What data is available that compares different SGLT2 inhibitors on MACE and heart failure hospitalizations?

Comment by InpharmD Researcher

There are a lack of direct comparative trials evaluating the effects of various SGLT2 inhibitors on the outcomes of MACE and heart failure hospitalizations. Indirect comparisons from meta-analyses and direct comparisons from two retrospective studies have typically found no differences between individual SGLT2 inhibitors for relevant outcomes including cardiovascular death and hospitalization for heart failure. Outcomes appear to be similar in patients regardless of the type of heart failure. However, meta-analyses have conflicting conclusions regarding the most effective agent for reduction of individual outcomes. In general, SGLT2 inhibitors have not been found to produce a significant reduction in cardiovascular death compared to placebo, but empagliflozin appears to produce the most notable effect on mortality. An economic analysis, however, discovered that dapagliflozin may have a higher lifetime economic value compared to empagliflozin.

Background

A 2023 network meta-analysis based on Bayesian methods indirectly compared sodium-glucose co-transporter 2 (SGLT2) inhibitors in patients with established heart failure. A total of 5 randomized controlled trials were included that evaluated 4 different treatment strategies among 21,927 patients. No significant differences were found in the composite of cardiovascular death or hospitalization for heart failure between dapagliflozin and empagliflozin (odds ratio [OR] 1.00, 95% confidence interval [CI] 0.66 to 1.55), dapagliflozin and sotagliflozin (OR 1.54, 95% CI 0.91 to 2.65), and empagliflozin and sotagliflozin (OR 1.53, 95% CI 0.90 to 2.69). The comparisons of dapagliflozin and empagliflozin (OR 0.92, 95% CI 0.71 to 1.18), dapagliflozin and sotagliflozin (OR 1.05, 95% CI 0.68 to 1.59), and empagliflozin and sotagliflozin (OR 1.14, 95% CI 0.74 to 1.73) revealed no significant differences in all-cause mortality. Cardiovascular death did not differ significantly when dapagliflozin was compared to empagliflozin (OR 0.94, 95% CI 0.71 to 1.23), dapagliflozin was compared to sotagliflozin (OR 0.96, 95% CI 0.61 to 1.55), and empagliflozin was compared to sotagliflozin (OR 1.03, 95% CI 0.64 to 1.66). There was no significant difference in hospitalization for heart failure between dapagliflozin and empagliflozin (OR 1.13, 95% CI 0.64 to 1.97), dapagliflozin and sotagliflozin (OR 1.56, 95% CI 0.74 to 3.15), and empagliflozin and sotagliflozin (OR 1.39, 95% CI 0.68 to 2.78). [1]

Subgroup analyses in patients with heart failure with reduced ejection fraction (HFrEF) and heart failure with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF) also observed no differences between dapagliflozin and empagliflozin for evaluated outcomes. It was determined that there were no significant differences in major efficacy outcomes among SGLT2 inhibitors in patients with established heart failure; however, sotagliflozin was identified to be associated with the lowest risk of cardiovascular death or hospitalization for heart failure, and dapagliflozin was identified to be associated with the lowest risk of all-cause and cardiovascular mortality. [1]

A 2022 network meta-analysis evaluated the relative efficacy of five SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, and sotagliflozin) on cardiorenal outcomes. Ten cardiovascular outcome trials were included in the analysis. Compared to placebo, canagliflozin (hazard ratio [HR] 0.64; 95% CI 0.53 to 0.77), dapagliflozin (HR 0.7; 95% CI 0.62 to 0.79), empagliflozin (HR 0.68; 95% CI 0.59 to 0.78), ertugliflozin (HR 0.7; 95% CI 0.54 to 0.9), and sotagliflozin (HR 0.66; 95% CI 0.56 to 0.77) all reduced hospitalization for heart failure. None of the five agents reduced myocardial infarction or stroke. Compared with ertugliflozin, empagliflozin reduced cardiovascular death or hospitalization for heart failure (HR 0.81; 95% CI 0.67 to 0.99); both empagliflozin (HR 0.65; 95% CI 0.45 to 0.93) and dapagliflozin (HR 0.69; 95% CI 0.52 to 0.92) reduced and kidney function progression. Surface under the cumulative ranking cure (SUCRA) probability to rank treatments was calculated. Canagliflozin had the greatest SUCRA value for reduction of major adverse cardiovascular events (MACE), stroke, and hospitalization for heart failure; empagliflozin had the greatest value for reduction of myocardial infarction, cardiovascular death, cardiovascular death or hospitalization for heart failure, kidney function progression, and all-cause death. [2]

A 2021 systematic review and meta-analysis investigated the comparative efficacy of individual SGLT2 inhibitors, including canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin. A total of 64 trials (N= 74,874) were included; the primary endpoint was all-cause mortality, while secondary endpoints included cardiovascular mortality and worsening heart failure. Compared to placebo, empagliflozin and canagliflozin were found to improve all three endpoints (all-cause mortality: empagliflozin risk ratio [RR] 0.67, 95% CI 0.55 to 0.8 and canagliflozin RR 0.85, 95% CI 0.75 to 0.97; cardiovascular mortality: empagliflozin RR 0.61, 95% CI 0.49 to 0.77 and canagliflozin RR 0.85, 95% CI 0.73 to 0.99; and worsening heart failure: empagliflozin 0.66, 95% CI 0.5 to 0.86 and canagliflozin 0.62, 95% CI 0.52 to 0.75), while dapagliflozin improved worsening heart failure (RR 0.75, 95% CI 0.62 to 0.88). Empagliflozin, compared with other SGLT2 inhibitors, was superior for reductions in all-cause (vs. canagliflozin RR 0.78, 95% CI 0.62 to 0.98; vs. dapagliflozin RR 0.72, 95% CI 0.58 to 0.9) and cardiovascular mortality (vs. canagliflozin RR 0.72, 95% CI 0.55 to 0.95; vs. dapagliflozin RR 0.52, 95% CI 0.48 to 0.85). Similar effects were seen between empagliflozin, canagliflozin, and dapagliflozin on improvement of worsening heart failure. Ertugliflozin was found to have no effect on any of the endpoints. [3]

A 2021 network meta-analysis evaluated the relative efficacy of various SGLT2 inhibitors and glucagon-like peptide 1 receptor agonists (GLP-1 RAs) on cardiorenal outcomes. A total of 14 cardiovascular or renal outcome trials were included in the analysis. Sotagliflozin (HR 0.76; 95% CI 0.61 to 0.94) lowered the risk of MACE, as did subcutaneous semaglutide and albiglutide. A lower risk of hospitalization for heart failure was seen for sotagliflozin (HR 0.59; 95% CI 0.4 to 0.90), canagliflozin (HR 0.58; 95% CI 0.38 to 0.87), and empagliflozin (HR 0.59; 95% CI 0.37 to 0.92). Risk of kidney function progression was lowered with dapagliflozin (HR 0.6; 95% CI 0.47 to 0.78) and empagliflozin (HR 0.61; 95% CI 0.43 to 0.87). Cardiovascular death was lowered with empagliflozin (HR 0.63; 95% CI 0.47 to 0.84) and oral semaglutide, while sotagliflozin (HR 0.65; 95% CI 0.47 to 0.91) and albiglutide lowered risk for myocardial infarction. Risk of stroke was lowered with sotagliflozin (HR 0.56; 95% CI 0.37 to 0.85) and subcutaneous semaglutide. Oral semaglutide and empagliflozin (HR 0.65; 95% CI 0.43 to 0.96) were found to lower risk of all-cause death. [4]

A 2020 meta-analysis that evaluated SGLT2 inhibitors and their effects on heart failure hospitalization in patients with type 2 diabetes. A total of 55,763 patients with type 2 diabetes were randomized to either SGLT2 inhibitors (n= 31,172) or placebo (n= 24,591) within the included trials. Subgroup analyses determined that canagliflozin (RR 0.60; 95% CI 0.49 to 0.72; p<0.00001), dapagliflozin (RR 0O.73; 95% CI 0.62 to 0.85; p<0.0001), empagliflozin (RR 0.52; 95% CI 0.28 to 1.00; p= 0.05), and ertugliflozin (RR 0.70; 95% CI, 0.54 to 0.90; p= 0.006) all significantly decreased the occurrence of heart failure hospitalization. However, there was noted to be significant heterogeneity among the eight trials included for analysis (I2= 74%). Subgroup analyses of the various agents and their respective effects on MACE found canagliflozin (RR 0.81; 95% CI 0.68 to 0.95; p<0.01) and empagliflozin (RR 0.86; 95% CI 0.75 to 0.99; p<0.04) to significantly decrease MACE occurrence. No significant heterogeneity was identified for the outcome of MACE (I2= 20%). Compared to placebo, no agent appeared to significantly decrease the occurrence of cardiovascular death. Significant heterogeneity was present in the analysis for cardiovascular death (I2= 88%). Notably, dapagliflozin was the only agent to significantly decrease the occurrence of death from any cause (RR 0.89; 95% CI 0.81 to 0.98; p= 0.02). Overall, it is difficult to distinguish the effects of all SGLT2 inhibitors due to a paucity of relevant trials and significant heterogeneity between trials for relevant outcomes. [5]

A 2023 study conducted a cost-effectiveness analysis in order to compare dapagliflozin and empagliflozin in patients with heart failure with reduced ejection fraction. The model estimated the expected lifetime costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER) for both medications. Patients 65 years of age at entry were included and their health outcomes were simulated over a lifetime horizon, based on the US healthcare system. The incremental expected lifetime cost of treating patients with dapagliflozin compared to empagliflozin was $37,684. This resulted in an ICER of $44,763 per QALY. The authors concluded that dapagliflozin may offer a greater lifetime economic value compared with empagliflozin. [6]

References:

[1] Chen HB, Yang YL, Meng RS, Liu XW. Indirect comparison of SGLT2 inhibitors in patients with established heart failure: evidence based on Bayesian methods. ESC Heart Fail. 2023;10(2):1231-1241. doi:10.1002/ehf2.14297
[2] Qiu M, Ding LL, Zhou HR. Comparative Efficacy of Five SGLT2i on Cardiorenal Events: A Network Meta-analysis Based on Ten CVOTs. Am J Cardiovasc Drugs. 2022;22(1):69-81. doi:10.1007/s40256-021-00484-8
[3] Täger T, Atar D, Agewall S, et al. Comparative efficacy of sodium-glucose cotransporter-2 inhibitors (SGLT2i) for cardiovascular outcomes in type 2 diabetes: a systematic review and network meta-analysis of randomised controlled trials. Heart Fail Rev. 2021;26(6):1421-1435. doi:10.1007/s10741-020-09954-8
[4] Duan XY, Liu SY, Yin DG. Comparative efficacy of 5 sodium glucose cotransporter 2 inhibitor and 7 glucagon-like peptide 1 receptor agonists interventions on cardiorenal outcomes in type 2 diabetes patients: A network meta-analysis based on cardiovascular or renal outcome trials. Medicine (Baltimore). 2021;100(30):e26431. doi:10.1097/MD.0000000000026431
[5] Zhang A, Luo X, Meng H, et al. Sodium Glucose Cotransporter 2 Inhibitors Reduce the Risk of Heart Failure Hospitalization in Patients With Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Front Endocrinol (Lausanne). 2021;11:604250. Published 2021 Jan 15. doi:10.3389/fendo.2020.604250
[6] Nechi RN, Rane A, Karaye RM, et al. Cost-Effectiveness of Dapagliflozin vs Empagliflozin for Treating Heart Failure With Reduced Ejection Fraction in the United States. Clin Ther. 2023;45(7):627-632. doi:10.1016/j.clinthera.2023.05.002

Literature Review

A search of the published medical literature revealed 2 studies investigating the researchable question:

What data is available that compares different SGLT2 inhibitors on MACE and heart failure hospitalizations?

Level of evidence

A - Multiple high-quality studies with consistent results  Read more→



Please see Tables 1-2 for your response.


 

Differences in outcomes of hospitalizations for heart failure after SGLT2 inhibitor treatment: effect modification by atherosclerotic cardiovascular disease

Design

Retrospective multi-institutional cohort study

N= 19,172

Objective

To examine differences in hospitalization for heart failure (hHF) outcomes after dapagliflozin or empagliflozin use between type 2 diabetes (T2D) patients with and without a history of established Atherosclerotic Cardiovascular Disease. 

Study Groups

Dapagliflozin (n= 9586)

Empagliflozin (n= 9586)

Inclusion Criteria

Adult patients with T2D, newly receiving at least 2 prescriptions of dapagliflozin or empagliflozin

Exclusion Criteria

No clinical visit before the index date, no laboratory examination, baseline estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2

Methods

Patient data was collected from Taiwan's multi-institutional Chang Gung Research Database (CGRD) consisting of seven hospitals located throughout northern and southern Taiwan. Patients were matched 1:1 via propensity scoring to create a homogenous group for comparison.

Duration

Intervention: 2016 to 2019

Follow up: December 31, 2020

Outcome Measures

Event rate of hHF, determined by the clinical diagnosis, ICD-10-CM codes: I50, at any point in the hospital discharge records

Baseline Characteristics

 

Dapagliflozin (n= 9586)

Empagliflozin (n= 9586)

 

Age, years

59.9 60.0  

Female, percentage

40.2 40.2  

Hemoglobin A1c, mean %

8.7 8.7  

Systolic blood preassure, mmHg

140.0 140  

Diastolic blood pressure, mmHg

78.7 78.6  

ASCVD, %

25.1 25.4  

Coronary heart disease

21.3% 21.7%  

Ischemic stroke 

3.9% 3.3%  

Peripheral artery disease

1.3% 1.5%  

 Comobidity

      Hypertension 

      Hyperlipidemia

      Heart failure

      Atrial Fibrillation

 

67.6%

72.6%

5.7%

3.2%

 

68.0%

72.3%

5.8%

3.3%

 

Co-medications, Percentage

     Anti-platelet agents

     Anti-coagulant agents

     Beta blockers

     ACEI / ARB

     Calcium channel blockers 

     Statin

 

32.8%

3.3%

28.4%

60.7%

40.3%

66.3%

 

32.7%

3.4%

28.5%

61.1%

41.2%

66.2%

 

Results

Endpoint

Dapagliflozin

Empagliflozin

 Hazard Ratio (95% Confidence interval [CI])

Events of hHF per 1000 person-years

7.56 8.39 0.90 (0.74 to 1.09)

Subanalysis, (95% CI)

Patients with established ASCVD

Patients without established ASCVD

ASCVD vs without ASCVD

 

1.12 (0.87 to 1.45)

0.21 (0.15 to 0.28)

5.47 (4.08 to 7.33)

 

1 (reference)

0.31 (0.24 to 0.40)

3.24 (1.48 to 4.23)

 

1.12 (0.87 to 1.45)

0.67 (0.49 to 0.90)

--

Adverse Events

N/A

Study Author Conclusions

In this study, history of established ASCVD was associated with different hHF risks among SGLT2 inhibitors. For T2D patients without  ASCVD, dapagliflozin may offer a more favorable hHF reduction effect, compared to empagliflozin, in clinical practice. Future prospective studies should be conducted to validate our findings.

InpharmD Researcher Critique

While dapagliflozin may offer better effects on hHF reduction compared to empagliflozin in T2D patients without ASCVD, A randomized control trial must be conducted to confirm the findings from this study and evaluate the primary outcome in other approved SGLT2 inhibitors.



References:

Shao SC, Chang KC, Lin SJ, et al. Differences in outcomes of hospitalizations for heart failure after SGLT2 inhibitor treatment: effect modification by atherosclerotic cardiovascular disease. Cardiovasc Diabetol. 2021;20(1):213. Published 2021 Oct 23. doi:10.1186/s12933-021-01406-3

 

Comparison of cardiovascular outcomes between SGLT2 inhibitors in diabetes mellitus

Design

Retrospective cohort study 

N= 25,315

Objective

To compare the cardiovascular outcomes between SGLT2 inhibitors in diabetes mellitus patients

Study Groups

Empagliflozin (n= 5302)

Dapagliflozin (n= 4681)

Canagliflozin (n= 4411)

Other SGLT2 inhibitors (n= 10,921) 

Inclusion Criteria

Presence of diabetes mellitus, started SGLT2 inhibitors at least 4 months after enrollment.

Exclusion Criteria

Age < 20, history of CVD (cardiovascular disease) or renal failure, any CVD events or were censored within an induction period (1 month), missing data on cigarette smoking and alcohol consumption

Methods

Patient data was collected from a Japanese Claims Database, which is a health check-up and insurance claims database. The data were extracted from 37,283 individuals with diabetes mellitus who had started taking SGLT2 inhibitors at least 4 months after enrollment (insurance coverage). 11,968 patients were excluded from the study by using exclusion criteria. Finally, the data of 25,315 patients with diabetes mellitus newly taking SGLT2 inhibitors (empagliflozin: 5302, dapagliflozin: 4681, canagliflozin: 4411, other SGLT2 inhibitors: 10,921) were analyzed.

Duration

Data collection: January 2005 and April 2021

Outcome Measures

Primary outcomes: Risk of developing heart failure, myocardial infarction, angina pectoris, stroke, and atrial fibrillation

Baseline Characteristics

 

Overall (N= 23,315)

Empagliflozin (n=5302)

Dapagliflozin (n= 4681)

Canagliflozin (n= 4411)

Other SGLT2 inhibitors (n= 10,921)

p-value

Age, years

52 (47 to 58) 52 (46 to 58) 52 (46 to 57) 52 (46 to 58) 52 (47 to 58) 0.037

male

20,875 (82.5%)  4392 (82.8%) 3838 (82.0%) 3710 (84.1%) 8935 (81.8%) 0.005 
Body mass index kg/m²

27.8 (25.1 to 31.1)

 27.8 (25.1 to 31.2) 27.9 (25.3 to 31.2) 27.7 (25.0 to 31.1) 27.7 (25.0 to 31.0) 0.025
SBP, mmHg

129 (120 to 140)

129 (120 to 140) 129 (120 to 140) 130 (121 to 139) 129 (120 to 140) 0.74
DBP, mmHg

82 (75 to 89)

82 (74 to 89) 82 (75 to 89) 82 (75 to 89) 82 (74 to 89) 0.52

Cigarette smoking

8634 (34.1%) 1761 (33.2%) 1625 (34.7%) 1526 (34.6%) 3722 (34.1%) 0.37

Alcohol consumption

5106 (20.2%) 1058 (20.0%) 937 (20.0%) 930 (21.1%) 2181 (20.0%) 0.43

Dyslipidemia

20,465 (80.8%) 4314 (81.4%) 3775 (80.6%) 3570 (80.9%) 8806 (80.6%) 0.71

HbA1c

7.5% (6.9 to 8.6%) 7.5% (6.9 to 8.6%) 7.5% (6.9 to 8.6%) 7.5% (6.8 to 8.5%) 7.6% (6.9 to 8.6%) 0.001

LDL-C, mg/dL

123 (103 to 145) 123 (103 to 146) 124 (103 to 146) 124 (103 to 146) 122 (103 to 144) 0.076

SBP: systolic blood pressure, DBP: diastolic blood pressure, LDL-C: low-density lipoprotein cholesterol

Results

Endpoint

Empagliflozin (n= 5,302)

Dapagliflozin (n= 4,681)

Canagliflozin (n= 4,411)

Other SGLT2- inhibitors (n= 10,921)

p-value

 

Heart failure events

155 171 160 369 0.1415  

Myocardial infarction events 

27 27 26 63 0.4569  

Angina Pectoris events

137 162 140 376 0.8367  

Stroke events

57 70 54 159 0.8607  

Atrial fibrillation events

30 22 27 60 0.2561  

Adverse Events

Common Adverse Events: lower limb amputation, bone fracture, genitourinary infection, ketoacidosis

Study Author Conclusions

Our analysis of a nationwide real-world dataset suggested that the risk of cardiovascular events, including HF, MI, AP, stroke, and AF would be comparable between individual SGLT2 inhibitors.

InpharmD Researcher Critique

The strength of this study is that it used a large sample size for statistical analysis, but the limitation is most of the participants were male (82.5%), and data on socioeconomic status, which could affect the risk of CVD events, were not available in this study.   



References:

Suzuki Y, Kaneko H, Okada A, et al. Comparison of cardiovascular outcomes between SGLT2 inhibitors in diabetes mellitus. Cardiovasc Diabetol. 2022;21(1):67. Published 2022 May 18. doi:10.1186/s12933-022-01508-6