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Dapagliflozin

(Farxiga®)

Dapagliflozin

Drug updated on 4/16/2024

Dosage FormTablet (oral: 5 mg, 10 mg)
Drug ClassSodium-glucose co-transporter 2 inhibitors
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • Indicated to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors.
  • Indicated to reduce the risk of cardiovascular death and hospitalization for heart failure, and urgent heart failure visit in adults with heart failure.
  • Indicated to reduce the risk of sustained eGFR decline, end stage kidney disease cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.

Summary
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  • Dapagliflozin (Farxiga) is indicated as an adjunct to diet and exercise for improving glycemic control in adults with type 2 diabetes mellitus, reducing the risk of hospitalization due to heart failure in adults with type 2 diabetes mellitus and cardiovascular disease or multiple cardiovascular risk factors. It also reduces the risks of cardiovascular death, urgent heart failure visits, sustained eGFR decline, end-stage kidney disease, and hospitalization for heart failure in adults at risk.
  • The information about dapagliflozin was derived from a total of 31 systematic reviews/meta-analyses studies that provided extensive data on its safety profile compared to other SGLT-2 inhibitors like enavogliflozin, canagliflozin, and empagliflozin across different populations.
  • Across these studies, dapagliflozin has a similar safety profile as other drugs within this class, such as increased risks of genital infections, urinary tract infections (UTIs), and pollakiuria but notably had protective effects against acute kidney injury.
  • Unlike canagliflozin, which has been associated with amputation risks in past studies, no significant association between dapagliflozin usage and amputation were noted, presenting a potential advantage, especially among the population at high risk for peripheral arterial diseases.
  • In terms of effectiveness towards glycemic control and cardiovascular outcomes, dapagliflozin showed significant reduction in all-cause mortality rates, heart failures hospitalizations, and cardiovascular deaths, particularly among patients suffering from heart failure.
  • The drug's efficacy remained consistent across various subgroups, including those without diabetes, varying degrees of cardiovascular risks, differing stages of renal impairment, thus suggesting broad applicability.
  • Dapagliflozin demonstrated a favorable safety profile concerning lower amputations when compared to some peers, while sharing common class effects, such as reduced risks of cardiovascular events and progression of renal disease.
  • The drug was also found to be effective in reducing the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in patients with chronic kidney disease.

Product Monograph / Prescribing Information

Document TitleYearSource
Farxiga (dapagliflozin) prescribing information.2024AstraZeneca Pharmaceuticals LP Wilmington, DE

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and safety of enavogliflozin vs. dapagliflozin as add-on therapy in patients with type 2 diabetes mellitus based on renal function: A pooled analysis of two randomized controlled trials.2024Cardiovascular Diabetology
Effect of dapagliflozin in patients with heart failure: A systematic review and meta-analysis.2023Global Heart
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 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
Heart failure, peripheral artery disease, and dapagliflozin: A patient-level meta-analysis of DAPA-HF and DELIVER.2023European Heart Journal
Systematic review of sodium-glucose cotransporter 2 inhibitors: A hopeful prospect in tackling heart failure-related events. 2023ESC Heart Failure
Therapeutic outcome of dapagliflozin in patients with type 2 diabetes and non-alcoholic fatty liver disease: A meta-analysis of randomized controlled trials. 2023African Health Sciences
Impact of SGLT2 inhibitors on patient outcomes: A network meta-analysis. 2023Cardiovascular Diabetology
Dose-dependent renoprotection efficacy of sglt2 inhibitors in type 2 diabetes: Systematic review and network meta-analysis. 2023Acta Diabetologica
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
Dapagliflozin for non-alcoholic fatty liver disease: A systematic review and meta-analysis.2022Diabetes Research and Clinical Practice
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
Treatments for chronic kidney disease: A systematic literature review of randomized controlled trials.2022Advances in Therapy
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
Effects of dapagliflozin in patients with nonalcoholic fatty liver disease: A systematic review and meta-analysis of randomized controlled trials.2022Clinics and Research in Hepatology and Gastroenterology
Effects of SGLT2 inhibitors on haematocrit and haemoglobin levels and the associated cardiorenal benefits in T2DM patients: A meta-analysis.2022Journal of Cellular and Molecular Medicine
The effectiveness of SGLT2 inhibitor in the incidence of atrial fibrillation/atrial flutter in patients with type 2 diabetes mellitus/ heart failure: A systematic review and meta-analysis.2022Journal of Thoracic Disease
Dapagliflozin across the range of ejection fraction in patients with heart failure: A patient-level, pooled meta-analysis of DAPA-HF and DELIVER. 2022Nature Medicine
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 & Metabolism
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: A network meta-analysis based on cardiovascular or renal outcome.2021Medicine
Microvascular benefits of new antidiabetic agents: A systematic review and network meta-analysis of kidney outcomes.2021Journal of Clinical Endocrinology & Metabolism
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
Effect of SGLT-2 inhibitors on non-alcoholic fatty liver disease among patients with type 2 diabetes mellitus: Systematic review with meta-analysis and trial sequential analysis of randomized clinical trials.2021Oman Medical Journal
Effects and safety of SGLT2 inhibitors compared to placebo in patients with heart failure: A systematic review and meta-analysis.2021IJC Heart & 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 trials.2020The Lancet
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

Clinical Practice Guidelines

Document TitleYearSource
Clinical evaluation of dapagliflozin in the management of CKD: Focus on patient selection and clinical perspectives. 2022International Journal of Nephrology and Renovascular Disease
UK Kidney Association clinical practice guideline: Sodium-glucose co-transporter-2 (SGLT-2) inhibition in adults with kidney disease.2021UK Kidney Association
Pharmacologic glycemic management of type 2 diabetes in adults: 2020 update.2020Canadian Journal of Diabetes
2019 ESC guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD. 2020European Heart Journal
Portuguese-Brazilian evidence-based guideline on the management of hyperglycemia in type 2 diabetes mellitus.2020Diabetology & Metabolic Syndrome
Practical considerations for the use of sodium-glucose co-transporter 2 inhibitors in heart failure.2020Circulation: Heart Failure