Table Info

Table 4.

Randomized clinical trial evaluating empagliflozin

Study name	Sample	Duration	Outcome	Adverse drug events		Reference
Study name	Sample	Duration	Outcome	Common	Uncommon	Reference
Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) Trial	7,020 participants	3.1 years	Reduced incidence of cardiovascular-related fatalities, non-lethal heart attacks, or non-lethal strokes within the empagliflozin group	Urinary tract infection, genital infection	Hypoglycemia, acute renal failure, diabetic ketoacidosis, volume depletion, fracture	[60]
Empagliflozin Outcome Trial in Patients with Chronic Heart Failure and a Reduced Ejection Fraction (EMPEROR-Reduced) Trial	3,730 participants	1.4 years	Fewer instances of heart failure hospitalizations and a decelerated decline in the estimated glomerular filtration rate were observed in the empagliflozin group	Volume depletion, hypotension, urinary tract infection, genital infection	Fracture, lower limb amputation, hypoglycemia, diabetic ketoacidosis	[63]
Empagliflozin Outcome Trial in Patients with Chronic Heart Failure with Preserved Ejection Fraction (EMPEROR-Preserved) Trial	5,988 participants	2.2 years	Empagliflozin lowered the combined likelihood of cardiovascular death or hospitalization due to heart failure in individuals with heart failure and a preserved ejection fraction, regardless of whether they had diabetes or not	Hypotension, symptomatic hypotension, urinary tract infection, genital infection, fracture	Lower limb amputation, ketoacidosis, hypoglycemia, acute renal failure	[64]
KCT0006157	152 participants	24 weeks	Empagliflozin exhibited more pronounced reductions in HbA1c levels and greater weight loss in patients with type 2 diabetes who had insufficient glycaemic control despite being treated with metformin, sulfonylurea, and a dipeptidyl peptidase 4 inhibitor (DPP-4i)	-	-	[65]
NCT01177813	899 participants	24 weeks	Empagliflozin offered a well-tolerated and effective approach to lowering HbA1c levels in patients with type 2 diabetes who had not been previously treated with medications	Urinary tract infection	Hypoglycemia, dyslipidemia, genital infection	[66]
NCT01167881	1,549 participants	104 weeks	Empagliflozin could serve as an efficient and well-tolerated choice for second-line treatment in individuals with type 2 diabetes who have not attained satisfactory glycemic control with metformin alone	Urinary tract infection, genital infection	Fracture, hypoglycemia, dyslipidemia, hypertension	[67]

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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