Moexipril for Primary Biliary Cirrhosis
Condition: Primary Biliary Cirrhosis
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Biliary; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The blockade of angiotensin II synthesis attenuates hepatic fibrosis in different
      experimental models of chronic liver injury. We aimed to determine the safety and efficacy of
      moexipril, an angiotensin-converting enzyme (ACE) inhibitor, on liver biochemistries, Mayo
      risk score, and health-related quality of life in patients with primary biliary cirrhosis
      (PBC) who have had a suboptimal response to ursodeoxycholic acid (UDCA).
    

Detailed description: 
      Primary biliary cirrhosis (PBC) is a chronic cholestatic liver disease of presumed autoimmune
      cause characterized by progressive inflammatory destruction of interlobular and septal bile
      ducts, resulting in fibrosis and eventual cirrhosis (1). In PBC patients, the most disabling
      symptoms are fatigue and pruritus which diminish health-related quality of life (HRQL.
      Ursodeoxycholic acid (UDCA), at a dose of 13 to 15 mg/kg per day, is a safe and effective
      medical therapy for most patients with PBC. Nevertheless, UDCA therapy has not ameliorated
      symptoms associated with PBC. Some UDCA-treated patients show progressive disease resulting
      in the liver transplantation or death from liver-related causes. For these patients, who show
      a persistent elevation of serum alkaline phosphatase at least twice the normal level after 6
      months of UDCA monotherapy (incomplete responders), the evaluation of combination therapy in
      clinical trials has been recommended.

      Moexipril is a long-acting, nonsulfhydryl ACE inhibitor with lipophilicity, and so can
      readily penetrate lipid membranes and thus target tissue ACE in addition to plasma ACE. This
      drug also demonstrated antioxidative properties in addition to efficiently controlling blood
      pressure in hypertensive postmenopausal subjects. Moreover, quality-of-life data suggest
      favorable effects of moexipril treatment in a patient population at high cardiovascular risk.
      The tolerability and safety profile of moexipril resembles that of other ACE inhibitors along
      with no reports of hepatotoxicity in controlled trials. Hence, moexipril is an attractive
      drug for evaluation in patients with chronic liver disease.
    

Intervention name(s): Moexipril
Intervention type(s): Drug
Intervention description(s): Moexipril was given at a starting dose of 7.5 mg daily for 1 week to all enrolled patients. If tolerated (no clinically significant hypotension or medication associated adverse event), the daily dosage was increased to 15 mg daily at the beginning of the 2nd treatment week. Patients took moexipril orally in the morning and 1 hour prior to food intake. The target dose was maintained for the 1-year period of the study unless the development of toxicities warranted dose reduction or discontinuation.
Intervention MeSH terms: Moexipril
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: primary biliary cirrhosis; ursodeoxycholic acid