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      Comparison of Outcomes in Patients with Obesity Between Two Administration Routes of Omeprazole After Laparoscopic Sleeve Gastrectomy: An Open-Label Randomized Clinical Trial

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          Abstract

          Background

          The effect of different administration routes of omeprazole remains unclear on the recovery in patients with obesity after laparoscopic sleeve gastrectomy (LSG).

          Methods

          We designed a randomized clinical trial enrolling 120 patients with a BMI≥32.5 kg/m 2 after LSG. They were randomized into two groups to be administered with omeprazole by rapid intravenous injection (group A) or by continuous micropump infusion (group B). The plasma concentration of omeprazole was monitored upon initiating administration. Change in intragastric pH and gastrointestinal symptoms during follow-up served as indicators for therapeutic evaluation.

          Results

          Patients in the two groups showed no difference in the AUC curves (P=0.25), but group A had significantly higher peak concentration (P<0.001), and shorter time to reach peak concentration after administration (P<0.001), compared to group B. Before and after the administration of omeprazole, the average change in intragastric pH was much lower in group A (0.031 ± 0.61) than in group B (0.48 ± 0.74) (P=0.004). The incidence of gastrointestinal symptoms was similar between the two groups (P=0.85); however, the average duration of remaining symptoms was longer in group A (3.97 months; 95% CI, 2.90–5.04) than in group B (2.82 months; 95% CI, 2.01–3.63) (P=0.04).

          Conclusion

          Continuous micropump infusion of omeprazole may improve the outcomes in patients with obesity after LSG.

          Trial registration

          China Clinical Trial Registration Center (ChiCTR), ChiCTR-IPR-17013365. Registered 13 November 2017. http://www.chictr.org.cn/showproj.aspx?proj=22892 .

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          Most cited references 27

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          Global, regional, and national prevalence of overweight and obesity in children and adults during 1980-2013: a systematic analysis for the Global Burden of Disease Study 2013.

          In 2010, overweight and obesity were estimated to cause 3·4 million deaths, 3·9% of years of life lost, and 3·8% of disability-adjusted life-years (DALYs) worldwide. The rise in obesity has led to widespread calls for regular monitoring of changes in overweight and obesity prevalence in all populations. Comparable, up-to-date information about levels and trends is essential to quantify population health effects and to prompt decision makers to prioritise action. We estimate the global, regional, and national prevalence of overweight and obesity in children and adults during 1980-2013. We systematically identified surveys, reports, and published studies (n=1769) that included data for height and weight, both through physical measurements and self-reports. We used mixed effects linear regression to correct for bias in self-reports. We obtained data for prevalence of obesity and overweight by age, sex, country, and year (n=19,244) with a spatiotemporal Gaussian process regression model to estimate prevalence with 95% uncertainty intervals (UIs). Worldwide, the proportion of adults with a body-mass index (BMI) of 25 kg/m(2) or greater increased between 1980 and 2013 from 28·8% (95% UI 28·4-29·3) to 36·9% (36·3-37·4) in men, and from 29·8% (29·3-30·2) to 38·0% (37·5-38·5) in women. Prevalence has increased substantially in children and adolescents in developed countries; 23·8% (22·9-24·7) of boys and 22·6% (21·7-23·6) of girls were overweight or obese in 2013. The prevalence of overweight and obesity has also increased in children and adolescents in developing countries, from 8·1% (7·7-8·6) to 12·9% (12·3-13·5) in 2013 for boys and from 8·4% (8·1-8·8) to 13·4% (13·0-13·9) in girls. In adults, estimated prevalence of obesity exceeded 50% in men in Tonga and in women in Kuwait, Kiribati, Federated States of Micronesia, Libya, Qatar, Tonga, and Samoa. Since 2006, the increase in adult obesity in developed countries has slowed down. Because of the established health risks and substantial increases in prevalence, obesity has become a major global health challenge. Not only is obesity increasing, but no national success stories have been reported in the past 33 years. Urgent global action and leadership is needed to help countries to more effectively intervene. Bill & Melinda Gates Foundation. Copyright © 2014 Elsevier Ltd. All rights reserved.
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            Effect of obesity on the pharmacokinetics of drugs in humans.

            The prevalence of obesity has dramatically increased in recent years and now includes a significant proportion of the world's children, adolescents and adults. Obesity is linked to a number of co-morbidities, the most prominent being type 2 diabetes mellitus. While many agents are available to treat these conditions, the current knowledge regarding their disposition in the obese remains limited. Over the years, both direct and indirect methodologies have been utilized to assess body composition. Commonly used direct measures include underwater weighing, skinfold measurement, bioelectrical impedance analysis and dual-energy x-ray absorptiometry. Unfortunately, these methods are not readily available to the majority of clinicians. As a result, a number of indirect measures to assess body composition have been developed. Indirect measures rely on patient attributes such as height, bodyweight and sex. These size metrics are often utilized clinically and include body mass index (BMI), body surface area (BSA), ideal bodyweight (IBW), percent IBW, adjusted bodyweight, lean bodyweight (LBW) and predicted normal weight (PNWT). An understanding of how the volume of distribution (V(d)) of a drug changes in the obese is critical, as this parameter determines loading-dose selection. The V(d) of a drug is dependent upon its physiochemical properties, the degree of plasma protein binding and tissue blood flow. Obesity does not appear to have an impact on drug binding to albumin; however, data regarding alpha(1)-acid glycoprotein binding have been contradictory. A reduction in tissue blood flow and alterations in cardiac structure and function have been noted in obese individuals. At the present time, a universal size descriptor to describe the V(d) of all drugs in obese and lean individuals does not exist. Drug clearance (CL) is the primary determinant to consider when designing a maintenance dose regimen. CL is largely controlled by hepatic and renal physiology. In the obese, increases in cytochrome P450 2E1 activity and phase II conjugation activity have been observed. The effects of obesity on renal tubular secretion, tubular reabsorption, and glomerular filtration have not been fully elucidated. As with the V(d), a single, well validated size metric to characterize drug CL in the obese does not currently exist. Therefore, clinicians should apply a weight-normalized maintenance dose, using a size descriptor that corrects for differences in absolute CL between obese and non-obese individuals. The elimination half-life (t((1/2))) of a drug depends on both the V(d) and CL. Since the V(d) and CL are biologically independent entities, changes in the t((1/2)) of a drug in obese individuals can reflect changes in the V(d), the CL, or both. This review also examines recent publications that investigated the disposition of several classes of drugs in the obese--antibacterials, anticoagulants, antidiabetics, anticancer agents and neuromuscular blockers. In conclusion, pharmacokinetic data in obese patients do not exist for the majority of drugs. In situations where such information is available, clinicians should design treatment regimens that account for any significant differences in the CL and V(d) in the obese.
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              Long-term results of laparoscopic sleeve gastrectomy for obesity.

              To determine the mid- and long-term efficacy and possible side effects of laparoscopic sleeve gastrectomy as treatment for morbid obesity. Laparoscopic sleeve gastrectomy is still controversial as single and final treatment for morbid obesity. Some favorable short-term results have been published, however long-term results are still lacking. In the period between November 2001 and October 2002, 53 consecutive morbidly obese patients who, according to our personal algorithm, were qualified for restrictive surgery were selected for laparoscopic sleeve gastrectomy. Of the 53 patients, 11 received an additional malabsorptive procedure at a later stage because of weight regain. The percentage of excess weight loss (EWL) was assessed at 3 and 6 years postoperatively. A retrospective review of a prospectively collected database was performed for evaluation after 3 years. Recently, after the sixth postoperative year, patients were again contacted and invited to fill out a questionnaire. Full cooperation was obtained in 41 patients, a response rate of 78%. Although after 3 years a mean EWL of 72.8% was documented, after 6 years EWL had dropped to 57.3%, which according to the Reinhold criteria is still satisfactory. These results included 11 patients who had benefited from an additional malabsorptive procedure (duodenal switch) and 2 patients who underwent a "resleeve" between the third and sixth postoperative year. Analyzing the results of the subgroup of 30 patients receiving only sleeve gastrectomy, we found a 3-year %EWL of 77.5% and 6+ year %EWL of 53.3%. The differences between the third and sixth postoperative year were statistically significant in both groups. Concerning long-term quality of life patient acceptance stayed good after 6 + years despite the fact that late, new gastro-esophageal reflux complaints appeared in 21% of patients. In this long-term report of laparoscopic sleeve gastrectomy, it appears that after 6+ years the mean excess weight loss exceeds 50%. However, weight regain and de novo gastroesophageal reflux symptoms appear between the third and the sixth postoperative year. This unfavorable evolution might have been prevented in some patients by continued follow-up office visits beyond the third year. Patient acceptance remains good after 6+ years.
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                Author and article information

                Journal
                Drug Des Devel Ther
                Drug Des Devel Ther
                dddt
                dddt
                Drug Design, Development and Therapy
                Dove
                1177-8881
                15 April 2021
                2021
                : 15
                : 1569-1576
                Affiliations
                [1 ]Department of Critical Care, The Sixth People’s Hospital, Shanghai Jiao Tong University , Shanghai, People’s Republic of China
                [2 ]Department of General Surgery, The Sixth People’s Hospital, Shanghai Jiao Tong University , Shanghai, People’s Republic of China
                [3 ]Department of Pharmacy, The Sixth People’s Hospital, Shanghai Jiao Tong University , Shanghai, People’s Republic of China
                [4 ]Department of Epidemiology, School of Public Health, Fudan University , Shanghai, People’s Republic of China
                [5 ]National Health Commission Key Laboratory of Health Technology Assessment, Fudan University , Shanghai, People’s Republic of China
                Author notes
                Correspondence: Weifeng Huang Department of Critical Care, The Sixth People’s Hospital, Shanghai Jiao Tong University , No. 600 Yi Shan Road, Shanghai, 200233, People’s Republic of China Email breeze-huang@hotmail.com
                [*]

                These authors contributed equally to this work

                Article
                297360
                10.2147/DDDT.S297360
                8055283
                © 2021 Tan et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                Page count
                Figures: 3, Tables: 2, References: 28, Pages: 8
                Funding
                Funded by: profit sectors;
                This study did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
                Categories
                Clinical Trial Report

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