Pharmacokinetics of Meloxicam in Patients with Hepatic Cirrhosis in Comparison with Healthy Volunteers

The pharmacokinetics of meloxicam were investigated in 12 patients with clinically stable liver cirrhosis after a single oral dose of 15mg. 12 healthy volunteers received the same regimen in earlier studies and the results of both groups were compared. Only minor differences in pharmacokinetic parameters were observed between the 2 groups. However, equivalence between the 2 groups could not be demonstrated, probably because of the large variation in the liver function status of the patients with cirrhosis. Mean maximum plasma concentration (Cmax) in the cirrhotic patients was 0.84 mg/L and the time to Cmax(tmax) was 10.3 hours. The corresponding values for the healthy volunteers were 0.91 mg/L and 7.0 hours, respectively. The elimination half-life (t1/2) was 16.4 hours in the cirrhotic patients and 21.2 hours in the healthy volunteers. The area under the plasma concentration-time curve (AUC) was approximately 25% lower in the cirrhotic patients (25.1 mg/L•h) than in the controls (31.2 mg/L•h). The plasma protein binding of meloxicam showed no relevant difference between the 2 groups. The cirrhotic patients revealed an unbound fraction of 0.35%, compared with 0.28% in the healthy controls. Since the data presented in this report show no substantial change in pharmacokinetics, and the drug is not retained in hepatically impaired patients, no dosage adjustments appear necessary in cirrhotic patients requiring meloxicam treatment.