From the Guidelines
Linagliptin does not require dose adjustment in patients with chronic kidney disease (CKD), regardless of severity, and the standard dose of 5 mg once daily can be used across all stages of kidney disease, including end-stage renal disease requiring dialysis. This is based on the most recent and highest quality study available, which discusses the pharmacologic approaches to glycemic treatment in diabetes 1. The study highlights that linagliptin, a DPP-4 inhibitor, has a unique pharmacokinetic profile that allows for primarily non-renal elimination, making it safe for patients with compromised kidney function.
Some key points to consider when prescribing linagliptin to patients with CKD include:
- The medication can be taken with or without food at any time of day
- Common side effects include nasopharyngitis, hypoglycemia (when used with insulin or sulfonylureas), and rarely pancreatitis
- Patients should be monitored for hypersensitivity reactions and joint pain
- Linagliptin should not be used during episodes of acute kidney injury until the condition stabilizes, though this is a precautionary measure rather than due to direct nephrotoxicity
- Other DPP-4 inhibitors, such as sitagliptin, saxagliptin, and alogliptin, require dose adjustments based on kidney function, but linagliptin does not require any dose adjustment 1.
It is essential to note that the study also discusses other medications used to treat diabetes, including metformin, SGLT2 inhibitors, GLP-1 RAs, and sulfonylureas, and their dosing considerations in patients with CKD 1. However, linagliptin's unique pharmacokinetic profile makes it a favorable option for patients with compromised kidney function.
From the FDA Drug Label
Patients with Renal Impairment An open-label pharmacokinetic study evaluated the pharmacokinetics of linagliptin 5 mg in male and female patients with varying degrees of chronic renal impairment ... For both type 2 diabetes mellitus groups, renal excretion was below 7% of the administered dose.
The recommended dosing of Linagliptin for patients with Chronic Kidney Disease (CKD) is not explicitly stated in the provided text, but it can be inferred that no dose adjustment is necessary for patients with renal impairment, as the renal excretion of linagliptin is below 7% of the administered dose 2.
From the Research
Recommended Dosing of Linagliptin for Patients with CKD
- The recommended dosing of Linagliptin for patients with Chronic Kidney Disease (CKD) does not require dose adjustment, as stated in studies 3, 4, 5.
- Linagliptin can be used in patients with all stages of CKD, including stage 5, without dose adjustments, as it is eliminated by a hepatobiliary route 4, 5.
- The standard dose of Linagliptin is 5mg, which can be administered to patients with CKD without any modifications 3, 6.
Pharmacokinetic Considerations
- Unlike other DPP-4 inhibitors, Linagliptin does not require dose reduction in patients with CKD, making it a suitable option for this patient population 7.
- The pharmacokinetics of Linagliptin are not significantly affected by renal impairment, allowing for its use in patients with CKD without dose adjustments 4, 5.
Clinical Efficacy and Safety
- Linagliptin has been shown to be effective in improving glycemic control in patients with type 2 diabetes and CKD, with a favorable safety profile 3, 4, 5, 6.
- Studies have demonstrated that Linagliptin can be used safely in patients with CKD, without an increased risk of hypoglycemia or other adverse effects 4, 5, 6.