Disposition, Elimination and Haemodynamic Effects of Gallopamil in Patients with Fatty Liver Disease

Twenty-one hypertensive patients were treated orally with 50mg gallopamil in a sustained-release formulation once daily for 1 week. 11 patients had a normal liver function (antipyrine clearance 41.2 ± 2.8 ml/min; mean ± SD), while 10 patients had fatty liver disease (antipyrine clearance 32.3 ± 1.4 ml/min). Maximum plasma concentrations of gallopamil were 15.2 (7.9 to 29.3) µg/L (geometric mean; 95% confidence interval) in patients with normal and 16.8 (8.7 to 32.5) µg/L in those with impaired hepatic function (p > 0.05). The elimination half-life was 8.8 hours in patients with normal liver function and 9.2 hours in patients with fatty liver disease (median, p > 0.05). No significant differences were found between patients with and without concomitant liver disease with regard to the effects of gallopamil on heart rate, PQ-time and blood pressure. First degree AV-block developed during treatment with gallopamil in one patient with fatty liver disease and in another with normal liver function. The AV-block in the patient with impaired hepatic function was considered to be severe (PQ-time 270ms). In conclusion, kinetic parameters of patients with fatty liver disease did not differ significantly from those of subjects with normal liver function.