Callréus T, Lundahl J, Höglund P, Bengtsson P
Department of Clinical Pharmacology, Lund University Hospital, Sweden.
Eur J Clin Pharmacol. 1999 Jun;55(4):305-9. doi: 10.1007/s002280050633.
The antidiuretic effect of desmopressin is widely utilized in the treatment of neurogenic diabetes insipidus and nocturnal enuresis in children. The objective of the present study was to assess how changes in gastrointestinal motility, induced by erythromycin and loperamide, influence the pharmacokinetics of orally administered desmopressin.
This study was conducted using an open randomized, three-period, three-treatment design in 18 healthy subjects. On each study day a single oral dose of 400 microg desmopressin was administered in the morning. The desmopressin dose was either given alone (reference) or after pretreatment with either loperamide tablets (4 mg at -24, -12 h and -1 h) or erythromycin capsules (250 mg q.i.d, with the first dose in the morning 3 days before the study day and the last dose at -1 h). On each study day, blood was sampled up to 8 h after dosing for assessment of desmopressin concentration.
Compared with administration of 400 microg of desmopressin alone, pretreatment with loperamide produced significantly (P < 0.05) altered pharmacokinetics of desmopressin as the endpoints; area under the curve up to infinity (AUC), area up to the last determinable plasma concentration (AUCt) and maximum plasma concentration (Cmax) increased 3.1-fold (95% CI 2.3-4.2), 3.2 (2.3-4.4) and 2.3 (1.6 3.2), respectively. Although the estimates were lower, pretreatment with erythromycin did not result in any significant changes in these endpoints. There were no significant changes observed between the three treatments regarding the terminal elimination half-life (t1/2). However, significant (P < 0.05) changes in the time to reach Cmax (tmax) values (median and range) were observed as, compared with administration of desmopressin alone (1.3 h and 0.5-4.0), it was longer after pretreatment with loperamide (2.0 h and 0.5-3.0) and shorter following pre-treatment with erythromycin (0.9 h and 0.5-1.3).
Presumably due to slower gastrointestinal motility, pretreatment with loperamide significantly increases the gastrointestinal absorption of desmopressin. Except for a shortening of tmax pretreatment with erythromycin did not significantly influence absorption of the drug.
去氨加压素的抗利尿作用被广泛应用于治疗儿童神经性尿崩症和夜间遗尿症。本研究的目的是评估由红霉素和洛哌丁胺引起的胃肠动力变化如何影响口服去氨加压素的药代动力学。
本研究采用开放随机、三周期、三治疗设计,纳入18名健康受试者。在每个研究日的上午给予单次口服400微克去氨加压素。去氨加压素剂量要么单独给予(对照),要么在预先服用洛哌丁胺片(-24、-12小时和-1小时各4毫克)或红霉素胶囊(250毫克,每日四次,首次剂量在研究日前3天上午服用,最后一次剂量在-1小时服用)后给予。在每个研究日,给药后长达8小时采集血样以评估去氨加压素浓度。
与单独给予400微克去氨加压素相比,预先服用洛哌丁胺后去氨加压素的药代动力学终点有显著(P<0.05)改变;至无穷大的曲线下面积(AUC)、至最后可测定血浆浓度的面积(AUCt)和最大血浆浓度(Cmax)分别增加3.1倍(95%CI 2.3 - 4.2)、3.2(2.3 - 4.4)和2.3(1.6 - 3.2)。虽然估计值较低,但预先服用红霉素并未导致这些终点有任何显著变化。三种治疗之间在终末消除半衰期(t1/2)方面未观察到显著变化。然而,观察到达峰时间(tmax)值(中位数和范围)有显著(P<0.05)变化,与单独给予去氨加压素(1.3小时和0.5 - 4.0)相比,预先服用洛哌丁胺后更长(2.0小时和0.5 - 3.0),而预先服用红霉素后更短(0.9小时和0.5 - 1.3)。
可能由于胃肠动力减慢,预先服用洛哌丁胺显著增加了去氨加压素的胃肠道吸收。除了tmax缩短外,预先服用红霉素对药物吸收没有显著影响。