Is lab monitoring for impaired renal function or hyperkalemia required when starting lisinopril (Angiotensin-Converting Enzyme inhibitor)?

From the Guidelines

Lab monitoring for impaired renal function or hyperkalemia is required when starting lisinopril, with serum creatinine and potassium levels to be monitored after initiation of treatment and during treatment, particularly among individuals with reduced glomerular filtration. This is based on the most recent evidence from the 2025 standards of care in diabetes, which emphasizes the importance of detecting and managing abnormalities caused by ACE inhibitors, such as AKI and hyperkalemia, to reduce the risks of cardiovascular events and death 1. Specifically, the guidelines recommend monitoring serum creatinine and potassium levels after initiation of treatment with an ACE inhibitor, such as lisinopril, and during treatment, especially in individuals with reduced glomerular filtration who are at increased risk of hyperkalemia and AKI. Key points to consider include:

• Monitoring serum creatinine and potassium levels after starting lisinopril
• Repeating these tests periodically, with the frequency depending on the patient's risk factors and kidney function
• Being aware of the potential for lisinopril to cause hyperkalemia or worsen kidney function, and adjusting therapy as needed
• Educating patients to report symptoms of hyperkalemia or worsening kidney function promptly to their healthcare provider. While older guidelines, such as the 2012 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure, also recommend monitoring renal function and electrolytes when starting ACE inhibitors, the most recent and highest quality evidence supports the approach outlined in the 2025 standards of care in diabetes 1.

From the FDA Drug Label

5.3 Impaired Renal Function Monitor renal function periodically in patients treated with lisinopril. Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system.

5.5 Hyperkalemia Serum potassium should be monitored periodically in patients receiving lisinopril. Drugs that inhibit the renin angiotensin system can cause hyperkalemia

Lab Monitoring Requirements:

• Renal Function: Monitor renal function periodically in patients treated with lisinopril.
• Hyperkalemia: Monitor serum potassium periodically in patients receiving lisinopril.

Key factors to consider when monitoring:

• Patients with pre-existing renal insufficiency or those at risk of developing acute renal failure may require closer monitoring.
• Risk factors for hyperkalemia include renal insufficiency, diabetes mellitus, and concomitant use of potassium-sparing diuretics or potassium supplements. 2 2

From the Research

Lab Monitoring for Impaired Renal Function or Hyperkalemia

When starting lisinopril, an Angiotensin-Converting Enzyme (ACE) inhibitor, lab monitoring for impaired renal function or hyperkalemia is crucial. The following points highlight the importance of monitoring:

• Hyperkalemia Risk: A study published in 2010 3 found that the risk of hyperkalemia increased gradually with declining estimated glomerular filtration rate (eGFR), with no apparent threshold for contraindicating ACE inhibitors. The study developed a risk score to predict the risk of hyperkalemia, which included factors such as age, eGFR, diabetes, heart failure, potassium supplements, and potassium-sparing diuretics.
• Renal Function Impairment: Another study from 1990 4 found that lisinopril was effective in treating hypertensive patients with impaired renal function, but hyperkalemia occurred in one-third of the patients. The study suggested that the dose of lisinopril should be adjusted according to the pretreatment eGFR.
• eGFR Calculation: A position statement published in 2005 5 recommended that pathology laboratories automatically report eGFR calculated from serum creatinine measurements to help identify asymptomatic kidney dysfunction at an earlier stage.
• CKD Detection and Staging: A systematic review published in 2015 6 summarized evidence supporting the use of laboratory tests for GFR and albuminuria to detect and stage acute and chronic kidney disease in adults. The review recommended measuring serum creatinine and reporting estimated GFR based on serum creatinine (eGFRcr) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2009 equation.
• Monitoring Requirements: While there is no direct evidence stating that lab monitoring is required when starting lisinopril, the studies suggest that monitoring renal function and potassium levels is essential to minimize the risk of hyperkalemia and to adjust the dose of lisinopril accordingly. A study from 2006 7 found that targeted screening of patients at risk for chronic kidney disease (CKD) can identify a large number of patients who require management of CKD and potential referral to nephrology services.

Overall, the evidence suggests that lab monitoring for impaired renal function or hyperkalemia is necessary when starting lisinopril to minimize potential risks and to ensure optimal management of patients with CKD.