scholarly journals Efficacy and safety of trelagliptin in Japanese patients with type 2 diabetes with severe renal impairment or end‐stage renal disease: Results from a randomized, phase 3 study

2019 ◽  
Vol 11 (2) ◽  
pp. 373-381
Author(s):  
Kohei Kaku ◽  
Kazuyuki Ishida ◽  
Kohei Shimizu ◽  
Meguru Achira ◽  
Yuusuke Umeda
Keyword(s):  
Type 2 Diabetes ◽  
Renal Impairment ◽  
End Stage Renal Disease ◽  
Severe Renal Impairment ◽  
Japanese Patients ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Stage Renal Disease ◽  
End Stage

scholarly journals Aspirin to Reduce the Risk of Thrombotic Events in Patients With End-Stage Renal Disease: Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Tiago Lemos Cerqueira ◽  
Armando Fartolino Guerrero ◽  
Clara Krystal Pérez Fermin ◽  
Ricardo Wang ◽  
Evelin Elfriede Balbino ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
End Stage Renal Disease ◽  
Controlled Trial ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Stage Renal Disease ◽  
End Stage

BACKGROUND End-stage renal disease (ESRD) is the last stage of chronic kidney disease, mainly caused by type 2 diabetes mellitus and characterized by an increased mortality risk related to cardiovascular disease. Low-dose aspirin (acetylsalicylic acid or ASA) seems to effectively prevent cardiovascular events in patients with ESRD. However, the number of interventional studies in this population remains limited and the mechanisms of aspirin-related bleeding remain poorly understood. Aspirin’s efficacy and safety may be modified by the presence of type 2 diabetes mellitus or platelet hyperreactivity. OBJECTIVE The overall objective of this protocol is to (1) evaluate aspirin’s safety and efficacy in reducing the risk of thrombotic events in patients with ESRD on hemodialysis and (2) examine whether aspirin’s efficacy is modified by the presence of type 2 diabetes mellitus or platelet hyperreactivity. Specifically, the primary objective is to compare the 12-month rate of any thrombotic event (cardiac death, nonfatal myocardial infarction, nonfatal stroke, arteriovenous fistula thrombosis) and Thrombolysis in Myocardial Infarction (TIMI) major bleeding in patients treated with aspirin compared to those on placebo. Secondary objectives are to test for effect modification of treatment by the presence of type 2 diabetes mellitus or platelet hyperreactivity and compare the rate of TIMI minor bleeding between treatment groups. METHODS We developed a protocol for a phase 2 randomized, single-center, placebo-controlled, triple-blind, superiority clinical trial to assess the prophylactic efficacy and safety of aspirin in patients with ESRD and on hemodialysis. It follows the ethical principles of the Declaration of Helsinki of the World Medical Association. A total of 342 participants would be enrolled over 12 months at a large dialysis center. Patients will be randomized in a 1:1 ratio and stratified by presence of type 2 diabetes mellitus and platelet hyperreactivity to receive either oral aspirin (100 mg/d) or placebo for a treatment period of 12 months. An intention-to-treat statistical analysis will be performed. RESULTS PLEASE WRITE RESULTS. CONCLUSIONS We provide a protocol for a randomized controlled trial to evaluate the safety and efficacy of treatment with aspirin to reduce the risk of thrombotic events. In addition, such a study would further our understanding of the mechanism of aspirin-related bleeding and help identify subgroups of best-responders and patients with a higher risk of adverse events.

Effects of two different dialytic treatments on inflammatory markers in people with end-stage renal disease with and without type 2 diabetes mellitus

Cytokine ◽  
2017 ◽  
Vol 92 ◽  
pp. 75-79 ◽  
Author(s):  
Giuseppe Derosa ◽  
Carmelo Libetta ◽  
Pasquale Esposito ◽  
Ilaria Borettaz ◽  
Carmine Tinelli ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Renal Disease ◽  
End Stage Renal Disease ◽  
Inflammatory Markers ◽  
Stage Renal Disease ◽  
End Stage
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