What is the recommended dose of Linagliptin for patients with Chronic Kidney Disease (CKD) and impaired renal function, specifically those with a Glomerular Filtration Rate (GFR) of 30?

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Last updated: April 17, 2025View editorial policy

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From the Guidelines

For patients with chronic kidney disease (CKD) and an estimated glomerular filtration rate (eGFR) of 30 ml/min/1.73m², the recommended dose of linagliptin is 5 mg once daily, with no dose adjustment required due to its primary elimination via the enterohepatic system and minimal renal excretion 1.

Key Considerations

  • Linagliptin can be safely used without dose modification across all stages of kidney disease, including those with severe renal impairment or end-stage renal disease requiring dialysis.
  • The medication is generally well-tolerated in CKD patients, with potential side effects including upper respiratory infections, nasopharyngitis, and headache.
  • It is essential to continue monitoring kidney function and glycemic control regularly while on this medication.

Comparison with Other DPP-4 Inhibitors

  • Unlike other DPP-4 inhibitors such as sitagliptin and saxagliptin, linagliptin does not require dose adjustment in patients with renal impairment 1.
  • Alogliptin, another DPP-4 inhibitor, requires dose adjustment in patients with eGFR < 60 mL/min/1.73m², with a maximum dose of 12.5 mg daily for eGFR 30-60 mL/min/1.73m² and 6.25 mg daily for eGFR < 30 mL/min/1.73m² 1.

Clinical Implications

  • The use of linagliptin in CKD patients with eGFR of 30 ml/min/1.73m² can help improve glycemic control without the need for dose adjustment, making it a convenient and safe treatment option.
  • Healthcare professionals should consider linagliptin as a viable treatment option for CKD patients with diabetes, taking into account its advantages and potential side effects.

From the FDA Drug Label

An open-label pharmacokinetic study evaluated the pharmacokinetics of linagliptin 5 mg in male and female patients with varying degrees of chronic renal impairment The study included 6 healthy subjects with normal renal function (creatinine clearance [CrCl] ≥80 mL/min), 6 patients with mild renal impairment (CrCl 50 to <80 mL/min), 6 patients with moderate renal impairment (CrCl 30 to <50 mL/min), 10 patients with type 2 diabetes mellitus and severe renal impairment (CrCl <30 mL/min), and 11 patients with type 2 diabetes mellitus and normal renal function In patients with moderate renal impairment under steady-state conditions, mean exposure of linagliptin increased (AUCτ,ss by 71% and Cmax by 46%) compared with healthy subjects. Patients with type 2 diabetes mellitus and severe renal impairment showed steady-state exposure approximately 40% higher than that of patients with type 2 diabetes mellitus and normal renal function (increase in AUCτ,ss by 42% and Cmax by 35%)

The dose of Linagliptin for patients with CKD and a GFR of 30 is not explicitly stated in the provided text, but based on the information about patients with moderate and severe renal impairment, it can be inferred that no dose adjustment is necessary for these patients. The standard dose of 5 mg can be used. However, it is essential to exercise caution and monitor patients closely due to the increased exposure of linagliptin in patients with renal impairment 2.

From the Research

Linagliptin Dosage for CKD Patients with GFR of 30

  • The recommended dose of linagliptin for patients with type 2 diabetes and chronic kidney disease (CKD) is 5mg once daily, regardless of the degree of renal impairment 3, 4, 5.
  • Studies have shown that linagliptin does not require dose adjustment in patients with CKD, including those with a GFR of 30 3, 5.
  • In a 1-year, randomized, double-blind, placebo-controlled study, linagliptin 5mg once daily was found to be effective and safe in patients with type 2 diabetes and severe renal impairment (eGFR <30 mL/min/1.73 m2) 5.
  • Another study found that linagliptin 5mg once daily did not affect the risk of major adverse cardiovascular events or kidney outcomes in patients with type 2 diabetes and CKD, including those with a GFR of 30 4.

Key Findings

  • Linagliptin 5mg once daily is a suitable dose for CKD patients with a GFR of 30 3, 4, 5.
  • Linagliptin does not require dose adjustment in patients with CKD, including those with severe renal impairment 3, 5.
  • Linagliptin is effective and safe in patients with type 2 diabetes and CKD, including those with a GFR of 30 4, 5.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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