Is ursodeoxycholic acid (UDCA) safe in patients with impaired renal function, specifically an estimated Glomerular Filtration Rate (eGFR) of 30?

From the Guidelines

Ursodeoxycholic acid (UDCA) is generally considered safe for patients with impaired renal function, including those with an eGFR of 30. No dose adjustment is typically required for patients with renal impairment since UDCA is primarily metabolized and eliminated through the liver and biliary system rather than the kidneys. The standard dosing of 13-15 mg/kg/day divided into 2-3 doses can be maintained in these patients. However, it's advisable to monitor these patients more closely for potential side effects such as diarrhea, which is the most common adverse effect. Patients with severe renal impairment should have regular liver function tests and kidney function monitoring during treatment. The safety profile of UDCA in renal impairment is favorable because the drug undergoes enterohepatic circulation with minimal renal excretion. Less than 1% of UDCA is excreted unchanged in urine, which explains why kidney function has minimal impact on its clearance and safety profile. If the patient is taking other medications that are primarily eliminated through the kidneys, potential drug interactions should be evaluated 1.

Some key points to consider:

• UDCA is primarily metabolized and eliminated through the liver and biliary system, not the kidneys.
• The standard dosing of UDCA can be maintained in patients with impaired renal function.
• Patients with severe renal impairment should be monitored closely for potential side effects.
• Regular liver function tests and kidney function monitoring are recommended during treatment.
• Potential drug interactions should be evaluated if the patient is taking other medications that are primarily eliminated through the kidneys.

It's essential to prioritize the patient's overall health and adjust treatment accordingly, taking into account their individual needs and medical history.

From the Research

Safety of Ursodeoxycholic Acid in Patients with Impaired Renal Function

The safety of ursodeoxycholic acid (UDCA) in patients with impaired renal function, specifically an estimated Glomerular Filtration Rate (eGFR) of 30, is a concern due to the potential for UDCA to affect renal function.

• The study 2 investigated the effects of UDCA on systemic, renal, and forearm haemodynamics and sodium homoeostasis in cirrhotic patients with refractory ascites. The results showed that UDCA caused a significant reduction in sodium excretion, which was due to a significant increase in sodium reabsorption proximal to the distal tubule. This suggests that UDCA may have a direct effect on the proximal nephron, which could be a concern in patients with impaired renal function.
• Another study 3 found that UDCA treatment was not beneficial for all patients with primary biliary cirrhosis, and special care should be taken in the early phase of UDCA therapy in later-stage patients. However, this study did not specifically address the safety of UDCA in patients with impaired renal function.
• The study 4 investigated the effects of UDCA therapy in patients with cystic fibrosis and evidence of liver disease. The results showed that UDCA can be used safely in this patient population, but the study did not address the specific concern of impaired renal function.
• A more recent study 5 compared the response between the current recommended dosage of UDCA and a higher dosage in primary biliary cholangitis patients who did not respond completely to a standard dose of UDCA. The results showed that the higher dosage of UDCA was beneficial to nonresponders, but the study did not address the safety of UDCA in patients with impaired renal function.
• The mechanisms of action and therapeutic efficacy of UDCA in cholestatic liver disease were reviewed in the study 6. The results showed that UDCA has multiple mechanisms of action, including protection of injured cholangiocytes, stimulation of impaired biliary secretion, stimulation of detoxification of hydrophobic bile acids, and inhibition of apoptosis of hepatocytes. However, the study did not address the specific concern of impaired renal function.

Key Findings

• UDCA may have a direct effect on the proximal nephron, which could be a concern in patients with impaired renal function 2.
• UDCA can be used safely in patients with cystic fibrosis and evidence of liver disease, but the study did not address the specific concern of impaired renal function 4.
• The safety of UDCA in patients with impaired renal function, specifically an eGFR of 30, is not well established based on the available studies.

Considerations for Patients with Impaired Renal Function

• Patients with impaired renal function should be closely monitored while taking UDCA, as the potential effects of UDCA on renal function are not well established.
• The benefits and risks of UDCA therapy should be carefully weighed in patients with impaired renal function, and alternative treatments should be considered if necessary.