Effects of Sotagliflozin on Health Status in Patients With Worsening Heart Failure: Results From SOLOIST-WHF

Ankeet S. Bhatt; Deepak L. Bhatt; Ph Gabriel Steg; Michael Szarek; Christopher P. Cannon; Lawrence A. Leiter; Darren K. McGuire; Julia B. Lewis; Matthew C. Riddle; Adriaan A. Voors; Marco Metra; Lars H. Lund; Jeffrey M. Testani; Christopher S. Wilcox; Michael Davies; Bertram Pitt; Mikhail N. Kosiborod

doi:10.1016/j.jacc.2024.06.036

Effects of Sotagliflozin on Health Status in Patients With Worsening Heart Failure: Results From SOLOIST-WHF

Ankeet S. Bhatt
, Deepak L. Bhatt
, Ph Gabriel Steg
, Michael Szarek
, Christopher P. Cannon
, Lawrence A. Leiter
, Darren K. McGuire
, Julia B. Lewis
, Matthew C. Riddle
, Adriaan A. Voors
, Marco Metra
, Lars H. Lund
, Jeffrey M. Testani
, Christopher S. Wilcox
, Michael Davies
, Bertram Pitt
, Mikhail N. Kosiborod

Research output: Contribution to journal › Article › peer-review

7 Scopus citations

Abstract

Background: Sodium-glucose cotransporter 2 (SGLT2) inhibitors improve health status in heart failure (HF) across the left ejection fraction ejection spectrum. However, the effects of SGLT1 and SGLT2 inhibition on health status are unknown. Objectives: These prespecified analyses of the SOLOIST-WHF (Effect of Sotagliflozin on Cardiovascular Events in Patients with Type 2 Diabetes Post Worsening Heart Failure) trial examined the effects of sotagliflozin vs placebo on HF-related health status. Methods: SOLOIST-WHF randomized patients hospitalized or recently discharged after a worsening HF episode to receive sotagliflozin or placebo. The primary endpoint was total number of HF hospitalizations, urgent HF visits, and cardiovascular death. Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score was a prespecified secondary endpoint. This analysis evaluated change in the KCCQ-12 score from baseline to month 4. Results: Of 1,222 patients randomized, 1,113 (91%) had complete KCCQ-12 data at baseline and 4 months. The baseline KCCQ-12 score was low overall (median: 41.7; Q1-Q3: 27.1-58.3) and improved by 4 months in both groups. Sotagliflozin vs placebo reduced the risk of the primary endpoint consistently across KCCQ-12 tertiles (P_trend = 0.54). Sotagliflozin-treated patients vs those receiving placebo experienced modest improvement in KCCQ-12 at 4 months (adjusted mean change: 4.1 points; 95% CI: 1.3-7.0 points; P = 0.005). KCCQ-12 improvements were consistent across prespecified subgroups, including left ventricular ejection fraction <50% or ≥50%. More patients receiving sotagliflozin vs those receiving placebo had at least small (≥5 points) improvements in KCCQ-12 at 4 months (OR: 1.38; 95% CI: 1.06-1.80; P = 0.017). Conclusions: Sotagliflozin improved symptoms, physical limitations, and quality of life within 4 months after worsening HF, with consistent benefits across baseline demographic and clinical characteristics.

Original language	English
Pages (from-to)	1078-1088
Number of pages	11
Journal	Journal of the American College of Cardiology
Volume	84
Issue number	12
DOIs	https://doi.org/10.1016/j.jacc.2024.06.036
State	Published - 17 Sep 2024

Keywords

KCCQ
dual SGLT1 and SGLT2 inhibitor
health status
sotagliflozin
worsening heart failure

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10.1016/j.jacc.2024.06.036

Cite this

Bhatt, A. S., Bhatt, D. L., Steg, P. G., Szarek, M., Cannon, C. P., Leiter, L. A., McGuire, D. K., Lewis, J. B., Riddle, M. C., Voors, A. A., Metra, M., Lund, L. H., Testani, J. M., Wilcox, C. S., Davies, M., Pitt, B., & Kosiborod, M. N. (2024). Effects of Sotagliflozin on Health Status in Patients With Worsening Heart Failure: Results From SOLOIST-WHF. Journal of the American College of Cardiology, 84(12), 1078-1088. https://doi.org/10.1016/j.jacc.2024.06.036

@article{a2ffddaa9688400a9876b37bb027e856,

title = "Effects of Sotagliflozin on Health Status in Patients With Worsening Heart Failure: Results From SOLOIST-WHF",

abstract = "Background: Sodium-glucose cotransporter 2 (SGLT2) inhibitors improve health status in heart failure (HF) across the left ejection fraction ejection spectrum. However, the effects of SGLT1 and SGLT2 inhibition on health status are unknown. Objectives: These prespecified analyses of the SOLOIST-WHF (Effect of Sotagliflozin on Cardiovascular Events in Patients with Type 2 Diabetes Post Worsening Heart Failure) trial examined the effects of sotagliflozin vs placebo on HF-related health status. Methods: SOLOIST-WHF randomized patients hospitalized or recently discharged after a worsening HF episode to receive sotagliflozin or placebo. The primary endpoint was total number of HF hospitalizations, urgent HF visits, and cardiovascular death. Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score was a prespecified secondary endpoint. This analysis evaluated change in the KCCQ-12 score from baseline to month 4. Results: Of 1,222 patients randomized, 1,113 (91\%) had complete KCCQ-12 data at baseline and 4 months. The baseline KCCQ-12 score was low overall (median: 41.7; Q1-Q3: 27.1-58.3) and improved by 4 months in both groups. Sotagliflozin vs placebo reduced the risk of the primary endpoint consistently across KCCQ-12 tertiles (Ptrend = 0.54). Sotagliflozin-treated patients vs those receiving placebo experienced modest improvement in KCCQ-12 at 4 months (adjusted mean change: 4.1 points; 95\% CI: 1.3-7.0 points; P = 0.005). KCCQ-12 improvements were consistent across prespecified subgroups, including left ventricular ejection fraction <50\% or ≥50\%. More patients receiving sotagliflozin vs those receiving placebo had at least small (≥5 points) improvements in KCCQ-12 at 4 months (OR: 1.38; 95\% CI: 1.06-1.80; P = 0.017). Conclusions: Sotagliflozin improved symptoms, physical limitations, and quality of life within 4 months after worsening HF, with consistent benefits across baseline demographic and clinical characteristics.",

keywords = "KCCQ, dual SGLT1 and SGLT2 inhibitor, health status, sotagliflozin, worsening heart failure",

author = "Bhatt, \{Ankeet S.\} and Bhatt, \{Deepak L.\} and Steg, \{Ph Gabriel\} and Michael Szarek and Cannon, \{Christopher P.\} and Leiter, \{Lawrence A.\} and McGuire, \{Darren K.\} and Lewis, \{Julia B.\} and Riddle, \{Matthew C.\} and Voors, \{Adriaan A.\} and Marco Metra and Lund, \{Lars H.\} and Testani, \{Jeffrey M.\} and Wilcox, \{Christopher S.\} and Michael Davies and Bertram Pitt and Kosiborod, \{Mikhail N.\}",

note = "Publisher Copyright: {\textcopyright} 2024 The Authors",

year = "2024",

month = sep,

day = "17",

doi = "10.1016/j.jacc.2024.06.036",

language = "English",

volume = "84",

pages = "1078--1088",

journal = "Journal of the American College of Cardiology",

issn = "0735-1097",

publisher = "Elsevier Inc.",

number = "12",

}

Bhatt, AS, Bhatt, DL, Steg, PG, Szarek, M, Cannon, CP, Leiter, LA, McGuire, DK, Lewis, JB, Riddle, MC, Voors, AA, Metra, M, Lund, LH, Testani, JM, Wilcox, CS, Davies, M, Pitt, B & Kosiborod, MN 2024, 'Effects of Sotagliflozin on Health Status in Patients With Worsening Heart Failure: Results From SOLOIST-WHF', Journal of the American College of Cardiology, vol. 84, no. 12, pp. 1078-1088. https://doi.org/10.1016/j.jacc.2024.06.036

TY - JOUR

T1 - Effects of Sotagliflozin on Health Status in Patients With Worsening Heart Failure

T2 - Results From SOLOIST-WHF

AU - Bhatt, Ankeet S.

AU - Bhatt, Deepak L.

AU - Steg, Ph Gabriel

AU - Szarek, Michael

AU - Cannon, Christopher P.

AU - Leiter, Lawrence A.

AU - McGuire, Darren K.

AU - Lewis, Julia B.

AU - Riddle, Matthew C.

AU - Voors, Adriaan A.

AU - Metra, Marco

AU - Lund, Lars H.

AU - Testani, Jeffrey M.

AU - Wilcox, Christopher S.

AU - Davies, Michael

AU - Pitt, Bertram

AU - Kosiborod, Mikhail N.

PY - 2024/9/17

Y1 - 2024/9/17

N2 - Background: Sodium-glucose cotransporter 2 (SGLT2) inhibitors improve health status in heart failure (HF) across the left ejection fraction ejection spectrum. However, the effects of SGLT1 and SGLT2 inhibition on health status are unknown. Objectives: These prespecified analyses of the SOLOIST-WHF (Effect of Sotagliflozin on Cardiovascular Events in Patients with Type 2 Diabetes Post Worsening Heart Failure) trial examined the effects of sotagliflozin vs placebo on HF-related health status. Methods: SOLOIST-WHF randomized patients hospitalized or recently discharged after a worsening HF episode to receive sotagliflozin or placebo. The primary endpoint was total number of HF hospitalizations, urgent HF visits, and cardiovascular death. Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score was a prespecified secondary endpoint. This analysis evaluated change in the KCCQ-12 score from baseline to month 4. Results: Of 1,222 patients randomized, 1,113 (91%) had complete KCCQ-12 data at baseline and 4 months. The baseline KCCQ-12 score was low overall (median: 41.7; Q1-Q3: 27.1-58.3) and improved by 4 months in both groups. Sotagliflozin vs placebo reduced the risk of the primary endpoint consistently across KCCQ-12 tertiles (Ptrend = 0.54). Sotagliflozin-treated patients vs those receiving placebo experienced modest improvement in KCCQ-12 at 4 months (adjusted mean change: 4.1 points; 95% CI: 1.3-7.0 points; P = 0.005). KCCQ-12 improvements were consistent across prespecified subgroups, including left ventricular ejection fraction <50% or ≥50%. More patients receiving sotagliflozin vs those receiving placebo had at least small (≥5 points) improvements in KCCQ-12 at 4 months (OR: 1.38; 95% CI: 1.06-1.80; P = 0.017). Conclusions: Sotagliflozin improved symptoms, physical limitations, and quality of life within 4 months after worsening HF, with consistent benefits across baseline demographic and clinical characteristics.

AB - Background: Sodium-glucose cotransporter 2 (SGLT2) inhibitors improve health status in heart failure (HF) across the left ejection fraction ejection spectrum. However, the effects of SGLT1 and SGLT2 inhibition on health status are unknown. Objectives: These prespecified analyses of the SOLOIST-WHF (Effect of Sotagliflozin on Cardiovascular Events in Patients with Type 2 Diabetes Post Worsening Heart Failure) trial examined the effects of sotagliflozin vs placebo on HF-related health status. Methods: SOLOIST-WHF randomized patients hospitalized or recently discharged after a worsening HF episode to receive sotagliflozin or placebo. The primary endpoint was total number of HF hospitalizations, urgent HF visits, and cardiovascular death. Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score was a prespecified secondary endpoint. This analysis evaluated change in the KCCQ-12 score from baseline to month 4. Results: Of 1,222 patients randomized, 1,113 (91%) had complete KCCQ-12 data at baseline and 4 months. The baseline KCCQ-12 score was low overall (median: 41.7; Q1-Q3: 27.1-58.3) and improved by 4 months in both groups. Sotagliflozin vs placebo reduced the risk of the primary endpoint consistently across KCCQ-12 tertiles (Ptrend = 0.54). Sotagliflozin-treated patients vs those receiving placebo experienced modest improvement in KCCQ-12 at 4 months (adjusted mean change: 4.1 points; 95% CI: 1.3-7.0 points; P = 0.005). KCCQ-12 improvements were consistent across prespecified subgroups, including left ventricular ejection fraction <50% or ≥50%. More patients receiving sotagliflozin vs those receiving placebo had at least small (≥5 points) improvements in KCCQ-12 at 4 months (OR: 1.38; 95% CI: 1.06-1.80; P = 0.017). Conclusions: Sotagliflozin improved symptoms, physical limitations, and quality of life within 4 months after worsening HF, with consistent benefits across baseline demographic and clinical characteristics.

KW - KCCQ

KW - dual SGLT1 and SGLT2 inhibitor

KW - health status

KW - sotagliflozin

KW - worsening heart failure

UR - https://www.scopus.com/pages/publications/85202483713

U2 - 10.1016/j.jacc.2024.06.036

DO - 10.1016/j.jacc.2024.06.036

M3 - Article

C2 - 39260929

AN - SCOPUS:85202483713

SN - 0735-1097

VL - 84

SP - 1078

EP - 1088

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

IS - 12

ER -

Effects of Sotagliflozin on Health Status in Patients With Worsening Heart Failure: Results From SOLOIST-WHF

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