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Hussein H Rimmani, Luma Basma O Rustom, Mahmoud A Rahal, Rani H Shayto, Hani Chaar, Ala I Sharara
BACKGROUND AND AIMS: Proton pump inhibitors are effective at reducing heartburn. No studies have evaluated their efficacy in Ramadan. Dexlansoprazole has a unique active formulation independent of time-of-day dosing or food. The aim is to investigate the efficacy of dexlansoprazole 60 mg during Ramadan in patients with symptomatic heartburn. METHODS: Subjects recruited using poster, radio, and SMS advertisements completed a diary using a mobile-friendly application and received daily SMS reminders...
January 9, 2019: Digestive Diseases
Karen E Hansen, Jeri W Nieves, Sai Nudurupati, David C Metz, Maria Claudia Perez
BACKGROUND & AIMS: Epidemiological studies have associated proton pump inhibitor (PPI) therapy with osteoporotic fractures, but it is not clear if PPIs directly cause osteoporosis. We evaluated the effect of dexlansoprazole and esomeprazole on bone turnover, bone mineral density (BMD), true fractional calcium absorption (TFCA), serum and urine levels of minerals, and levels of parathyroid hormone (PTH) in healthy postmenopausal women. METHODS: We performed a prospective, multicenter, double-blind study of 115 healthy, postmenopausal women (45 to 75 years of age) from November 4, 2010, through August 7, 2014...
November 13, 2018: Gastroenterology
David Gremse, Benjamin D Gold, Betsy Pilmer, Barbara Hunt, Bartosz Korczowski, Maria Claudia Perez
BACKGROUND: In gastroesophageal reflux disease (GERD), the frequency of heartburn symptoms and erosive esophagitis (EE) increases with age in children and adolescents. Proton pump inhibitor, dexlansoprazole, is approved for healing EE of all grades, maintenance of healed EE, relief of heartburn, and treatment of symptomatic non-erosive GERD in patients ≥ 12 years. AIM: To assess safety and efficacy of dexlansoprazole dual delayed-release capsule in healing of EE and maintenance of healed EE in adolescents...
November 2, 2018: Digestive Diseases and Sciences
Richard H Hunt, Carmelo Scarpignato
PURPOSE OF THE REVIEW: Acid suppression treatment has revolutionized the management of the acid-related disorders since the introduction of the H2 -receptor antagonists (H2 -RAs) and the proton pump inhibitors (PPIs). However, there has been increasing identification of needs for improvement in antisecretory therapy, especially in gastroesophageal reflux disease (GERD), the eradication of Helicobacter pylori (H. pylori), protection from aspirin (ASA) and non-steroidal inflammatory drug (NSAID) injury and the management of upper gastrointestinal (UGI) bleeding...
December 2018: Current Treatment Options in Gastroenterology
Nawal Farhat, Nisrine Haddad, James Crispo, Nicholas Birkett, Doug McNair, Franco Momoli, Shi-Wu Wen, Donald R Mattison, Daniel Krewski
PURPOSE: The US Food and Drug Administration (FDA) issued three safety announcements between January 2009 and October 2010 warning against concomitant use of clopidogrel and proton pump inhibitors (PPIs) due to a potential drug-drug interaction that may attenuate clopidogrel's antiplatelet activity. This primary objective of this study was to examine trends in concomitant clopidogrel/PPI use among acute coronary syndrome (ACS) inpatients in the US between 2000 and 2016, in relation to the FDA safety communications...
October 15, 2018: European Journal of Clinical Pharmacology
Michael Kukulka, Sai Nudurupati, Maria Claudia Perez
Objective: To assess the effect of route of administration on the bioavailability of dexlansoprazole 60 mg delayed-release capsule granules. Methods: One open-label, Phase I, single-dose, 3-period crossover study was conducted in healthy adults. The bioavailability of Dexilant® (dexlansoprazole) after dexlansoprazole capsule granules were mixed with water and administered via 16 French nasogastric tube or orally via syringe was compared to administration of the intact capsule in the fasted state, swallowed with water...
2018: Clinical and Experimental Gastroenterology
Linda Luo, Xiaoli Wen, Yueying Du, Zhen Jiang, Xingjie Guo
A rapid, sensitive and enantioselective method was developed and fully validated for the separation and determination of lansoprazole enantiomers in rat plasma by liquid chromatography-tandem mass spectrometry (LC-MS/MS). The analytes and the internal standard (esomeprazole) were both extracted from plasma samples by liquid-liquid extraction with diethyl ether-dichloromethane (70:30; v/v). Satisfactory resolution (Rs  = 2.0) was achieved within 7.3 min on a Chiralpak ID column (250 × 4.6 mm, 5 μm) employing acetonitrile-water (60:40, v/v) as the mobile phase at a flow rate of 0...
November 2018: Biomedical Chromatography: BMC
Eugene R Przespolewski, Erica S Westphal, Michelle Rainka, Nicholas M Smith, Vernice Bates, Fran M Gengo
BACKGROUND AND GOAL: Cytochrome P450 (CYP) enzymes are responsible for the conversion of clopidogrel into its active metabolite and the metabolism of proton pump inhibitors (PPIs), which may also inhibit CYP enzymes. A current Food and Drug Administration advisory suggests avoiding esomeprazole and omeprazole while taking clopidogrel because of concerns that PPIs may compromise clopidogrel's antiplatelet effects. The objective of the present study was to examine the robustness of this interaction using a well-controlled study design in a population of participants free of confounders...
June 2018: Journal of Stroke and Cerebrovascular Diseases: the Official Journal of National Stroke Association
Chih-Ming Liang, Ming-Te Kuo, Pin-I Hsu, Chao-Hung Kuo, Wei-Chen Tai, Shih-Cheng Yang, Keng-Liang Wu, Hsing-Ming Wang, Chih-Chien Yao, Cheng-En Tsai, Yao-Kuang Wang, Jiunn-Wei Wang, Chih-Fang Huang, Deng-Chyang Wu, Seng-Kee Chuah
AIM: To compare the one-week clinical effects of single doses of dexlansoprazole and esomeprazole on grades A and B erosive esophagitis. METHODS: We enrolled 175 adult patients with gastroesophageal reflux disease (GERD). The patients were randomized in a 1:1 ratio into two sequence groups to define the order in which they received single doses of dexlansoprazole ( n = 88) and esomeprazole ( n = 87) for an intention-to-treat analysis. The primary end-points were the complete symptom resolution (CSR) rates at days 1, 3, and 7 after drug administration...
December 21, 2017: World Journal of Gastroenterology: WJG
Peranart Chotivitayatarakorn, Varocha Mahachai, Ratha-Korn Vilaichone
Background: Helicobacter pylori (H. pylori) is important cause of peptic ulcer and gastric cancer. Moxifloxacin is effective antibiotic for treatment for H. pylori. However, there were limited studies as first line therapy. Probiotics had been shown to decrease therapy-related side-effect and increase eradication rate. Aim of this study was to evaluate the efficacy of moxifloxacin-dexlansoprazole based triple therapy with probiotic for H. pylori treatment in Thailand. Methods: Patients with H. pylori infected gastritis were randomized to receive 7- or 14-day moxifloxacin-dexlansoprazole based triple therapy with probiotic or placebo...
October 26, 2017: Asian Pacific Journal of Cancer Prevention: APJCP
Biljana Jovov, Craig C Reed, Nicholas J Shaheen, Amy Pruitt, Kathleen Ferrell, Geraldine S Orlando, Zorka Djukic, Roy C Orlando
BACKGROUND: Approximately, 20% of patients with heartburn and normal endoscopic findings do not symptomatically improve on proton pump inhibitor (PPI) therapy making diagnosis and treatment uncertain. A biomarker distinguishing PPI-responsive from PPI-refractory heartburn is desirable. AIMS: We performed a pilot study assessing whether carboxy(C)-terminal fragments (CTFs) of e-cadherin in esophageal biopsies or amino(N)-terminal fragments (NTFs) of e-cadherin in serum could serve this purpose...
March 2018: Digestive Diseases and Sciences
Hye Yoon Park, Eun Jeong Kang, Dong Gun Kim, Ki Ju Kim, Jin Woo Choi, Su Youn Nam, Yong Hwan Kwon, Hyun Seok Lee, Seong Woo Jeon
Background/Aims: Recently, the eradication rate of Helicobacter pylori ( H. pylori ) infection has decreased to less than 80% worldwide with the use of clarithromycin-based triple therapy owing to the increased resistance of H. pylori to antibiotics, especially clarithromycin and metronidazole. This prospective study aimed to determine eradication rate of H. pylori following high and frequent doses of extended-release dexlansoprazole and amoxicillin, as a dual therapy in a region with high clarithromycin resistance rate...
October 25, 2017: Korean Journal of Gastroenterology, Taehan Sohwagi Hakhoe Chi
Lu-Ning Sun, Yang Cao, Yue-Qi Li, Yun-Qian Fang, Hong-Wen Zhang, Mei-Feng Wang, Li-Jun Xie, Juan Chen, Zhi-Cheng Yang, Ming-Liang Bian, Hao Li, Pei-Pei Zhang, Ji-Fu Wei, Ling Meng, Xue-Hui Zhang, Ping Zhao, Yong-Qing Wang
Background: Not all patients with acid-related disorders receiving proton pump inhibitor (PP) treatment get adequate gastric pH control. The genetic variation of receptors, metabolic enzymes, and transporters are known to cause failures of therapies. We have conducted a study to evaluate the influence of gastric H + /K + -ATPase, CYP2C19 , and ABCB1 polymorphisms on the pharmacokinetic and pharmacodynamic profiles of dexlansoprazole injection in healthy Chinese subjects. Methods: A total of 51 subjects were enrolled for pharmacokinetic and pharmacodynamic study after a single intravenous administration of 20 or 30 mg dexlansoprazole...
2017: Frontiers in Pharmacology
Mei-Juan Li, Qing Li, Min Sun, Li-Qin Liu
BACKGROUND: This study compared the effectiveness and acceptability of all Food and Drug Administration (FDA)-recommended dose proton pump inhibitors (PPIs) in erosive esophagitis (EE): Dexlansoprazole 60 mg, Esomeprazole 40 mg, Esomeprazole 20 mg, Pantoprazole 40 mg, Lansoprazole 30 mg, Rabeprazole 20 mg, Omeprazole 20 mg. METHODS: A systematic literature search was performed using PubMed, Embase, and Cochrane Library. Totally, 25 randomized controlled trials (RCTs) met study selection criteria and were incorporated in this network meta-analysis (NMA) study...
September 2017: Medicine (Baltimore)
Benjamin D Gold, Betsy Pilmer, Jaroslaw Kierkuś, Barbara Hunt, Maria Claudia Perez, David Gremse
BACKGROUND: Proton pump inhibitors are commonly used to treat gastro-esophageal reflux disease (GERD) and nonerosive GERD (NERD) in adolescents and adults. Despite the efficacy of available medications, many patients have persisting symptoms, indicating a need for more effective agents. AIMS: To assess the safety and efficacy of dexlansoprazole dual delayed-release capsules in adolescents for treatment of symptomatic NERD. METHODS: A phase 2, open-label, multicenter study was conducted in adolescents aged 12-17 years...
November 2017: Digestive Diseases and Sciences
Hyun Kyu Chung, Quoc-Ky Truong, Xuan-Lan Mai, Yusung Choi, Jong-Seong Kang, Woongchon Mar, Kyeong Ho Kim
Capillary zone electrophoresis was successfully applied to the enantiomeric purity determination of dexlansoprazole using sulfobutyl ether-β-cyclodextrin and methyl-β-cyclodextrin as chiral selectors. Separations were carried out in a 50 μm, 64/56 cm fused-silica capillary. The optimized conditions included 90 mM phosphate buffer, pH 6.0, containing 30 mM sulfobutyl ether-β-cyclodextrin, 20 mM methyl-β-cyclodextrin as background electrolyte, an applied voltage of 25 kV and a temperature of 16 °C, detection was at 280 nm...
August 2017: Archives of Pharmacal Research
Michael Kukulka, Sai Nudurupati, Maria Claudia Perez
BACKGROUND: Dexlansoprazole is a proton pump inhibitor (PPI) approved for use in dual delayed-release capsule and orally disintegrating tablet (ODT) formulations. AIM: To assess effects of food, water, and route of administration on the bioavailability of dexlansoprazole 30-mg ODT. METHODS: Two separate open-label, phase 1, single-dose crossover studies were conducted in healthy adults. In study 1, pharmacokinetic parameters were analyzed in participants receiving dexlansoprazole ODT in a fed or fasted state with and without water...
2017: Clinical and Experimental Gastroenterology
Ronnie Fass, Rosita Frazier
Dexlansoprazole modified-release (MR) is the R-enantiomer of lansoprazole and is currently the only proton-pump inhibitor (PPI) with a novel dual delayed release (DDR) formulation. Overall, dexlansoprazole MR demonstrates a similar safety and side-effect profile as lansoprazole. Dexlansoprazole MR has been shown to be highly efficacious in healing erosive esophagitis, maintaining healed esophageal mucosa in patients with erosive esophagitis and controlling symptoms of patients with nonerosive reflux disease (NERD)...
February 2017: Therapeutic Advances in Gastroenterology
Yue-Qi Li, Zheng-Yu Yan, Hong-Wen Zhang, Lu-Ning Sun, Hui-Wen Jiao, Mei-Feng Wang, Li-Yuan Yu, Lei Yu, Zi-Qing-Yun Yuan, Ling Meng, Yong-Qing Wang
PURPOSE: This study was conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of dexlansoprazole injection in healthy subjects. METHODS: Dexlansoprazole (20-90 mg) or lansoprazole (30 mg) was administrated intravenously to healthy male and female volunteers. All the subjects were sampled for pharmacokinetic (PK) analysis and 64 of them were monitored for 24-h intragastric pH prior to and after administration in the pharmacodynamic (PD) study...
May 2017: European Journal of Clinical Pharmacology
Duowu Zou, Khean-Lee Goh
Both proton pump inhibitors (PPIs) and clopidogrel are widely prescribed in the Asia-Pacific population. PPIs are the mainstay therapeutic agents for prophylaxis against aspirin gastropathy and for acid-related disorders including gastroesophageal reflux disease. They are also co-prescribed with oral anticoagulant agents and with dual-antiplatelet therapy for the treatment and prevention of gastrointestinal bleeding. Clopidogrel belongs to the drug class of thienopyridines and is currently the most widely prescribed oral anticoagulant agent either alone or in combination with aspirin...
June 2017: Journal of Gastroenterology and Hepatology
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