University of Virginia Health Sciences Center, Charlottesville, VA, USA.
Aliment Pharmacol Ther. 2009 Nov 15;30(10):1010-21. doi: 10.1111/j.1365-2036.2009.04137.x. Epub 2009 Sep 4.
Dexlansoprazole MR is a dual delayed release formulation of dexlansoprazole, an enantiomer of lansoprazole.
To assess safety of dexlansoprazole MR in phase 3 clinical trials.
Data from 4270 patients receiving dexlansoprazole MR 30 mg (n = 455), 60 mg (n = 2311) or 90 mg (n = 1864); lansoprazole 30 mg (n = 1363); or placebo (n = 896) in six randomized controlled trials and a 12-month safety study were pooled. Safety was assessed via adverse events, vital signs, electrocardiograms, clinical laboratory results and gastric biopsies. Adverse events were summarized per 100 patient-months of exposure to account for imbalances in study drug exposure.
The number of patients with > or =1 treatment-emergent adverse event per 100 patient-months was higher in placebo (24.49) and lansoprazole (21.06) groups than in any dexlansoprazole MR (15.64-18.75) group. Fewer patients receiving dexlansoprazole MR discontinued therapy because of an adverse event (P < or = 0.05 vs. placebo). Seven patients died of events considered unrelated to study drug. Mean serum gastrin rose in all groups except placebo; increases were not dose-related. No clinically concerning trends were seen in gastric biopsy results. Endocrine cell hyperplasia, dysplasia and neoplasia were not observed.
Dexlansoprazole MR 30-90 mg has a safety profile comparable to that of lansoprazole.
多库兰索拉唑 MR 是多库兰索拉唑的双迟释制剂，多库兰索拉唑是兰索拉唑的对映异构体。
评估多库兰索拉唑 MR 在 3 期临床试验中的安全性。
汇总了 6 项随机对照试验和 1 项 12 个月安全性研究中 4270 例接受多库兰索拉唑 MR 30mg（n=455）、60mg（n=2311）或 90mg（n=1864）、兰索拉唑 30mg（n=1363）或安慰剂（n=896）治疗的患者的数据。通过不良事件、生命体征、心电图、临床实验室结果和胃活检评估安全性。不良事件按每 100 患者-月暴露数进行总结，以平衡研究药物暴露的差异。
安慰剂（24.49）和兰索拉唑（21.06）组每 100 患者-月治疗期间出现>或=1 次治疗相关不良事件的患者数多于多库兰索拉唑 MR 任何剂量组（15.64-18.75）。因不良事件而停止治疗的患者数少于安慰剂组（P<或=0.05）。7 例患者死于被认为与研究药物无关的事件。除安慰剂组外，所有组的血清胃泌素均升高；升高与剂量无关。胃活检结果未见临床相关趋势。未观察到内分泌细胞增生、异型增生和肿瘤。
多库兰索拉唑 MR 30-90mg 的安全性与兰索拉唑相似。
