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1.
Cardiovasc Diabetol ; 21(1): 50, 2022 04 08.
Article in English | MEDLINE | ID: covidwho-1779649

ABSTRACT

The 7th Cardiovascular Outcome Trial (CVOT) Summit on Cardiovascular, Renal, and Glycemic Outcomes, was held virtually on November 18-19, 2021. Pursuing the tradition of the previous summits, this reference congress served as a platform for in-depth discussion and exchange on recently completed CVOTs. This year's focus was placed on the outcomes of EMPEROR-Preserved, FIGARO-DKD, AMPLITUDE-O, SURPASS 1-5, and STEP 1-5. Trial implications for diabetes and obesity management and the impact on new treatment algorithms were highlighted for endocrinologists, diabetologists, cardiologists, nephrologists, and general practitioners. Discussions evolved from outcome trials using SGLT2 inhibitors as therapy for heart failure, to CVOTs with nonsteroidal mineralocorticoid receptor antagonists and GLP-1 receptor agonists. Furthermore, trials for glycemic and overweight/obesity management, challenges in diabetes management in COVID-19, and novel guidelines and treatment strategies were discussed.Trial registration The 8th Cardiovascular Outcome Trial Summit will be held virtually on November 10-11, 2022 ( http://www.cvot.org ).


Subject(s)
Cardiovascular Diseases , Diabetes Mellitus , Blood Glucose , COVID-19 , Cardiovascular Diseases/drug therapy , Clinical Trials as Topic , Diabetes Mellitus/drug therapy , Humans , Hypoglycemic Agents/therapeutic use , Sodium-Glucose Transporter 2 Inhibitors/therapeutic use , Treatment Outcome
2.
BMC Med Res Methodol ; 22(1): 44, 2022 02 11.
Article in English | MEDLINE | ID: covidwho-1690972

ABSTRACT

BACKGROUND: Prospective cohort studies are challenging to deliver, with one of the main difficulties lying in retention of participants. The need to socially distance during the COVID-19 pandemic has added to this challenge. The pre-COVID-19 adaptation of the European Quality (EQUAL) study in the UK to a remote form of follow-up for efficiency provides lessons for those who are considering changing their study design. METHODS: The EQUAL study is an international prospective cohort study of patients ≥65 years of age with advanced chronic kidney disease. Initially, patients were invited to complete a questionnaire (SF-36, Dialysis Symptom Index and Renal Treatment Satisfaction Questionnaire) at research clinics every 3-6 months, known as "traditional follow-up" (TFU). In 2018, all living patients were invited to switch to "efficient follow-up" (EFU), which used an abbreviated questionnaire consisting of SF-12 and Dialysis Symptom Index. These were administered centrally by post. Response rates were calculated using returned questionnaires as a proportion of surviving invitees, and error rates presented as the average percentage of unanswered questions or unclear answers, of total questions in returned questionnaires. Response and error rates were calculated 6-monthly in TFU to allow comparisons with EFU. RESULTS: Of the 504 patients initially recruited, 236 were still alive at the time of conversion to EFU; 111 of these (47%) consented to the change in follow-up. In those who consented, median TFU was 34 months, ranging from 0 to 42 months. Their response rates fell steadily from 88% (98/111) at month 0 of TFU, to 20% (3/15) at month 42. The response rate for the first EFU questionnaire was 60% (59/99) of those alive from TFU. With this improvement in response rates, the first EFU also lowered errors to baseline levels seen in early follow-up, after having almost trebled throughout traditional follow-up. CONCLUSIONS: Overall, this study demonstrates that administration of shorter follow-up questionnaires by post rather than in person does not negatively impact patient response or error rates. These results may be reassuring for researchers who are trying to limit face-to-face contact with patients during the COVID-19 pandemic.


Subject(s)
COVID-19 , Pandemics , Follow-Up Studies , Humans , Prospective Studies , SARS-CoV-2 , United Kingdom/epidemiology
3.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-312328

ABSTRACT

Introduction: There is evidence that SARS-CoV2 has a particular affinity for kidney tissue and is often associated with kidney failure. Methods: We assessed whether proteinuria can be predictive of kidney failure, the development of chronic kidney disease, and mortality in 37 critically ill COVID-19 patients. We used machine learning (ML) methods as decision trees and cut-off points created by the OneR package to add new aspects, even in smaller cohorts. Results: Among a total of 37 patients, 24 suffered higher-grade renal failure, 20 of whom required kidney replacement therapy. More than 40% of patients remained on hemodialysis after intensive care unit discharge or died (27%). Due to frequent anuria proteinuria measured in two-thirds of the patients, it was not predictive for the investigated endpoints;albuminuria was higher in patients with AKI 3, but the difference was not significant. ML found cut-off points of > 31.4 kg/m 2 for BMI and > 69 years for age, constructed decision trees with great accuracy, and identified highly predictive variables for outcome and remaining chronic kidney disease. Conclusions: Different ML methods and their clinical application, especially decision trees, can provide valuable support for clinical decisions. Presence of proteinuria was not predictive of CKD or AKI and should be confirmed in a larger cohort.

4.
N Engl J Med ; 385(25): 2325-2335, 2021 12 16.
Article in English | MEDLINE | ID: covidwho-1575626

ABSTRACT

BACKGROUND: Among patients with chronic kidney disease (CKD), the use of recombinant human erythropoietin and its derivatives for the treatment of anemia has been linked to a possibly increased risk of stroke, myocardial infarction, and other adverse events. Several trials have suggested that hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitors (PHIs) are as effective as erythropoiesis-stimulating agents (ESAs) in increasing hemoglobin levels. METHODS: In this randomized, open-label, phase 3 trial, we assigned patients with CKD who were undergoing dialysis and who had a hemoglobin level of 8.0 to 11.5 g per deciliter to receive an oral HIF-PHI (daprodustat) or an injectable ESA (epoetin alfa if they were receiving hemodialysis or darbepoetin alfa if they were receiving peritoneal dialysis). The two primary outcomes were the mean change in the hemoglobin level from baseline to weeks 28 through 52 (noninferiority margin, -0.75 g per deciliter) and the first occurrence of a major adverse cardiovascular event (a composite of death from any cause, nonfatal myocardial infarction, or nonfatal stroke), with a noninferiority margin of 1.25. RESULTS: A total of 2964 patients underwent randomization. The mean (±SD) baseline hemoglobin level was 10.4±1.0 g per deciliter overall. The mean (±SE) change in the hemoglobin level from baseline to weeks 28 through 52 was 0.28±0.02 g per deciliter in the daprodustat group and 0.10±0.02 g per deciliter in the ESA group (difference, 0.18 g per deciliter; 95% confidence interval [CI], 0.12 to 0.24), which met the prespecified noninferiority margin of -0.75 g per deciliter. During a median follow-up of 2.5 years, a major adverse cardiovascular event occurred in 374 of 1487 patients (25.2%) in the daprodustat group and in 394 of 1477 (26.7%) in the ESA group (hazard ratio, 0.93; 95% CI, 0.81 to 1.07), which also met the prespecified noninferiority margin for daprodustat. The percentages of patients with other adverse events were similar in the two groups. CONCLUSIONS: Among patients with CKD undergoing dialysis, daprodustat was noninferior to ESAs regarding the change in the hemoglobin level from baseline and cardiovascular outcomes. (Funded by GlaxoSmithKline; ASCEND-D ClinicalTrials.gov number, NCT02879305.).


Subject(s)
Anemia/drug therapy , Barbiturates/therapeutic use , Darbepoetin alfa/therapeutic use , Epoetin Alfa/therapeutic use , Glycine/analogs & derivatives , Hematinics/therapeutic use , Renal Dialysis , Renal Insufficiency, Chronic/complications , Aged , Anemia/etiology , Barbiturates/adverse effects , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/etiology , Cardiovascular Diseases/mortality , Darbepoetin alfa/adverse effects , Epoetin Alfa/adverse effects , Female , Glycine/adverse effects , Glycine/therapeutic use , Hematinics/adverse effects , Hemoglobins/analysis , Humans , Hypoxia-Inducible Factor-Proline Dioxygenases/antagonists & inhibitors , Intention to Treat Analysis , Male , Middle Aged , Myocardial Infarction/epidemiology , Renal Insufficiency, Chronic/blood , Renal Insufficiency, Chronic/therapy , Stroke/epidemiology
5.
N Engl J Med ; 385(25): 2313-2324, 2021 12 16.
Article in English | MEDLINE | ID: covidwho-1575625

ABSTRACT

BACKGROUND: Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor. In patients with chronic kidney disease (CKD) who are not undergoing dialysis, the efficacy and safety of daprodustat, as compared with the conventional erythropoiesis-stimulating agent darbepoetin alfa, are unknown. METHODS: In this randomized, open-label, phase 3 trial with blinded adjudication of cardiovascular outcomes, we compared daprodustat with darbepoetin alfa for the treatment of anemia in patients with CKD who were not undergoing dialysis. The primary outcomes were the mean change in the hemoglobin level from baseline to weeks 28 through 52 and the first occurrence of a major adverse cardiovascular event (MACE; a composite of death from any cause, nonfatal myocardial infarction, or nonfatal stroke). RESULTS: Overall, 3872 patients were randomly assigned to receive daprodustat or darbepoetin alfa. The mean (±SD) baseline hemoglobin levels were similar in the two groups. The mean (±SE) change in the hemoglobin level from baseline to weeks 28 through 52 was 0.74±0.02 g per deciliter in the daprodustat group and 0.66±0.02 g per deciliter in the darbepoetin alfa group (difference, 0.08 g per deciliter; 95% confidence interval [CI], 0.03 to 0.13), which met the prespecified noninferiority margin of -0.75 g per deciliter. During a median follow-up of 1.9 years, a first MACE occurred in 378 of 1937 patients (19.5%) in the daprodustat group and in 371 of 1935 patients (19.2%) in the darbepoetin alfa group (hazard ratio, 1.03; 95% CI, 0.89 to 1.19), which met the prespecified noninferiority margin of 1.25. The percentages of patients with adverse events were similar in the two groups. CONCLUSIONS: Among patients with CKD and anemia who were not undergoing dialysis, daprodustat was noninferior to darbepoetin alfa with respect to the change in the hemoglobin level from baseline and with respect to cardiovascular outcomes. (Funded by GlaxoSmithKline; ASCEND-ND ClinicalTrials.gov number, NCT02876835.).


Subject(s)
Anemia/drug therapy , Barbiturates/therapeutic use , Darbepoetin alfa/therapeutic use , Glycine/analogs & derivatives , Hematinics/therapeutic use , Renal Insufficiency, Chronic/complications , Aged , Anemia/etiology , Barbiturates/adverse effects , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/etiology , Cardiovascular Diseases/mortality , Darbepoetin alfa/adverse effects , Female , Glycine/adverse effects , Glycine/therapeutic use , Hematinics/adverse effects , Hemoglobins/analysis , Humans , Hypoxia-Inducible Factor-Proline Dioxygenases/antagonists & inhibitors , Intention to Treat Analysis , Male , Middle Aged , Myocardial Infarction/epidemiology , Renal Insufficiency, Chronic/blood , Stroke/epidemiology
6.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-292325

ABSTRACT

Background: Prospective cohort studies are challenging to deliver, with one of the main difficulties lying in retention of participants. The need to socially distance during the COVID-19 pandemic has added to this challenge. The pre-COVID-19 adaptation of the European Quality (EQUAL) study in the UK to a remote form of follow-up for efficiency provides lessons for those who are considering changing their study design.MethodsThe EQUAL study is an international prospective cohort study of patients ≥65 years of age with advanced chronic kidney disease. Initially, patients were invited to complete a questionnaire (SF-36, Dialysis Symptom Index and Renal Treatment Satisfaction Questionnaire) at research clinics every 3-6 months, known as “traditional follow-up” (TFU). In 2018, all living patients were invited to switch to “efficient follow-up” (EFU), which used an abbreviated questionnaire consisting of SF-12 and Dialysis Symptom Index. These were administered centrally by post. Response rates were calculated using returned questionnaires as a proportion of surviving invitees, and error rates presented as the average percentage of unanswered questions or unclear answers, of total questions in returned questionnaires. Response and error rates were calculated 6-monthly in TFU to allow comparisons with EFU.ResultsOf the 504 patients initially recruited, 236 were still alive at the time of conversion to EFU;111 of these (47%) consented to the change in follow-up. In those who consented, median TFU was 34 months, ranging from 0 to 42 months. Their response rates fell steadily from 88% (98/111) at month 0 of TFU, to 20% (3/15) at month 42. The response rate for the first EFU questionnaire was 60% (59/99) of those alive from TFU. With this improvement in response rates, the first EFU also lowered errors to baseline levels seen in early follow-up, after having almost trebled throughout traditional follow-up.ConclusionsOverall, this study demonstrates that administration of shorter follow-up questionnaires by post rather than in person does not negatively impact patient response or error rates. These results may be reassuring for researchers who are trying to limit face-to-face contact with patients during the COVID-19 pandemic.

7.
Nephrol Dial Transplant ; 36(1): 1-4, 2021 01 01.
Article in English | MEDLINE | ID: covidwho-1343705
8.
Clin Kidney J ; 14(7): 1719-1730, 2021 Jul.
Article in English | MEDLINE | ID: covidwho-1341109

ABSTRACT

A brief comprehensive overview is provided of the elements constituting the burden of kidney disease [chronic kidney disease (CKD) and acute kidney injury]. This publication can be used for advocacy, emphasizing the importance and urgency of reducing this heavy and rapidly growing burden. Kidney diseases contribute to significant physical limitations, loss of quality of life, emotional and cognitive disorders, social isolation and premature death. CKD affects close to 100 million Europeans, with 300 million being at risk, and is projected to become the fifth cause of worldwide death by 2040. Kidney disease also imposes financial burdens, given the costs of accessing healthcare and inability to work. The extrapolated annual cost of all CKD is at least as high as that for cancer or diabetes. In addition, dialysis treatment of kidney diseases imposes environmental burdens by necessitating high energy and water consumption and producing plastic waste. Acute kidney injury is associated with further increases in global morbidity, mortality and economic burden. Yet investment in research for treatment of kidney disease lags behind that of other diseases. This publication is a call for European investment in research for kidney health. The innovations generated should mirror the successful European Union actions against cancer over the last 30 years. It is also a plea to nephrology professionals, patients and their families, caregivers and kidney health advocacy organizations to draw, during the Decade of the Kidney (2020-30), the attention of authorities to realize changes in understanding, research and treatment of kidney disease.

9.
PLoS One ; 16(5): e0251932, 2021.
Article in English | MEDLINE | ID: covidwho-1236592

ABSTRACT

INTRODUCTION: There is evidence that SARS-CoV2 has a particular affinity for kidney tissue and is often associated with kidney failure. METHODS: We assessed whether proteinuria can be predictive of kidney failure, the development of chronic kidney disease, and mortality in 37 critically ill COVID-19 patients. We used machine learning (ML) methods as decision trees and cut-off points created by the OneR package to add new aspects, even in smaller cohorts. RESULTS: Among a total of 37 patients, 24 suffered higher-grade renal failure, 20 of whom required kidney replacement therapy. More than 40% of patients remained on hemodialysis after intensive care unit discharge or died (27%). Due to frequent anuria proteinuria measured in two-thirds of the patients, it was not predictive for the investigated endpoints; albuminuria was higher in patients with AKI 3, but the difference was not significant. ML found cut-off points of >31.4 kg/m2 for BMI and >69 years for age, constructed decision trees with great accuracy, and identified highly predictive variables for outcome and remaining chronic kidney disease. CONCLUSIONS: Different ML methods and their clinical application, especially decision trees, can provide valuable support for clinical decisions. Presence of proteinuria was not predictive of CKD or AKI and should be confirmed in a larger cohort.


Subject(s)
COVID-19/complications , Critical Illness/mortality , Machine Learning , Proteinuria/etiology , Renal Insufficiency, Chronic/etiology , Adult , Aged , Aged, 80 and over , Body Mass Index , COVID-19/mortality , Female , Humans , Male , Middle Aged , Prognosis , Proteinuria/mortality , Renal Insufficiency, Chronic/mortality , Renal Replacement Therapy , Retrospective Studies
10.
Cardiovasc Diabetol ; 20(1): 75, 2021 03 31.
Article in English | MEDLINE | ID: covidwho-1166910

ABSTRACT

The 6th Cardiovascular Outcome Trial (CVOT) Summit "Cardiovascular and Renal Outcomes 2020" was the first to be held virtually on October 29-30, 2020. As in previous years, this summit served as reference meeting for in-depth discussions on the topic of recently completed and presented major outcome trials. This year, focus was placed on the outcomes of VERTIS-CV, EMPEROR-Reduced, DAPA-CKD, and FIDELIO-DKD. Trial implications for diabetes management and the impact on new treatment algorithms were highlighted for diabetologists, cardiologists, endocrinologists, nephrologists, and general practitioners. Discussion evolved from major outcome trials using SGLT-2 inhibitors for treatment and prevention of heart failure and chronic kidney disease in people with and without diabetes, to additional therapy options for chronic kidney disease with a novel mineralocorticoid receptor antagonist. Furthermore, challenges in diabetes management like COVID-19 and obesity, as well as novel treatment strategies and guidelines, were discussed.The 7th Cardiovascular Outcome Trial Summit will be held virtually on November, 18-19, 2021 ( http://www.cvot.org ).


Subject(s)
COVID-19/epidemiology , Cardiovascular Diseases/epidemiology , Clinical Trials as Topic/methods , Congresses as Topic/trends , Renal Insufficiency, Chronic/epidemiology , Research Report/trends , COVID-19/therapy , Cardiovascular Diseases/therapy , Diabetes Mellitus, Type 2/epidemiology , Diabetes Mellitus, Type 2/therapy , Humans , Kidney/drug effects , Kidney/physiology , Mineralocorticoid Receptor Antagonists/administration & dosage , Renal Insufficiency, Chronic/therapy , Sodium-Glucose Transporter 2 Inhibitors/administration & dosage , Treatment Outcome
11.
Kidney Int ; 98(6): 1540-1548, 2020 12.
Article in English | MEDLINE | ID: covidwho-1023695

ABSTRACT

The aim of this study was to investigate 28-day mortality after COVID-19 diagnosis in the European kidney replacement therapy population. In addition, we determined the role of patient characteristics, treatment factors, and country on mortality risk with the use of ERA-EDTA Registry data on patients receiving kidney replacement therapy in Europe from February 1, 2020, to April 30, 2020. Additional data on all patients with a diagnosis of COVID-19 were collected from 7 European countries encompassing 4298 patients. COVID-19-attributable mortality was calculated using propensity score-matched historic control data and after 28 days of follow-up was 20.0% (95% confidence interval 18.7%-21.4%) in 3285 patients receiving dialysis and 19.9% (17.5%-22.5%) in 1013 recipients of a transplant. We identified differences in COVID-19 mortality across countries, and an increased mortality risk in older patients receiving kidney replacement therapy and male patients receiving dialysis. In recipients of kidney transplants ≥75 years of age, 44.3% (35.7%-53.9%) did not survive COVID-19. Mortality risk was 1.28 (1.02-1.60) times higher in transplant recipients compared with matched dialysis patients. Thus, the pandemic has had a substantial effect on mortality in patients receiving kidney replacement therapy, a highly vulnerable population due to underlying chronic kidney disease and a high prevalence of multimorbidity.


Subject(s)
COVID-19/mortality , Kidney Failure, Chronic/complications , Kidney Transplantation/mortality , Postoperative Complications/mortality , Registries , Adolescent , Adult , Aged , COVID-19/complications , Child , Child, Preschool , Europe/epidemiology , Female , Humans , Infant , Kidney Failure, Chronic/mortality , Kidney Failure, Chronic/therapy , Male , Middle Aged , Pandemics , Postoperative Complications/virology , Renal Dialysis , Risk Factors , Young Adult
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