Protocol of the Long-term Impact of RAS Inhibition on Cardiorenal Outcomes (LIRICO) randomized trial

Ausilia Maione, Antonio Nicolucci, Jonathan C. Craig, Giovanni Tognoni, Antonio Moschetta, Giuseppe Palasciano, Giuseppe Pugliese, Deni A. Procaccini, Loreto Gesualdo, Fabio Pellegrini, Giovanni F M Strippoli, Miriam Valentini, Celeste Pirozzoli, Ausilia Maione, Barbara Di Nardo, Sonia Ferrari, Marco Piaggione, Rosalia Di Lallo

Research output: Contribution to journalArticlepeer-review

Abstract

Microalbuminuria is a strong, consistent and independent risk factor for cardiovascular and renal disease in patients with diabetes and/or hypertension and in the general population. Several randomized trials have shown the efficacy of inhibiting the renin-angiotensin system (RAS) with angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs) to prevent cardiovascular events and the progression of kidney disease. These 2 classes of drugs are equally effective for renal outcomes in patients with diabetic nephropathy, but only ACEIs have been found to significantly impact the risk of all-cause mortality, predominantly cardiovascular, in patients with diabetic nephropathy. Studies on the cardiorenal efficacy of combined therapy with ACEIs and ARBs in individuals with microalbuminuria or macroalbuminuria and other cardiovascular risk factors have been inconclusive. The Long-term Impact of RAS Inhibition an Cardiorenal Outcomes (LIRICO) study aims to address existing questions in this setting. This is a phase III, randomized, comparative, pragmatic trial with prospective randomized open blinded endpoint (PROBE) design. It will evaluate the comparative efficacy of combined therapy with ACEIs and ARBs versus monotherapy with either ACEIs or ARBs in improving cardiovascular and renal outcomes in microalbuminuric or macroalbuminuric individuals at cardiorenal risk. The study will enroll 2,100 patients, selected in a network of internal medicine, diabetology or nephrology outpatient clinics. Patients will be randomly allocated to ACEIs, ARBs or their combination. The study has been approved and funded by the Agenzia Italiana del Farmaco (A.I.F.A.) within the 2005 funding plan for independent research on drugs.

Original languageEnglish
Pages (from-to)646-655
Number of pages10
JournalJournal of Nephrology
Volume20
Issue number6
Publication statusPublished - Nov 2007

Keywords

  • Angiotensin II receptor blockers
  • Angiotensin-converting enzyme inhibitors
  • Cardiovascular risk factors
  • Combined therapy
  • Microalbuminuria
  • Urinary albumin-creatinine ratio

ASJC Scopus subject areas

  • Nephrology

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