Pub Date : 2023-11-07DOI: 10.1016/j.lpm.2023.104204
Thanush D , M.P. Venkatesh
Fecal microbiota transplantation (FMT) is a medical treatment which involves the transfer of feces from a healthy donor to a recipient to restore the balance of gut microbiota and improve clinical outcomes. FMT has gained recognition in recent years due to its effectiveness in treating recurrent Clostridioides difficile infections (rCDI) and other gastrointestinal disorders. Additionally, it has been studied as an intervention for some other conditions, like inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS). This review covers regulatory considerations related to FMT, including the current state of FMT regulation and the need for further research to fully understand the safety and efficacy of this treatment. For transplantation of fecal microbiota, the Food and Drug Administration (FDA) classifies the treatment as an investigational new drug (IND), which typically requires physicians and scientists to submit an IND application. Ethical issues surrounding FMT, including the necessity of informed consent from donors and recipients and the potential transmission of infectious agents, are also discussed. Overall, FMT has the potential to offer significant therapeutic benefits, but it also raises regulatory and ethical considerations that require careful consideration. Further research is necessary to fully comprehend risks and benefits of FMT and to develop guidelines for its use in clinical practice.
{"title":"Fecal microbiota transplantation: History, procedure and regulatory considerations","authors":"Thanush D , M.P. Venkatesh","doi":"10.1016/j.lpm.2023.104204","DOIUrl":"10.1016/j.lpm.2023.104204","url":null,"abstract":"<div><p><span><span><span>Fecal microbiota transplantation<span> (FMT) is a medical treatment<span> which involves the transfer of feces from a healthy donor to a recipient to restore the balance of gut microbiota and improve clinical outcomes. FMT has gained recognition in recent years due to its effectiveness in treating recurrent Clostridioides difficile infections (rCDI) and other </span></span></span>gastrointestinal disorders. Additionally, it has been studied as an intervention for some other conditions, like inflammatory bowel disease (IBD) and </span>irritable bowel syndrome (IBS). This review covers regulatory considerations related to FMT, including the current state of FMT regulation and the need for further research to fully understand the safety and efficacy of this treatment. For transplantation of fecal microbiota, the Food and Drug Administration (FDA) classifies the treatment as an investigational new </span>drug<span> (IND), which typically requires physicians and scientists to submit an IND application. Ethical issues surrounding FMT, including the necessity of informed consent from donors and recipients and the potential transmission of infectious agents, are also discussed. Overall, FMT has the potential to offer significant therapeutic benefits, but it also raises regulatory and ethical considerations that require careful consideration. Further research is necessary to fully comprehend risks and benefits of FMT and to develop guidelines for its use in clinical practice.</span></p></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"52 4","pages":"Article 104204"},"PeriodicalIF":2.7,"publicationDate":"2023-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72015195","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pregnancy is a particularly risky period in the life of patients with sickle cell disease (SCD). Physiological changes during pregnancy increase the risk of vaso-occlusive crises (VOC), acute chest syndrome, venous thromboembolic events, and infections. This concerns haemoglobin (Hb) S/C and S/β+-thalassaemia patients as much than S/S or S/β0-thalassaemia patients. SCD also increases the risk of obstetrical complications, such as preeclampsia, in utero foetal death, preterm delivery mostly induced, and intrauterine growth restriction. Thus, pregnancy should be planned and closely monitored by a multidisciplinary team involving obstetricians and sickle cell disease specialists. Before pregnancy, the parents should also be informed about the risk of transmission of this autosomal recessive disease, and the father should therefore be prescribed haemoglobin electrophoresis. Treatments have to be revised when planning pregnancy: hydroxyurea (HU) should be stopped as soon as pregnancy is suspected or confirmed. Preventive blood transfusion is not systematic, but is recommended in the case of a pre-existing transfusion program prior to pregnancy, severe pre-existing organ damage, severe obstetric history, and severe or repeated crises during follow-up, especially in patients taking HU before. Despite the risks of prematurity, systematic administration of corticosteroids for foetal lung maturation is not recommended due to the risk of maternal vaso-occlusive event. Although more frequent, due to obstetrical and maternal complications, caesarean section is not systematic, in the absence of maternal contraindications. It is advisable not to exceed the term of 39 weeks of amenorrhoea. Post-partum follow-up is recommended, particularly because of the risk of thromboembolism.
{"title":"Sickle cell disease and pregnancy","authors":"Julie Carrara , Anoosha Habibi , Alexandra Benachi , Geoffrey Cheminet","doi":"10.1016/j.lpm.2023.104203","DOIUrl":"10.1016/j.lpm.2023.104203","url":null,"abstract":"<div><p><span><span>Pregnancy is a particularly risky period in the life of patients with sickle cell disease (SCD). Physiological changes during pregnancy increase the risk of vaso-occlusive crises (VOC), acute chest syndrome, venous </span>thromboembolic events, and infections. This concerns haemoglobin (Hb) S/C and S/β</span><sup>+</sup>-thalassaemia patients as much than S/S or S/β<sup>0</sup><span><span><span>-thalassaemia patients. SCD<span><span><span> also increases the risk of obstetrical complications, such as preeclampsia<span>, in utero foetal death, </span></span>preterm delivery mostly induced, and </span>intrauterine growth restriction<span><span>. Thus, pregnancy should be planned and closely monitored by a multidisciplinary team involving obstetricians and sickle cell disease specialists. Before pregnancy, the parents should also be informed about the risk of transmission of this autosomal recessive disease, and the father should therefore be prescribed </span>haemoglobin electrophoresis<span>. Treatments have to be revised when planning pregnancy: </span></span></span></span>hydroxyurea<span><span> (HU) should be stopped as soon as pregnancy is suspected or confirmed. Preventive blood transfusion is not systematic, but is recommended in the case of a pre-existing transfusion program prior to pregnancy, severe pre-existing organ damage, severe </span>obstetric history, and severe or repeated crises during follow-up, especially </span></span>in patients<span><span> taking HU before. Despite the risks of prematurity, systematic administration of corticosteroids for foetal lung maturation<span> is not recommended due to the risk of maternal vaso-occlusive event. Although more frequent, due to obstetrical and maternal complications, caesarean section is not systematic, in the absence of maternal contraindications. It is advisable not to exceed the term of 39 weeks of </span></span>amenorrhoea. Post-partum follow-up is recommended, particularly because of the risk of thromboembolism.</span></span></p></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"52 4","pages":"Article 104203"},"PeriodicalIF":2.7,"publicationDate":"2023-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71522467","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-10-26DOI: 10.1016/j.lpm.2023.104191
Karl Bounader , Erwan Flécher
In the last decades, outcomes significantly improved for both heart transplantation and LVAD. Heart transplantation remains the gold standard for the treatment of end stage heart failure and will remain for many years to come. The most relevant limitations are the lack of grafts and the effects of long-term immunosuppressive therapy that involve infectious, cancerous and metabolic complications despite advances in immunosuppression management. Mechanical circulatory support has an irreplaceable role in the treatment of end-staged heart failure, as bridge to transplant or as definitive implantation in non-transplant candidates. Although clinical results do not overcome those of HTx, improvement in the new generation of devices may help to reach the equipoise between the two therapies.
This review will go through the evolution, current status and perspectives of both therapeutics.
{"title":"End-stage heart failure: The future of heart transplant and artificial heart","authors":"Karl Bounader , Erwan Flécher","doi":"10.1016/j.lpm.2023.104191","DOIUrl":"10.1016/j.lpm.2023.104191","url":null,"abstract":"<div><p>In the last decades, outcomes significantly improved for both heart transplantation<span><span><span> and LVAD. Heart transplantation remains the gold standard for the treatment of end stage heart failure and will remain for many years to come. The most relevant limitations are the lack of grafts and the effects of long-term </span>immunosuppressive therapy that involve infectious, cancerous and metabolic complications despite advances in immunosuppression management. Mechanical </span>circulatory support has an irreplaceable role in the treatment of end-staged heart failure, as bridge to transplant or as definitive implantation in non-transplant candidates. Although clinical results do not overcome those of HTx, improvement in the new generation of devices may help to reach the equipoise between the two therapies.</span></p><p>This review will go through the evolution, current status and perspectives of both therapeutics.</p></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"53 1","pages":"Article 104191"},"PeriodicalIF":2.7,"publicationDate":"2023-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66784227","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-10-26DOI: 10.1016/j.lpm.2023.104192
Cecilia Linde
Device therapy for heart failure has rapidly evolved over 2 decades. The knowledge of indications, assessment lead and device technology has expanded to include CRT, leadless pacing and conduction system pacing such as His bundle and left bundle branch area pacing. But there is still a lack of evidence for these new technologies as well as for common indications such as atrial fibrillation and upgrading from a previous device. The role of personalized medicine will become increasingly important when selecting candidates for CRT, primary preventive ICD ablation procedures and emerging new devices such as cardiac contractility modulation (CCM). Rapidity of therapy is associated with outcome which will be a challenge. If properly implemented devices and drugs will have a large positive affect of HF outcomes.
{"title":"Electrical therapies in heart failure: Evolving technologies and indications","authors":"Cecilia Linde","doi":"10.1016/j.lpm.2023.104192","DOIUrl":"10.1016/j.lpm.2023.104192","url":null,"abstract":"<div><p>Device therapy for heart failure has rapidly evolved over 2 decades. The knowledge of indications, assessment lead and device technology has expanded to include CRT, leadless pacing and conduction system pacing such as His bundle and left bundle branch area pacing. But there is still a lack of evidence for these new technologies as well as for common indications such as atrial fibrillation and upgrading from a previous device. The role of personalized medicine will become increasingly important when selecting candidates for CRT, primary preventive ICD ablation procedures and emerging new devices such as cardiac contractility modulation (CCM). Rapidity of therapy is associated with outcome which will be a challenge. If properly implemented devices and drugs will have a large positive affect of HF outcomes.</p></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"53 1","pages":"Article 104192"},"PeriodicalIF":2.7,"publicationDate":"2023-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0755498223000295/pdfft?md5=308445461c6b675bf60093ce261c8143&pid=1-s2.0-S0755498223000295-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66784226","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-10-22DOI: 10.1016/j.lpm.2023.104185
Damien Logeart
Heart failure (HF) is a major public health problem affecting millions of adults worldwide. HF with preserved ejection fraction, i.e. > 50 %, (HFpEF) accounts for more than half of all HF cases, and its incidence and prevalence are increasing with the aging of the population and the growing prevalence of metabolic disorders such as obesity, diabetes and hypertension. Diagnosis of HFpEF requires a combination of numerous echocardiographic parameters and also results of natriuretic peptide assays, to which may be added the need for a stress test. HFpEF is characterized by complex, interrelated pathophysiological mechanisms, which must be understood. This complexity probably accounts for the lack of evidence-based medicine compared with HF with reduced EF. Nevertheless, significant progress has been made recently, with a high level of evidence obtained for the SGLT2 inhibitor class on the one hand, and promising data with new drugs targeting more specifically certain mechanisms such as obesity and inflammation on the other.
{"title":"Heart failure with preserved ejection fraction: New challenges and new hopes","authors":"Damien Logeart","doi":"10.1016/j.lpm.2023.104185","DOIUrl":"10.1016/j.lpm.2023.104185","url":null,"abstract":"<div><p>Heart failure (HF) is a major public health<span><span> problem affecting millions of adults worldwide. HF with preserved ejection fraction<span>, i.e. > 50 %, (HFpEF) accounts for more than half of all HF cases, and its incidence and prevalence are increasing with the aging of the population and the growing prevalence of metabolic disorders<span> such as obesity, diabetes and hypertension. Diagnosis of HFpEF<span> requires a combination of numerous echocardiographic parameters and also results of natriuretic peptide assays, to which may be added the need for a stress test. HFpEF is characterized by complex, interrelated pathophysiological mechanisms, which must be understood. This complexity probably accounts for the lack of evidence-based medicine compared with HF with reduced EF. Nevertheless, significant progress has been made recently, with a high level of evidence obtained for the </span></span></span></span>SGLT2 inhibitor<span> class on the one hand, and promising data with new drugs targeting more specifically certain mechanisms such as obesity and inflammation on the other.</span></span></p></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"53 1","pages":"Article 104185"},"PeriodicalIF":2.7,"publicationDate":"2023-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"50158629","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-10-21DOI: 10.1016/j.lpm.2023.104184
Ayu Asakage , Alexandre Mebazaa , Benjamin Deniau
Acute heart failure (AHF) is a clinical complex disease and a worldwide issue due to its inconsistent diagnosis and poor prognosis. The cornerstone of pathophysiology of AHF is systemic venous congestion, which is led by the underlying structural and functional cardiac condition. Systemic venous congestion is a major target for AHF management because it causes symptoms and organs dysfunction, and is associated with poor prognosis. The mainstay of decongestive therapy is diuresis with intravenous loop diuretics combined with other diuretics including thiazides when necessary, and non-invasive ventilation. The presence of unresolved congestion at discharge can lead heart failure related rehospitalization, and careful follow-up is required especially during “vulnerable phase”, several months after discharge. The updated recommendation for management of AHF has been provided by latest guidelines from European Society of Cardiology and American Heart Association/American College of Cardiology/Heart Failure Society of America. Several large studies have currently demonstrated the benefits of guideline-directed oral medical therapies, and trials are ongoing on medication such as selective sodium-glucose transport proteins 2 inhibitors and protocols for congestive therapy. This review aimed to summarize the latest insights in AHF, based primarily on the most recent guidelines and large randomized controlled trials.
{"title":"New insights in acute heart failure","authors":"Ayu Asakage , Alexandre Mebazaa , Benjamin Deniau","doi":"10.1016/j.lpm.2023.104184","DOIUrl":"10.1016/j.lpm.2023.104184","url":null,"abstract":"<div><p><span><span><span>Acute heart failure (AHF) is a clinical complex disease and a worldwide issue due to its inconsistent diagnosis and poor prognosis. The cornerstone of </span>pathophysiology<span><span> of AHF is systemic venous congestion, which is led by the underlying structural and functional cardiac condition. Systemic venous congestion is a major target for AHF management because it causes symptoms and organs dysfunction, and is associated with poor prognosis. The mainstay of decongestive therapy is </span>diuresis with intravenous </span></span>loop diuretics<span><span> combined with other diuretics including </span>thiazides when necessary, and non-invasive ventilation. The presence of unresolved congestion at discharge can lead heart failure related rehospitalization, and careful follow-up is required especially during “vulnerable phase”, several months </span></span>after discharge<span><span>. The updated recommendation for management of AHF has been provided by latest guidelines from European Society of Cardiology and American Heart Association/American College of Cardiology/Heart Failure Society of America. Several large studies have currently demonstrated the benefits of guideline-directed oral medical therapies, and trials are ongoing on medication such as selective sodium-glucose transport proteins 2 inhibitors and protocols for congestive therapy. This review aimed to summarize the latest insights in AHF, based primarily on the most recent guidelines and large </span>randomized controlled trials.</span></p></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"53 1","pages":"Article 104184"},"PeriodicalIF":2.7,"publicationDate":"2023-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49681531","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-10-05DOI: 10.1016/j.lpm.2023.104179
Michel Marre
{"title":"Facing the Evidences with Type 2 Diabetes: Contemporary Challenges","authors":"Michel Marre","doi":"10.1016/j.lpm.2023.104179","DOIUrl":"10.1016/j.lpm.2023.104179","url":null,"abstract":"","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"52 1","pages":"Article 104179"},"PeriodicalIF":2.7,"publicationDate":"2023-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41145528","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-10-04DOI: 10.1016/j.lpm.2023.104177
Samy Hadjadj , Pierre Jean Saulnier , Bertrand Cariou , SURDIAGENE study investigators
Type 2 diabetes is associated with an increased risk for end-stage renal disease and heart failure, contributing to premature death. All these 3 events are inter-related, suggesting common risk factors and/or pathophysiological pathways.
The SURDIAGENE (SUrvie Rénale DIAbète et GENEtique) cohort is a single centre hospital-based cohort of persons living with type 2 diabetes, recruiting participants at Poitiers university hospital, France, from 2002 to 2011 with further follow-up till 2015.
Here, we describe the cumulative prevalence of hard renal events (sustained doubling of serum creatinine and/or renal replacement therapy), heart failure leading to hospitalization (HFH) and all-cause death, according to the KDIGO classification, which considers CKD stages according to CKD EPI equation [1], [2], [3], [4], [5] and albuminuria (A1, A2, A3) according to albumin/creatinine ratio with thresholds at 30 and 300 mg/g. We considered 1450 participants with KDIGO stage available at baseline.
Considering a cumulated follow-up duration of 10667 patient.years with 100 renal events, 247 HFH and 527 deaths, our study showed that the more severe the KDIGO stage, the higher the incidence rate not only for renal event, but also for HFH and for all-cause death. For instance, in CKD1A1 and CKD4A3 the incidence rates for hard renal events, HFH and death were 0.98 and 140.70, 4.46 and 107.09, 13.64 and 156.56 per 1000 patient.years, respectively. Interestingly, the incidence of renal event was lower than the incidence of all-cause death in all KDIGO stages, at variance with the data from recent renal outcome trials on SGLT2 inhibitors and finerenone.
We conclude that KDIGO stages should be considered for renal but also for HFH risk classification. The analysis of the respective incidence of renal events and deaths in observational studies and RCTs deserves further evaluation in type 2 diabetes.
2型糖尿病与终末期肾病和心力衰竭的风险增加有关,导致过早死亡。所有这3个事件都是相互关联的,提示共同的危险因素和/或病理生理途径。SURDIAGENE(SUrvie Rénale DIAbète et GENEtique)队列是一个以2型糖尿病患者为基础的单中心医院队列,从2002年到2011年在法国普瓦捷大学医院招募参与者,并进一步随访到2015年。在这里,我们描述了根据KDIGO分类的硬肾事件(血清肌酐持续翻倍和/或肾脏替代治疗)、导致住院的心力衰竭(HFH)和全因死亡的累积患病率,根据CKD EPI方程[1-5]考虑CKD分期,根据白蛋白/肌酐比值考虑白蛋白尿(A1、A2、A3),阈值为30和300mg/g。我们在基线时考虑了1450名KDIGO阶段的参与者。考虑到10667名患者的累计随访时间,100例肾事件、247例HFH和527例死亡,我们的研究表明,KDIGO阶段越严重,不仅肾事件的发生率越高,HFH和全因死亡的发生率也越高。例如,在CKD1A1和CKD4A3中,硬肾事件、HFH和死亡的发生率分别为0.98和140.70、4.46和107.09、13.64和156.56/1000名患者年。有趣的是,在所有KDIGO阶段,肾事件的发生率都低于全因死亡的发生率,这与最近SGLT2抑制剂和芬瑞酮的肾结果试验数据不一致。我们得出的结论是,肾脏和HFH风险分类应考虑KDIGO分期。在2型糖尿病的观察性研究和随机对照试验中对肾脏事件和死亡的各自发生率的分析值得进一步评估。
{"title":"Severity of kidney involvement as predictor of death, severe heart failure and renal events in patients with type 2 diabetes: data from a prospective cohort","authors":"Samy Hadjadj , Pierre Jean Saulnier , Bertrand Cariou , SURDIAGENE study investigators","doi":"10.1016/j.lpm.2023.104177","DOIUrl":"10.1016/j.lpm.2023.104177","url":null,"abstract":"<div><p>Type 2 diabetes is associated with an increased risk for end-stage renal disease and heart failure, contributing to premature death. All these 3 events are inter-related, suggesting common risk factors and/or pathophysiological pathways.</p><p>The SURDIAGENE (SUrvie Rénale DIAbète et GENEtique) cohort is a single centre hospital-based cohort of persons living with type 2 diabetes, recruiting participants at Poitiers university hospital, France, from 2002 to 2011 with further follow-up till 2015.</p><p>Here, we describe the cumulative prevalence of hard renal events (sustained doubling of serum creatinine and/or renal replacement therapy), heart failure leading to hospitalization (HFH) and all-cause death, according to the KDIGO classification, which considers CKD stages according to CKD EPI equation <span>[1]</span>, <span>[2]</span>, <span>[3]</span>, <span>[4]</span>, <span>[5]</span> and albuminuria (A1, A2, A3) according to albumin/creatinine ratio with thresholds at 30 and 300 mg/g. We considered 1450 participants with KDIGO stage available at baseline.</p><p>Considering a cumulated follow-up duration of 10667 patient.years with 100 renal events, 247 HFH and 527 deaths, our study showed that the more severe the KDIGO stage, the higher the incidence rate not only for renal event, but also for HFH and for all-cause death. For instance, in CKD1A1 and CKD4A3 the incidence rates for hard renal events, HFH and death were 0.98 and 140.70, 4.46 and 107.09, 13.64 and 156.56 per 1000 patient.years, respectively. Interestingly, the incidence of renal event was lower than the incidence of all-cause death in all KDIGO stages, at variance with the data from recent renal outcome trials on SGLT2 inhibitors and finerenone.</p><p>We conclude that KDIGO stages should be considered for renal but also for HFH risk classification. The analysis of the respective incidence of renal events and deaths in observational studies and RCTs deserves further evaluation in type 2 diabetes.</p></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"52 1","pages":"Article 104177"},"PeriodicalIF":2.7,"publicationDate":"2023-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41145870","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-09-30DOI: 10.1016/j.lpm.2023.104178
Tomasz J. Block , Mark E. Cooper
Major clinical advances over the last 25 years in the area of diabetic kidney disease (DKD) have been confirmed in large seminal clinical trials. These findings add to the previously identified benefits resulting from intensive glucose and blood pressure control therapies. Furthermore, newer glucose lowering treatments such as SGLT2 inhibitors and GLP-1 agonists appear very promising and are likely to transform the management and outlook of DKD over the next decade. In addition, newer mineralocorticoid receptor antagonists and a recently reported trial with an endothelin receptor blocker also have the potential to change clinical practice.
{"title":"Clinical Trials with reno-vascular end points in patients with diabetes: Changing the scenario over the past 20 years","authors":"Tomasz J. Block , Mark E. Cooper","doi":"10.1016/j.lpm.2023.104178","DOIUrl":"10.1016/j.lpm.2023.104178","url":null,"abstract":"<div><p>Major clinical advances over the last 25 years in the area of diabetic kidney disease (DKD) have been confirmed in large seminal clinical trials. These findings add to the previously identified benefits resulting from intensive glucose and blood pressure control therapies. Furthermore, newer glucose lowering treatments such as SGLT2 inhibitors and GLP-1 agonists appear very promising and are likely to transform the management and outlook of DKD over the next decade. In addition, newer mineralocorticoid receptor antagonists and a recently reported trial with an endothelin receptor blocker also have the potential to change clinical practice.</p></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"52 1","pages":"Article 104178"},"PeriodicalIF":2.7,"publicationDate":"2023-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41125791","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-09-30DOI: 10.1016/j.lpm.2023.104176
Helen C Looker , Douglas C Chang , Leslie J Baier , Robert L Hanson , Robert G Nelson
The Phoenix Epidemiology and Clinical Research Branch of the National Institute of Diabetes and Digestive and Kidney Diseases has conducted prospective studies of diabetes and its complications in the Pima Indians living in Arizona, USA for over 50 years. In this review we highlight areas in which these studies provided vital insights into the criteria used to diagnose type 2 diabetes, the pathophysiologic changes that accompany the development of type 2 diabetes, and the course and determinants of diabetes complications—focusing specifically on diabetic kidney disease. We include data from our longitudinal population-based study of diabetes and its complications, studies on the role of insulin resistance and insulin secretion in the pathophysiology of type 2 diabetes, and in-depth studies of diabetic kidney disease that include measures of glomerular function and research kidney biopsies. We also focus on the emerging health threat posed by youth-onset type 2 diabetes, which was first seen in the Pima Indians in the 1960s and is becoming an increasing issue worldwide.
{"title":"Diagnostic Criteria and Etiopathogenesis of Type 2 Diabetes and Its Complications: Lessons from the Pima Indians","authors":"Helen C Looker , Douglas C Chang , Leslie J Baier , Robert L Hanson , Robert G Nelson","doi":"10.1016/j.lpm.2023.104176","DOIUrl":"10.1016/j.lpm.2023.104176","url":null,"abstract":"<div><p>The Phoenix Epidemiology and Clinical Research Branch of the National Institute of Diabetes and Digestive and Kidney Diseases has conducted prospective studies of diabetes and its complications in the Pima Indians living in Arizona, USA for over 50 years. In this review we highlight areas in which these studies provided vital insights into the criteria used to diagnose type 2 diabetes, the pathophysiologic changes that accompany the development of type 2 diabetes, and the course and determinants of diabetes complications—focusing specifically on diabetic kidney disease. We include data from our longitudinal population-based study of diabetes and its complications, studies on the role of insulin resistance and insulin secretion in the pathophysiology of type 2 diabetes, and in-depth studies of diabetic kidney disease that include measures of glomerular function and research kidney biopsies. We also focus on the emerging health threat posed by youth-onset type 2 diabetes, which was first seen in the Pima Indians in the 1960s and is becoming an increasing issue worldwide.</p></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"52 1","pages":"Article 104176"},"PeriodicalIF":2.7,"publicationDate":"2023-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41131536","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}