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[PMID]: 29524805
[Au] Autor:Roh HF; Kim JM
[Ad] Address:Department of Biomedical Science, Hanyang University College of Medicine and Graduate School of Biomedical Science and Engineering, Seoul, South Korea. Electronic address: frank@ngene.org.
[Ti] Title:Noninvasive pulmonary arterial pressure estimation using a logistic-based systolic model.
[So] Source:Comput Biol Med;95:209-216, 2018 Feb 24.
[Is] ISSN:1879-0534
[Cp] Country of publication:United States
[La] Language:eng
[Ab] Abstract:RATIONALE: A hemodynamic relationship of pulmonary artery pressure (PAP) to pulmonary acceleration time (PAcT) has not yet been explicitly presented. OBJECTIVE: We employed a logistic-based systolic model with a subtle modification for pulmonary circulation and provided a logical ground for the relationship between systolic PAP and PAcT using transthoracic echocardiography. Additionally, the logistic-based PAP estimation equation was deduced from the model to relate systolic PAP and PAcT. METHODS AND RESULTS: This equation was statistically tested in comparison to existing PAP estimation equations. Results showed that the logistic-based PAP estimation equation was at least as accurate as previous equations with respect to previously published mean PAP versus PAcT values. After the subtle pulmonary modification of the model, the pulmonary blood flow velocity and pressure not only well reflected the underlying pulmonary circulation physiology, but could also be presented in harmony with systemic circulation physiology. CONCLUSIONS: A future clinical study with actual systolic PAP versus PAcT measurements is needed to test the application of the logistic-based PAP estimation equation.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1803
[Cu] Class update date: 180310
[Lr] Last revision date:180310
[St] Status:Publisher

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[PMID]: 29524562
[Au] Autor:Zera T; Przybylski J; Grygorowicz T; Kasarello K; Podobinska M; Mirowska-Guzel D; Cudnoch-Jedrzejewska A
[Ad] Address:Department of Experimental and Clinical Physiology, Laboratory of Centre for Preclinical Research, the Medical University of Warsaw, Banacha 1B, 02-097 Warsaw, Poland. Electronic address: tzera@wum.edu.pl.
[Ti] Title:Vasopressin V1a receptors are present in the carotid body and contribute to the control of breathing in male Sprague-Dawley rats.
[So] Source:Peptides;, 2018 Mar 07.
[Is] ISSN:1873-5169
[Cp] Country of publication:United States
[La] Language:eng
[Ab] Abstract:Vasopressin (AVP) maintains body homeostasis by regulating water balance, cardiovascular system and stress response. AVP inhibits breathing through central vasopressin 1a receptors (V1aRs). Chemoreceptors within carotid bodies (CBs) detect chemical and hormonal signals in the bloodstream and provide sensory input to respiratory and cardiovascular centers of the brainstem. In the study we investigated if CBs contain V1aRs and how the receptors are involved in the regulation of ventilation by AVP. We first immunostained CBs for V1aRs and tyrosine hydroxylase, a marker of chemoreceptor type I (glomus) cells. In urethane-anesthetized adult Sprague-Dawley male rats, we then measured hemodynamic and respiratory responses to systemic (intravenous) or local (carotid artery) administration of AVP prior and after systemic blockade of V1aRs. Immunostaining of CBs showed colocalization of V1aRs and tyrosine hydroxylase within glomus cells. Systemic administration of AVP increased mean arterial blood pressure (MABP) and decreased respiratory rate (RR) and minute ventilation (MV). Local administration of AVP increased MV and RR without significant changes in MABP or heart rate. Pretreatment with V1aR antagonist abolished responses to local and intravenous AVP administration. Our findings show that chemosensory cells within CBs express V1aRs and that local stimulation of the CB with AVP increases ventilation, which is contrary to systemic effects of AVP manifested by decreased ventilation. The responses are mediated by V1aRs, as blockade of the receptors prevents changes in ventilation. We hypothesize that excitatory effects of AVP within the CB provide a counterbalancing mechanism for the inhibitory effects of systemically acting AVP on the respiration.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1803
[Cu] Class update date: 180310
[Lr] Last revision date:180310
[St] Status:Publisher

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[PMID]: 29524483
[Au] Autor:Chen L; Li Y; Zhang F; Zhang S; Zhou X; Ji L
[Ad] Address:Department of Endocrinology and Metabolism, Peking University People's Hospital, the 11th south street, Xicheng, Beijing, China. Electronic address: chenling19841227@163.com.
[Ti] Title:Elevated serum ferritin concentration is associated with incident type 2 diabetes mellitus in a Chinese population: A prospective cohort study.
[So] Source:Diabetes Res Clin Pract;, 2018 Mar 07.
[Is] ISSN:1872-8227
[Cp] Country of publication:Ireland
[La] Language:eng
[Ab] Abstract:AIMS: We aimed to evaluate the association between serum ferritin levels and incident type 2 diabetes mellitus risk in a Chinese population. METHODS: This cohort study assessed 2,225 Chinese individuals aged 25-75 years. Diabetes mellitus was diagnosed using the 1999 World Health Organization definition with a median follow-up period of 20 months. Cox proportional hazard models were used to estimate adjusted hazard ratios and 95% confidence intervals (CI) for incident diabetes when serum ferritin concentrations increased by one standard deviation. RESULTS: During the follow-up period, 112 cases (62 men and 50 women) of type 2 diabetes mellitus were identified. Baseline serum ferritin levels were higher in the diabetes than the non-diabetes group. After adjusting for age, body mass index, waist circumference, mean arterial pressure, fasting plasma glucose, fasting insulin, hemoglobin A1c, total cholesterol, high-density lipoprotein cholesterol, alanine transaminase and triglyceride levels, family history of diabetes mellitus, pork meat consumption, neutrophil/lymphocyte ratio, education, and annual household income, the hazard ratios for incident diabetes corresponding to one standard deviation increase in serum ferritin levels were 1.17 (95% CI 1.03, 1.34), 1.20 (95% CI 1.003, 1.43), and 1.03 (95% CI 0.82, 1.31) for the total population, men, and women, respectively. CONCLUSIONS: High serum ferritin levels were associated with a higher risk of incident type 2 diabetes mellitus independent of traditional risk factors in the total population and men.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1803
[Cu] Class update date: 180310
[Lr] Last revision date:180310
[St] Status:Publisher

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[PMID]: 29524482
[Au] Autor:Osman MW; Nath M; Khalil A; Webb DR; Robinson TG; Mousa HA
[Ad] Address:University Hospitals of Leicester. Electronic address: mwo3@le.ac.uk.
[Ti] Title:The effects of metformin on maternal haemodynamics in gestational diabetes mellitus: A pilot study.
[So] Source:Diabetes Res Clin Pract;, 2018 Mar 07.
[Is] ISSN:1872-8227
[Cp] Country of publication:Ireland
[La] Language:eng
[Ab] Abstract:BACKGROUND: Gestational diabetes mellitus (GDM) is a major clinical challenge and is likely to remain so as the incidence of GDM continues to increase AIM: To assess longitudinal changes in maternal haemodynamics amongst women diagnosed with GDM requiring either metformin or dietary intervention in comparison to low-risk healthy controls. METHODOLOGY: Fifty-six pregnant women attending their first appointment at the GDM clinic and 60 low-risk healthy pregnant controls attending their routine antenatal clinics were recruited and assigned to three groups: GDM Metformin (GDM-M), GDM Diet (GDM-D) and Control. Non-invasive assessment of maternal haemodynamics, using recognised measures of arterial stiffness and central blood pressure (Arteriograph®), were undertaken under controlled conditions within four gestational windows: antenatal; AN1 (26-28 weeks), AN2 (32-34 weeks) and AN3 (37-40 weeks), and postnatal (PN) (6-8 weeks after delivery). Data were analysed using a linear mixed model incorporating gestational age and other relevant predictors, including age, blood pressure (BP), baseline bodyweight and pulse as fixed effects, and patient as a random effect. RESULTS: Fitted linear mixed models showed evidence of a two-way interaction effect between groups (GDM-D, GDM-M and Control) and stages of gestation (AN1, AN2, AN3 and PN) for maternal haemodynamic parameters: brachial artery augmentation index (AIx) (p=0.004), aortic AIx (p=0.008), and central systolic BP (p=0.001). However, differences in respect of aortic pulse wave velocity (p=0.001) and heart rate (p<0.001) were only significant for gestational stage. At AN2, we did not observe any evidence that the mean brachial Aix in the GDM-M was different from the control group (p=0.158). CONCLUSION: AIx and central systolic BP measures of arterial stiffness are adversely affected by GDM in comparison to controls during pregnancy. The possible beneficial effects of metformin therapy seen at 32 to 34 weeks of gestation require further exploration.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1803
[Cu] Class update date: 180310
[Lr] Last revision date:180310
[St] Status:Publisher

  5 / 365587 MEDLINE  
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[PMID]: 29515645
[Au] Autor:Bini R; Chiara O; Cimbanassi S; Olivero G; Trombetta A; Cotogni P
[Ad] Address:1Department of Surgery, S. Giovanni Bosco Hospital, Turin, Italy.
[Ti] Title:Evaluation of capillary leakage after vasopressin resuscitation in a hemorrhagic shock model.
[So] Source:World J Emerg Surg;13:11, 2018.
[Is] ISSN:1749-7922
[Cp] Country of publication:England
[La] Language:eng
[Ab] Abstract:Background: Hemorrhagic shock (HS) is a major threat to patients with trauma and spontaneous bleeding. The aim of the study was to investigate early effects of vasopressin on metabolic and hemodynamic parameters and endothelium permeability by measuring capillary leakage compared to those of other resuscitation strategies in a HS model. Methods: Forty-five Sprague-Dawley rats were randomized into five groups: S group ( = 5), sham-operated rats without shock or resuscitation; HS group ( = 10), HS and no resuscitation; RL group ( = 10), HS and resuscitation with Ringer's lactate (RL); RLB group ( = 10), HS and resuscitation with two-third shed blood plus RL; and vasopressin group ( = 10), HS and resuscitation with RL, followed by continuous infusion of 0.04 U/kg/min vasopressin. The effects of resuscitation on hemodynamic parameters [mean arterial pressure (MAP), superior mesenteric artery blood flow (MBF), and mesenteric vascular resistances (MVR)], arterial blood gases, bicarbonate, base deficit, and lactate levels as well as on capillary leakage in the lung, ileum, and kidney were investigated. Capillary leakage was evaluated with Evans blue dye extravasation. Results: In the vasopressin group, the MAP was higher than in the RL and RLB groups ( < 0.001), while MBF was decreased ( < 0.001). MVR were increased only in the vasopressin group ( < 0.001). Capillary leakage was increased in the lungs of the animals in the vasopressin group compared to that in the lungs of animals in the RLB group ( < 0.05); this increase was associated with the lowest partial pressure of oxygen ( < 0.05). Conversely, decreased capillary leakage was observed with vasopressin in the ileum ( < 0.05). Increased capillary leakage was observed in the kidney in the RLB and vasopressin groups ( < 0.05). Lastly, vasopressin use was associated with higher base deficit and lactate levels when compared to the RL and RLB groups ( < 0.001). Conclusion: Although vasopressin was proposed as a vasoactive drug for provisional hemodynamic optimization in the early phase of HS resuscitation, the overall findings of this experimental study focus on the possible critical side effects of vasopressin on metabolic parameters and endothelium permeability.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1803
[Cu] Class update date: 180311
[Lr] Last revision date:180311
[St] Status:In-Data-Review
[do] DOI:10.1186/s13017-018-0172-7

  6 / 365587 MEDLINE  
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[PMID]: 29511676
[Au] Autor:Rai N; Veeroju S; Schymura Y; Janssen W; Wietelmann A; Kojonazarov B; Weissmann N; Stasch JP; Ghofrani HA; Seeger W; Schermuly RT; Novoyatleva T
[Ad] Address:Universities of Giessen and Marburg Lung Centre (UGMLC), Aulweg 130, 35392 Giessen, Germany.
[Ti] Title:Effect of Riociguat and Sildenafil on Right Heart Remodeling and Function in Pressure Overload Induced Model of Pulmonary Arterial Banding.
[So] Source:Biomed Res Int;2018:3293584, 2018.
[Is] ISSN:2314-6141
[Cp] Country of publication:United States
[La] Language:eng
[Ab] Abstract:Pulmonary arterial hypertension (PAH) is a progressive disorder characterized by remodeling of the pulmonary vasculature and a rise in right ventricular (RV) afterload. The increased RV afterload leads to right ventricular failure (RVF) which is the reason for the high morbidity and mortality in PAH patients. The objective was to evaluate the therapeutic efficacy and antiremodeling potential of the phosphodiesterase type 5 (PDE5) inhibitor sildenafil and the soluble guanylate cyclase stimulator riociguat in a model of pressure overload RV hypertrophy induced by pulmonary artery banding (PAB). Mice subjected to PAB, one week after surgery, were treated with either sildenafil (100 mg/kg/d, = 5), riociguat (30 mg/kg/d, = 5), or vehicle ( = 5) for 14 days. RV function and remodeling were assessed by right heart catheterization, magnetic resonance imaging (MRI), and histomorphometry. Both sildenafil and riociguat prevented the deterioration of RV function, as determined by a decrease in RV dilation and restoration of the RV ejection fraction (EF). Although both compounds did not decrease right heart mass and cellular hypertrophy, riociguat prevented RV fibrosis induced by PAB. Both compounds diminished TGF-beta1 induced collagen synthesis of RV cardiac fibroblasts . Treatment with either riociguat or sildenafil prevented the progression of pressure overload-induced RVF, representing a novel therapeutic approach.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1803
[Cu] Class update date: 180311
[Lr] Last revision date:180311
[St] Status:In-Process
[do] DOI:10.1155/2018/3293584

  7 / 365587 MEDLINE  
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[PMID]: 29485979
[Au] Autor:Ni X; Zhang L; Peng M; Shen TW; Yu XS; Shan LY; Li L; Si JQ; Li XZ; Ma KT
[Ad] Address:Department of Physiology, Medical College of Shihezi University, Shihezi, Xinjiang, China (mainland).
[Ti] Title:Hydrogen Sulfide Attenuates Hypertensive Inflammation via Regulating Connexin Expression in Spontaneously Hypertensive Rats.
[So] Source:Med Sci Monit;24:1205-1218, 2018 Feb 27.
[Is] ISSN:1643-3750
[Cp] Country of publication:United States
[La] Language:eng
[Ab] Abstract:BACKGROUND Hydrogen sulfide (H2S) has anti-inflammatory and anti-hypertensive effects, and connexins (Cxs) are involved in regulation of immune homeostasis. In this study, we explored whether exogenous H2S prevents hypertensive inflammation by regulating Cxs expression of T lymphocytes in spontaneously hypertensive rats (SHR). MATERIAL AND METHODS We treated SHR with sodium hydrosulfide (NaHS) for 9 weeks. Vehicle-treated Wistar-Kyoto rats (WKYs) were used as a control. The arterial pressure was monitored by the tail-cuff method, and vascular function in basilar arteries was examined by pressure myography. Hematoxylin and eosin staining was used to show vascular remodeling and renal injury. The percentage of T cell subtypes in peripheral blood, surface expressions of Cx40/Cx43 on T cell subtypes, and serum cytokines level were determined by flow cytometry or ELISA. Expression of Cx40/Cx43 proteins in peripheral blood lymphocytes was analyzed by Western blot. RESULTS Chronic NaHS treatment significantly attenuated blood pressure elevation, and inhibited inflammation of target organs, vascular remodeling, and renal injury in SHR. Exogenous NaHS also improved vascular function by attenuating KCl-stimulated vasoconstrictor response in basilar arteries of SHR. In addition, chronic NaHS administration significantly suppressed inflammation of peripheral blood in SHR, as evidenced by the decreased serum levels of IL-2, IL-6, and CD4/CD8 ratio and the increased IL-10 level and percentage of regulatory T cells. NaHS treatment decreased hypertension-induced Cx40/Cx43 expressions in T lymphocytes from SHR. CONCLUSIONS Our data demonstrate that H2S reduces hypertensive inflammation, at least partly due to regulation of T cell subsets balance by Cx40/Cx43 expressions inhibition.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1802
[Cu] Class update date: 180311
[Lr] Last revision date:180311
[St] Status:In-Process

  8 / 365587 MEDLINE  
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[PMID]: 29408444
[Au] Autor:Kim K; Hurr C; Patik JC; Matthew Brothers R
[Ad] Address:Department of Pathology, The University of Alabama at Birmingham, United States.
[Ti] Title:Attenuated cutaneous microvascular function in healthy young African Americans: Role of intradermal l-arginine supplementation.
[So] Source:Microvasc Res;118:1-6, 2018 Feb 03.
[Is] ISSN:1095-9319
[Cp] Country of publication:United States
[La] Language:eng
[Ab] Abstract:It has been established that endothelial function in conduit vessels is reduced in young African Americans (AA) relative to Caucasian Americans (CA). However, less is known regarding endothelial function in microvasculature of young AA. We hypothesized that microvascular function in response to local heating of skin is attenuated in young AA relative to age-matched CA due largely to the lack of NO bioavailability, which is in turn improved by intradermal l-arginine supplementation and/or inhibition of arginase. Nine AA and nine CA adults participated in this study. Participants were instrumented with four microdialysis membranes in the cutaneous vasculature of one forearm and were randomly assigned to receive 1) lactated Ringer's solution as a control site; 2) 20 mM NG-nitro-l-arginine (l-NAME) to inhibit NO synthase activity; 3) 10 mM l-arginine to local supplement l-arginine; or 4) a combination of 5.0 mM (S)-(2­boronoethyl)-l-cysteine-HCL (BEC) and 5.0 mM Nω-hydroxy-nor-l-arginine (nor-NOHA) at a rate of 2.0 µl/min to locally inhibit arginase activity. Cutaneous vascular conductance (CVC) was calculated as red blood cell flux divided by mean arterial pressure. All CVC data were presented as a percentage of maximal CVC (%CVCmax) that was determined by maximal cutaneous vasodilation induced by 44 °C heating plus sodium nitroprusside administration. The response during the 42 °C local heating plateau was blunted in the AA at the control site (CA: 84 ±â€¯12 vs. AA: 62 ±â€¯6 vs. %CVCmax; P < 0.001). This response was improved in AA at the l-arginine site (Control: 62 ±â€¯6 vs. l-arginine: 70 ±â€¯18%CVCmax; P < 0.05) but not in the arginase inhibited site (Control: 62 ±â€¯6 vs. Arginase inhibited: 62 ±â€¯13%CVCmax; P = 0.91). In addition, the AA group had an attenuated NO contribution to the plateau phase during 42 °C local heating relative to the CA group (CA: 56 ±â€¯14 vs. AA: 44 ±â€¯6 Δ %CVCmax; P < 0.001). These findings suggest that 1) cutaneous microvascular function in response to local heating is blunted in young AA when compared to age-matched young CA; 2) this attenuated response is partly related to decrease in NO bioavailability in young AA; and 3) a local infusion of l-arginine, but not arginase inhibition, improves cutaneous microvascular responses to local heating in young AA relative to CA.
[Pt] Publication type:JOURNAL ARTICLE
[Em] Entry month:1802
[Cu] Class update date: 180310
[Lr] Last revision date:180310
[St] Status:Publisher

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[PMID]: 29340680
[Au] Autor:Jakobsen GS; Småstuen MC; Sandbu R; Nordstrand N; Hofsø D; Lindberg M; Hertel JK; Hjelmesæth J
[Ad] Address:Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.
[Ti] Title:Association of Bariatric Surgery vs Medical Obesity Treatment With Long-term Medical Complications and Obesity-Related Comorbidities.
[So] Source:JAMA;319(3):291-301, 2018 01 16.
[Is] ISSN:1538-3598
[Cp] Country of publication:United States
[La] Language:eng
[Ab] Abstract:Importance: The association of bariatric surgery and specialized medical obesity treatment with beneficial and detrimental outcomes remains uncertain. Objective: To compare changes in obesity-related comorbidities in patients with severe obesity (body mass index ≥40 or ≥35 and at least 1 comorbidity) undergoing bariatric surgery or specialized medical treatment. Design, Setting, and Participants: Cohort study with baseline data of exposures from November 2005 through July 2010 and follow-up data from 2006 until death or through December 2015 at a tertiary care outpatient center, Vestfold Hospital Trust, Norway. Consecutive treatment-seeking adult patients (n = 2109) with severe obesity assessed (221 patients excluded and 1888 patients included). Exposures: Bariatric surgery (n = 932, 92% gastric bypass) or specialized medical treatment (n = 956) including individual or group-based lifestyle intervention programs. Main Outcomes and Measures: Primary outcomes included remission and new onset of hypertension based on drugs dispensed according to the Norwegian Prescription Database. Prespecified secondary outcomes included changes in comorbidities. Adverse events included complications retrieved from the Norwegian Patient Registry and a local laboratory database. Results: Among 1888 patients included in the study, the mean (SD) age was 43.5 (12.3) years (1249 women [66%]; mean [SD] baseline BMI, 44.2 [6.1]; 100% completed follow-up at a median of 6.5 years [range, 0.2-10.1]). Surgically treated patients had a greater likelihood of remission and lesser likelihood for new onset of hypertension (remission: absolute risk [AR], 31.9% vs 12.4%); risk difference [RD], 19.5% [95% CI, 15.8%-23.2%], relative risk [RR], 2.1 [95% CI, 2.0-2.2]; new onset: AR, 3.5% vs 12.2%, RD, 8.7% [95% CI, 6.7%-10.7%], RR, 0.4 [95% CI, 0.3-0.5]; greater likelihood of diabetes remission: AR, 57.5% vs 14.8%; RD, 42.7% [95% CI, 35.8%-49.7%], RR, 3.9 [95% CI, 2.8-5.4]; greater risk of new-onset depression: AR, 8.9% vs 6.5%; RD, 2.4% [95% CI, 1.3%-3.5%], RR, 1.5 [95% CI, 1.4-1.7]; and treatment with opioids: AR, 19.4% vs 15.8%, RD, 3.6% [95% CI, 2.3%-4.9%], RR, 1.3 [95% CI, 1.2-1.4]). Surgical patients had a greater risk for undergoing at least 1 additional gastrointestinal surgical procedure (AR, 31.3% vs 15.5%; RD, 15.8% [95% CI, 13.1%-18.5%]; RR, 2.0 [95% CI, 1.7-2.4]). The proportion of patients with low ferritin levels was significantly greater in the surgical group (26% vs 12%, P < .001). Conclusions and Relevance: Among patients with severe obesity followed up for a median of 6.5 years, bariatric surgery compared with medical treatment was associated with a clinically important increased risk for complications, as well as lower risks of obesity-related comorbidities. The risk for complications should be considered in the decision-making process.
[Mh] MeSH terms primary: Bariatric Surgery
Obesity, Morbid/complications
[Mh] MeSH terms secundary: Adult
Bariatric Surgery/adverse effects
Body Mass Index
Cohort Studies
Comorbidity
Depression/complications
Diabetes Mellitus, Type 2/complications
Female
Ferritins/blood
Humans
Hypertension/complications
Male
Middle Aged
Obesity, Morbid/drug therapy
Obesity, Morbid/surgery
Remission Induction
Treatment Outcome
[Pt] Publication type:COMPARATIVE STUDY; JOURNAL ARTICLE
[Nm] Name of substance:9007-73-2 (Ferritins)
[Em] Entry month:1801
[Cu] Class update date: 180311
[Lr] Last revision date:180311
[Js] Journal subset:AIM; IM
[Da] Date of entry for processing:180118
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.21055

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[PMID]: 29340676
[Au] Autor:Salminen P; Helmiö M; Ovaska J; Juuti A; Leivonen M; Peromaa-Haavisto P; Hurme S; Soinio M; Nuutila P; Victorzon M
[Ad] Address:Division of Digestive Surgery and Urology, Turku University Hospital, Turku, Finland.
[Ti] Title:Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss at 5 Years Among Patients With Morbid Obesity: The SLEEVEPASS Randomized Clinical Trial.
[So] Source:JAMA;319(3):241-254, 2018 01 16.
[Is] ISSN:1538-3598
[Cp] Country of publication:United States
[La] Language:eng
[Ab] Abstract:Importance: Laparoscopic sleeve gastrectomy for treatment of morbid obesity has increased substantially despite the lack of long-term results compared with laparoscopic Roux-en-Y gastric bypass. Objective: To determine whether laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass are equivalent for weight loss at 5 years in patients with morbid obesity. Design, Setting, and Participants: The Sleeve vs Bypass (SLEEVEPASS) multicenter, multisurgeon, open-label, randomized clinical equivalence trial was conducted from March 2008 until June 2010 in Finland. The trial enrolled 240 morbidly obese patients aged 18 to 60 years, who were randomly assigned to sleeve gastrectomy or gastric bypass with a 5-year follow-up period (last follow-up, October 14, 2015). Interventions: Laparoscopic sleeve gastrectomy (n = 121) or laparoscopic Roux-en-Y gastric bypass (n = 119). Main Outcomes and Measures: The primary end point was weight loss evaluated by percentage excess weight loss. Prespecified equivalence margins for the clinical significance of weight loss differences between gastric bypass and sleeve gastrectomy were -9% to +9% excess weight loss. Secondary end points included resolution of comorbidities, improvement of quality of life (QOL), all adverse events (overall morbidity), and mortality. Results: Among 240 patients randomized (mean age, 48 [SD, 9] years; mean baseline body mass index, 45.9, [SD, 6.0]; 69.6% women), 80.4% completed the 5-year follow-up. At baseline, 42.1% had type 2 diabetes, 34.6% dyslipidemia, and 70.8% hypertension. The estimated mean percentage excess weight loss at 5 years was 49% (95% CI, 45%-52%) after sleeve gastrectomy and 57% (95% CI, 53%-61%) after gastric bypass (difference, 8.2 percentage units [95% CI, 3.2%-13.2%], higher in the gastric bypass group) and did not meet criteria for equivalence. Complete or partial remission of type 2 diabetes was seen in 37% (n = 15/41) after sleeve gastrectomy and in 45% (n = 18/40) after gastric bypass (P > .99). Medication for dyslipidemia was discontinued in 47% (n = 14/30) after sleeve gastrectomy and 60% (n = 24/40) after gastric bypass (P = .15) and for hypertension in 29% (n = 20/68) and 51% (n = 37/73) (P = .02), respectively. There was no statistically significant difference in QOL between groups (P = .85) and no treatment-related mortality. At 5 years the overall morbidity rate was 19% (n = 23) for sleeve gastrectomy and 26% (n = 31) for gastric bypass (P = .19). Conclusions and Relevance: Among patients with morbid obesity, use of laparoscopic sleeve gastrectomy compared with use of laparoscopic Roux-en-Y gastric bypass did not meet criteria for equivalence in terms of percentage excess weight loss at 5 years. Although gastric bypass compared with sleeve gastrectomy was associated with greater percentage excess weight loss at 5 years, the difference was not statistically significant, based on the prespecified equivalence margins. Trial Registration: clinicaltrials.gov Identifier: NCT00793143.
[Mh] MeSH terms primary: Gastrectomy
Gastric Bypass
Laparoscopy
Obesity, Morbid/surgery
Weight Loss
[Mh] MeSH terms secundary: Adolescent
Adult
Diabetes Mellitus, Type 2/complications
Female
Follow-Up Studies
Gastrectomy/adverse effects
Gastrectomy/methods
Gastric Bypass/adverse effects
Gastric Bypass/methods
Humans
Hyperlipidemias/complications
Hypertension/complications
Male
Middle Aged
Obesity, Morbid/complications
Obesity, Morbid/physiopathology
Postoperative Complications
Quality of Life
Treatment Outcome
Young Adult
[Pt] Publication type:COMPARATIVE STUDY; EQUIVALENCE TRIAL; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Em] Entry month:1801
[Cu] Class update date: 180311
[Lr] Last revision date:180311
[Js] Journal subset:AIM; IM
[Da] Date of entry for processing:180118
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.20313


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