What are the treatment options for overlapping syndrome, specifically using Ursodeoxycholic acid (UDCA) and brand name medications like Actigall (Ursodeoxycholic acid) or Urso (Ursodeoxycholic acid)?

From the Guidelines

Ursodeoxycholic acid (UDCA), available as brand names Actigall or Urso, is a primary treatment option for overlapping syndrome, particularly when primary biliary cholangitis (PBC) features are present, and should be used in combination with immunosuppressants in patients with autoimmune hepatitis (AIH) features, as evidenced by the study published in the Journal of Hepatology in 2009 1.

The recommended dosage of UDCA is typically 13-15 mg/kg body weight daily, which can be taken as a single dose or divided into multiple doses. Treatment with UDCA is generally long-term, often lifelong, as overlapping syndrome is a chronic condition. UDCA works by reducing the concentration of toxic bile acids, protecting liver cells from damage, and improving bile flow. It has anti-inflammatory and immunomodulatory effects that help address the autoimmune components of overlapping syndrome.

Some key points to consider when treating overlapping syndrome with UDCA include:

• Monitoring patients with regular liver function tests to assess treatment response, typically every 3-6 months 1
• Using immunosuppressants such as prednisone or azathioprine in addition to UDCA if AIH features predominate, as suggested by the study published in Hepatology in 2020 1
• Considering the use of alternative immunosuppressants such as budesonide or cyclosporine A in patients who do not respond to conventional therapy, as mentioned in the study published in the Journal of Hepatology in 2009 1
• Being aware of the potential side effects of UDCA, which are generally mild and may include diarrhea, constipation, or mild abdominal discomfort, and advising patients to take UDCA with food to minimize gastrointestinal side effects.

Overall, the treatment of overlapping syndrome with UDCA and immunosuppressants should be individualized and based on the specific characteristics of each patient, with the goal of improving liver function, reducing symptoms, and slowing disease progression, as recommended by the study published in the Journal of Hepatology in 2009 1.

From the FDA Drug Label

Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.

The treatment options for overlapping syndrome using Ursodeoxycholic acid (UDCA) and brand name medications like Actigall (Ursodeoxycholic acid) or Urso (Ursodeoxycholic acid) are not explicitly stated in the provided drug labels. However, UDCA is indicated for patients with specific types of gallstones and for the prevention of gallstone formation in certain patients.

• The FDA drug label does not provide information on the use of UDCA for overlapping syndrome. 2 2

From the Research

Treatment Options for Overlapping Syndrome

• The treatment of overlapping syndrome, which combines features of autoimmune hepatitis (AIH) and primary biliary cirrhosis (PBC) or primary sclerosing cholangitis (PSC), is empiric and includes ursodeoxycholic acid (UDCA) for the cholestatic component and immunosuppressive agents for the hepatitic component 3.
• UDCA brand name medications such as Actigall (Ursodeoxycholic acid) or Urso (Ursodeoxycholic acid) can be used to treat the cholestatic component of overlapping syndrome.
• The combination of UDCA and corticosteroids is required in most patients to obtain a complete biochemical response 4.
• In some cases, azathioprine may also be used in combination with prednisolone and UDCA to treat overlapping syndrome 5, 6.

Response to Treatment

• Treatment with prednisone, azathioprine, and UDCA has been shown to lead to a good response in patients with AIH-PSC overlap syndrome 5.
• The combination of prednisolone, UDCA, and azathioprine has been shown to be superior to UDCA alone in treating pure PBC patients with high levels of immunoglobulin G and transaminases 6.
• Empiric treatment for patients with AIH-PBC overlap is immunosuppressive therapy plus UDCA, while empiric treatment for patients with AIH-PSC and AIH-cholestatic overlap is immunosuppressive therapy with or without UDCA 7.

Important Considerations

• The diagnosis of overlap syndrome requires the prominent features of classic AIH and secondary objective findings of PBC or PSC 7.
• The dominant clinical feature should be treated first, and therapy adjusted according to the response 3.
• Liver transplantation is indicated for patients who have end-stage liver disease 7.