Pub Date : 2026-02-05DOI: 10.1016/s0140-6736(25)01632-0
Teba Alnima, Mark M Smits
No Abstract
没有抽象的
{"title":"Response to STRIDE: semaglutide in peripheral artery disease and type 2 diabetes","authors":"Teba Alnima, Mark M Smits","doi":"10.1016/s0140-6736(25)01632-0","DOIUrl":"https://doi.org/10.1016/s0140-6736(25)01632-0","url":null,"abstract":"No Abstract","PeriodicalId":22898,"journal":{"name":"The Lancet","volume":"31 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146129484","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-05DOI: 10.1016/s0140-6736(25)01578-8
<h3>Background</h3>Statin product labels (eg, Summaries of Product Characteristics [SmPCs]) list certain adverse outcomes as potential treatment-related effects based mainly on non-randomised and non-blinded studies, which might be subject to bias. We aimed to assess the evidence for such undesirable effects more reliably through a meta-analysis of individual participant data from large double-blind trials of statin therapy.<h3>Methods</h3>In this meta-analysis of individual participant-level data from double-blind randomised controlled trials, we generated a list of all undesirable effect terms listed in statin SmPCs by searching an electronic medicines compendium for five statins (atorvastatin, fluvastatin, pravastatin, rosuvastatin, and simvastatin). Randomised trials were eligible for meta-analysis of these effects if they involved at least 1000 participants, had a scheduled treatment period of at least 2 years, and involved a double-blind comparison of statin versus placebo or of a more intensive versus a less intensive statin regimen. Event rate ratios (RRs) and 95% CIs were calculated with statistical significance assessed after controlling the false discovery rate (FDR) at 5%.<h3>Findings</h3>19 trials compared statin versus placebo (123 940 participants, median follow-up 4·5 years [IQR 3·1–5·4]). In addition to previously reported effects on muscle outcomes and diabetes, only four of 66 further undesirable outcomes that had been attributed to statins were FDR significant: abnormal liver transaminases (783 participants [0·30% per annum] allocated statin <em>vs</em> 556 [0·22% per annum] allocated placebo, RR 1·41 [95% CI 1·26–1·57]) and other liver function test abnormalities (651 participants [0·25% per annum] allocated statin <em>vs</em> 518 [0·20% per annum] allocated placebo, RR 1·26 [1·12–1·41]; absolute annual excess of 0·13% for combined liver function test abnormality), urinary composition alteration (556 [0·21% per annum] allocated statin <em>vs</em> 472 [0·18% per annum] allocated placebo, RR 1·18 [1·04–1·33]), and oedema (3495 [1·38% per annum] allocated statin <em>vs</em> 3299 [1·31% per annum] allocated placebo, RR 1·07 [1·02–1·12]). Analysis of the four trials of more intensive versus less intensive statin regimens also found significant excesses for abnormal liver transaminases and other liver function test abnormalities (supporting a dose-dependent effect), but no significant excess was found for urinary composition alteration or oedema.<h3>Interpretation</h3>Adverse event data from blinded randomised trials do not support causal relationships between statin therapy and most of the conditions (including cognitive impairment, depression, sleep disturbance, and peripheral neuropathy) listed in product labels as potential undesirable effects. In light of these findings, such labelling and other official sources of health information should be revised so that patients and their doctors can make appropriately informed decisions
{"title":"Assessment of adverse effects attributed to statin therapy in product labels: a meta-analysis of double-blind randomised controlled trials","authors":"","doi":"10.1016/s0140-6736(25)01578-8","DOIUrl":"https://doi.org/10.1016/s0140-6736(25)01578-8","url":null,"abstract":"<h3>Background</h3>Statin product labels (eg, Summaries of Product Characteristics [SmPCs]) list certain adverse outcomes as potential treatment-related effects based mainly on non-randomised and non-blinded studies, which might be subject to bias. We aimed to assess the evidence for such undesirable effects more reliably through a meta-analysis of individual participant data from large double-blind trials of statin therapy.<h3>Methods</h3>In this meta-analysis of individual participant-level data from double-blind randomised controlled trials, we generated a list of all undesirable effect terms listed in statin SmPCs by searching an electronic medicines compendium for five statins (atorvastatin, fluvastatin, pravastatin, rosuvastatin, and simvastatin). Randomised trials were eligible for meta-analysis of these effects if they involved at least 1000 participants, had a scheduled treatment period of at least 2 years, and involved a double-blind comparison of statin versus placebo or of a more intensive versus a less intensive statin regimen. Event rate ratios (RRs) and 95% CIs were calculated with statistical significance assessed after controlling the false discovery rate (FDR) at 5%.<h3>Findings</h3>19 trials compared statin versus placebo (123 940 participants, median follow-up 4·5 years [IQR 3·1–5·4]). In addition to previously reported effects on muscle outcomes and diabetes, only four of 66 further undesirable outcomes that had been attributed to statins were FDR significant: abnormal liver transaminases (783 participants [0·30% per annum] allocated statin <em>vs</em> 556 [0·22% per annum] allocated placebo, RR 1·41 [95% CI 1·26–1·57]) and other liver function test abnormalities (651 participants [0·25% per annum] allocated statin <em>vs</em> 518 [0·20% per annum] allocated placebo, RR 1·26 [1·12–1·41]; absolute annual excess of 0·13% for combined liver function test abnormality), urinary composition alteration (556 [0·21% per annum] allocated statin <em>vs</em> 472 [0·18% per annum] allocated placebo, RR 1·18 [1·04–1·33]), and oedema (3495 [1·38% per annum] allocated statin <em>vs</em> 3299 [1·31% per annum] allocated placebo, RR 1·07 [1·02–1·12]). Analysis of the four trials of more intensive versus less intensive statin regimens also found significant excesses for abnormal liver transaminases and other liver function test abnormalities (supporting a dose-dependent effect), but no significant excess was found for urinary composition alteration or oedema.<h3>Interpretation</h3>Adverse event data from blinded randomised trials do not support causal relationships between statin therapy and most of the conditions (including cognitive impairment, depression, sleep disturbance, and peripheral neuropathy) listed in product labels as potential undesirable effects. In light of these findings, such labelling and other official sources of health information should be revised so that patients and their doctors can make appropriately informed decisions","PeriodicalId":22898,"journal":{"name":"The Lancet","volume":"42 4 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146129481","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-05DOI: 10.1016/s0140-6736(25)01948-8
Amy E Colson, Anthony M Mills, Moti N Ramgopal, Christopher Bettacchi, Olayemi O Osiyemi, Federico Hinestrosa, Gordon Crofoot, Harold P Katner, Hiroyuki Gatanaga, Margaret Johnson, Tracy L Diamond, Erika Barninger, Karen Eves, Feng-Hsiu Su, Yayun Xu, Stephanie O Klopfer, Luisa M Stamm, Michelle C Fox, Rima Lahoulou
{"title":"Switch to fixed-dose doravirine (100 mg) and islatravir (0·25 mg) once daily in virologically suppressed adults with HIV-1 on bictegravir, emtricitabine, and tenofovir alafenamide: 48-week results of a phase 3, multicentre, randomised, controlled, double-blind, non-inferiority trial","authors":"Amy E Colson, Anthony M Mills, Moti N Ramgopal, Christopher Bettacchi, Olayemi O Osiyemi, Federico Hinestrosa, Gordon Crofoot, Harold P Katner, Hiroyuki Gatanaga, Margaret Johnson, Tracy L Diamond, Erika Barninger, Karen Eves, Feng-Hsiu Su, Yayun Xu, Stephanie O Klopfer, Luisa M Stamm, Michelle C Fox, Rima Lahoulou","doi":"10.1016/s0140-6736(25)01948-8","DOIUrl":"https://doi.org/10.1016/s0140-6736(25)01948-8","url":null,"abstract":"","PeriodicalId":22898,"journal":{"name":"The Lancet","volume":"91 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146134292","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-05DOI: 10.1016/s0140-6736(25)02013-6
Timo E Strandberg, Raul D Santos
{"title":"Product labels downplay the safety of statin therapy: evidence from randomised controlled trials","authors":"Timo E Strandberg, Raul D Santos","doi":"10.1016/s0140-6736(25)02013-6","DOIUrl":"https://doi.org/10.1016/s0140-6736(25)02013-6","url":null,"abstract":"","PeriodicalId":22898,"journal":{"name":"The Lancet","volume":"110 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146134306","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-05DOI: 10.1016/s0140-6736(25)02505-x
Howard Lopes Ribeiro, Mauer Alexandre da Ascensão Gonçalves, Lúcio Lara Santos
No Abstract
没有抽象的
{"title":"Improving cancer surveillance and global cancer burden estimates","authors":"Howard Lopes Ribeiro, Mauer Alexandre da Ascensão Gonçalves, Lúcio Lara Santos","doi":"10.1016/s0140-6736(25)02505-x","DOIUrl":"https://doi.org/10.1016/s0140-6736(25)02505-x","url":null,"abstract":"No Abstract","PeriodicalId":22898,"journal":{"name":"The Lancet","volume":"38 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146129486","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-05DOI: 10.1016/s0140-6736(26)00206-0
Lisa M Force
No Abstract
没有抽象的
{"title":"Improving cancer surveillance and global cancer burden estimates – Author's reply","authors":"Lisa M Force","doi":"10.1016/s0140-6736(26)00206-0","DOIUrl":"https://doi.org/10.1016/s0140-6736(26)00206-0","url":null,"abstract":"No Abstract","PeriodicalId":22898,"journal":{"name":"The Lancet","volume":"39 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146129489","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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