[Acemetacin in patients with rheumatic disease with concomitant liver diseases. Pharmacokinetics, effectiveness and tolerance]

Abstract

10 male patients suffering from rheumatic diseases and from a liver disease (fat liver, cirrhosis) received acemetacin (Rantudil forte capsules) t.i.d. for 10 days. Blood levels were measured on days 2, 4, 7 and 9, 2 and 4 hours after the administration at noon, as well as after the last dose (day 10) during a 48 hours elimination period. The following kinetic parameters were determined: maximal blood level (cmax), elimination half life (during the 48 hours elimination period), area under the blood level time curve (AUC). Values are compared to corresponding data of rheumatic patients and healthy volunteers. Daily doses were 180 mg acemetacin each. Mean maximal blood levels (cmax) were 1.51 +/- 0.19 (rheumatic patients with liver diseases), 1.85 +/- 0.33 (rheumatic patients without liver diseases) and 1.24 +/- 0.05 mumol/l (healthy volunteers). Elimination half lives are 4.63 +/- 2.25, 4.52 +/- 2.81 and 4.03 hours. AUC-values were in the same range for rheumatic patients with liver diseases (11.62 +/- 5.56) and volunteers after Rantudil forte (14.30 +/- 8.79) or Rantudil retard (12.52 +/- 5.90 mumol.l-1.h). Toxic or infective liver damage therefore does not substantially change kinetics of acemetacin. The drug was efficient and well tolerated in all patients. There were no hints as for a special risk for patients with liver damage taking this drug.