PMID- 28625368
OWN - NLM
STAT- MEDLINE
DCOM- 20170810
LR  - 20220331
IS  - 1097-6744 (Electronic)
IS  - 0002-8703 (Linking)
VI  - 189
DP  - 2017 Jul
TI  - Effect of aspirin on renal disease progression in patients with type 2 diabetes: 
      A multicenter, double-blind, placebo-controlled, randomized trial. The renaL 
      disEase progression by aspirin in diabetic pAtients (LEDA) trial. Rationale and 
      study design.
PG  - 120-127
LID - S0002-8703(17)30124-2 [pii]
LID - 10.1016/j.ahj.2017.04.005 [doi]
AB  - Type 2 diabetes mellitus (T2DM) is one of the most common causes of chronic 
      kidney disease and kidney failure. It has been estimated that the annual decline 
      of estimated glomerular filtration rate (eGFR) among patients with T2DM is 
      approximately 2.0-2.5mL min(-1) y(-1). Cyclooxygenase-dependent eicosanoids, such 
      as 11-dehydro-thromboxane (Tx)B(2), are increased in T2DM patients and are 
      potentially involved in the regulation of renal blood flow. Animal models showed 
      that cyclooxygenase inhibitors, such as aspirin, are associated with improvements 
      in renal plasma flow and eGFR values. HYPOTHESIS: The primary end point of the 
      LEDA trial is to evaluate the 1-year decline of eGFR in T2DM patients treated or 
      not with low-dose aspirin (100mg/d). Secondary end points will be the rapid 
      decline in renal function, defined as a reduction of eGFR >/=5mL/min, and change of 
      renal function class after 1-year follow-up. Furthermore, urinary excretion 
      11-dehydro-TxB(2) will be related to renal function modifications. STUDY DESIGN: 
      A phase 3 no-profit, multicenter, double-blind, randomized intervention trial of 
      aspirin 100mg/dvs placebo (ClinicalTrials.gov Identifier: NCT02895113). All 
      patients will be monitored at 6 and 12months after randomization to assess drug 
      adherence and eGFR changes. SUMMARY: The LEDA trial is the first double-blind, 
      placebo-controlled, randomized clinical trial aimed at examining whether aspirin 
      treatment may beneficially affect kidney function in patients with T2DM by 
      reducing the annual eGFR decline. The trial will also examine whether the 
      potential renoprotective effects of aspirin might be partly due to its inhibition 
      of TxB(2) production.
CI  - Copyright (c) 2017 Elsevier Inc. All rights reserved.
FAU - Violi, Francesco
AU  - Violi F
AD  - Department of Internal Medicine and Medical Specialties, Sapienza University, 
      Rome, Italy. Electronic address: francesco.violi@uniroma1.it.
FAU - Targher, Giovanni
AU  - Targher G
AD  - Section of Endocrinology, Diabetes and Metabolism, Department of Medicine, 
      University of Verona, Verona, Italy.
FAU - Vestri, Annarita
AU  - Vestri A
AD  - Department of Public Health and Infections Disease, Sapienza University of Rome, 
      Roma, Italy.
FAU - Carnevale, Roberto
AU  - Carnevale R
AD  - Department of Internal Medicine and Medical Specialties, Sapienza University, 
      Rome, Italy; Department of Medical-Surgical Sciences and Biotechnologies, 
      Sapienza University of Rome, Latina, Italy.
FAU - Averna, Maurizio
AU  - Averna M
AD  - Department of Internal Medicine and Medical Specialties and DIBIMIS, School of 
      Medicine, University of Palermo, Palermo, Italy.
FAU - Farcomeni, Alessio
AU  - Farcomeni A
AD  - Department of Public Health and Infections Disease, Sapienza University of Rome, 
      Roma, Italy.
FAU - Lenzi, Andrea
AU  - Lenzi A
AD  - Department Experimental Medicine-Medical Physiopathology, Food Science and 
      Endocrinology Section, Sapienza University of Rome, Rome, Italy.
FAU - Angelico, Francesco
AU  - Angelico F
AD  - Department of Public Health and Infections Disease, Sapienza University of Rome, 
      Roma, Italy.
FAU - Cipollone, Francesco
AU  - Cipollone F
AD  - Department of Medicine and Ageing, University of Chieti, Chieti, Italy.
FAU - Pastori, Daniele
AU  - Pastori D
AD  - Department of Internal Medicine and Medical Specialties, Sapienza University, 
      Rome, Italy; Department of Anatomical, Histological, Forensic Medicine and 
      Orthopedics Sciences, Sapienza University of Rome, Rome, Italy.
LA  - eng
SI  - ClinicalTrials.gov/NCT02895113
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20170418
PL  - United States
TA  - Am Heart J
JT  - American heart journal
JID - 0370465
RN  - 0 (Cyclooxygenase Inhibitors)
RN  - R16CO5Y76E (Aspirin)
SB  - IM
MH  - Aspirin/*administration & dosage
MH  - Cyclooxygenase Inhibitors/administration & dosage
MH  - Diabetes Mellitus, Type 2/complications/drug therapy
MH  - Disease Progression
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Follow-Up Studies
MH  - Glomerular Filtration Rate/*drug effects
MH  - Humans
MH  - Prognosis
MH  - Renal Insufficiency, Chronic/diagnosis/*etiology/physiopathology
MH  - Time Factors
EDAT- 2017/06/20 06:00
MHDA- 2017/08/11 06:00
CRDT- 2017/06/20 06:00
PHST- 2016/12/16 00:00 [received]
PHST- 2017/04/12 00:00 [accepted]
PHST- 2017/06/20 06:00 [entrez]
PHST- 2017/06/20 06:00 [pubmed]
PHST- 2017/08/11 06:00 [medline]
AID - S0002-8703(17)30124-2 [pii]
AID - 10.1016/j.ahj.2017.04.005 [doi]
PST - ppublish
SO  - Am Heart J. 2017 Jul;189:120-127. doi: 10.1016/j.ahj.2017.04.005. Epub 2017 Apr 
      18.