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The first T2D therapy approved by the FDA to reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults who have T2D and diabetic nephropathy with albuminuria >300 mg/day1
In adults with DKD* and T2D,
INVOKANA® 100 mg: The first SGLT2i indicated to
INVOKANA® has a proven safety profile in patients with an eGFR of 30 to <901
- Similar overall AEs with INVOKANA® vs placebo (35.1 vs 37.9 per 100 patient-years). Male GMI incidence was 0.84 vs 0.09 per 100 patient-years, respectively. DKA incidence was 0.22 vs 0.02 per 100 patient-years, respectively.|| No imbalance in fracture or amputation. Hypotension incidence was 2.8% vs 1.5%, respectively. Hypoglycemia incidence was 4.43 vs 4.89 per 100 patient-years, respectively1,5¶
- INVOKANA® 100 mg can be initiated in patients with an eGFR as low as 30.* Patients already on INVOKANA® whose eGFR declines below 30* can continue on the 100-mg dose unless dialysis is initiated1
- INVOKANA® is contraindicated in patients who have serious hypersensitivity reaction to INVOKANA®, such as anaphylaxis or angioedema, and in patients on dialysis1
eGFR is measured in mL/min/1.73 m 2.
*With albuminuria >300 mg/day.
†End-stage kidney disease was defined as dialysis for ≥30 days, kidney transplantation, or an eGFR <15 mL/min/1.73 m 2 sustained for ≥30 days.
‡There were not enough events to evaluate the risk of renal death (placebo, n=5; INVOKANA®, n=2). INVOKANA® is not indicated to reduce the risk of renal death.
§RRR was calculated using the following formula: 100 x (1–HR).
||All potential ketone-related events were adjudicated for diabetic ketoacidosis by an independent adjudication committee on the basis of clinical presentation and predefined biochemical measures.
¶In all glycemic control trials of INVOKANA®, hypoglycemia was defined as any event, regardless of symptoms, in which biochemical hypoglycemia was documented (any glucose value ≤70 mg/dL) or any hypoglycemic episode was considered severe. Severe hypoglycemia was defined as an event consistent with hypoglycemia in which the patient required the assistance of another person to recover, lost consciousness, or experienced a seizure (regardless of whether biochemical documentation of a low glucose value was obtained).1
AEs=adverse events; CV=cardiovascular; DKA=diabetic ketoacidosis; DKD=diabetic kidney disease; GMI=genital mycotic infection; RRR=relative risk reduction; SGLT2i=sodium-glucose co-transporter 2 inhibitor; T2D=type 2 diabetes.