From the Guidelines
Saxagliptin is suitable for patients with stage 4 chronic kidney disease (CKD), with a recommended dose of 2.5 mg once daily, which is half the standard dose. This dose adjustment is necessary because saxagliptin is partially eliminated by the kidneys, and reduced kidney function leads to higher drug concentrations in the body 1. Saxagliptin offers advantages for CKD patients as it has minimal risk of hypoglycemia compared to other diabetes medications and doesn't require frequent blood glucose monitoring. The medication works by inhibiting DPP-4 enzymes, which increases incretin hormones that stimulate insulin release and reduce glucagon secretion, helping to control blood glucose levels.
Key Considerations
- Patients with CKD stage 4 (eGFR 15-29 mL/min/1.73m²) should receive a reduced dose of saxagliptin to minimize the risk of adverse effects 1.
- Saxagliptin can be used in combination with other antihyperglycemic medications, such as metformin, to achieve individualized glycemic targets 1.
- Regular kidney function tests should continue during treatment to ensure appropriate dosing as kidney function may change over time 1.
- Patients should be monitored for potential side effects, including upper respiratory infections, urinary tract infections, and headaches 1.
Benefits and Risks
- Saxagliptin has been shown to reduce HbA1c levels by 0.4% to 0.9% in clinical trials 1.
- The use of saxagliptin alone does not increase the risk of hypoglycemia and has a neutral or mild effect on weight gain 1.
- Saxagliptin does not increase the risk of cardiovascular disease, making it a suitable option for patients with CKD and high cardiovascular risk 1.
From the FDA Drug Label
The recommended dosage of saxagliptin tablets in patients with an eGFR greater than or equal to 45 mL/minute/1. 73 m2 is the same as the recommended dosage in patients with normal renal function ... The dosage of saxagliptin tablets is 2.5 mg orally once daily for patients with eGFR <45 mL/min/1.73 m2 [which includes a subset of moderate or severe renal impairment, or with end-stage renal disease (ESRD) requiring hemodialysis]
Saxagliptin dosage for CKD 4:
- CKD 4 is defined as an eGFR of 15-29 mL/min/1.73 m2, which falls into the category of eGFR <45 mL/min/1.73 m2.
- The recommended dosage of saxagliptin for patients with eGFR <45 mL/min/1.73 m2 is 2.5 mg orally once daily 2.
- Saxagliptin can be used in patients with CKD 4, but the dosage should be adjusted to 2.5 mg orally once daily.
From the Research
Saxagliptin Suitability for CKD 4
- Saxagliptin is a dipeptidyl peptidase-4 inhibitor used to treat type 2 diabetes mellitus, and its suitability for patients with chronic kidney disease (CKD) stage 4 has been evaluated in several studies 3, 4, 5, 6, 7.
- A 52-week efficacy and safety study found that saxagliptin 2.5 mg once daily offers sustained efficacy and good tolerability for patients with type 2 diabetes and renal impairment, including those with moderate or severe renal impairment 3.
- Another study found that saxagliptin 2.5 and 5 mg/day improve glycemic control and are generally well tolerated in patients with type 2 diabetes and moderate CKD 4.
- The pharmacokinetics of saxagliptin and its metabolite, 5-hydroxy saxagliptin, are affected by renal impairment, with increased exposure to both saxagliptin and 5-hydroxy saxagliptin in patients with moderate or severe renal impairment 5.
- DPP-4 inhibitors, including saxagliptin, can be used in patients with CKD, including those on dialysis, and have been shown to provide effective and consistent glycemic control with a good tolerability profile and without severe hypoglycemia or weight gain 6, 7.
- However, dosage adjustment is necessary for patients with moderate or severe renal impairment, with a recommended dose of 2.5 mg once daily for patients with CKD stage 4 5, 7.
Key Findings
- Saxagliptin is effective and well tolerated in patients with type 2 diabetes and CKD stage 4 3, 4.
- Dosage adjustment is necessary for patients with CKD stage 4, with a recommended dose of 2.5 mg once daily 5, 7.
- DPP-4 inhibitors, including saxagliptin, can be used in patients with CKD, including those on dialysis, and have been shown to provide effective and consistent glycemic control with a good tolerability profile 6, 7.