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• W1967133334 abstract "P199 Aims: Catabolism by cytochrome P450 3A4 (CYP3A4) is one of the major determinants of the oral bioavailability of tacrolimus. Cimetidine and omeprazole are known modulators of several CYPs in vitro. In the present study, the impact of cimetidine and omeprazole on oral bioavailability of tacrolimus and on CYP3A4 activity in vivo was examined. Methods: In a historical cohort of 48 (19 females/29 males) renal transplant recipients, who switched standard ulcer prophylaxis with 400 mg of cimetidine to 20 mg of losec, an index of oral bioavailability (BAI = through level of tacrolimus (μg/l), normalized for dose (mg) and weight (kg) and multiplied by 100) was studied. The switch was made at 16-1095 days after transplantation because of epigastric discomfort. Endoscopic evaluation showed reflux oesophagitis in 33 and non complicated gastric/duodenal ulceration in 7 patients. Ulceration was complicated with bleeding in 2 and the remaining 6 patients had a compound of reflux oesophagitis and candidiasis (n=3) or CMV (n=2) or herpes (n=1) infection. For each patient, mean steroid dose, hematocrit, albumin, bilirubin and creatinin during a 5 days’ interval before and after switch were determined. A paired comparison for each parameter before and after switch was made. In addition, the impact of sex, age, days of follow-up, diagnosis and Δ (= value before – after switch) of all determined biological parameters on ΔBAI was studied with multivariate ANOVA. In a cohort of 6 healthy, drug free volunteers, the effect of a 5 days’ course of cimetidine and omeprazole (randomized, cross over design) on intestinal and hepatic CYP3A4/PGP activity was measured by comparing the results of a combined per oral and intravenous 14C-erythromycin breath and urine test after each treatment to baseline values. Results: In the patients, BAI decreased significantly with 15% from 13 to 11 and serumcreatinin decreased significantly with 26% from 2.38 to 1.76 mg/d after switch. Multivariate ANOVA retained a significant but weak (r2=0.16) impact of age on ΔBAI. In the healthy volunteers, a significant increase of intestinal CYP3A4 activity was noticed after treatment with omeprazole, whereas treatment with cimetidine yielded results similar to baseline. Conclusions: Switching antacid therapy from cimetidine to omeprazole in renal transplant recipients is associated with a decrease of dose and weight normalized trough levels of tacrolimus which is independent of corticosteroid dose, time after transplantation, sex, renal function, hematocrit and serumalbumin. This clinical finding can be explained by the increase of intestinal CYP3A4 activity as observed in healthy volunteers after a 5 days’ course of omeprazole." @default.
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• W1967133334 date "2004-07-01" @default.
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• W1967133334 title "DIFFERENTIAL EFFECTS OF ANTACIDS ON ORAL BIOAVAILABILITY OF TACROLIMUS." @default.
• W1967133334 doi "https://doi.org/10.1097/00007890-200407271-00695" @default.
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