1004-P: Oral Semaglutide vs. Placebo in Patients with Type 2 Diabetes and Moderate Renal Impairment: PIONEER 5

Mosenzon, Ofri; Rosenlund, Signe; Eriksson, Jan W.; Heller, Simon; Pratley, Richard E.; Sathyapalan, Thozhukat; Blicher, Thalia Marie; Hels, Ole; Desouza, Cyrus

doi:10.2337/db19-1004-p

Cited by 19 publications

(46 citation statements)

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“…There was no significant reported difference in the eGFR decline from baseline to the end of treatment or in the rate of renal death (Husain et al, 2019). The PIONEER-5 trial showed that semaglutide use in T2D patients with renal impairment (eGFR 30-59 ml/min/1.73 m 2 ) was safe and effective (Mosenzon et al, 2019a). Further study is needed to elucidate whether the renoprotective effects of semaglutide are consistent in those individuals.…”

Section: Semaglutidementioning

confidence: 97%

GLP-1 Receptor Agonists in Diabetic Kidney Disease: From Clinical Outcomes to Mechanisms

Kawanami

Yuasa

2020

Front. Pharmacol.

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Diabetic Kidney Disease (DKD) is the leading cause of end stage renal disease (ESRD) worldwide. Glucagon-like peptide 1 receptor agonists (GLP-1RAs) are now widely used in the treatment of patients with type 2 diabetes (T2D). A series of clinical and experimental studies demonstrated that GLP-1RAs have beneficial effects on DKD, independent of their glucose-lowering abilities, which are mediated by natriuresis, antiinflammatory and anti-oxidative stress properties. Furthermore, GLP-1RAs have been shown to suppress renal fibrosis. Recent clinical trials have demonstrated that GLP-1RAs have beneficial effects on renal outcomes, especially in patients with T2D who are at high risk for CVD. These findings suggest that GLP-1RAs hold great promise in preventing the onset and progression of DKD. However, GLP-1RAs have only been shown to reduce albuminuria, and their ability to reduce progression to ESRD remains to be elucidated. In this review article, we highlight the current understanding of the clinical efficacy and the mechanisms underlying the effects of GLP-1RAs in DKD.

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Section: Semaglutidementioning

confidence: 97%

GLP-1 Receptor Agonists in Diabetic Kidney Disease: From Clinical Outcomes to Mechanisms

Kawanami

Yuasa

2020

Front. Pharmacol.

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“…considering whether or not patients took rescue medication or whether treatment was discontinued due to lack of efficacy or other personal/ administrative reasons), has been incorporated into trial designs in other therapy areas. 12,13,[39][40][41][42][43][44] We propose that estimands are used in AD trials and are defined early in the trial design to ensure that other relevant factors, such as prospective recording of trial data and sample size determination, can be considered accordingly. 13 We also suggest that estimand definitions should be transparently communicated to facilitate better understanding of results.…”

Section: Discussionmentioning

confidence: 99%

Estimands for atopic dermatitis clinical trials: Expert opinion on the importance of intercurrent events

Bissonnette

Eichenfield

Simpson

et al. 2023

Acad Dermatol Venereol

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Despite the emergence of novel targeted treatments for atopic dermatitis (AD), there is a lack of guidelines on standardizing analysis of clinical trial data. To define and estimate meaningful treatment comparisons, several factors, including intercurrent events, must be taken into account. Intercurrent events are defined as events occurring after treatment initiation that affect either the interpretation or existence of the measurements associated with clinical questions of interest. Due to the relapsing, unpredictable nature of AD, intercurrent events frequently occur in AD trials, such as use of rescue therapy for intense itch and sleep deprivation. Despite the impact of intercurrent events in AD, they are often handled in an inconsistent manner across trials, which limits results interpretation. The estimand framework is increasingly used to estimate treatment effects while accounting for intercurrent events. This review explores how guidance from the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) on the use of estimands can be applied to support AD clinical trial design and analysis. We propose that estimands are used in AD trials and defined early during trial design. The use of estimands can provide clinicians with interventional trial results that are more reflective of clinical practice, help facilitate comparisons across clinical trials, and are more informative to enable improved treatment selection for patients.

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“…While current research does not have a definitive stance on the effect of GLP1-RAs on GFR, there has been strong evidence to show that they provide a marked reduction in UACR, notably seen by 14 of the 16 unique trials and observational studies analyzed in Table 1 [25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42]. In Table 1, four papers used insulin glargine rather than placebo as a control to compare against the efficacy of the GLP1-RA being studied [36,[38][39]41].…”

Section: Glp1-ras and Insulin Therapy In Diabetic Nephropathymentioning

confidence: 99%

An Investigation on the Efficacy of Glucagon-Like Peptide 1 Receptor Agonists Drugs in Reducing Urine Albumin-to-Creatinine Ratio in Patients With Type 2 Diabetes: A Potential Treatment for Diabetic Nephropathy

Yarlagadda¹,

Abutineh²,

Reddy³

et al. 2023

Cureus

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As diabetes mellitus becomes increasingly prevalent globally, so does diabetic nephropathy, a complication leading to one of the world's leading causes of end-stage renal disease (ESRD). Current research has linked an increase in the urine albumin-to-creatinine ratio (UACR), a marker for kidney damage, to a greater risk of adverse renal outcomes and ESRD in patients with diabetes. Of the diabetes medications studied and implemented in clinical settings, glucagon-like peptide-1 receptor agonist (GLP1-RA) drugs have been shown to not only help control HbA1c in diabetes but have also demonstrated numerous cardiovascular, hepatic, and renal benefits. The objective of our study was to assess the efficacy of GLP1-RA drugs in reducing UACR in patients with type 2 diabetes mellitus (T2 DM) to determine if GLP1-RAs could be used to provide renoprotection in diabetic nephropathy in addition to their glucose-lowering effects. Upon a comprehensive review of the literature, we conducted a statistical analysis to determine the efficacy of GLP1-RA monotherapy and combination therapy in reducing UACR in comparison to placebo and insulin glargine. Of the studies analyzed, GLP1-RAs exhibited a statistically significant effect in reducing UACR in comparison to a placebo but not in comparison to insulin glargine. GLP1-RA combination therapy (GLP1-RA used with either insulin glargine, metformin, or dapagliflozin) did not exhibit statistically significant UACR reductions in comparison with insulin glargine. However, GLP1-RA combination therapy showed a trend suggestive of being more effective than insulin glargine in reducing UACR, but due to the limited literature studying this treatment method, further studies in a more focused group of patients with diabetic nephropathy may produce stronger and more definitive results. GLP1-RA monotherapy or combination therapy has been determined to be an effective method for reducing UACR and decreasing the incidence of adverse renal outcomes associated with diabetic kidney disease. GLP1-RA therapy could serve as an alternative treatment in diabetic nephropathy to insulin glargine, which carries a higher risk of hypoglycemia and unintentional weight gain while potentially being less cost-effective.

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1004-P: Oral Semaglutide vs. Placebo in Patients with Type 2 Diabetes and Moderate Renal Impairment: PIONEER 5

Cited by 19 publications

References 0 publications

GLP-1 Receptor Agonists in Diabetic Kidney Disease: From Clinical Outcomes to Mechanisms

GLP-1 Receptor Agonists in Diabetic Kidney Disease: From Clinical Outcomes to Mechanisms

Estimands for atopic dermatitis clinical trials: Expert opinion on the importance of intercurrent events

An Investigation on the Efficacy of Glucagon-Like Peptide 1 Receptor Agonists Drugs in Reducing Urine Albumin-to-Creatinine Ratio in Patients With Type 2 Diabetes: A Potential Treatment for Diabetic Nephropathy

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