial, Dapagliflozin, Heart failure, Outcomes",

author = "Butt, {Jawad H} and Henri Lu and Toru Kondo and Erasmus Bachus and {de Boer}, {Rudolf A} and Inzucchi, {Silvio E} and Jhund, {Pardeep S} and Kosiborod, {Mikhail N} and Lam, {Carolyn S P} and Martinez, {Felipe A} and Muthiah Vaduganathan and Solomon, {Scott D} and McMurray, {John J V}",

year = "2023",

month = nov,

doi = "10.1002/ejhf.3000",

language = "English",

volume = "25",

pages = "2078--2090",

journal = "European Journal of Heart Failure",

issn = "1388-9842",

publisher = "John Wiley and Sons Ltd",

number = "11",

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TY - JOUR

T1 - Heart failure, chronic obstructive pulmonary disease and efficacy and safety of dapagliflozin in heart failure with mildly reduced or preserved ejection fraction

T2 - Insights from DELIVER

AU - Butt, Jawad H

AU - Lu, Henri

AU - Kondo, Toru

AU - Bachus, Erasmus

AU - de Boer, Rudolf A

AU - Inzucchi, Silvio E

AU - Jhund, Pardeep S

AU - Kosiborod, Mikhail N

AU - Lam, Carolyn S P

AU - Martinez, Felipe A

AU - Vaduganathan, Muthiah

AU - Solomon, Scott D

AU - McMurray, John J V

PY - 2023/11

Y1 - 2023/11

N2 - AIM: Chronic obstructive pulmonary disease (COPD) is common in heart failure with a mildly reduced or preserved ejection fraction (HFmrEF/HFpEF) and is associated with worse outcomes. In a pre-specified analysis of DELIVER, we investigated the relationship between COPD status and outcomes, and the efficacy and safety of dapagliflozin, compared with placebo, according to COPD status.METHODS AND RESULTS: Patients with severe pulmonary disease (including COPD) were excluded from the trial. The primary outcome was a composite of cardiovascular death or worsening heart failure. Of the 6261 patients with data on baseline COPD status, 694 (11.1%) had a known history of this condition. The risk of the primary endpoint was higher in patients with mild-to-moderate COPD compared with those without COPD (adjusted hazard ratio [HR] 1.28, 95% confidence interval [CI] 1.08-1.51). The benefit of dapagliflozin on the primary outcome was consistent irrespective of COPD status (no COPD: HR 0.82 [95% CI 0.72-0.93]; COPD: HR 0.82 [95% CI 0.62-1.10]; p interaction = 0.98). Consistent effects were observed for heart failure, cardiovascular, and all-cause hospitalization, and deaths, and composites of these. Dapagliflozin, as compared with placebo, improved the Kansas City Cardiomyopathy Questionnaire scores from baseline to 8 months to a similar extent in patients with and without mild-to-moderate COPD (p interaction ≥ 0.63). Adverse events and treatment discontinuation were not more frequent with dapagliflozin than with placebo irrespective of COPD status. CONCLUSIONS: Mild-to-moderate COPD is common in patients with HFmrEF/HFpEF and is associated with worse outcomes. The beneficial effects of dapagliflozin compared with placebo on clinical events and symptoms were consistent, regardless of COPD status.CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT03619213.

AB - AIM: Chronic obstructive pulmonary disease (COPD) is common in heart failure with a mildly reduced or preserved ejection fraction (HFmrEF/HFpEF) and is associated with worse outcomes. In a pre-specified analysis of DELIVER, we investigated the relationship between COPD status and outcomes, and the efficacy and safety of dapagliflozin, compared with placebo, according to COPD status.METHODS AND RESULTS: Patients with severe pulmonary disease (including COPD) were excluded from the trial. The primary outcome was a composite of cardiovascular death or worsening heart failure. Of the 6261 patients with data on baseline COPD status, 694 (11.1%) had a known history of this condition. The risk of the primary endpoint was higher in patients with mild-to-moderate COPD compared with those without COPD (adjusted hazard ratio [HR] 1.28, 95% confidence interval [CI] 1.08-1.51). The benefit of dapagliflozin on the primary outcome was consistent irrespective of COPD status (no COPD: HR 0.82 [95% CI 0.72-0.93]; COPD: HR 0.82 [95% CI 0.62-1.10]; p interaction = 0.98). Consistent effects were observed for heart failure, cardiovascular, and all-cause hospitalization, and deaths, and composites of these. Dapagliflozin, as compared with placebo, improved the Kansas City Cardiomyopathy Questionnaire scores from baseline to 8 months to a similar extent in patients with and without mild-to-moderate COPD (p interaction ≥ 0.63). Adverse events and treatment discontinuation were not more frequent with dapagliflozin than with placebo irrespective of COPD status. CONCLUSIONS: Mild-to-moderate COPD is common in patients with HFmrEF/HFpEF and is associated with worse outcomes. The beneficial effects of dapagliflozin compared with placebo on clinical events and symptoms were consistent, regardless of COPD status.CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT03619213.

KW - Chronic obstructive pulmonary disease

KW - Clinical trial

KW - Dapagliflozin

KW - Heart failure

KW - Outcomes

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U2 - 10.1002/ejhf.3000

DO - 10.1002/ejhf.3000

M3 - Journal article

C2 - 37634087

SN - 1388-9842

VL - 25

SP - 2078

EP - 2090

JO - European Journal of Heart Failure

JF - European Journal of Heart Failure

IS - 11

ER -

Heart failure, chronic obstructive pulmonary disease and efficacy and safety of dapagliflozin in heart failure with mildly reduced or preserved ejection fraction: Insights from DELIVER

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