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BACKGROUND: This study aimed to compare the humoral responses to mRNA COVID-19 vaccination in people living with HIV (PWH) and HIV-negative individuals. METHODS: We included PWH with an undetectable viral load under ART and HIV-negative participants from the French nationwide ANRS COV-POPART cohort who had received two doses of vaccine as a primary vaccination. We compared humoral response between controls and PWH, stratified by CD4 cell count (<200/mm3 and ≥200/mm3 CD4 cell counts) at 1, 6, and 12 months after primary vaccination. RESULTS: A total of 1776 participants were included in this analysis, 684 PWH (99% were on ART, median CD4 counts 673 cells/mm3) and 1092 controls. At 1 month, after adjustment on age, sex, and BMI, PWH had lower seroneutralization titers than controls, and PWH with <200 CD4 cell/mm3 had lower anti-Spike SARS-CoV-2 IgG antibodies. Same results were found at 6 months. However, in participants who received a booster dose between 6 and 12 months postprimary vaccination, we did not observe differences between PWH and controls at 12 months. CONCLUSION: PWH had high responses to primary mRNA COVID-19 vaccination. In those who received a booster dose after 6 months, the humoral response at 12 months increased to similar levels to controls, even in those with low CD4 counts at baseline.
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Anticorpos Antivirais , Vacinas contra COVID-19 , COVID-19 , Infecções por HIV , Imunidade Humoral , Imunização Secundária , SARS-CoV-2 , Humanos , Masculino , Feminino , COVID-19/imunologia , COVID-19/prevenção & controle , Pessoa de Meia-Idade , Infecções por HIV/imunologia , França , Anticorpos Antivirais/sangue , SARS-CoV-2/imunologia , Vacinas contra COVID-19/imunologia , Vacinas contra COVID-19/administração & dosagem , Adulto , Contagem de Linfócito CD4 , Estudos de Coortes , Vacinação , Carga Viral , Anticorpos Neutralizantes/sangue , Anticorpos Neutralizantes/imunologia , Imunoglobulina G/sangueRESUMO
INTRODUCTION: Obesity is a chronic disease that increases cardiovascular and metabolic morbidity and mortality, decreases quality of life, and increases health care costs. While the role of lifestyle behavioral factors in the development of obesity is well established, the role of traumatic life events, including violence, is unclear. The purpose of this study was to describe situations of traumatic life events reported by patients undergoing a bariatric surgery program, with a particular focus on sexual violence and its clinical correlates. METHODS: In this cross-sectional study, patients with grade II or III obesity, admitted to our digestive surgery department for bariatric surgery from August 01, 2019, to December 31, 2020, underwent a structured interview by a trained psychologist to describe the history of traumatic life events self-reported by the patients. The primary endpoint was the presence of a history of sexual violence (SV). Multivariate logistic regressions were applied to identify independent risk factors for SV. RESULTS: Of the 408 patients interviewed, 87.1% reported at least one traumatic life event and 33.1% reported having had an SV in the past. Female gender (aOR = 7.44, 95% confidence interval: 3.85-15.73; p < 0.001) and higher body mass index (1.05, 1.02-1.08; p = 0.002) were associated with an increased risk of SV. Male gender was associated with a higher risk of difficulties including sports cessation, depression, and work-related distress. CONCLUSION: In the context of obesity, psychosocial trauma is characterized by a high frequency and several gender specificities that must be taken into account in the management of these patients.
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Cirurgia Bariátrica , Obesidade , Delitos Sexuais , Humanos , Estudos Transversais , Feminino , Masculino , Adulto , Pessoa de Meia-Idade , Obesidade/cirurgia , Obesidade/psicologia , Delitos Sexuais/psicologia , Delitos Sexuais/estatística & dados numéricos , Fatores de Risco , Índice de Massa Corporal , Violência/psicologia , Qualidade de Vida , Acontecimentos que Mudam a VidaRESUMO
BACKGROUND: Poliomyelitis is a global disabling disease affecting 12-20 million of people. Post poliomyelitis syndrome (PPS) may affect up to 80% of polio survivors: increased muscle weakness, pain, fatigue, functional decline. It relies on aging of an impaired neuro-muscular system with ongoing denervation processes. A late involvement of humoral or cellular pro-inflammatory phenomena is also suspected. AIM: To assess the dysimmune hypothesis of PPS by comparing lymphocyte subpopulations and humoral immune factors between PPS patients and controls. DESIGN: Cross-sectional study. SETTING: Montpellier University Hospital. POPULATION: Forty-seven PPS and 27 healthy controls. METHODS: PPS patients and controls were compared on their lymphocyte subpopulations and humoral immune factors (IL-1ß, IL-6, IL-8, IL-17, IL-21, IL-22, IL-23, IFN-γ, TNF-α, GM-CSF, RANTES, MCP1, MIP-3a, IL-10, TGF-ß, IL4, IL13). Patients were further compared according to their dominant clinical symptoms. Sample size guaranteed a power >90% for all comparisons. RESULTS: PPS patients and controls were comparable in gender, age and corpulence. Most patients had lower limb motor sequelae (N.=45, 95.7%), a minority had upper limb motor impairment (N.=16, 34.0%). Forty-five were able to walk (94%), 35/45 with technical aids. The median of the two-minute walking test was 110 meters (interquartile range 55; 132). Eighteen (38%) required help in their daily life. Their quality of life was low (SF36). All described an increased muscular weakness, 40 (85%) a general fatigue, and 39 (83%) muscular or joint pain. Blood count, serum electrolytes, T and B lymphocyte subpopulations and cytokines were comparable between patients and controls, except for creatine phospho kinase that was significantly higher in PPS patients. None of these variables differed between the 20/47 patients whose late main symptoms were pain or fatigue, and other patients. CONCLUSIONS: Our results suggest that PPS is not a dysimmune disease. CLINICAL REHABILITATION IMPACT: Our results do not sustain immunotherapy for PPS. Our work suggest that PPS may be mostly linked to physiological age-related phenomena in a disabled neuromuscular condition. Thus, our results emphasize the role of prevention and elimination of aggravating factors to avoid late functional worsening, and the importance of rehabilitation programs that should be adapted to patients' specific conditions.
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Poliomielite , Síndrome Pós-Poliomielite , Humanos , Estudos Transversais , Qualidade de Vida , Poliomielite/complicações , Dor , Fadiga/complicações , Debilidade Muscular/reabilitação , Fatores ImunológicosRESUMO
AIMS: To investigate the impact of glucose-lowering therapy-induced glycated haemoglobin (HbA1c) reduction on the risk of major clinical events according to body weight change and, as a secondary objective, to evaluate the impact of concomitant reductions in HbA1c and body weight on major clinical events. MATERIALS AND METHODS: We searched the MEDLINE and EMBASE databases up to June 30, 2022, for large-scale studies on glucose-lowering therapies in which more than 1000 patient-years of follow-up in each randomized group were completed. The primary outcome was all-cause mortality. The study was registered in PROSPERO (CRD42022355479). RESULTS: Thirty-four trials involving 227 220 patients with type 2 diabetes were meta-analysed using a random-effects model. Each 1% reduction in HbA1c was associated with a different risk of mortality depending on the ability of glucose-lowering therapies to induce body weight loss or gain. When glucose-lowering therapies were associated with weight gain, the risk of mortality increased by 8% (hazard ratio [HR] 1.08, 95% confidence interval [CI] 1.00-1.16) for each 1% reduction in HbA1c. When glucose-lowering therapies were associated with weight loss, the risk of mortality was reduced by 22% (HR 0.78, 95% CI 0.72-0.85) for each 1% reduction in HbA1c. In addition, concomitant reductions in HbA1c and body weight were associated with a significantly lower risk of mortality and vascular events. CONCLUSIONS: In patients with type 2 diabetes, concomitant reductions in HbA1c and body weight might be more effective in preventing the risk of vascular events and mortality.
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Doenças Cardiovasculares , Diabetes Mellitus Tipo 2 , Humanos , Hipoglicemiantes/uso terapêutico , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/induzido quimicamente , Hemoglobinas Glicadas , Glucose/uso terapêutico , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/prevenção & controle , Doenças Cardiovasculares/induzido quimicamente , Peso CorporalAssuntos
Doenças Cardiovasculares , Diabetes Mellitus Tipo 2 , Insuficiência Cardíaca , Inibidores do Transportador 2 de Sódio-Glicose , Humanos , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/tratamento farmacológico , Glucose , Insuficiência Cardíaca/tratamento farmacológico , Hospitalização , Sódio , Inibidores do Transportador 2 de Sódio-Glicose/efeitos adversos , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêuticoRESUMO
BACKGROUND: Although bariatric surgery (BS) is recommended for patients with type 2 diabetes (T2D) and moderate to severe obesity, only approximately 2% of patients undergo surgery. OBJECTIVE: To compare the knowledge and perception of BS with that of other treatments for diabetes among patients with diabetes. SETTING: French social media platforms. METHODS: A self-administered questionnaire was distributed from May 13 to June 3, 2020, via different French social media, including patients with T2D (main target), and patients with type 1 diabetes (control population). Different profiles of reluctance to BS were identified using a factorial analysis. RESULTS: Of the 4481 responders (50.4% women, 33.9% aged over 65), 60% had T2D. Of the 1736 patients who had heard of BS (38.7%), 1493 declared they never addressed it with their physician. Among T2D patients, BS is the treatment that elicits the most negative response, with more than 10% showing reluctance. Four reluctance profiles were identified: (1) cluster 1 (43.4%), fear of consequences on their eating habits and irreversibility of the procedure; (2) cluster 2 (34.9%), fear of poorer diabetes control; (3) cluster 3 (9.3%), fear of surgical risk; and (4) cluster 4 (12.4%), fear of side effects. In all clusters, the opinion of their physician would be the most important factor to change their mind. CONCLUSION: Bariatric surgery for T2D is rarely addressed in routine medical visits. Fear of operative risks and irreversibility of the procedure largely explains the reluctance to BS. Information and education campaigns on the benefit of metabolic surgery for patients with T2D remain necessary.
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Cirurgia Bariátrica , Diabetes Mellitus Tipo 2 , Obesidade Mórbida , Humanos , Feminino , Idoso , Masculino , Diabetes Mellitus Tipo 2/cirurgia , Cirurgia Bariátrica/métodos , Obesidade/cirurgia , Obesidade Mórbida/complicações , Obesidade Mórbida/cirurgia , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Weight loss trajectories after bariatric surgery vary widely between individuals, and predicting weight loss before the operation remains challenging. We aimed to develop a model using machine learning to provide individual preoperative prediction of 5-year weight loss trajectories after surgery. METHODS: In this multinational retrospective observational study we enrolled adult participants (aged ≥18 years) from ten prospective cohorts (including ABOS [NCT01129297], BAREVAL [NCT02310178], the Swedish Obese Subjects study, and a large cohort from the Dutch Obesity Clinic [Nederlandse Obesitas Kliniek]) and two randomised trials (SleevePass [NCT00793143] and SM-BOSS [NCT00356213]) in Europe, the Americas, and Asia, with a 5 year follow-up after Roux-en-Y gastric bypass, sleeve gastrectomy, or gastric band. Patients with a previous history of bariatric surgery or large delays between scheduled and actual visits were excluded. The training cohort comprised patients from two centres in France (ABOS and BAREVAL). The primary outcome was BMI at 5 years. A model was developed using least absolute shrinkage and selection operator to select variables and the classification and regression trees algorithm to build interpretable regression trees. The performances of the model were assessed through the median absolute deviation (MAD) and root mean squared error (RMSE) of BMI. FINDINGS: 10â231 patients from 12 centres in ten countries were included in the analysis, corresponding to 30â602 patient-years. Among participants in all 12 cohorts, 7701 (75·3%) were female, 2530 (24·7%) were male. Among 434 baseline attributes available in the training cohort, seven variables were selected: height, weight, intervention type, age, diabetes status, diabetes duration, and smoking status. At 5 years, across external testing cohorts the overall mean MAD BMI was 2·8 kg/m2 (95% CI 2·6-3·0) and mean RMSE BMI was 4·7 kg/m2 (4·4-5·0), and the mean difference between predicted and observed BMI was -0·3 kg/m2 (SD 4·7). This model is incorporated in an easy to use and interpretable web-based prediction tool to help inform clinical decision before surgery. INTERPRETATION: We developed a machine learning-based model, which is internationally validated, for predicting individual 5-year weight loss trajectories after three common bariatric interventions. FUNDING: SOPHIA Innovative Medicines Initiative 2 Joint Undertaking, supported by the EU's Horizon 2020 research and innovation programme, the European Federation of Pharmaceutical Industries and Associations, Type 1 Diabetes Exchange, and the Juvenile Diabetes Research Foundation and Obesity Action Coalition; Métropole Européenne de Lille; Agence Nationale de la Recherche; Institut national de recherche en sciences et technologies du numérique through the Artificial Intelligence chair Apprenf; Université de Lille Nord Europe's I-SITE EXPAND as part of the Bandits For Health project; Laboratoire d'excellence European Genomic Institute for Diabetes; Soutien aux Travaux Interdisciplinaires, Multi-établissements et Exploratoires programme by Conseil Régional Hauts-de-France (volet partenarial phase 2, project PERSO-SURG).
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Cirurgia Bariátrica , Trajetória do Peso do Corpo , Diabetes Mellitus Tipo 1 , Obesidade Mórbida , Adulto , Humanos , Adolescente , Obesidade Mórbida/cirurgia , Estudos Retrospectivos , Inteligência Artificial , Estudos Prospectivos , Obesidade/cirurgia , Aprendizado de MáquinaRESUMO
AIMS: To investigate the lowering BP effects of sodium glucose cotransporter 2 inhibitors (SGLT2i) and glucagon-like peptide 1 receptor agonists (GLP-1 RAs) on the risk of major cardiovascular event stratified by glucose-lowering drugs, baseline BP, glycated hemoglobin (HbA1c), and history of cardiovascular disease in patients with type 2 diabetes. METHODS: We performed a systematic review of the MEDLINE and EMBASE databases search up to December 31, 2022, (PROSPERO, CRD42023400899) to identify all large-scale cardiovascular outcomes (CVO) trials of SGLT2i and GLP-1 RAs in which more than 1,000 patient-years of follow-up in each randomized group. Outcomes included all-cause mortality, major adverse cardiovascular event (MACE) and its component (cardiovascular death, myocardial infarction [MI], and stroke), heart failure, and renal failure. A random-effects meta-analyses were used to pool the estimates. RESULTS: Eighteen CVOTs (ten for SGLT2i and eight for GLP-1 RAs) with 127,606 patients with type 2 diabetes were included. Over 2.5 years median follow-up, the average reduction of systolic BP was 2.2 mmHg (mean difference [MD] - 2.2; 95% CI - 2.7 to - 1.7) with more important reduction (Pinteraction = 0.001) with SGLT2 inhibitors (- 2.9; - 3.4 to - 2.5) than with GLP-1 RAs (- 1.4; - 1.8 to - 1). With SGLT2i, every 5-mmHg reduction in systolic BP was associated with a significantly lower risk of mortality (hazard ratio[HR], 0.77; 95% CI 0.65-0.90), MACE (HR 0.81 [0.74-0.89]), cardiovascular death (HR 0.72 [0.59-0.88]), MI (HR 0.82 [0.71-0.95]), heart failure (HR 0.49 [0.42-0.57]), and renal failure (HR 0.46 [0.38-0.55]), while the association was not significant for stroke (HR 0.91 [0.69-1.19]). The corresponding effects for every 5-mmHg reduction in SBP with GLP-1 RAs were 0.65 (0.51-0.84) for all-cause mortality, 0.65 (0.56-0.76) for MACE, 0.62 (0.45-0.85) for CV death, 0.71 (0.52-0.76) for MI, 0.49 (0.35-0.69) for stroke, and 0.49 (0.35-0.66) for renal failure, while the association was not significant for heart failure (HR 0.82 [0.63-1.08]). CONCLUSION: In patients with type 2 diabetes, the hypotensive effects of SGLT2i and GLP-1 RAs were significantly associated with a reduction in mortality and cardiorenal events. These findings suggest that the lowering BP effect could be seen as an additive indicator of cardiovascular protection by SGLT2i and GLP-1 RAs drugs.
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Doenças Cardiovasculares , Diabetes Mellitus Tipo 2 , Insuficiência Cardíaca , Infarto do Miocárdio , Insuficiência Renal , Inibidores do Transportador 2 de Sódio-Glicose , Acidente Vascular Cerebral , Humanos , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/induzido quimicamente , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico , Receptor do Peptídeo Semelhante ao Glucagon 1 , Pressão Sanguínea , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/etiologia , Doenças Cardiovasculares/prevenção & controle , Insuficiência Cardíaca/complicações , Infarto do Miocárdio/complicações , Peptídeo 1 Semelhante ao Glucagon , Acidente Vascular Cerebral/complicações , Insuficiência Renal/induzido quimicamente , Insuficiência Renal/complicações , Hipoglicemiantes/uso terapêuticoRESUMO
AIM: To compare treatment effect sizes between a composite kidney outcome (CKO) and three-point major adverse cardiovascular event (MACE-3) outcomes with use of sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP-1RAs), and to investigate the relationship between treatment effects on CKO and MACE-3 in patients with type 2 diabetes (T2D). MATERIALS AND METHODS: We performed a MEDLINE database search up to December 31, 2021 to identify all placebo-controlled Phase 3 trials which investigated the efficacy of glucose-lowering interventions, and selected those reporting results for CKO and MACE-3. Hazard ratios (HRs) with 95% confidence intervals (CIs) for both outcomes were extracted for each trial, and we evaluated differences in treatment effect sizes by using a ratio of HRs (rHR): the HR for CKO to the HR for MACE-3. A random-effects meta-analysis was used to obtain the overall rHR across trials and according to subgroup. We investigated the relationship between treatment effects on CKO and MACE-3 using the coefficient of determination (R2 ) with weighted meta-regression. The study protocol was registered on PROSPERO (CRD42022299690). RESULTS: A total of 12 studies fulfilled the prespecified criteria, and comprised a total of 104 987 patients with T2D. On average, treatment effect sizes were 17% greater for CKO than for MACE-3 (rHR 0.83, 95% CI 0.74 to 0.92; I2 = 50%; P = 0.03; τ2 = 0.0161), especially for trials of SGLT2 inhibitors compared with GLP-1RAs. For secondary outcomes, treatment effect size was 22%, 21%, 16% and 9% greater for CKO than for myocardial infarction, stroke, death from cardiovascular causes, and hospitalization for heart disease, respectively. MACE-3 and CKO were moderately correlated (ρ = 0.40; P = 0.21), and only 11% (95% CI 1% to 54%) of the variability in the MACE-3 effect could be explained by the variability in the CKO effect. CONCLUSION: In T2D patients, treatment effect sizes were greater for kidney than for macrovascular (MACE-3) outcomes, with important differences according to the drugs considered. CKO and MACE-3 are independent. Caution must be taken when interpreting CKO in the absence of MACE-3 data.
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Doenças Cardiovasculares , Diabetes Mellitus Tipo 2 , Receptor do Peptídeo Semelhante ao Glucagon 1 , Inibidores do Transportador 2 de Sódio-Glicose , Humanos , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/prevenção & controle , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/tratamento farmacológico , Receptor do Peptídeo Semelhante ao Glucagon 1/agonistas , Rim , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico , Ensaios Clínicos Fase III como Assunto , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: The objective of the COMET (COllection of MEtabolic Tissues) biobank project is to create a high-quality collection of insulin-sensitive tissues (liver, muscle, adipose tissues, and epiploic artery) and blood sample derivatives (plasma, serum, DNA and RNA), collected from 270 grade 2-3 obese patients undergoing bariatric surgery. Relevant data on patient such as clinical/biological characteristics and sample handling are also collected. For this, our aim was to establish a Quality Management System (QMS) to meet the reliability and quality requirements necessary for its scientific exploitation. MATERIALS AND METHODS: The COMET QMS includes: (1) Quality Assurance to standardize all stages of the biobanking process, (2) Quality Controls on samples from the first patients included in order to validate the sample management process and ensure reproducible quality; and 3) "in process" Quality Controls to ensure the reliability of the storage procedures and the stability of the samples over time. RESULTS: For serum and plasma, several corrective actions, such as temperature handling and centrifugation conditions, were made to the protocol and led to improvement of the volume and quality of samples. Regarding DNA, all samples evaluated achieved a satisfactory level of purity and integrity and most of them yielded the required DNA quantity. All frozen tissue samples had RNAs of good purity. RNA quality was confirmed by RIN, achieving values in most cases over 7 and efficient amplification of housekeeping genes by RT-qPCR, with no significant differences among samples from the same tissue type. In the "in process" Quality Controls, DNA, RNA, and histological integrity of tissues showed no differences among samples after different preservation times. CONCLUSION: Quality Control results have made it possible to validate the entire biobank process and confirm the utility of implementing QMS to guarantee the quality of a biospecimen collection.
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Bancos de Espécimes Biológicos , RNA , Humanos , Reprodutibilidade dos Testes , Preservação Biológica , Manejo de Espécimes/métodos , DNARESUMO
Background: Summarized data of cardiovascular outcomes trials (CVOTs) of sodium glucose cotransporter 2 inhibitors (SGLT2i) and glucagon-like peptide 1 receptor agonists (GLP-1 RAs) have shown a reduction in major adverse cardiovascular event (MACE), whether these benefits are extended in certain risk groups (elderly or obese patients or those with a longer duration of diabetes) or certain minorities (Black participants) are not clearly established. We aimed to provide overall hazard ratios (HRs) estimates for MACE of SGLT2i and GLP-1 RAs stratified by age (< 65 years vs. ≥ 65 years and < 75 years vs. ≥ 75 years), sex (male vs. female), race (Black vs. White, Black vs. Asian, and White vs. Asian), body mass index (BMI: < 30 kg/m2 vs. ≥ 30 kg/m2), and duration of diabetes (< 10 years vs. ≥ 10 years). Methods: We performed a MEDLINE database search from inception up to July 31, 2022 to identify all placebo-controlled phase 3 CVOTs that evaluated the efficacy of SGLT2i and GLP-1 RAs on vascular events at least 1-year after randomisation in participants with type 2 diabetes, and we selected those reporting hazard ratios (HRs) for the specific risk groups for MACE. Differences on MACE in risk groups were examined using a random-effect meta-analysis. The study protocol was registered on PROSPERO (CRD42022347901). Findings: A total of 11 studies fulfilled the prespecified criteria, comprising 96,580 patients with T2D were included. Of these patients, 61,975 (64.2%) were male, 34,605 (35.8%) were female, and race groups included 74,982 (77.6%) White, 7760 (8.0%) Asian, and 4023 (4.2%) Black. In two SGLT2i trials, the HR (95% CI) for long-term diabetes duration more than10 years versus short duration was 0.84 (0.77-0.93) vs. 1.02 (0.89-1.16), respectively (P interaction = 0.03). In four SGLT2i trials, the MACE benefit was similar by sex (P interaction = 0.13), age (P interaction = 0.36), BMI (P interaction = 0.69), and race groups (P interaction = 0.86 between Black and White, P interaction = 0.98 between Black and Asian, and P interaction = 0.69 between White and Asian). For GLP-1 RAs, the MACE benefit from the seven trials tended to be greater for Asian (0.71, [0.58-0.87]) than for White (0.87, [0.81-0.94]), (P interaction = 0.07). In two GLP-1 RAs trials, the MACE outcome was reduced by 22% (0.78, 0.63-0.95) in elderly patients (≥ 75 years) while no difference was observed in those < 75 years (0.87; 0.75-1.01), (P interaction = 0.37). In the remaining risk groups, the MACE benefit was similar by sex (P interaction = 0.37), age < 65 years (P interaction = 0.80), duration of diabetes (P interaction = 0.70), and race (P interaction = 0.57 between Black and White, and P interaction = 0.15 between Black and Asian), BMI (P interaction = 0.78). Risk of bias was lower, and overall heterogeneity was high for sex with SGLT2i, and moderate to low for the remaining comparisons, with a I2 values ranging from 0% to 54%. Interpretation: In patients with type 2 diabetes at highest risk of cardiovascular disease or established cardiovascular disease, a greater benefit on MACE was found for elderly patients and for Asian individuals compared with White individuals with GLP-1 RAs, and those with a long duration of diabetes with SGLT2i. These findings could help in providing guidance for treatment prescription and facilitate selection and stratification of patients for future CVOTs. Furthermore, pooled individual patient-level data are urgently needed to support our conclusions, and to derive definitive evidence. Funding: None.
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BACKGROUND AND OBJECTIVE: A clinician was intrigued about HbA1c upper 9% (75 mmol/mol) in a 76 year-old women with normal glycemia. Further explorations were performed in order to understand this discordance. METHODS: First HbA1c test was performed on a HLC -723 G11 apparatus (Tosoh Bioscience) and thereafter compared to the HLC-723-G8 (Tosoh Bioscience), the Capillaris 3 Tera (Sebia) and the DCA Vantage point of care testing (POCT) (Siemens) apparatus. In addition, study of Hemoglobin (Hb) fraction and mutation analysis of HBB gene was realized due to the suspicion of an Hb variant. RESULTS: Twice high results of HbA1c (9.3%, 78 mmol/mol and 10%, 86 mmol/mol) on the HLC-723 G11 was not confirmed with other instruments. HbA1c result for the same sample was 5.2% (33 mmol/mol) for the HLC-723 G8, 5.3% (34 mmol/mol) for the Capillaris and 6.2% (44 mmol/mol) for the DCA Vantage POCT. The subject had normal glycemia and none signs of diabetes mellitus. An abnormal Hb fraction was visualized on the graphs for the HLC-723 G11 and Capillaris but not for the HLC-723 G8 analyzer. Study of Hb fraction confirmed the presence of an abnormal Hb fraction that was identifed as an Hb G-Copenhagen through mutation analysis of HBB gene. CONCLUSION: This case evidenced an interference on HbA1c test in presence of Hb G-Copenhagen depending to the analyzer used. This report help to alert of such possibility and to remain that a discordance between HbA1c and glycemia can be due to an Hb variant.
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PURPOSE: Over the last decade, an important interest was taken to prevent the reflux following sleeve. A new variant, Nissen-sleeve, was described with the purpose to prevent GERD and to decrease the occurrence of leak. The current study reports the preliminary results of a prospective trial. MATERIALS AND METHODS: All consecutive patients who underwent a Nissen-Sleeve between January 2018 and September 2020 were included. Baseline characteristics including age, gender, weight, body mass index (BMI), GERD symptoms, and treatment were evaluated after 1 year. Operative time, length of stay, complication, and reoperation data were also collected. RESULTS: Three hundred sixty-five consecutive patients decided to undergo Nissen-sleeve: 75% females with median age of 41.2 years (+ / - 14.1) and an average BMI of 41.6 kg/m2 (+ / - 5.4). There were 16 cases (4.4%) of early postoperative complications (< 30 days): six cases of acute wrap perforation (1.6%), intraabdominal bleeding for 5 patients (1.4%), one case of wrap dilatation (0.3%), one case of acute complete aphagia, one case of incarcerated umbilical hernia, and 2 cases (0.5%) of pulmonary atelectasis/pneumonia and one venous pulmonary embolism. We recorded the following complications: 16 patients (4.4%) mild dysphagia; 3 patients (0.8%) chronic dysphagia; and 2 cases of wrap perforation that have been diagnosed 8 and 9 months respectively, after the procedure due to the use of steroids not associated with PPI intake. The mean operative time was 83 min (46-125 min). The conversion and mortality rates were nil. CONCLUSION: Following the initial learning curve and additional technical modifications, the Nissen-Sleeve appears to be a safe surgical technique with an acceptable early postoperative complication rate. CLINICAL TRIAL REGISTRATION: NCT02310178.
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Gastrectomia , Refluxo Gastroesofágico , Adulto , Transtornos de Deglutição/epidemiologia , Feminino , Gastrectomia/efeitos adversos , Gastrectomia/métodos , Refluxo Gastroesofágico/cirurgia , Humanos , Curva de Aprendizado , Masculino , Pessoa de Meia-Idade , Morbidade , Complicações Pós-Operatórias/epidemiologia , Estudos ProspectivosRESUMO
AIM: Diagnosis of nonalcoholic steatohepatitis (NASH) relies on liver biopsy. Noninvasive tools would be useful to target patients to refer for a biopsy. We aimed to determine the diagnostic value of the triglycerides and glucose (TyG) index, an insulin-resistance indicator, to predict NASH. METHODS: Our study included grade II-III obese patients aged 18-65 years undergoing bariatric surgery and included in the COMET (COllection of MEtabolic Tissues) biobank (NCT02861781). Liver biopsies performed during bariatric surgery were collected from the biobank along with blood derivatives. Biopsies were analysed according to the steatosis, activity and fibrosis (SAF) scoring system to diagnose NASH, nonalcoholic fatty liver disease (NAFLD), and fibrosis. Logistic regression models were performed to identify factors predicting NASH, NAFLD, and fibrosis. RESULTS: Of 238 analysed subjects (mean age 43±12 years, 33.6% men), 29% had type 2 diabetes. Steatosis was present in 67.2%, while NASH and advanced fibrosis (stage F3) were diagnosed in 18.1% and 2.9% respectively. TyG index was independently associated with NASH (odds ratio (OR): 4.7 [95% confidence interval: 2.3;9.5] P < 0.0001), NAFLD (OR: 2.0 [1.1;3.7] P = 0.03) and stages 2-3 fibrosis (OR: 4.0 [1.5;10.8] P = 0.007). NASH was also predicted by gamma-glutamyl transferase (GGT) with an area under the ROC curve: 0.79 [0.71;0.87 P = 0.04] for GGT and TyG index combined. CONCLUSION: In our cohort of severely obese patients, TyG index, when associated with GGT level, exhibited high diagnostic performance to predict NASH. Although validation in larger populations is needed, this result may be of considerable clinical value to predict need for liver biopsy.
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Diabetes Mellitus Tipo 2 , Hepatopatia Gordurosa não Alcoólica , Adolescente , Adulto , Idoso , Biomarcadores , Biópsia , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/epidemiologia , Diabetes Mellitus Tipo 2/patologia , Feminino , Fibrose , Glucose , Humanos , Fígado/patologia , Masculino , Pessoa de Meia-Idade , Hepatopatia Gordurosa não Alcoólica/complicações , Hepatopatia Gordurosa não Alcoólica/epidemiologia , Obesidade/complicações , Obesidade/epidemiologia , Obesidade/patologia , Triglicerídeos , Adulto JovemRESUMO
Aim: To optimize vaccination strategy, evidence on vaccine efficacy against COVID-19 is needed. Method: The present network meta-analysis uses reconstructed individual patient data from phase III trials on vaccine efficacy (VE), identified through MEDLINE, EMBASE, and Cochrane library (CENTRAL) peer-reviewed and published in English before August 31, 2021. The primary outcome was the VE against confirmed COVID-19 at any time after the first dose as defined in each study. VE was re-estimated using the two-stage approach. Poisson regression models were applied to each trial at the first stage, and the incidence risk ratio (IRR) and their 95% CI were aggregated to allow random-effects network meta-analysis (NMA) at the second stage. VE was expressed as: (1-IRR) × 100. The study protocol is registered in PROSPERO (CRD42020200012). Results: A total of eight studies, evaluating nine different vaccines were identified and analyzed. Between April 23, 2020 and January 05, 2021, 210,418 participants were recruited in 354 sites worldwide. During a median (IQR) follow-up duration of 69.8 (69.7-70.3) days, 2131 confirmed COVID-19 cases occurred (604; 26.0 per 1000 person-years in vaccine recipients and 1527; 85.9 per 1000 person-years in the control group). The mRNA-1273 vaccine was the most effective (P-score 0.99); at any time after dose 1, incidence reduction for mRNA-1273 ranged from 78% to 98% compared to the other vaccines. Conclusion: Our results provide evidence for the short-term superiority of mRNA vaccines, especially the mRNA-1273 vaccine in prevention of COVID-19 in different populations. Supplementary Information: The online version contains supplementary material available at 10.1007/s10389-022-01707-1.
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Inhaled corticosteroids (ICS) have been associated with increased risk of pneumonia. Their impact on respiratory virus infections is unclear. We performed a post-hoc analysis of the FLUVAC cohort, a multicenter prospective cohort study of adults hospitalized with influenza-like illness (ILI) during six consecutive influenza seasons (2012-2018). All patients were tested for respiratory virus infection by multiplex PCR on nasopharyngeal swabs and/or bronchoalveolar lavage. Risk factors were identified by logistic regression analysis. Among the 2658 patients included, 537 (20.2%) were treated with ICS before admission, of whom 282 (52.5%, 282/537) tested positive for at least one respiratory virus. Patients on ICS were more likely to test positive for non-influenza respiratory viruses (25.1% vs. 19.5%, P = 0.004), especially for adenovirus (aOR 2.36, 95% CI 1.18-4.58), and respiratory syncytial virus (aOR 2.08, 95% CI 1.39-3.09). Complications were reported in 55.9% of patients on ICS (300/537), primarily pneumonia (171/535, 32%). Among patients on chronic ICS who tested positive for respiratory virus, 14.2% (40/282) were admitted to intensive care unit, and in-hospital mortality rate was 2.8% (8/282). Chronic use of ICS is associated with an increased risk of adenovirus or RSV infections in patients admitted for ILI.
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Influenza Humana , Infecções por Vírus Respiratório Sincicial , Vírus Sincicial Respiratório Humano , Infecções Respiratórias , Viroses , Vírus , Corticosteroides/efeitos adversos , Adulto , Humanos , Estudos Prospectivos , Infecções Respiratórias/tratamento farmacológico , Infecções Respiratórias/epidemiologia , Viroses/epidemiologiaRESUMO
Background and Objectives: Vaccination coverage is suboptimal in people living with diabetes. The objectives of this study were to determine the impact of hospitalization on vaccination coverage and the variables associated with vaccination during hospital stay. Materials and Methods: This observational study was conducted from May 2019 to December 2019 in the Endocrinology-Nutrition-Diabetes Department of the University Hospital of Montpellier, France. This department encompasses three medical units, two of which have a full-time clinical pharmacist involved in the multidisciplinary management of patients. All adult diabetic patients who completed a questionnaire about vaccines were prospectively included by a clinical pharmacist and followed until department discharge. Coverage at the time of admission for the tetanus, diphtheria, pertussis (Tdap), pneumococcal, influenza, and herpes zoster vaccines was assessed from patient interviews and/or contact with the general practitioner and/or with the community pharmacist. Multivariable logistic regression analysis was performed to identify the factors associated with a vaccination update during the hospital stay. Results: A total of 222 patients were included (mean age: 59.4 years, 68.5% type 2 diabetes). Vaccination coverage increased by 26.7% (47.3% to 59.9%), 188.0% (10.8% to 31.1%) and 8.9% (45.9% to 50.0%), respectively, for the Tdap, pneumococcal and influenza vaccines during hospital stay. Female sex, admission to a diabetes care unit with a full-time pharmacist, favorable feelings about vaccination, unknown immunization coverage for pneumococcal vaccines, and evaluation and recording of vaccine coverage at admission in the patient medical records were associated with at least one vaccination during hospital stay. Conclusions: Our real-life study highlights that hospitalization and multidisciplinary management (i.e., physician-pharmacist) may be key points in the diabetes care pathway to improve vaccination coverage, especially for patients with advanced diabetes and comorbidities.
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Diabetes Mellitus Tipo 2 , Vacinas contra Influenza , Adulto , Feminino , Hospitalização , Humanos , Pessoa de Meia-Idade , Vacinação , Cobertura VacinalRESUMO
In the context of social events reopening and economic relaunch, sanitary surveillance of SARS-CoV-2 infection is still required. Here, we evaluated the diagnostic performances of a rapid, extraction-free and connected reverse-transcription loop-mediated isothermal amplification (RT-LAMP) assay on saliva. Nasopharyngeal (NP) swabs and saliva from 443 outpatients were collected simultaneously and tested by reverse-transcription quantitative PCR (RT-qPCR) as reference standard test. Seventy-one individuals (16.0%) were positive by NP and/or salivary RT-qPCR. Sensitivity and specificity of salivary RT-LAMP were 85.9% (95%CI 77.8-94.0%) and 99.5% (98.7-100%), respectively. Performances were similar for symptomatic and asymptomatic participants. Moreover, SARS-CoV-2 genetic variants were analyzed and no dominant mutation in RT-LAMP primer region was observed during the period of the study. We demonstrated that this RT-LAMP test on self-collected saliva is reliable for SARS-CoV-2 detection. This simple connected test with optional automatic results transfer to health authorities is unique and opens the way to secure professional and social events in actual context of economics restart.
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Teste de Ácido Nucleico para COVID-19/estatística & dados numéricos , Técnicas de Diagnóstico Molecular/estatística & dados numéricos , Técnicas de Amplificação de Ácido Nucleico/estatística & dados numéricos , SARS-CoV-2/isolamento & purificação , Saliva/virologia , Adulto , Infecções Assintomáticas , Feminino , Humanos , Masculino , Programas de Rastreamento , Pessoa de Meia-Idade , Carga Viral , Adulto JovemRESUMO
BACKGROUND: Subtle gait changes associated with idiopathic rapid eye movement sleep behavior disorder (iRBD) could allow early detection of subjects with future synucleinopathies. OBJECTIVE: The aim of this study was to create a multiclass model, using statistical learning from probability distribution of gait parameters, to distinguish between patients with iRBD, healthy control subjects (HCs), and patients with Parkinson's disease (PD). METHODS: Gait parameters were collected in 21 participants with iRBD, 21 with PD, and 21 HCs, matched for age, sex, and education level. Lasso sparse linear regression explored gait features able to classify the three groups. RESULTS: The final model classified iRBD from HCs and from patients with PD equally well, with 95% accuracy, 100% sensitivity, and 90% specificity. CONCLUSIONS: Gait parameters and a pretrained statistical model can robustly distinguish participants with iRBD from HCs and patients with PD. This could be used to screen subjects with future synucleinopathies in the general population and to identify a conversion threshold to PD. © 2022 International Parkinson and Movement Disorder Society.
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Doença de Parkinson , Transtorno do Comportamento do Sono REM , Sinucleinopatias , Marcha , Humanos , Doença de Parkinson/complicações , Doença de Parkinson/diagnóstico , Transtorno do Comportamento do Sono REM/complicações , Transtorno do Comportamento do Sono REM/diagnósticoRESUMO
BACKGROUND: Measuring vaccine effectiveness (VE) using real-life data is critical to confirm the effectiveness of licensed vaccine, which could strengthen vaccination adherence. METHODS: We measured VE against adult COVID-19 hospitalization in five hospitals in France using a test negative design. We compared the odds of vaccinated patients hospitalized with COVID-19 with the odds of vaccinated patients hospitalized for the same symptoms with a negative test. RESULTS: A total of 853 patients (463 cases and 390 controls) were included, with a total of 170 patients vaccinated (104 with one dose, 65 with two doses, and one with three doses). There were four cases of breakthrough infections, all in immunocompromised patients. The VE was 84.0% (CI0.95=[72.6; 90.6]) for one dose and 96.2% (CI0.95=[86.8; 98.9]) for two doses. CONCLUSION: Our results confirm the high VE of COVID-19 vaccine in France to prevent hospitalizations due to the alpha variant.