The LancetPub Date : 2025-12-21Epub Date: 2024-08-28DOI: 10.1016/S0140-6736(24)01564-2
Wyatte C Hall, Julia L Hecht
{"title":"Primary health-care practices for deaf children should include early incorporation of a signed language.","authors":"Wyatte C Hall, Julia L Hecht","doi":"10.1016/S0140-6736(24)01564-2","DOIUrl":"10.1016/S0140-6736(24)01564-2","url":null,"abstract":"","PeriodicalId":18014,"journal":{"name":"The Lancet","volume":" ","pages":"2498-2500"},"PeriodicalIF":98.4,"publicationDate":"2025-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142108869","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The LancetPub Date : 2025-08-23Epub Date: 2025-08-18DOI: 10.1016/S0140-6736(25)01153-5
Lonnie Pyne, Patrick Rossignol, Cameron Giles, Mats Junek, Patrick B Mark, Martin Gallagher, Janak R de Zoysa, P J Devereaux, Michael Walsh
{"title":"Safety and efficacy of steroidal mineralocorticoid receptor antagonists in patients with kidney failure requiring dialysis: a systematic review and meta-analysis of randomised controlled trials.","authors":"Lonnie Pyne, Patrick Rossignol, Cameron Giles, Mats Junek, Patrick B Mark, Martin Gallagher, Janak R de Zoysa, P J Devereaux, Michael Walsh","doi":"10.1016/S0140-6736(25)01153-5","DOIUrl":"https://doi.org/10.1016/S0140-6736(25)01153-5","url":null,"abstract":"<p><strong>Background: </strong>Mineralocorticoid receptor antagonists can prevent cardiovascular events in patients with heart failure and non-severe chronic kidney disease, but their effects in patients with kidney failure requiring dialysis are uncertain. We aimed to assess the efficacy and safety of mineralocorticoid receptor antagonists in this patient population.</p><p><strong>Methods: </strong>In this systematic review and meta-analysis, we updated our previous systematic review by searching MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and the Cumulative Index to Nursing and Allied Health Literature for randomised controlled trials published between database inception and March 18, 2025. Trials comparing a mineralocorticoid receptor antagonist with placebo or standard of care in adults (aged ≥18 years) receiving maintenance dialysis were eligible. Studies that did not report an outcome of interest (cardiovascular mortality, heart failure hospitalisation, all-cause mortality, all-cause hospitalisation, hyperkalaemia, gynaecomastia or breast pain, or hypotension) were excluded. Two reviewers independently identified studies, extracted data, and assessed the risk of bias using the Cochrane risk-of-bias tool. The main outcome was cardiovascular mortality assessed using the empirical Bayes random-effects models, stratified by risk-of-bias. The protocol is registered with PROSPERO (CRD420251008119).</p><p><strong>Findings: </strong>19 trials of steroidal mineralocorticoid receptor antagonists including 4675 participants met eligibility criteria. Effect estimates differed trials with low and high risk of bias. In four trials with a low risk of bias (n=3562), 264 cardiovascular deaths occurred in 1785 patients in the mineralocorticoid receptor antagonist group compared with 276 of 1777 patients in the control group (odds ratio 0·98 [95% CI 0·80-1·20]; I<sup>2</sup>=0·0%; τ<sup>2</sup>=0·0; moderate certainty) resulting in an absolute risk reduction of 1 fewer event per 1000 patients per year (95% CI 14 fewer to 11 more).</p><p><strong>Interpretation: </strong>Our findings suggest that steroidal mineralocorticoid receptor antagonists have little to no effect on cardiovascular mortality in patients requiring dialysis. There is insufficient information on the effects of steroidal mineralocorticoid receptor antagonists in subgroups of patients requiring dialysis and no information on non-steroidal mineralocorticoid receptor antagonists. Future trials would need to consider the likelihood of only smaller effects or effects limited to patients or events with pathophysiology that is more clearly driven by aldosterone in their design.</p><p><strong>Funding: </strong>None.</p>","PeriodicalId":18014,"journal":{"name":"The Lancet","volume":"406 10505","pages":"811-820"},"PeriodicalIF":88.5,"publicationDate":"2025-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144959389","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Is Gaza still a place for newborn life?","authors":"Bilal Irfan, Shaymaa Abuhaiba, Meran Abusultan, Othman Nassar","doi":"10.1016/S0140-6736(25)01627-7","DOIUrl":"https://doi.org/10.1016/S0140-6736(25)01627-7","url":null,"abstract":"","PeriodicalId":18014,"journal":{"name":"The Lancet","volume":"406 10505","pages":"803"},"PeriodicalIF":88.5,"publicationDate":"2025-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144959418","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The LancetPub Date : 2025-08-23Epub Date: 2025-08-18DOI: 10.1016/S0140-6736(25)01324-8
Qandeel H Soomro, David M Charytan
{"title":"Requiem for mineralocorticoid blockade in maintenance dialysis.","authors":"Qandeel H Soomro, David M Charytan","doi":"10.1016/S0140-6736(25)01324-8","DOIUrl":"https://doi.org/10.1016/S0140-6736(25)01324-8","url":null,"abstract":"","PeriodicalId":18014,"journal":{"name":"The Lancet","volume":"406 10505","pages":"780-782"},"PeriodicalIF":88.5,"publicationDate":"2025-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144959430","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The LancetPub Date : 2025-08-23Epub Date: 2025-08-18DOI: 10.1016/S0140-6736(25)01628-9
Sally Pezaro, John Pendleton, Isaac Samuels
{"title":"Clarity in gender-inclusive language in reproductive health care.","authors":"Sally Pezaro, John Pendleton, Isaac Samuels","doi":"10.1016/S0140-6736(25)01628-9","DOIUrl":"https://doi.org/10.1016/S0140-6736(25)01628-9","url":null,"abstract":"","PeriodicalId":18014,"journal":{"name":"The Lancet","volume":"406 10505","pages":"804"},"PeriodicalIF":88.5,"publicationDate":"2025-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144959387","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The LancetPub Date : 2025-08-23DOI: 10.1016/S0140-6736(25)00859-1
Margarita Alegría, Gabriela Livas Stein, Mario Cruz-Gonzalez, Irene Falgas-Bague, Sheri Lapatin Markle, Kari M Eddington, Andrew Supple, Larimar Fuentes, Claire Poindexter, Patrick E Shrout
{"title":"Building community capacity in mental health care with the Strong Minds-Strong Communities programme: a randomised controlled trial in the USA.","authors":"Margarita Alegría, Gabriela Livas Stein, Mario Cruz-Gonzalez, Irene Falgas-Bague, Sheri Lapatin Markle, Kari M Eddington, Andrew Supple, Larimar Fuentes, Claire Poindexter, Patrick E Shrout","doi":"10.1016/S0140-6736(25)00859-1","DOIUrl":"10.1016/S0140-6736(25)00859-1","url":null,"abstract":"<p><strong>Background: </strong>Provider shortages and lack of culturally responsive care limit mental health services in reaching multicultural populations worldwide. We examined the effectiveness of a psychoeducational intervention aimed at building community capacity to address depression and anxiety among racial, ethnic, and linguistic minoritised adults.</p><p><strong>Methods: </strong>Strong Minds-Strong Communities (SM-SC) was a 6-month, multicentre, longitudinal, randomised trial done in 37 community-based organisations and clinics in two US sites (Massachusetts and North Carolina). Adults aged 18 years and older speaking English, Spanish, Mandarin, or Cantonese, with moderate to severe depression or anxiety symptoms assessed using the Computerized Adaptive Test for Mental Health (CAT-MH), were eligible for inclusion. Participants were randomly assigned (1:1) to a psychoeducational intervention provided by community health workers or a usual care condition, which constituted receiving a US National Institutes of Health booklet about anxiety and depression. Both conditions included referrals for social determinants of health needs. Randomisation was stratified by site using computer-generated blocks of size 2. Investigators and participants were not masked to treatment allocation, but outcome assessors were. Primary outcomes were changes from baseline at months 6 and 12 in self-reported depression and anxiety symptoms using the Hopkins Symptom Checklist-25 (HSCL-25), level of functioning using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2·0), and perceived quality of care using the Global Evaluation of Care domain of the Perceptions of Care Outpatient Survey (PoC-OP) in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT04092777, and has been completed.</p><p><strong>Findings: </strong>From Sept 4, 2019, to March 3, 2023, 5265 potential participants were approached for study inclusion. 2681 were excluded and 2584 were assessed for eligibility. A further 1417 were excluded, and 1167 were deemed eligible for study inclusion. 1044 participants were randomly assigned, 524 to the SM-SC intervention and 520 to the usual care group. The mean age of participants was 42·6 years (SD 13·3) and 875 (83·8%) were female, 165 (15·8%) were male, and four (0·4%) were other. Between baseline and 6 months, intervention participants reported greater improvements in depression and anxiety symptoms (standardised effect size, 0·39 [95% CI 0·27-0·52]), functioning (standardised effect size, 0·28 [0·16-0·39]), and perceived quality of care (standardised effect size, 0·47 [0·31-0·62]). These greater improvements in depression and anxiety symptoms, functioning, and perceived quality of care attenuated but remained significant 6 months post-intervention (standardised effect sizes of 0·28 [95% CI 0·16-0·40] for depression and anxiety, 0·21 [0·08-0·33]) for functioning, and 0·33 [0·16 -0·50] for perceived","PeriodicalId":18014,"journal":{"name":"The Lancet","volume":"406 10505","pages":"832-845"},"PeriodicalIF":88.5,"publicationDate":"2025-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12506403/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144959398","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The LancetPub Date : 2025-08-23DOI: 10.1016/S0140-6736(25)00979-1
Rohit Loomba, Erin Morgan, Keyvan Yousefi, Dan Li, Richard Geary, Sanjay Bhanot, Naim Alkhouri
{"title":"Antisense oligonucleotide DGAT-2 inhibitor, ION224, for metabolic dysfunction-associated steatohepatitis (ION224-CS2): results of a 51-week, multicentre, randomised, double-blind, placebo-controlled, phase 2 trial.","authors":"Rohit Loomba, Erin Morgan, Keyvan Yousefi, Dan Li, Richard Geary, Sanjay Bhanot, Naim Alkhouri","doi":"10.1016/S0140-6736(25)00979-1","DOIUrl":"https://doi.org/10.1016/S0140-6736(25)00979-1","url":null,"abstract":"<p><strong>Background: </strong>ION224, a liver-directed antisense inhibitor of diacylglycerol O-acyltransferase 2 (DGAT2), suppresses de novo lipogenesis, an important metabolic pathway associated with lipotoxicity and the underlying inflammation, hepatocellular injury, and fibrosis in metabolic dysfunction-associated steatohepatitis (MASH). This study aimed to prospectively assess the safety and efficacy of ION224 in patients with MASH and fibrosis.</p><p><strong>Methods: </strong>ION224-CS2 was an adaptive, two-part, multicentre, randomised, double-blind, placebo-controlled, phase 2 trial conducted at 43 clinical sites in the USA and Puerto Rico in patients aged 18-75 years with biopsy-confirmed MASH and fibrosis (stages F1, F2, and F3) and baseline liver steatosis ≥10%. In part 1, participants were randomly assigned (1:1:1) to subcutaneous injections of ION224 60 mg, 90 mg, or 120 mg, or placebo, once per month. In part 2, participants were randomly assigned (2:1) to ION224 90 mg and 120 mg or placebo after a pre-specified interim analysis of safety and efficacy (liver steatosis). The primary endpoint was ≥2-point reduction in Non-Alcoholic Fatty Liver Disease Activity Score Activity Score (NAS) with ≥1-point improvement in hepatocellular ballooning or lobular inflammation, and without worsening of fibrosis at week 51. The primary analysis was in a predefined per-protocol set that included patients who received at least ten of 13 doses of the study drug without missing three consecutive doses and completed the final liver biopsy at the end of treatment. ION224-CS2 was registered at ClinicalTrials.gov (NCT04932512) and is closed.</p><p><strong>Findings: </strong>Between June 8, 2021, and Dec 27, 2022, 160 participants were randomly assigned to receive ION224 60 mg (n=23), 90 mg (n=45), or 120 mg (n=46), or placebo (n=46), of whom 123 were included in the per-protocol set. The primary endpoint was met in 18 (46%) of 39 participants in the 90-mg group (predicted risk 46·2% [95% CI 30·5-61·8]; risk difference 27·4% [95% CI 6·7-48·1], p=0·0094) and 20 (59%) of 34 in the 120-mg group (58·8% [42·3-75·4]; 40·1% [18·7- 61·4], p=0·0002) compared with six (19%) of 32 in the placebo group (predicted risk 18·7% [95% CI 5·2-32·3]). ION224 was safe and well tolerated. Adverse events were reported in 107 (94%) of participants treated with ION224 and 41 (89%) of 46 participants treated with placebo. There were no deaths and no treatment-related serious adverse events.</p><p><strong>Interpretation: </strong>This study provides the first clinical evidence that antisense-mediated inhibition of DGAT2 with ION224 could be a safe and efficacious strategy for the treatment of MASH. The observed histological improvements were independent of changes in bodyweight, suggesting potential to combine with other therapies such as GLP-1 based treatments.</p><p><strong>Funding: </strong>Ionis Pharmaceuticals.</p>","PeriodicalId":18014,"journal":{"name":"The Lancet","volume":"406 10505","pages":"821-831"},"PeriodicalIF":88.5,"publicationDate":"2025-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144959475","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The LancetPub Date : 2025-08-23DOI: 10.1016/S0140-6736(25)01070-0
Maud Robert, Tigran Poghosyan, Nicolas Romain-Scelle, Sebastien Czernichow, Dominique Delaunay, Adrien Sterkers, Litavan Khamphommala, Andrea Lazzati, Claire Blanchard, Robert Caiazzo, François Pattou, Emmanuel Disse
{"title":"Efficacy and safety of single-anastomosis duodeno-ileal bypass with sleeve gastrectomy versus Roux-en-Y gastric bypass in France (SADISLEEVE): results of a randomised, open-label, superiority trial at 2 years of follow-up.","authors":"Maud Robert, Tigran Poghosyan, Nicolas Romain-Scelle, Sebastien Czernichow, Dominique Delaunay, Adrien Sterkers, Litavan Khamphommala, Andrea Lazzati, Claire Blanchard, Robert Caiazzo, François Pattou, Emmanuel Disse","doi":"10.1016/S0140-6736(25)01070-0","DOIUrl":"https://doi.org/10.1016/S0140-6736(25)01070-0","url":null,"abstract":"<p><strong>Background: </strong>Since 2007, single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) has been proposed as an alternative to Roux-en-Y gastric bypass (RYGB) in the treatment of obesity. We conducted a multicentre randomised trial, with the hypothesis that SADI-S could be more effective than RYGB at 2-year follow-up.</p><p><strong>Methods: </strong>This multicentre, open-label, individually randomised superiority trial was conducted in France; patients were recruited from 22 bariatric institutions, mostly public academic hospitals. Key inclusion criteria were patients with a BMI ≥40 kg/m<sup>2</sup> or ≥35 kg/m<sup>2</sup> with obesity-related comorbidities (type 2 diabetes, hypertension, dyslipidaemia, sleep apnoea, or osteoarthrosis), and a candidate for SADI-S or RYGB gastric bypass as a primary surgery or after a sleeve gastrectomy. Main key exclusions included previous bariatric surgery (other than sleeve gastrectomy), inflammatory bowel disease, type 1 diabetes, and untreated Helicobacter pylori infection. Participants were randomly assigned (1:1) to SADI-S or RYGB, stratified by centre, failure of sleeve gastrectomy, and presence of type 2 diabetes. The primary endpoint was percentage excess weight loss (%EWL) at 2 years (%EWL=[(weight at 2 years - initial weight)/(initial weight - ideal weight)] × 100). The study is registered with ClinicalTrials.gov, NCT03610256 and is completed.</p><p><strong>Findings: </strong>Between Nov 8, 2018, and Sept 29, 2021, a total of 381 patients were randomly assigned (intention-to-treat population) and included in the primary analysis (SADI-S: 190, RYGB: 191). Mean age was 44·4 years (SD 10·64), mean BMI was 46·2 kg/m<sup>2</sup> (6·40), 265 (70%) were female, and 79 (21%) had a primary sleeve gastrectomy. 43 (12%) of 370 participants were lost to follow-up. At 2 years, the mean %EWL was statistically significantly higher in the SADI-S group compared with the RYGB group (-76·0% [SD 26·7] vs -68·1% [28·7], confirming the superiority of SADI-S (mean difference -6·72% [95% CI -12·64 to -0·80], p=0·026). The primary outcome was missing for 78 (20%) of 381 participants, with 46 (59%) of 78 participants in the SADI-S group and 32 (41%) of 78 in the RYGB group, p=0·09. The number of serious adverse events related to the surgical technique in the safety population, including all operated patients, was 40 in the SADI-S group including three anastomotic leaks and eight severe diarrhoea compared with 35 in the RYGB group including five internal hernia and five severe abdominal pain cases of which two required diagnostic laparoscopy.</p><p><strong>Interpretation: </strong>SADI-S showed superior weight loss compared with RYGB at 2 years, with a similar safety profile.</p><p><strong>Funding: </strong>French Ministry of Health (Direction Générale de l'offre de Soin - DGOS).</p>","PeriodicalId":18014,"journal":{"name":"The Lancet","volume":"406 10505","pages":"846-859"},"PeriodicalIF":88.5,"publicationDate":"2025-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144959457","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The LancetPub Date : 2025-03-08Epub Date: 2024-07-25DOI: 10.1016/S0140-6736(24)01493-4
Elisa Pineda, Mauricio Hernández-F, Ana G Ortega-Avila, Alexandra Jones, Juan A Rivera
{"title":"Mexico's bold new law on adequate and sustainable nutrition.","authors":"Elisa Pineda, Mauricio Hernández-F, Ana G Ortega-Avila, Alexandra Jones, Juan A Rivera","doi":"10.1016/S0140-6736(24)01493-4","DOIUrl":"10.1016/S0140-6736(24)01493-4","url":null,"abstract":"","PeriodicalId":18014,"journal":{"name":"The Lancet","volume":" ","pages":"764-767"},"PeriodicalIF":98.4,"publicationDate":"2025-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141788516","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The LancetPub Date : 2025-03-01Epub Date: 2024-05-21DOI: 10.1016/S0140-6736(24)00931-0
G C Oniscu, K Rockell, D E Martin
{"title":"Challenges in undertaking research in transplantation.","authors":"G C Oniscu, K Rockell, D E Martin","doi":"10.1016/S0140-6736(24)00931-0","DOIUrl":"10.1016/S0140-6736(24)00931-0","url":null,"abstract":"","PeriodicalId":18014,"journal":{"name":"The Lancet","volume":" ","pages":"681-683"},"PeriodicalIF":98.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141092778","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}