6533b7d8fe1ef96bd126b6e5
RESEARCH PRODUCT
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
Daniele PastoriFrancesco AngelicoAnnarita VestriAndrea LenziFrancesco VioliFrancesco CipolloneGiovanni TargherMaurizio AvernaAlessio FarcomeniRoberto Carnevalesubject
Time Factorskidney disease030204 cardiovascular system & hematologylaw.invention0302 clinical medicineRandomized controlled triallawClinical endpointMedicineRenal Insufficiency030212 general & internal medicineChronicKidneyAspirinkidney disease progressionclinical trialtrialPrognosisType 2 diabetes mellituAspirin; Cyclooxygenase Inhibitors; Diabetes Mellitus Type 2; Disease Progression; Dose-Response Relationship Drug; Double-Blind Method; Follow-Up Studies; Glomerular Filtration Rate; Humans; Prognosis; Renal Insufficiency Chronic; Time Factors; Cardiology and Cardiovascular Medicinemedicine.anatomical_structureAspirin; Cyclooxygenase Inhibitors; Diabetes Mellitus; Type 2; Disease Progression; Dose-Response Relationship; Drug; Double-Blind Method; Follow-Up Studies; Glomerular Filtration Rate; Humans; Prognosis; Renal Insufficiency; Chronic; Time Factors; Cardiology and Cardiovascular MedicineDisease Progressiontype 2 diabetesDrugSettore SECS-S/01 - StatisticaCardiology and Cardiovascular MedicineType 2Glomerular Filtration Ratemedicine.drugmedicine.medical_specialtyUrologyRenal functionDose-Response Relationship03 medical and health sciencesDouble-Blind MethodDiabetes MellitusHumansCyclooxygenase InhibitorsRenal Insufficiency Chronickidney disease kidney disease progression type 2 diabetes aspirin trialDose-Response Relationship DrugAspirinbusiness.industryrenal functionmedicine.diseaseSurgeryClinical trialDiabetes Mellitus Type 2Renal blood flowbusinessFollow-Up StudiesKidney diseasedescription
Background 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 2.0-2.5 mL min−1 y−1. Cyclooxygenase-dependent eicosanoids, such as 11-dehydro-thromboxane (Tx)B2, 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 (100 mg/d). Secondary end points will be the rapid decline in renal function, defined as a reduction of eGFR ≥5 mL/min, and change of renal function class after 1-year follow-up. Furthermore, urinary excretion 11-dehydro-TxB2 will be related to renal function modifications. Study design A phase 3 no-profit, multicenter, double-blind, randomized intervention trial of aspirin 100 mg/dvs placebo ( ClinicalTrials.gov Identifier: NCT02895113 ). All patients will be monitored at 6 and 12 months 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 TxB2 production.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2017-01-01 |