From the Guidelines
Yes, a creatinine level of 1.58 and eGFR of 36 does warrant reducing the Januvia (sitagliptin) dose to 25 mg once daily. According to the study published in Endocrine Reviews in 2020 1, sitagliptin requires dose adjustment in patients with moderate to severe renal impairment. The recommended dosing for sitagliptin based on eGFR is as follows:
- 100 mg daily if eGFR > 50 mL/min/1.73 m²
- Maximum dose of 25 mg daily if eGFR 30 to 50 mL/min/1.73 m²
- 25 mg daily if eGFR < 30 mL/min/1.73 m² Given the patient's eGFR of 36, which falls into the moderate renal impairment category, the recommended dose is 25 mg daily. This dose adjustment is necessary to minimize the risk of adverse effects, as sitagliptin is primarily eliminated by the kidneys and reduced kidney function can lead to higher blood levels of the medication. Regular monitoring of kidney function is also recommended while on this medication 1.
Key points to consider:
- The patient's eGFR of 36 indicates moderate renal impairment, requiring a dose adjustment of sitagliptin
- The recommended dose of sitagliptin for patients with an eGFR of 30-50 mL/min/1.73 m² is 25 mg daily
- Dose adjustment is necessary to minimize the risk of adverse effects due to reduced kidney function
- Regular monitoring of kidney function is recommended while on sitagliptin 1
From the FDA Drug Label
2.2 Recommendations for Use in Renal Impairment
Assess renal function before initiating SITAGLIPTIN and periodically thereafter.
For patients with moderate renal impairment (eGFR greater than or equal to 30 to less than 50 mL/min/1.73 m^2), the dose of SITAGLIPTIN is 25 mg once daily 2.
- Renal Impairment: A creatinine level of 1.58 and eGFR of 36 indicates moderate renal impairment.
- Dosing Recommendation: The recommended dose of Januvia (sitagliptin) for patients with moderate renal impairment is 25 mg once daily.
- Clinical Decision: Patients with a creatinine level of 1.58 and eGFR of 36 should receive Januvia 25 mg once a day.
From the Research
Significance of Creatinine Level and eGFR
- A creatinine level of 1.58 and an eGFR of 36 indicates impaired renal function, which is a significant concern in patients with type 2 diabetes mellitus (T2DM) 3, 4.
- The eGFR value of 36 falls into stage 3b or 4 of chronic kidney disease (CKD), which requires careful consideration of medication dosages, including those for diabetes management 4, 5.
Januvia (Sitagliptin) Dosage Considerations
- Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, is commonly used in the treatment of T2DM, but its dosage needs to be adjusted in patients with impaired renal function 3, 4.
- For patients with an eGFR of 30-50 mL/min/1.73 m^2, the recommended dosage of sitagliptin is 25-50 mg once daily, depending on the severity of renal impairment 5, 6.
- However, the specific dosage of 25 mg once daily for a patient with an eGFR of 36 is consistent with recommendations for managing T2DM in the context of CKD 5, 7.
Safety and Efficacy of Sitagliptin in CKD
- Studies have shown that sitagliptin is generally well-tolerated in patients with CKD, with no significant increase in the risk of adverse events, including congestive heart failure, compared to placebo 5, 6.
- The TECOS trial demonstrated that sitagliptin had no clinically significant impact on cardiovascular or CKD outcomes, irrespective of baseline eGFR, including in patients with stage 3b CKD 5, 7.