Table Info

Table 3.

Randomized clinical trial evaluating dapagliflozin

Study name	Sample	Duration	Outcome	Adverse drug events		Reference
Study name	Sample	Duration	Outcome	Common	Uncommon	Reference
Dapagliflozin Effect on Cardiovascular Events (DECLARE-TIMI 58) Trial	17,160 participants	11 years	Reduced frequency of cardiovascular fatalities or hospital admissions due to heart failure and a preventive effect on cardiovascular incidents observed in the dapagliflozin group	Amputation, fracture, volume depletion, genital infections, urinary tract infection, diabetic ketoacidosis	Major hypoglycemia, acute kidney injury, breast cancer, bladder cancer, urosepsis	[51]
Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure (DAPA-HF) Trial	4,744 participants	1.5 years	Decreased likelihood of heart failure exacerbation or mortality due to cardiovascular reasons within the dapagliflozin group	Fracture, amputation, volume depletion	Major hypoglycemia, renal adverse events	[52]
Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) Trial	4,304 participants	2.4 years	Continuous reduction in the estimated glomerular filtration rate by a minimum of 50%, end-stage kidney disease, or fatalities stemming from renal or cardiovascular origins in the dapagliflozin group	Fracture, volume depletion, renal related adverse events	Major hypoglycemia, amputation	[53]
Dapagliflozin Evaluation to Improve the Lives of Patients with Preserved Ejection Fraction Heart Failure (DELIVER) Trial	6,263 participants	2.3 years	Reduced rate of heart failure deterioration or cardiovascular-related fatalities among individuals in the dapagliflozin group	Lower limb amputation, volume depletion, renal related adverse events	Diabetic ketoacidosis, major hypoglycemia	[54]
Dapagliflozin versus Sitagliptin Treatment Efficacy on Prevention of Cardiovascular Risk Factors in Type 2 Diabetes Patients (DIVERSITY-CVR) Trial	340 participants	24 weeks	Dapagliflozin demonstrated superior efficacy in enhancing cardiometabolic risk factors and proved to be more effective in preventing cardiovascular events in individuals with early-stage type 2 diabetes that was not adequately controlled	-	Major hypoglycemia, fracture	[55]
NCT04120623	66 participants	5 weeks	The combination of dapagliflozin and insulin represents a secure and efficient treatment option for ameliorating fluctuations in blood sugar levels, enhancing insulin sensitivity, and promoting weight reduction in individuals newly diagnosed with type 2 diabetes	-	Urinary tract infection	[56]
NCT01730534	17,160 participants	4 years	Dapagliflozin exhibited clinical advantages and safety across a diverse spectrum of patients with type 2 diabetes, irrespective of their prior treatment. Consistently, dapagliflozin decreased the likelihood of cardiovascular and kidney-related consequences	-	Volume depletion, acute kidney injury, hyperkalemia, diabetic ketoacidosis, amputation	[57]

Declarations

Author contributions

FH, HN: Conceptualization, Investigation, Writing—original draft. DS: Writing—original draft. M Arshad: Investigation, Writing—original draft. SZ: Investigation, Writing—review & editing. MKR: Investigation. MAH, M Akhtar: Writing—review & editing. AKN: Supervision. All authors reviewed and approved the final version of the manuscript.

Conflicts of interest

The authors have no conflicts of interest to declare.

Ethical approval

Not applicable.

Consent to participate

Not applicable.

Consent to publication

Not applicable.

Availability of data and materials

Not applicable.

Funding

Not applicable.

Copyright

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