Sotagliflozin in patients with diabetes and recent worsening heart failure
Open accessAbstract
BACKGROUND: Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure or death from cardiovascular causes among patients with stable heart failure. However, the safety and efficacy of SGLT2 inhibitors when initiated soon after an episode of decompensated heart failure are unknown. METHODS: We performed a multicenter, double-blind trial in which patients with type 2 diabetes mellitus who were recently hospitalized for worsening heart failure were randomly assigned to receive sotagliflozin or placebo. The primary end point was the total number of deaths from cardiovascular causes and hospitalizations and urgent visits for heart failure (first and subsequent events). The trial ended early because of loss of funding from the sponsor. RESULTS: A total of 1222 patients underwent randomization (608 to the sotagliflozin group and 614 to the placebo group) and were followed for a median of 9.0 months; the first dose of sotagliflozin or placebo was administered before discharge in 48.8% and a median of 2 days after discharge in 51.2%. Among these patients, 600 primary end-point events occurred (245 in the sotagliflozin group and 355 in the placebo group). The rate (the number of events per 100 patient-years) of primary end-point events was lower in the sotagliflozin group than in the placebo group (51.0 vs. 76.3; hazard ratio, 0.67; 95% confidence interval [CI], 0.52 to 0.85; P<0.001). The rate of death from cardiovascular causes was 10.6 in the sotagliflozin group and 12.5 in the placebo group (hazard ratio, 0.84; 95% CI, 0.58 to 1.22); the rate of death from any cause was 13.5 in the sotagliflozin group and 16.3 in the placebo group (hazard ratio, 0.82; 95% CI, 0.59 to 1.14). Diarrhea was more common with sotagliflozin than with placebo (6.1% vs. 3.4%), as was severe hypoglycemia (1.5% vs. 0.3%). The percentage of patients with hypotension was similar in the sotagliflozin group and the placebo group (6.0% and 4.6%, respectively), as was the percentage with acute kidney injury (4.1% and 4.4%, respectively). The benefits of sotagliflozin were consistent in the prespecified subgroups of patients stratified according to the timing of the first dose. CONCLUSIONS: In patients with diabetes and recent worsening heart failure, sotagliflozin therapy, initiated before or shortly after discharge, resulted in a significantly lower total number of deaths from cardiovascular causes and hospitalizations and urgent visits for heart failure than placebo. (Funded by Sanofi and Lexicon Pharmaceuticals; SOLOIST-WHF ClinicalTrials.gov number, NCT03521934.).
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A meta-analysis of six major SGLT2 inhibitor trials in type 2 diabetes, with nearly 50,000 participants, found a 32% reduction in heart failure hospitalization risk (HR 0.68, 95% CI 0.61-0.76) for SGLT2 inhibitors versus placebo.
“A comprehensive meta-analysis of 6 major SGLT2i trials in individuals with T2D, comprising nearly 50,000 participants showed a 32% reduction in the risk of hospitalization for HF (HR, 0.68; 95% CI, 0.61–0.76), a 22% reduction in the composite of hypertensive HF and CV death (HR, 0.78; 95% CI, 0.73–0.84), and a 15% reduction in CV death (HR, 0.85; 95% CI, 0.78–0.93) with SGLT2is vs placebo.649”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [649]
Split into 2 atoms — 0 confirmed, 1 partially supported, 1 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
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Experimental — accuracy not yet measuredThe benefits of SGLT2 inhibitors were consistent regardless of the presence or absence of atherosclerotic cardiovascular disease.
“All of these benefits were consistent regardless of presence or absence of ASCVD.”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [649]
The Discussion (p. 9) reports a benefit for the primary endpoint and says it was consistent across multiple prespecified subgroups, specifically mentioning treatment timing and ejection fraction. Our copy does not report whether the benefit was consistent between patients with and without ASCVD, and it does not establish that all benefits were consistent across those groups. (LLM, conf=0.78)
Experimental — accuracy not yet measuredThe same meta-analysis found a 22% reduction in the composite of heart failure and cardiovascular death (HR 0.78, 95% CI 0.73-0.84) with SGLT2 inhibitors versus placebo.
“A comprehensive meta-analysis of 6 major SGLT2i trials in individuals with T2D, comprising nearly 50,000 participants showed a 32% reduction in the risk of hospitalization for HF (HR, 0.68; 95% CI, 0.61–0.76), a 22% reduction in the composite of hypertensive HF and CV death (HR, 0.78; 95% CI, 0.73–0.84), and a 15% reduction in CV death (HR, 0.85; 95% CI, 0.78–0.93) with SGLT2is vs placebo.649”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [649]
The Discussion (p. 9) reports fewer cardiovascular deaths and heart-failure events with sotagliflozin than placebo in the SOLOIST-WHF trial. It does not report the claimed six-trial meta-analysis or its 22% reduction (HR 0.78, 95% CI 0.73–0.84); the Results (p. 2) instead give HR 0.67 for this trial’s primary endpoint. (LLM, conf=0.86)
Experimental — accuracy not yet measuredHeart failure prevention benefits of SGLT2 inhibitors are present regardless of baseline cardiovascular or antihyperglycemic therapies, including metformin.
“Secondary analyses across several of these trials also showed that HF prevention benefits of SGLT2is are present regardless of baseline CV or antihyperglycemic therapies (including metformin) (Fig. 5).649”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [649]
The Efficacy End Points section (p. 7) reports fewer cardiovascular deaths and heart-failure events with sotagliflozin in patients recently hospitalized for worsening heart failure. Table 1 (p. 6) lists baseline therapies, including metformin, but the paper does not report that benefit was independent of those therapies. Its listed subgroup findings concern factors such as ejection fraction, age, and treatment timing—not the secondary analyses across several trials described in the claim. (LLM, conf=0.87)
Experimental — accuracy not yet measuredThe same meta-analysis found a 15% reduction in cardiovascular death (HR 0.85, 95% CI 0.78-0.93) with SGLT2 inhibitors versus placebo.
“A comprehensive meta-analysis of 6 major SGLT2i trials in individuals with T2D, comprising nearly 50,000 participants showed a 32% reduction in the risk of hospitalization for HF (HR, 0.68; 95% CI, 0.61–0.76), a 22% reduction in the composite of hypertensive HF and CV death (HR, 0.78; 95% CI, 0.73–0.84), and a 15% reduction in CV death (HR, 0.85; 95% CI, 0.78–0.93) with SGLT2is vs placebo.649”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [649]
The Results (p. 2) report a similar point estimate for cardiovascular death with sotagliflozin versus placebo, but it is from a 1,222-patient trial, not a six-trial meta-analysis. Its estimate is HR 0.84 (95% CI 0.58–1.22), which does not support the claimed HR 0.85 (95% CI 0.78–0.93) or a statistically established reduction. The Discussion (p. 10) notes that early trial closure limited power to assess cardiovascular death. (LLM, conf=0.88)
Experimental — accuracy not yet measured
The same meta-analysis found a 10% reduction in major adverse cardiovascular events (HR 0.90, 95% CI 0.85-0.95) with SGLT2 inhibitors versus placebo.
“In addition, there was also a modest but significant 10% reduction in the risk of MACE (HR, 0.90; 95% CI, 0.85–0.95).649”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [649]
The Results (p. 2) report fewer cardiovascular deaths and heart-failure events with sotagliflozin than with placebo, and the outcomes table (p. 9) reports a cardiovascular composite with a hazard ratio of 0.72. This paper is a single trial, not the claimed meta-analysis, and it does not report a 10% MACE reduction with HR 0.90 (95% CI 0.85–0.95). (LLM, conf=0.82)
Experimental — accuracy not yet measuredCardiovascular and heart failure outcomes trials evaluating SGLT inhibition had low rates of ketoacidosis but excluded individuals with type 1 diabetes and/or recent history of diabetic ketoacidosis.
“Although there were low rates of ketoacidosis in the cardiovascular and heart failure outcomes trials evaluating SGLT inhibition, these studies excluded individuals with type 1 diabetes and/or recent history of diabetic ketoacidosis (309,312).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [309]
The Eligibility section (p. 3) required a diagnosis of type 2 diabetes, supporting the statement that this trial did not enroll people with type 1 diabetes. The Safety End Points section (p. 9) mentions diabetic ketoacidosis but refers readers to a supplementary table for its rates; our copy does not establish that rates were low or that a recent history of ketoacidosis was an exclusion criterion. (LLM, conf=0.82)
Experimental — accuracy not yet measuredIn the SOLOIST trial, the relatively small percentage of individuals with ejection fraction >50% (21%) and early termination limited the ability to determine the effects of sotagliflozin in HFpEF specifically.
“However, the relatively small percentage of such individuals enrolled (only 21% of participants had ejection fraction >50%) and the early termination of the trial limited the ability to determine the effects of sotagliflozin in HFpEF specifically (309).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [309]
Statistical Analysis (p. 4) reports that 256 of 1,222 participants—about 21%—had an ejection fraction of ≥50%, not >50% as claimed. The Discussion (p. 10) says early termination and the small preserved-ejection-fraction subgroup made firm conclusions about treatment effects difficult. (LLM, conf=0.86)
Experimental — accuracy not yet measuredAlthough there were low rates of ketoacidosis in the cardiovascular and heart failure outcomes trials evaluating SGLT inhibition, these studies excluded individuals with type 1 diabetes and/or recent history of diabetic ketoacidosis.
“Although there were low rates of ketoacidosis in the cardiovascular and heart failure outcomes trials evaluating SGLT inhibition, these studies excluded individuals with type 1 diabetes and/or recent history of diabetic ketoacidosis (296,298).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [296]
The Eligibility section (p. 3) requires a diagnosis of type 2 diabetes, supporting that this trial did not enroll people with type 1 diabetes. The Safety End Points section (p. 9) mentions diabetic ketoacidosis but directs readers to a supplementary table for its rates; our copy does not report those rates or establish an exclusion for recent diabetic ketoacidosis. This trial alone also cannot establish the claim about the other outcomes trials. (LLM, conf=0.85)
Experimental — accuracy not yet measuredThe studies that led to the approved indication for heart failure (HF) excluded individuals with type 1 diabetes or a history of DKA.
“The studies that led to the approved indication for heart failure (HF) excluded individuals with type 1 diabetes or a history of DKA (82,83).”
From 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025 (2025) · cites this paper as [82]
The Eligibility section (p. 3) requires a diagnosis of type 2 diabetes, supporting the point that this trial did not enroll people with type 1 diabetes. It does not list a history of DKA as an exclusion; the Safety End Points section (p. 9) mentions diabetic ketoacidosis only as an adverse event. The paper also does not establish the eligibility rules for all studies behind an approved heart-failure indication. (LLM, conf=0.85)
Experimental — accuracy not yet measuredIn the SOLOIST-WHF trial, sotagliflozin significantly reduced the risk of the primary end point of CV death, HHF, or urgent visit for HF (51.0 vs 76.3 events per 100 patient-years; HR, 0.67 [95% CI 0.52-0.85]).
“Sotagliflozin significantly reduced the risk of achieving the primary end point of CV death, HHF, or urgent visit for HF (51.0 vs 76.3 events per 100 patient-years; HR, 0.67 [95% CI 0.52-0.85]).”
From CCS/CHFS Heart Failure Guidelines Update: Defining a New Pharmacologic Standard of Care for Heart Failure With Reduced Ejection Fraction (2021) · cites this paper as [83]
In SOLOIST, there was no significant interaction by eGFR status for the primary outcome.
“There was no signi fi cant interaction by eGFR status for the primary outcome.”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [103]
In SOLOIST, sotagliflozin reduced the primary outcome (deaths from cardiovascular causes and hospitalizations and urgent visits for heart failure) by 33% (HR 0.67; 95% CI 0.52-0.85).
“sotaglifl ozin did reduce the primary outcome by 33% (HR: 0.67; 95% CI: 0.52 -0.85).”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [103]
In the SOLOIST trial, sotagliflozin initiated during or shortly after hospitalization in people with diabetes reduced the risk for the primary end point of deaths from cardiovascular causes and hospitalizations and urgent visits for heart failure.
“In the SOLOIST trial, sotagliflozin initiated during or shortly after hospitalization in people with diabetes also reduced the risk for the primary end point of deaths from cardiovascular causes and hospitalizations and urgent visits for heart failure (309).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [309]
In the SOLOIST trial, no evidence of heterogeneity of treatment effect by ejection fraction was noted.
“ultimately no evidence of heterogeneity of treatment effect by ejection fraction was noted.”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [309]
In the SOLOIST-WHF trial, sotagliflozin initiated during or shortly after hospitalization for heart failure in people with diabetes reduced the risk for the primary end point of deaths from cardiovascular causes and hospitalizations and urgent visits for heart failure.
“In the Effect of Sotagliflozin on Cardiovascular Events in Patients With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF) trial, sotagliflozin, a combined SGLT1/2 inhibitor, initiated during or shortly after hospitalization for heart failure in people with diabetes, also reduced the risk for the primary end point of deaths from cardiovascular causes and hospitalizations and urgent visits”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [296]
Canagliflozin, Dapagliflozin, and Sotagliflozin significantly decrease the composite primary endpoint including cardiovascular mortality and other cardiovascular outcomes.
“Canagliflozin, Dapagliflozin, Sotagliflozin significantly decrease the composed primary end-point, including cardiovascular mortality and other cardiovascular outcomes [10,11,12].”
From Neuroprotective effect of SGLT2 inhibitors. (2021) · cites this paper as [12]
In the SOLOIST-WHF trial, sotagliflozin reduced the risk of the primary composite outcome of cardiovascular death, heart failure hospitalization, and urgent visit for heart failure by 33%, with a consistent effect across baseline LVEF; however, the number of events in the HFpEF group was too small to draw any firm conclusion.
“Sotagliflozin reduced the risk of the primary composite outcome of CV death, HF hospitalization, and urgent visit for HF by 33%, with a consistent effect across the spectrum of baseline LVEF.However, the number of events in the HFpEF group was too small to draw any firm conclusion.189”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [189]
In the SOLOIST-WHF trial, sotagliflozin significantly reduced the relative risk of the composite primary outcome of cardiovascular death, heart failure hospitalization, or urgent visit for heart failure by 33% compared with placebo (HR 0.67; 95% CI 0.52-0.85), with a consistent treatment effect across the spectrum of LVEF.
“Sotagliflozin significantly reduced the RR of the composite primary outcome (CV death, HF hospitalization, or urgent visit for HF) by 33% compared with placebo (HR 0.67; 95% CI, 0.52-0.85).The treatment effect was consistent across the spectrum of LVEF.189”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [189]
Sub-group analyses considering those co-prescribed mineralocorticoid receptor antagonists and SGLT2 inhibitors suggest their combined use does not modify safety findings from the key trials.
“Sub-group analyses considering those co-prescribed MRA and SGLT2 inhibitors suggest their combined use does not modify safety findings from the key trials.150,189,[722][723][724][725][726]”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [189]
In SOLOIST-WHF, the small percentage of HFpEF patients and early trial termination limited the ability to determine the effects of sotagliflozin specifically in HFpEF.
“However, the relatively small percentage of such patients enrolled (only 21% of participants had ejection fraction > 50%) and the early termination of the trial limited the ability to determine the effects of sotagli fl ozin in HFpEF speci fi cally.”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [228]
In SOLOIST-WHF, there were no significant between-group differences in cardiovascular death or all-cause mortality.
“No signi fi cant between-group differences were found in the rates of cardiovascular death or all-cause mortality.”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [228]
In SOLOIST-WHF, among 1,222 people with type 2 diabetes recently hospitalized for worsening heart failure, sotagliflozin reduced primary endpoint events compared with placebo (51.0 vs 76.3; HR 0.67).
“At a median follow-up of 9 months, the rate of primary end point events (the total number of cardiovascular deaths and hospitalizations and urgent visits for heart failure) was lower in the sotaglifl ozin group than in the placebo group (51.0 vs. 76.3; HR 0.67 [95% CI 0.52 -0.85]; P < 0.001).”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [228]
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- Authors
- Bhatt, D. L., Szarek, M., Steg, P. G., Cannon, C. P., Leiter, L. A., McGuire, D. K., Lewis, J. B., Riddle, M. C., Voors, A. A., Metra, M., Lund, L. H., Komajda, M., Testani, J. M., Wilcox, C. S., Ponikowski, P., Lopes, R. D., Verma, S., Lapuerta, P., & Pitt, B.
- Affiliations
- Brigham and Women's Hospital (US)
- From Brigham and Women’s Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique–Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 ...
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2021-01-14
- Volume
- 384
- Issue
- 2
- Pages
- 117-128
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W3100542962
- Semantic Scholar
- a022df46be992be653dc8f2439f324470b7eb318
- Cited by
- 1,868
- References
- 51
- Citations by year
- 2026: 160 · 2025: 231 · 2024: 316 · 2023: 373 · 2022: 409 · 2021: 355 · 2020: 19 · 2019: 1
- FWCI
- 178.84
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- New England Journal of Medicine (publishedVersion, other-oa)
- PubMed (publishedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion, other-oa)
- Institutional Research Information System (Università degli Studi di Brescia) (submittedVersion)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
- Archivio Istituzionale della Ricerca - Università Vita-Salute San Raffaele (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, other-oa)
- Funders
- Sanofi
- Lexicon Pharmaceuticals
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Function and Risk Factors
- Keywords
- sotagliflozin, SGLT2 inhibitors, type 2 diabetes, worsening heart failure, acute decompensated heart failure, heart failure hospitalization, cardiovascular mortality, diarrhea, hypoglycemia, drug safety, DAPA-HF
- MeSH terms
- Sodium-Glucose Transporter 2 Inhibitors, Aged, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Double-Blind Method, Female, Glycosides, Heart Failure, Hospitalization, Humans, Hypotension, Male, Middle Aged, Sodium-Glucose Transporter 1, Acute Kidney Injury
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