Abstract:
BACKGROUND:Dexlansoprazole MR is a Dual Delayed Release formulation of dexlansoprazole, an enantiomer of lansoprazole, designed to extend the duration of acid suppression. AIM:To assess the 12-month safety of dexlansoprazole MR in patients with symptomatic gastro-oesophageal reflux disease (GERD). METHODS:In this randomised open-label study, patients received dexlansoprazole MR 60 or 90 mg once-daily for 12 months. Safety was evaluated at months 1, 3, 6, 9 and 12/final visit through physical examinations, laboratory evaluations, endoscopies, gastric biopsies, fasting serum gastrin values and adverse events (AEs). RESULTS:Of 591 patients receiving dexlansoprazole MR 60 and 90 mg, 71% and 65%, respectively, experienced ≥1 treatment-emergent AE; the most frequent AE was upper respiratory infection (14% and 13% in the 60- and 90-mg groups). Thirty patients experienced ≥1 serious AE; a majority of serious AEs were unrelated to study drug. No clinically meaningful change in any clinical laboratory parameters was noted. As expected, serum gastrin values rose with dexlansoprazole therapy; increases were not dose related. No clinically concerning trends were identified in gastric pathology results; no endocrine cell hyperplasia, adenocarcinoma, or lymphoma were observed. CONCLUSIONS:Twelve-month treatment with dexlansoprazole MR 60 and 90 mg was well tolerated by GERD patients in this study (Clinicaltrials.gov identifier NCT00255190).
journal_name
Aliment Pharmacol Therjournal_title
Alimentary pharmacology & therapeuticsauthors
Dabholkar AH,Han C,Paris MM,Perez MC,Atkinson SN,Peura DAdoi
10.1111/j.1365-2036.2010.04519.xsubject
Has Abstractpub_date
2011-02-01 00:00:00pages
366-77issue
3eissn
0269-2813issn
1365-2036journal_volume
33pub_type
杂志文章,多中心研究,随机对照试验abstract:BACKGROUND:Bovine colostrum is a rich source of nutrients, antibodies and growth factors. AIM:To examine the efficacy of colostrum enemas in the treatment of distal colitis using a randomized, double-blind, controlled protocol. METHODS:Fourteen patients (eight female), with a mean age of 45 years (range, 16-75 years)...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1046/j.1365-2036.2002.01354.x
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abstract:BACKGROUND:Chronic hepatitis C (HCV) treatment with pegylated-interferon (PEG-IFN)/ribavirin (RBV) is often limited by preexisting medical, psychiatric and psychosocial contraindications. However, limited data exist in general patient populations. AIM:To evaluate the percentage of HCV-infected patients in the general ...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.12200
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journal_title:Alimentary pharmacology & therapeutics
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journal_title:Alimentary pharmacology & therapeutics
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journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
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journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
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pub_type: 杂志文章,评审
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journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:2000-02-01 00:00:00
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pub_type: 杂志文章,多中心研究
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更新日期:2013-09-01 00:00:00
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