Empagliflozin

(Jardiance®)

Empagliflozin

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Drug updated on 4/16/2024

Dosage FormTablets (oral: 10 mg, 25 mg)
Drug ClassSodium-glucose co-transporter 2 inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure.
  • Indicated to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression.
  • Indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.
  • Indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.

Summary
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  • Empagliflozin has demonstrated significant benefits in reducing hemoglobin A1c, body weight, systolic blood pressure, and improving heart failure outcomes. These effects are consistent with the broader class of sodium-glucose cotransporter-2 inhibitors (SGLT2i), which includes dapagliflozin and canagliflozin.
  • The process involved 45 systematic reviews/meta-analyses that encompassed a wide range of patient populations including those with type 2 diabetes mellitus (T2DM), heart failure (HF), and chronic kidney disease (CKD).
  • In terms of cardiovascular and renal outcomes, empagliflozin significantly lowers the risk of cardiovascular death, hospitalization for heart failure, and progression of kidney disease in patients with T2DM. This is comparable or superior to other SGLT2i drugs, as well as GLP-1 receptor agonists.
  • Subgroup analysis reveals that the efficacy and safety profile remains consistent across different age groups, genders, and the presence or absence of diabetes mellitus status along with baseline kidney function levels. However, it shows specific beneficial effects in HF patients, especially those suffering from reduced ejection fraction.
  • When compared to other SGLT2 inhibitors like dapagliflozin & canagliflozin or active comparators such as metformin & GLP-1 receptor agonists (GLP-RAs), empagliflozin demonstrates superior efficacy particularly in reducing the risk associated with cardiovascular mortality based on certain analyses.
  • The side effect profile indicates an increased risk for genitourinary infections, but this is considered manageable while concerns about potential risks such as lower limb amputations primarily associated were not observed significantly during trials involving empagliflozin use.
  • Empagliflozin does not increase risks of acute kidney injury substantially, thereby offering renal protective benefits making it a compelling option for management, especially for patients with high cardiovascular and renal risk.
  • The safety profile of empagliflozin is favorable, with manageable risks that do not outweigh its therapeutic benefits. Compared to other SGLT2 inhibitors and diabetes medications, empagliflozin offers distinct advantages, especially in specific patient subsets such as those suffering from heart failure or chronic kidney disease.

Product Monograph / Prescribing Information

Document TitleYearSource
Jardiance (empagliflozin) prescribing information.2023Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Selective sodium-glucose cotransporter-2 inhibitors in the improvement of hemoglobin and hematocrit in patients with type 2 diabetes mellitus: A network meta-analysis. 2024Frontiers in Endocrinology
Effects of dapagliflozin and empagliflozin on 6-min walk distance in heart failure with preserved and reduced ejection fraction: A systematic review and meta-analysis of randomized controlled trials involving 2624 patients.2024European Journal of Clinical Pharmacology
The effect of SGLT-2 inhibitors on cardiorespiratory fitness capacity: A systematic review and meta-analysis.2023Frontiers in Psychcology
Effect of sodium–glucose cotransporter 2 inhibitors on insulin resistance; a systematic review and meta-analysis.2023Acta Diabetologica
The efficacy of sodium-glucose cotransporter-2 inhibitors in improving morbidity and mortality of heart failure: A systematic review.2023Cureus
The effects of cardioprotective antidiabetic therapy on microbiota in patients with type 2 diabetes mellitus-a systematic review.2023Internal Journal of Molecular Sciences
Systematic review of sodium-glucose cotransporter 2 inhibitors: A hopeful prospect in tackling heart failure-related events. 2023European Journal of Heart Failure
Serum uric acid lowering and effects of sodium-glucose cotransporter-2 inhibitors on gout: A meta-analysis and meta-regression of randomized controlled trials. 2023Diabetes, Obesity and Metabolism
Effects of empagliflozin on serum uric acid level of patients with type 2 diabetes mellitus: A systematic review and meta-analysis. 2023Diabetology & Metabolic Syndrome
Impact of SGLT2 inhibitors on patient outcomes: A network meta-analysis.2023Cardiovascular Diabetology
Comparative cardiovascular benefits of individual SGLT2 inhibitors in type 2 diabetes and heart failure: A systematic review and network meta-analysis of randomized controlled trials. 2023Frontiers in Endocrinology
Comparative safety of different sodium-glucose transporter 2 inhibitors in patients with type 2 diabetes: A systematic review and network meta-analysis of randomized controlled trials. 2023Frontiers in Endocrinology
Comparative safety of different recommended doses of sodium-glucose cotransporter 2 inhibitors in patients with type 2 diabetes mellitus: A systematic review and network meta-analysis of randomized clinical trials.2023Frontiers in Endocrinology
Association between sodium-glucose cotransporter-2 inhibitors and incident atrial fibrillation/atrial flutter in heart failure patients with reduced ejection fraction: A meta-analysis of randomized controlled trials.2023Heart Failure Reviews
Efficacy and safety of sodium-glucose cotransporter-2 inhibitors for heart failure with mildly reduced or preserved ejection fraction: A systematic review and meta-analysis of randomized controlled trials.2023Frontiers in Cardiovascular Medicine
Cardiovascular benefits and safety of sotagliflozin in type 2 diabetes mellitus patients with heart failure or cardiovascular risk factors: A Bayesian network meta-analysis.2023Frontiers in Pharmacology
Impacts of sodium/glucose cotransporter-2 inhibitors on circulating uric acid concentrations: A systematic review and meta-analysis.2022Journal of Diabetes Research
Sodium-glucose cotransporter-2 inhibitors and risk of diabetic ketoacidosis among adults with type 2 diabetes: A systematic review and meta-analysis.2022Canadian Journal of Diabetes
Comparative cardiovascular outcomes of SGLT2 inhibitors in type 2 diabetes mellitus: A network meta-analysis of randomized controlled trials.2022Frontiers in Endocrinology
Comparative efficacy of five SGLT2i on cardiorenal events: A network meta-analysis based on ten CVOTS.2022American Journal of Cardiovascular Drugs
Association of SGLT2 inhibitors with risk of atrial fibrillation and stroke in patients with and without type 2 diabetes: A systemic review and meta-analysis of randomized controlled trials.2022Journal of Cardiovascular Pharmacology
Sodium-glucose cotransporter 2 inhibitors in patients with heart failure: A systematic review and meta-analysis of randomized trials.2022European Heart Journal- Quality of Care and Clinical Outcomes
Beneficial effect of sodium-glucose co-transporter 2 inhibitors on left ventricular function2022The Journal of Clinical Endocrinology & Metabolism
Effect of sodium-glucose cotransporter-2 inhibitors on cardiac remodelling: A systematic review and meta-analysis.2022European Journal of Preventative Cardiology
Relationship between SGLT-2i and ocular diseases in patients with type 2 diabetes mellitus: A meta-analysis of randomized controlled trials.2022Frontiers in Endocrinology
Efficacy and safety of empagliflozin at different doses in patients with type 2 diabetes mellitus: A network meta-analysis based on randomized controlled trials.2022Journal of Clinical Pharmacy and Therapeutics
The impact of pharmacological and lifestyle interventions on body weight in people with type 1 diabetes: A systematic review and meta-analysis.2021Diabetes, Obesity and Metabolism
Do SGLT2 inhibitors improve cardio-renal outcomes in patients with type II diabetes mellitus: A systematic review. 2021Cureus
Association of SGLT2 inhibitors with arrhythmias and sudden cardiac death in patients with type 2 diabetes or heart failure: A meta-analysis of 34 randomized controlled trials.2021Heart Rhythm
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. 2021Medicine
Microvascular benefits of new antidiabetic agents: A systematic review and network meta-analysis of kidney outcomes.2021Journal of Clinical Endocrinology & Metabolism
Empagliflozin in patients with heart failure: A systematic review and meta-analysis of randomized controlled trials. 2021Frontiers in Cardiovascular Medicine
Efficacy and safety of the glucagon-like peptide-1 receptor agonist oral semaglutide in patients with type 2 diabetes mellitus: A systematic review and meta-analysis. 2021Diabetes Research and Clinical Practice
Relative efficacy of sacubitril-valsartan, vericiguat, and SGLT2 inhibitors in heart failure with reduced ejection fraction: A systematic review and network meta-analysis. 2021Cardiovascular Drugs and Therapy
Comparative efficacy of glucose-lowering medications on body weight and blood pressure in patients with type 2 diabetes: A systematic review and network meta-analysis.2021Diabetes, Obesity and Metabolism
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.2021Heart Failure Reviews
High-dose sodium-glucose co-transporter-2 inhibitors are superior in type 2 diabetes: A meta-analysis of randomized clinical trials.2021Diabetes, Obesity and Metabolism
Effects and safety of SGLT2 inhibitors compared to placebo in patients with heart failure: A systematic review and meta-analysis.2020IJC Heart and Vasculature
Comparative effectiveness of glucose-lowering drugs for type 2 diabetes: A systematic review and network meta-analysis.2020Annals of Internal Medicine
SGLT2 inhibitors in patients with heart failure with reduced ejection fraction: A meta-analysis of the EMPEROR-Reduced and DAPA-HF trials2020The Lancet Diabetes and Endocrinology
Association of glucose-lowering medications with cardiovascular outcomes: An umbrella review and evidence map.2020The Lancet Diabetes and Endocrinology
Association between sodium-glucose cotransporter 2 (SGLT2) inhibitors and lower extremity amputation: A systematic review and meta-analysis2020PLoS One
Efficacy and safety of SGLT-2 inhibitors for treatment of diabetes mellitus among kidney transplant patients: A systematic review and meta-analysis.2020Medical sciences
Effect of sodium-dependent glucose transporter inhibitors on glycated hemoglobin A1c after 24 weeks in patients with diabetes mellitus: A systematic review and meta-analysis.2020Medicine
Acute kidney injury and adverse renal events in patients receiving SGLT2-inhibitors: A systematic review and meta-analysis.2019PLoS Medicine
Peripheral artery disease and amputations with Sodium-Glucose co-Transporter-2 (SGLT-2) inhibitors: A meta-analysis of randomized controlled trials.2019Diabetes Research and Clinical Practice

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