Review of the renal endpoints used in cardiovascular safety clinical trials in type 2 diabetes mellitus patients and their importance in primary care

Górriz, José Luis; Cos-Claramunt, Xavier; Duque, Natalia; Matalí, Arantxa

doi:10.1016/j.pcd.2019.07.001

Cited by 6 publications

(9 citation statements)

References 33 publications

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“…This disparity in the endpoints makes the comparison between them difficult. The scientific community has the necessity to establish relevant cardiovascular variables in the follow-up of patients with type 2 diabetes in CVOTs and to redefine which variables have repercussions on a real-world scenario [ 38 , 39 ].…”

Section: Cardiovascular Endpoints In Diabetic Kidney Diseasementioning

confidence: 99%

“…However, it is not the best method, since it depends on multiple variables, such as muscle mass, age, sex, race, etc. For this reason, even in the presence of a normal creatinine level, it is possible that a reduction in nephrons function already exists, indicated by a decrease in GFR [ 39 ]. There are two ways to obtain the GFR: a direct measurement and an indirect calculation.…”

Section: Gfr Decline In Dkd: Ways Of Measurement and Thresholdmentioning

confidence: 99%

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How to Assess Diabetic Kidney Disease Progression? From Albuminuria to GFR

García-Carro

Vergara

Bermejo

et al. 2021

JCM

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Diabetic kidney disease (DKD) is one of the most relevant complications of type 2 diabetes and dramatically increases the cardiovascular risk in these patients. Currently, DKD is severely infra-diagnosed, or its diagnosis is usually made at advanced stages of the disease. During the last decade, new drugs have demonstrated a beneficial effect in terms of cardiovascular and renal protection in type 2 diabetes, supporting the crucial role of an early DKD diagnosis to permit the use of new available therapeutic strategies. Moreover, cardiovascular and renal outcome trials, developed to study these new drugs, are based on diverse cardiovascular and renal simple and composite endpoints, which makes difficult their interpretation and the comparison between them. In this article, DKD diagnosis is reviewed, focusing on albuminuria and the recommendations for glomerular filtration rate measurement. Furthermore, cardiovascular and renal endpoints used in classical and recent cardiovascular outcome trials are assessed in a pragmatic way.

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Section: Cardiovascular Endpoints In Diabetic Kidney Diseasementioning

confidence: 99%

Section: Gfr Decline In Dkd: Ways Of Measurement and Thresholdmentioning

confidence: 99%

How to Assess Diabetic Kidney Disease Progression? From Albuminuria to GFR

García-Carro

Vergara

Bermejo

et al. 2021

JCM

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“…51 When obtaining sequential albuminuria measurements, day-to-day variability in urinary protein levels needs to be considered for a meaningful representation of change in albuminuria. 13,52 A reduction of ≥30% in albuminuria could potentially become a component of a standardized composite endpoint for renal outcomes in diabetes. Whether this is more apparent in patients with macroalbuminuria rather than microalbuminuria remains to be determined.…”

Section: Renal Outcomesmentioning

confidence: 99%

“…In patients with CKD who have a UACR of ≥300 mg/g, the American Diabetes Association (ADA) recommends a reduction in UACR of ≥30% to slow kidney disease progression 51 . When obtaining sequential albuminuria measurements, day‐to‐day variability in urinary protein levels needs to be considered for a meaningful representation of change in albuminuria 13,52 …”

Section: Albuminuriamentioning

confidence: 99%

Change in albuminuria as a surrogate endpoint for cardiovascular and renal outcomes in patients with diabetes

Palmer

2023

Diabetes Obesity Metabolism

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For the purpose of predicting clinical outcomes in patients with diabetes and chronic kidney disease, change in albuminuria is a good candidate to be a surrogate marker for future cardiovascular events and progression of kidney disease. Spot urine albumin/creatinine ratio is convenient and recognized as a viable alternative to 24‐h albumin, with some limitations. Although there is sufficient evidence to validate its use in clinical trials as a surrogate endpoint for renal outcomes, this is not yet the case for cardiovascular outcomes. While change in albuminuria as a primary or secondary endpoint is trial‐specific, its use should be encouraged, nonetheless.

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“…The prevalence in Mexico in 2016 of previously diagnosed type 2 diabetes mellitus (T2DM), and the combined prevalence of overweightness and obesity were 9.4% and 72.5%, respectively (Rojas-Martínez et al, 2018). Chronic kidney disease (CKD) is a common complication of T2DM, which confers an increased risk of cardiovascular morbidity and mortality (Górriz et al, 2019). Although urine albumin concentration is normally used according to the KDIGO guideline (Kidney Disease Improving Global Outcomes (KDIGO), CKD Work Group, 2012).…”

Section: Introductionmentioning

confidence: 99%

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Review of the renal endpoints used in cardiovascular safety clinical trials in type 2 diabetes mellitus patients and their importance in primary care

Cited by 6 publications

References 33 publications

How to Assess Diabetic Kidney Disease Progression? From Albuminuria to GFR

How to Assess Diabetic Kidney Disease Progression? From Albuminuria to GFR

Change in albuminuria as a surrogate endpoint for cardiovascular and renal outcomes in patients with diabetes

Data S1: Raw data

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