The 12-month safety profile of dexlansoprazole, a proton pump inhibitor with a dual delayed release formulation, in patients with gastro-oesophageal reflux disease.


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 ( identifier NCT00255190).


Aliment Pharmacol Ther


Dabholkar AH,Han C,Paris MM,Perez MC,Atkinson SN,Peura DA




Has Abstract


2011-02-01 00:00:00












  • Patterns and predictors of mortality and disease progression among patients with non-alcoholic fatty liver disease.

    abstract:BACKGROUND:Factors associated with mortality and disease progression in non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) are poorly understood. AIMS:To assess the impact of liver disease severity, demographics and comorbidities on all-cause mortality and liver disease progression in a...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章


    authors: Canbay A,Kachru N,Haas JS,Sowa JP,Meise D,Ozbay AB

    更新日期:2020-10-01 00:00:00

  • Meta-analysis: Lactobacillus GG for treating acute diarrhoea in children.

    abstract:AIM:To review evidence for the effectiveness of Lactobacillus GG (LGG) in treating acute infectious diarrhoea in children. METHODS:The following electronic databases were searched through August 2006 for studies relevant to acute infectious diarrhoea and LGG: MEDLINE, EMBASE, CINAHL and The Cochrane Library; additiona...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章,meta分析,评审


    authors: Szajewska H,Skórka A,Ruszczyński M,Gieruszczak-Białek D

    更新日期:2007-04-15 00:00:00

  • Real-life study of safety of thiopurine-allopurinol combination therapy in inflammatory bowel disease: myelotoxicity and hepatotoxicity rarely affect maintenance treatment.

    abstract:BACKGROUND:Low-dose thiopurine-allopurinol (LDTA) combination therapy is a commonly applied optimisation strategy in IBD patients with a skewed thiopurine metabolism. AIM:To assess continued LDTA maintenance treatment at annual intervals and explore risk factors for treatment cessation METHODS: Adult IBD patients trea...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章


    authors: Kreijne JE,de Veer RC,de Boer NK,Dijkstra G,West R,Moorsel SAW,de Jong DJ,van der Woude CJ,de Vries AC,of the Dutch Initiative on Crohn, Colitis (ICC).

    更新日期:2019-08-01 00:00:00

  • Systematic review: managing anaemia in Crohn's disease.

    abstract:BACKGROUND:Anaemia is a serious complication of Crohn's disease that triggers hospitalization and, if not interfered with, may lead to death. AIMS:To systematically summarize and compare the literature on anaemia in Crohn's disease. METHODS:For this systematic review the literature was searched for English-language a...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章,评审


    authors: Kulnigg S,Gasche C

    更新日期:2006-12-01 00:00:00

  • Randomised clinical trial: identification of responders to short-term treatment with esomeprazole for dyspepsia in primary care - a randomised, placebo-controlled study.

    abstract:BACKGROUND:Response to proton pump inhibitor (PPI) treatment in dyspepsia is unpredictable. AIM:To identify symptoms associated with response to esomeprazole in order to target patients for empirical treatment. METHODS:Eight hundred and five uninvestigated, primary care patients with upper GI symptoms that were consi...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章,随机对照试验


    authors: Meineche-Schmidt V,Christensen E,Bytzer P

    更新日期:2011-01-01 00:00:00

  • High-dose, ten-day esomeprazole, amoxicillin and metronidazole triple therapy achieves high Helicobacter pylori eradication rates.

    abstract:BACKGROUND:Strong acid inhibition using esomeprazole increases cure rates with triple therapy and 10-day treatments are more effective than 7-day ones. The combination of amoxicillin plus metronidazole at full doses, and using a physiologically-correct schedule three times a day, and has been shown to overcome metronid...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章


    authors: Sánchez-Delgado J,García-Iglesias P,Castro-Fernández M,Bory F,Barenys M,Bujanda L,Lisozain J,Calvo MM,Torra S,Gisbert JP,Calvet X

    更新日期:2012-07-01 00:00:00

  • Twenty-four-hour intragastric acidity and nocturnal gastric secretion in gastric ulcer patients--the effects of cimetidine.

    abstract::In a double-blind randomized study, the profile of 24-h intragastric acidity and nocturnal gastric secretion was measured in a group of patients with healed gastric ulcer on placebo and 400 mg cimetidine b.d. and 800 mg nocte. Neither cimetidine regimen significantly decreased daytime intragastric acidity, but the 800...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Derodra JK,Howden CW,Burget DW,Hunt RH

    更新日期:1990-06-01 00:00:00

  • Helicobacter pylori eradication using one-week low-dose lansoprazole plus amoxycillin and either clarithromycin or azithromycin.

    abstract:AIM:To evaluate and compare two 1-week low-dose triple therapies based on lansoprazole, amoxycillin and a macrolide in eradicating Helicobacter pylori. METHODS:Seventy consecutive patients, suffering from dyspeptic symptoms with H. pylori infection, were randomly allocated to one of two treatment groups: (A) (LAC; n =...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Cammarota G,Tursi A,Papa A,Montalto M,Veneto G,Cuoco L,Fedeli G,Gasbarrini G

    更新日期:1996-12-01 00:00:00

  • Steroid dependency and trends in prescribing for inflammatory bowel disease - a 20-year national population-based study.

    abstract:BACKGROUND:It is unclear whether adherence to prescribing standards has been achieved in inflammatory bowel disease (IBD). AIM:To determine how prescribing of 5-aminosalicylates (5-ASAs), steroids and thiopurines has changed in response to emerging evidence. METHODS:We examined trends in oral and topical therapies in...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章


    authors: Chhaya V,Saxena S,Cecil E,Subramanian V,Curcin V,Majeed A,Pollok RC

    更新日期:2016-09-01 00:00:00

  • Cyclo-oxygenase-2 expression in Barrett's oesophageal carcinogenesis: an immunohistochemical study.

    abstract:BACKGROUND:The incidence of Barrett's oesophageal adenocarcinoma is increasing more rapidly than any other malignancy in industrialized countries. Cyclo-oxygenase-2 appears to play an important role in gastrointestinal carcinogenesis. Previous studies on cyclo-oxygenase-2 expression in Barrett's oesophageal carcinogene...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章


    authors: Cheong E,Igali L,Harvey I,Mole M,Lund E,Johnson IT,Rhodes M

    更新日期:2003-02-01 00:00:00

  • A pilot study of orlistat treatment in obese, non-alcoholic steatohepatitis patients.

    abstract:BACKGROUND:Treatment options for non-alcoholic steatohepatitis (NASH) are limited. Weight loss remains the most recommended therapy. Orlistat is an effective adjunct to dietary weight loss therapy. AIM:To evaluate the efficacy of orlistat, given for 6 months to patients with obesity and biopsy confirmed NASH. METHODS...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Harrison SA,Fincke C,Helinski D,Torgerson S,Hayashi P

    更新日期:2004-09-15 00:00:00

  • The effect of bolus viscosity on swallowing function in neurogenic dysphagia.

    abstract:AIM:To assess the pathophysiology and treatment of neurogenic dysphagia. METHODS:46 patients with brain damage, 46 with neurodegenerative diseases and eight healthy volunteers were studied by videofluoroscopy while swallowing 3-20 mL liquid (20.4 mPa s), nectar (274.4 mPa s) and pudding (3931.2 mPa s) boluses. RESULT...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章


    authors: Clavé P,de Kraa M,Arreola V,Girvent M,Farré R,Palomera E,Serra-Prat M

    更新日期:2006-11-01 00:00:00

  • Meta-analysis: Smectite in the treatment of acute infectious diarrhoea in children.

    abstract:BACKGROUND:Although not currently recommended, dioctahedral smectite (smectite) is commonly used to treat acute infectious diarrhoea in many countries. AIM:To evaluate systematically the effectiveness of smectite in treating acute infectious diarrhoea in children. METHODS:Using medical subject headings and free-langu...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章,meta分析


    authors: Szajewska H,Dziechciarz P,Mrukowicz J

    更新日期:2006-01-15 00:00:00

  • Prospective study of the need for long-term antisecretory therapy in patients with Zollinger-Ellison syndrome following successful curative gastrinoma resection.

    abstract::A long-term cure is now possible in more than 30% of selected patients with Zollinger-Ellison syndrome who undergo gastrinoma resection. The need, however, for continued gastric acid antisecretory therapy in these patients remains controversial. The current study was designed to determine whether post-operative antise...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章


    authors: Metz DC,Benya RV,Fishbeyn VA,Pisegna JR,Orbuch M,Strader DB,Norton JA,Jensen RT

    更新日期:1993-06-01 00:00:00

  • Long-term effect of tacrolimus therapy in patients with refractory ulcerative colitis.

    abstract:BACKGROUND:Little is known about long-term outcome of tacrolimus therapy for ulcerative colitis. Aim To evaluate long-term efficacy and safety of tacrolimus in Japanese patients with refractory ulcerative colitis. METHODS:Twenty-seven patients with UC refractory to conventional therapy were administered tacrolimus wit...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章,随机对照试验


    authors: Yamamoto S,Nakase H,Mikami S,Inoue S,Yoshino T,Takeda Y,Kasahara K,Ueno S,Uza N,Kitamura H,Tamaki H,Matsuura M,Inui K,Chiba T

    更新日期:2008-09-01 00:00:00

  • Renal function and cardiovascular risk profile after conversion from ciclosporin to tacrolimus: prospective study in 80 liver transplant recipients.

    abstract:BACKGROUND:Increased risk of cardiovascular and cerebrovascular disease in liver transplant recipients results in particular from the side effects of calcineurin inhibitor-based immunosuppressive therapy. Several studies have demonstrated a more favourable outcome for patients receiving tacrolimus (TAC) as compared wit...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章


    authors: Beckebaum S,Klein C,Varghese J,Sotiropoulos GC,Saner F,Schmitz K,Gerken G,Paul A,Cicinnati VR

    更新日期:2009-10-15 00:00:00

  • Review article: FODMAPS, prebiotics and gut health-the FODMAP hypothesis revisited.

    abstract:BACKGROUND:Restriction of dietary FODMAP intake can alleviate symptoms in patients with irritable bowel syndrome. Because many FODMAPs have prebiotic actions, there is concern that their dietary restriction leads to dysbiosis with health consequences, and their intake is being encouraged by addition to foods and via su...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章,评审


    authors: Gibson PR,Halmos EP,Muir JG

    更新日期:2020-07-01 00:00:00

  • Localization of the beta(beta)3-adrenoceptor in the human gastrointestinal tract: an immunohistochemical study.

    abstract:BACKGROUND:Activation of human and non-human colonic beta(beta)3-adrenoceptors causes smooth muscle relaxation. beta3-Adrenoceptor agonists protect against experimental indomethacin-induced jejunal ulceration. The mechanism of protection may involve spasmolytic/vasodilatory agonist activity. The precise localization of...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章


    authors: Anthony A,Schepelmann S,Guillaume JL,Strosberg AD,Dhillon AP,Pounder RE,Wakefield AJ

    更新日期:1998-06-01 00:00:00

  • Risk factors and outcome of HIV-associated idiopathic noncirrhotic portal hypertension.

    abstract:BACKGROUND:Idiopathic noncirrhotic portal hypertension (INCPH) has been reported increasingly in patients with HIV infection. AIM:To evaluate the number of nationwide diagnosed HIV-associated INCPH cases and to assess its clinical features, risk factors and outcome. METHODS:All HIV centres in the Netherlands were con...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章


    authors: Schouten JN,Van der Ende ME,Koëter T,Rossing HH,Komuta M,Verheij J,van der Valk M,Hansen BE,Janssen HL

    更新日期:2012-11-01 00:00:00

  • Review article: short chain fatty acids as potential therapeutic agents in human gastrointestinal and inflammatory disorders.

    abstract:BACKGROUND:Butyrate, propionate and acetate are short chain fatty acids (SCFA), important for maintaining a healthy colon and are considered as protective in colorectal carcinogenesis. However, they may also regulate immune responses and the composition of the intestinal microbiota. Consequently, their importance in a ...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章,评审


    authors: Gill PA,van Zelm MC,Muir JG,Gibson PR

    更新日期:2018-07-01 00:00:00

  • Review article: the management of acute variceal bleeding.

    abstract::Variceal haemorrhage is a common medical emergency with a high mortality (30-50%). Adequate resuscitation is vital, and once stabilised the patient should be moved to a high-dependency area. Antibiotics reduce mortality, and the vasoactive drug terlipressin should be administered if early endoscopy is unavailable. Ear...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章,评审


    authors: Ferguson JW,Tripathi D,Hayes PC

    更新日期:2003-08-01 00:00:00

  • A comparison of lansoprazole and ranitidine in the treatment of erosive oesophagitis. Multicentre Investigational Group.

    abstract:BACKGROUND:Lansoprazole is a new proton pump inhibitor which produces prolonged decrease of gastric acidity. The aim of this study was to compare lansoprazole to a standard dose of ranitidine in the treatment of patients with reflux oesophagitis. METHODS:Two hundred and forty-seven patients with erosive oesophagitis w...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验


    authors: Robinson M,Sahba B,Avner D,Jhala N,Greski-Rose PA,Jennings DE

    更新日期:1995-02-01 00:00:00

  • Efficacy of long-term therapy with low doses of omeprazole in the control of gastric acid secretion in Zollinger-Ellison syndrome patients.

    abstract::Thirteen patients with Zollinger-Ellison syndrome were investigated: 8 without, and 5 with, previous gastric surgery. After 7-34 months of treatment with famotidine, 8 out of 13 patients were resistant to this drug. Omeprazole 60 mg/day was administered to these 8 patients; after one month, the dose was reduced to 40 ...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章


    authors: Corleto V,Annibale B,D'Ambra G,Saggioro A,Ferrua B,Cassetta MR,Delle Fave G

    更新日期:1993-04-01 00:00:00

  • The efficacy and safety of direct acting antiviral treatment and clinical significance of drug-drug interactions in elderly patients with chronic hepatitis C virus infection.

    abstract:BACKGROUND:Direct antiviral therapies for chronic hepatitis C virus (HCV) infection have expanded treatment options for neglected patient populations, including elderly patients who are ineligible/intolerant to receive interferon (IFN)-based therapy. AIM:To investigate the efficacy, tolerability and potential for drug...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章


    authors: Vermehren J,Peiffer KH,Welsch C,Grammatikos G,Welker MW,Weiler N,Zeuzem S,Welzel TM,Sarrazin C

    更新日期:2016-10-01 00:00:00

  • Systematic review with meta-analysis: the relationship between chronic Salmonella typhi carrier status and gall-bladder cancer.

    abstract:BACKGROUND:Carcinoma of the gall-bladder is the fifth commonest gastrointestinal tract cancer and is endemic in several countries. An association of chronic typhoid carriage and carcinoma of the gall-bladder has been reported. AIM:To clarify whether chronic Salmonella typhi carrier state is associated with carcinoma o...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章,meta分析,评审


    authors: Nagaraja V,Eslick GD

    更新日期:2014-04-01 00:00:00

  • Systematic review with network meta-analysis: pharmacological prophylaxis against post-ERCP pancreatitis.

    abstract:BACKGROUND:The efficacy of many pharmacological agents for preventing post-ERCP pancreatitis (PEP) has been evaluated in randomised controlled trials (RCTs), but it is unclear which agent(s) should be used in clinical practice. Network meta-analyses of RCTs are used to simultaneously compare several agents to determine...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章,meta分析,评审


    authors: Akshintala VS,Hutfless SM,Colantuoni E,Kim KJ,Khashab MA,Li T,Elmunzer BJ,Puhan MA,Sinha A,Kamal A,Lennon AM,Okolo PI,Palakurthy MK,Kalloo AN,Singh VK

    更新日期:2013-12-01 00:00:00

  • Review article: Medical therapy for fistulizing Crohn's disease.

    abstract:BACKGROUND:Fistulae will develop in approximately one-third of patients with Crohn's disease. With an expected spontaneous healing rate of only 10%, fistulizing Crohn's disease requires a comprehensive strategy with a medical and possible surgical approach. AIM:To summarize the current literature evaluating various me...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章,评审


    authors: Bressler B,Sands BE

    更新日期:2006-11-01 00:00:00

  • Optimised infliximab monotherapy is as effective as optimised combination therapy, but is associated with higher drug consumption in inflammatory bowel disease.

    abstract:BACKGROUND:Combination treatment with azathioprine for 6-12 months is the preferred strategy for starting infliximab due to improved pharmacokinetics. However, optimised infliximab monotherapy with proactive dose escalations in case of low trough levels is a safer but under-studied alternative. AIM:To compare the clin...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章


    authors: Drobne D,Kurent T,Golob S,Švegl P,Rajar P,Hanžel J,Koželj M,Novak G,Smrekar N,Ferkolj I,Štabuc B

    更新日期:2019-04-01 00:00:00

  • Hepatitis E virus in patients with decompensated chronic liver disease: a prospective UK/French study.

    abstract:BACKGROUND:In developed countries, hepatitis E is a porcine zoonosis caused by hepatitis E virus (HEV) genotype 3. In developing countries, hepatitis E is mainly caused by genotype 1, and causes increased mortality in patients with pre-existing chronic liver disease (CLD). AIM:To determine the role of HEV in patients ...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章


    authors: Blasco-Perrin H,Madden RG,Stanley A,Crossan C,Hunter JG,Vine L,Lane K,Devooght-Johnson N,Mclaughlin C,Petrik J,Stableforth B,Hussaini H,Phillips M,Mansuy JM,Forrest E,Izopet J,Blatchford O,Scobie L,Peron JM,Dalton H

    更新日期:2015-09-01 00:00:00

  • The risk of later surgery at the anastomotic site following right hemicolectomy for Crohn's disease in a national cohort of 12 230 patients.

    abstract:BACKGROUND:Crohn's disease (CD) has a high-risk of bowel resection and later surgery for recurrent disease. Recent guidelines recommend colonoscopy 6-12 months following surgery to reduce further surgical intervention through medical therapy intensification. AIMS:To investigate the risk of further surgery at the anast...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章


    authors: King D,Coupland B,Dosanjh A,Cole A,Adderley NJ,Reulen RC,Patel P,Trudgill NJ

    更新日期:2021-01-01 00:00:00