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Suzannah August,1 Stephen Granier,2 Mark P Tighe,1 Lee W Tbaily,1 Henrik Ahlbom3 1University Hospitals Dorset NHS Trust, Dorset, BH15 2JB, UK; 2Whiteladies Medical Group, Bristol, BS8 2PU, UK; 3Mölnlycke® Health Care, Gothenburg, 402 52, SwedenCorrespondence: Suzannah August Email Suzannah.August@uhd.nhs.ukIntroduction: Emollients provide an occlusive barrier for dry and atopic skin, retain moisture, protect it from irritants, and form the basis of eczema treatment.Methods and Analysis: A prospective interventional single arm study to evaluate the performance and safety of Epaderm® Cream, an emollient and cleanser containing 25% (w/w) paraffin and 5% (w/w) glycerine (thereafter, an emollient cream), in patients with dry skin conditions. The primary outcome measure was participant evaluation of skin moisturisation after treatment with an emollient cream for up to 4 weeks. Secondary outcome measures included: evaluation of skin softness using a questionnaire and of pruritus on a visual analogue scale (VAS); clinician assessment of xerosis using Overall Dry Skin (ODS) score and measurement of skin hydration using a non-invasive device (MoistureMeterEpiD, Delfin Technologies) at each visit. Sign test and Wilcoxon signed rank test were used to analyse changes from baseline.Results: A total of 114 participants completed the study. 84.2% (80 out of 95) of participants or parents strongly agreed or agreed that the cream improved skin moisturisation at 4 weeks of treatment at the target area (p< 0.0001). 86.3% of participants agreed that skin softness improved after 4 weeks (p < 0.0001). ODS score improved from 2.1 (standard deviation (SD) 1.0) to 0.7 (SD 0.8) at 4 weeks. Skin hydration at the target area improved from 31.5 (SD 9.3) to 40.5 (SD 8.3) (p< 0.001) at 4 weeks. Mean skin itchiness reduced from 38.0 (SD 25.4) to 17.7 (SD 19.8) at 4 weeks (p< 0.0001). Ten (8.3%) adverse device events (ADEs) were reported.Conclusion: The emollient cream was well tolerated and demonstrated significant improvements in patient-reported skin moisturisation and softness as well as in clinical measurement of xerosis and skin hydration across all age groups including infants. The emollient cream can be recommended for dry skin conditions including atopic dermatitis and psoriasis.Keywords: emollient, Epaderm, dry skin, eczema, psoriasis, atopic dermatitis

August S, Granier S, Tighe MP, Tbaily LW, Ahlbom H. Clin Cosmet Investig Dermatol. 2021;14:909–920. The authors have advised the author list on page 909 is incorrect. The correct author list and affiliations are as follows. Suzannah August1 Stephen Granier2 Mark P Tighe1 Lee W Tbaily1 Sabrina Chowdhury3 Henrik Ahlbom3 1University Hospitals Dorset NHS Trust, Dorset, BH15 2JB, UK; 2Whiteladies Medical Group, Bristol, BS8 2PU, UK; 3Mölnlycke® Health Care, Gothenburg, 402 52, Sweden The authors apologize for this error. Read the original article

Summary Background The use of non-steroidal anti-inflammatory drugs (NSAIDs) is often associated with upper gastrointestinal symptoms such as heartburn and acid regurgitation. Aim To assess the efficacy of esomeprazole 20 and 40 mg for resolution of heartburn and acid regurgitation in continuous NSAIDs. Methods A post hoc analysis of five clinical trials was performed. Two identically designed, placebo-controlled, 4-week studies (NASA1, SPACE1) enrolled non-ulcer, NSAIDs-treated patients with upper abdominal pain, discomfort or burning. PLUTO and VENUS were identically designed, placebo-controlled, 6-month studies that enrolled patients at risk of NSAIDs-induced ulcers. Study 285 was an 8-week comparative study with ranitidine (300 mg/day) in patients with NSAIDs-induced gastric ulcers. Resolution of investigator-assessed heartburn and acid regurgitation was defined as symptom severity of ‘none’ in the last 7 days. Results In NASA1/SPACE1, heartburn resolved in 61% and 62% of patients taking esomeprazole 20 and 40 mg, respectively (vs. 36% on placebo, P

Objectives Two studies compared the effects of intravenous (i.v.) and oral esomeprazole (40 mg and 20 mg) on gastric acid suppression and pharmacokinetics after both single (day 1) and repeated (day 5) dosing. Methods Two randomized, two-way, cross-over, comparative studies of similar design were performed in healthy male and female volunteers. In both studies, subjects received esomeprazole as a 30-min i.v. infusion or orally once-daily for 5 days, separated by a wash-out period of at least 13 days. In one study, which was double-blind (double dummy), subjects received 40 mg esomeprazole. In the other open study, subjects were given 20 mg esomeprazole. Results In total, 40 and 24 subjects were randomized for treatment with 40 mg and 20 mg esomeprazole, respectively. No significant differences were found between i.v or oral administration of esomeprazole with respect to the amount of time with mean intragastric pH>4 throughout day 1 or day 5 of treatment in the 40 mg study (day 1, 10.1 h and 8.8 h versus day 5, 15.9 h and 15.3 h, respectively) and the 20 mg study (day 1, 7.3 h and 6.6 h versus day 5, 11.9 h and 12.3 h, respectively). The area under the plasma concentration-time curve values were higher following i.v. relative to oral administration on day 1 of dosing, with less pronounced differences after repeated (day 5) dosing. Both administration routes were similarly well tolerated. Conclusions Esomeprazole, 40 mg and 20 mg i.v., provides similar levels of intragastric acid control on both day 1 and day 5 of treatment compared with oral administration.

Background: An intravenous (IV) formulation of esomeprazole has been developed as an alternative to oral administration. To meet the needs of different clinical situations it would be preferable if an IV dose could be administered as either an injection or an infusion, while producing similar effects. Aim: To compare the effects of IV esomeprazole 40mg given as a 3-minute injection or a 30-minute infusion on intragastric pH during single and repeated once-daily dosing in healthy subjects. Methods: In this single-centre, double-blind, double-dummy, randomised, two-way crossover study, subjects were randomised to receive either a 3-minute IV injection or a 30-minute IV infusion of esomeprazole 40mg. Both regimens were given once daily for 10 days. After a washout period of at least 13 days, subjects were crossed over to the other treatment. Intragastric pH monitoring was performed on days 1 and 10. Blood samples were also taken throughout days 1 and 10. Results: Data were available from 41 subjects. Time with intragastric pH >4 was 3.1h/24h at baseline, increasing to almost 8h in association with IV esomeprazole injection or infusion on day 1, and to >13h on day 10. Geometric mean time with pH >4/24h ratios (injection/infusion) were 0.99 on day 1 and 1.03 on day 10. Mean esomeprazole AUC values were approximately 15% higher with the injection than the infusion, but 90% CI limits for geometric mean AUC ratios ranged from 1.07 to 1.23, indicating bioequivalence. Conclusions: IV esomeprazole 40mg provides similarly potent acid control whether administered by injection or infusion.

Summary Background : Oral esomeprazole 40 mg provides greater acid control than oral pantoprazole 40 mg. Aim : To compare the effects on intragastric acid control of esomeprazole 40 mg administered intravenously with pantoprazole 40 mg intravenously. Methods : Healthy Helicobacter pylori-negative male and female subjects were enrolled into this single-centre, open, randomized, two-way crossover study. Esomeprazole 40 mg intravenously and pantoprazole 40 mg intravenously were administered as 15-min infusions once daily at 09:00 hours for 5 days. Continuous 24-h intragastric pH monitoring was carried out at baseline and on days 1 and 5. Results : pH-data were available for all 25 subjects who completed the study. Esomeprazole 40 mg intravenously resulted in 8.3 and 13.9 h with an intragastric pH > 4 on days 1 and 5 compared with 5.3 and 9.0 h, respectively for pantoprazole 40 mg intravenously (day 1: P

Efficacy of a continuous high-dose intravenous infusion of esomeprazole, followed by an oral regimen after successful endoscopic therapy for peptic ulcer bleeding (PUB) was established in the PUB study (ClinicalTrials. gov identifier: NCT00251979). Mortality rates and detailed safety and tolerability results from this study are reported here. This was a double-blind, randomized study in patients a parts per thousand yen18 years with overt signs of upper gastrointestinal bleeding, following endoscopic diagnosis of a single gastric or duodenal ulcer (a parts per thousand yen5 mm) with stigmata indicating current/ recent bleeding (Forrest class Ia, Ib, IIa, or IIb). Postendoscopic hemostasis, patients received intravenous esomeprazole (80 mg/30 minutes, then 8 mg/hour for 71.5 hours) or placebo. Postinfusion, all patients received open-label oral esomeprazole 40 mg once daily for 27 days. Mortality rates were analyzed using Fisher's exact test; other safety variables were analyzed descriptively. A total of 767 patients were randomized; 764 comprised the safety analysis set (375 patients received esomeprazole, 389 placebo). Baseline characteristics were similar across the two treatment groups. Three deaths from the esomeprazole treatment group and eight from the placebo group occurred during the trial (0.8% versus 2.1%; P=0.22). From these 11 all-cause deaths, one (esomeprazole group; rebleeding from duodenal ulcer) occurred during the 72-hour intravenous treatment phase. Adverse event (AE) frequency was similar for the two groups over the intravenous treatment phase (esomeprazole, 39.2%; placebo, 41.9%), with gastrointestinal disorders being most commonly reported (12.3% and 19.8%, respectively). Serious AEs were mostly related to bleeding events. Infusion-site reactions (mild, transient) were reported in 4.3% of esomeprazole-treated patients versus 0.5% of placebo patients. These did not lead to treatment discontinuation. Esomeprazole, given as a continuous high-dose intravenous infusion followed by an oral regimen after successful endoscopic therapy for PUB, was well tolerated, with no apparent safety concerns from either the high-dose intravenous treatment or oral phases.

Esomeprazole 40 mg intravenous provides faster and more effective acid control than pantoprazole 40 mg intravenous after first dose and 5 days

and quantified CagA translocation by Western blot using anti-phosphotyrosine and antiCagA antibodies. Significantly higher levels of CagA were translocated by the 7.13 0310mutant compared to wild-type H. pylori strain 7.13. By utilizing proteomics technology to contrast two closely related H. pylori strains that induce distinct phenotypes, we have shown that HP0310 may function to alter levels of peptidoglycan, thereby affecting the composition of substrates translocated by the cag secretion system. These studies also provide an important foundation for investigating the role of bacterial virulence factors in H. pylori-induced pathologic sequelae, as such results would ultimately allow for generation of a profile of H. pylori proteins to use for screening persons infected with strains most likely to induce severe disease.

Background: Use of proton-pump inhibitors in the management of peptic ulcer bleeding is controversial because discrepant results have been reported in different ethnic groups. Objective: To determine whether intravenous esomeprazole prevents recurrent peptic ulcer bleeding better than placebo in a multi-ethnic patient sample. Design: Randomized trial conducted between October 2005 and December 2007; patients, providers, and researchers were blinded to group assignment. Setting: 91 hospital emergency departments in 16 countries. Patients: Patients 18 years or older with peptic ulcer bleeding from a single gastric or duodenal ulcer showing high-risk stigmata. Intervention: Intravenous esomeprazole bolus, 80 mg, followed by 8-mg/h infusion, over 72 hours or matching placebo, each given after successful endoscopic hemostasis. Intervention was allocated by computer-generated randomization. After infusion, both groups received oral esomeprazole, 40 mg/d, for 27 days. Measurements: The primary end point was rate of clinically significant recurrent bleeding within 72 hours. Recurrent bleeding within 7 and 30 days, death, surgery, endoscopic re-treatment, blood transfusions, hospitalization, and safety were also assessed. Results: Of 767 patients randomly assigned, 764 provided data for an intention-to-treat analysis (375 esomeprazole recipients and 389 placebo recipients). Fewer patients receiving intravenous esomeprazole (22 of 375) had recurrent bleeding within 72 hours than those receiving placebo (40 of 389) (5.9% vs. 10.3%; difference, 4.4 percentage points [95% Cl, 0.6% to 8.3%]; P = 0.026). The difference in bleeding recurrence remained significant at 7 days and 30 days (P = 0.010). Esomeprazole also reduced endoscopic retreatment (6.4% vs. 11.6%; difference, 5.2 percentage points [95% Cl of difference, 1.1 percentage points to 9.2 percentage points]; P = 0.012), surgery (2.7% vs. 5.4%), and all-cause mortality rates (0.8% vs. 2.1%) more than placebo, although differences for the latter 2 comparisons were not significant. About 10% and 40% of patients in both groups reported serious and nonserious adverse events, respectively. Limitation: Endoscopic therapy was not completely standardized; some patients received epinephrine injection, thermal coagulation, or hemoclips alone, whereas others received combination therapy, but there were similar proportions with single therapy in each group. Conclusion: High-dose intravenous esomeprazole given after successful endoscopic therapy to patients with high-risk peptic ulcer bleeding reduced recurrent bleeding at 72 hours and had sustained clinical benefits for up to 30 days.

1David Geffen School of Medicine at UCLA and CURE Digestive Diseases Research Center, Los Angeles, CA, USA; 2Glasgow Royal Infirmary, Glasgow, UK; 3AstraZeneca RD 4Division of Gastroenterology, McGill University Health Center, Montreal, Canada; 5Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands; 6Medizinische Klinik und Poliklinik II, University of Leipzig, Leipzig, Germany; 7Institute of Digestive Diseases, Chinese University of Hong Kong, Shatin, Hong Kong, China

the adequacy of current screening interval. Methods: Three hundreds one medical records from the patients who underwent surgical treatment for primary GC at Korea University Ansan Hospital from January 2002 through December 2006 were reviewed retrospectively. After patients were divided into three groups according to the previous history of gastric endoscopy and the motivation for endoscopic examination based on the presence or absence of symptoms: the group I, patients with repeated endoscopy within the last 2 years (before the detection of GC) regardless of symptom (nZ12), the group II, asymptomatic patients without endoscopic screening within the last 2 years (nZ37), and the group III, symptomatic patiens without endoscopy (nZ252), the clinicopathologic characteristics of three groups were compared. Results: The proportion of early gastric cancer and the tumor size among the 3 groups were 75% vs. 68% vs. 41% (pZ0.001) and 2.7 ! 3.6 cm vs. 4.1 ! 2.5 cm vs. 5.2 ! 3.3 cm (p Z 0.012), respectively. GC in the group I and II was characterized by smaller cancer in an earlier stage. However, notable differences among the 3 gropus were not found in age, sex, tumor location and histology. Conclusion: Endoscopic screening for asymptomatic patients is useful for detecting GC at the early stage. Probably, periodic(2 years interval) endoscopy enables early detection of GC at a smaller size regardless of symptom.

Esomeprazole 20 mg administered as a 30-minute infusion provides a similar level of acid control as oral administration in healthy subjects