A Pilot Interventional Study to Evaluate the Safety and Tolerability of Mirabegron and Montelukast in Patients With Liver Cirrhosis

This study was a prospective, interventional, pilot clinical study conducted over 3 months on Egyptian cirrhotic patients with overactive bladder and asthma. Adult patients aged >18 years with confirmed liver cirrhosis, concomitant overactive bladder and asthma were eligible for inclusion. Patients were experienced acute episodes of disease associated with deterioration of hepatic function within 2 months prior to screening, and received concomitant medications known to strongly interact with the study drugs were excluded. In part 1: Mirabegron dosing was determined based on Simcyp -generated predictions and clinical assessment. 100mg,50 mg, 50 mg, and 25 mg received by control, CP-A, CP-B, and CP-C cirrhosis patients, respectively, orally once daily. In part 2: Montelukast dosing was determined based on Simcyp-generated predictions and clinical assessment. 10mg 5 mg,5 mg, and 4 mg received by control, and CP-A, CP-B, and CP-C cirrhosis patients, respectively, orally once daily. Clinical evaluation included number of incontinence episodes, number of micturation, volume voided per micturation, cough, and wheezing. Routine laboratory investigations were conducted to assess efficacy and safety and included liver function tests (serum albumin, total bilirubin, alanine aminotransferase [ALT],a aspartate aminotransferase [AST]), kidney function tests (serum creatinine and blood urea nitrogen [BUN]),and CBC.