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Table 1 Overview of the most important inclusion criteria in SGLT-2 trials on type 2 diabetes patients as well as their outcomes, incl. hazard ratios and confidence intervals (CI). In EMPA-REG patients received Empagliflozin, for CANVAS patients were treated with Canagliflozin and DECLARE-TIMI 58 was carried out to study the effect of Dapagliflozin.

From: Redox-driven cardioprotective effects of sodium-glucose co-transporter-2 inhibitors: comparative review

 

EMPA-REG

CANVAS

DECLARE-TIMI 58

No. of patients

7,028

10,142

17,160

Inclusion criteria

   

Type 2 diabetes

Type 2 diabetes

Type 2 diabetes

 

HbA1c ≥ 7% and ≤ 10%

  
 

≥ 18 years

≥ 30 years or ≥ 50 years (s.b.)

≥ 40 years

Cardiovascular (CV) diseases

Established CV diseases

a) ≥ 30 years and history of symptomatic CV diseases or

b) ≥ 50 years and ≥ 2 risk factors for CV diseases (duration of type 2 diabetes ≥ 10 years, systolic blood pressure > 140 mmHg (blood pressure–lowering treatment), current daily cigarette smoker, documented micro- or macroalbuminuria, or high-density lipoprotein (HDL) cholesterol of < 1 mmol/l (< 39 mg/dl)

a) Est. CV (40.6%) or

b) ≥ 2 risk factors for it (age (≥ 55 years male ≥ 60 years female), dyslipidemia, hypertension, current tobacco use) (59.5%)

Medication

Possible, incl. insulin

Possible, antihyperglycemic agents as mono- or combination therapy

Possible with antihyperglycemic agents

Outcomes

   

Cardiovascular

Significant lower risk of death from CV (hazard ratio, 0.62 (95% CI, 0.49 to 0.77)) or any cause (hazard ratio, 0.68 (95% CI, 0.57 to 0.82))

Reduced occurrence of death from CV causes, nonfatal myocardial infarction, nonfatal stroke (hazard ratio, 0.86 (95% CI, 0.75 to 0.97))

Reduced occurrence of CV death, myocardial infarction or ischemic stroke (hazard ratio, 0.93 (95% CI, 0.84 to 1.03))

Hospitalization

Significant lower risk of hospitalization for heart failure (hazard ratio, 0.65 (95% CI, 0.50 to 0.85))

Lower risk of hospitalization for heart failure (hazard ratio, 0.67 (95% CI, 0.52 to 0.87))

Lower risk for hospitalization for heart failure (hazard ratio, 0.83 (95% CI, 0.73 to 0.95))

Other

Lower glycated hemoglobin levels (after 12 weeks with decreasing impact), slight reduction in weight, waist circumference, uric acid level and blood pressure (systolic and diastolic); slight increase of LDL and HDL cholesterol

Lower glycated hemoglobin levels, slight reduction in weight, waist circumference, blood pressure (systolic and diastolic); slight increase of LDL and HDL cholesterol

Lower glycated hemoglobin levels, slight reduction in weight and blood pressure (systolic and diastolic)

Adverse side effects

Genital infections

Genital infections,

higher risk of amputations (toe or metatarsal) and increased bone fractures with existing burden

Genital infections