Ramipril versus placebo in kidney transplant patients with proteinuria: a multicentre, double-blind, randomised controlled trial

Knoll, Greg; Fergusson, Dean; Chassé, Michaël; Hébert, Paul C.; Wells, George A.; Tibbles, Lee Anne; Treleaven, Darin; Holland, David C; White, Christine A.; Muirhead, Norman; Cantarovich, Marcelo; Paquet, Marie‐Eve; Kiberd, Bryce A.; Gourishankar, Sita; Shapiro, Jamie; Prasad, Ramesh; Cole, Edward; Pilmore, Helen; Cronin, Valerie; Hogan, Debora; Ramsay, Tim; Gill, John S.

doi:10.1016/s2213-8587(15)00368-x

Cited by 97 publications

(63 citation statements)

References 31 publications

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“…However, data on their effectiveness in patients with ESRD have been mixed. Notably, three randomized clinical trials involving patients with ESRD on hemodialysis and one in kidney transplant recipients found no reduction in CV outcomes with the use of an ACEI or ARB [9][10][11][12].…”

Section: Introductionmentioning

confidence: 99%

Angiotensin-converting enzyme inhibitor/angiotensin receptor blocker use and cardiovascular outcomes in patients initiating peritoneal dialysis

Shen

Saxena

Montez‐Rath

et al. 2016

Nephrol. Dial. Transplant.

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A B S T R A C TBackground: Data on the effectiveness of angiotensinconverting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs) in reducing cardiovascular (CV) risk in patients undergoing peritoneal dialysis (PD) are limited. We investigated the association between ACEI/ARB use and CV outcomes in patients initiating PD. Methods: In this observational cohort study, we identified from the United States Renal Data System all adult patients who initiated PD from 2007 to 2011 and participated in Medicare Part D, a federal prescription drug benefits program, for the first 90 days of dialysis. Patients who filled a prescription for an ACEI or ARB in those 90 days were considered users. We applied Cox regression to an inverse probability of treatment weighted cohort to estimate the hazard ratios (HRs) for the combined outcome of death, ischemic stroke or myocardial infarction (MI) and each outcome individually. Results: Among 4879 patients, 2063 (42%) used an ACEI/ARB. Patients were followed up for a median of 1.2 years. We recorded 1771 events, for a composite rate of 25 events per 100 person-years. ACEI/ARB use (versus nonuse) was associated with a reduced risk of the composite outcome {HR 0.84 [95% confidence interval (CI) 0.76-0.93]}, all-cause mortality ] and CV death ], but not MI )] or ischemic stroke [HR 1.06 (95% CI 0.79-1.43)]. Results were similar in astreated analyses. In a subgroup analysis, we did not find any effect modification by residual renal function. Conclusions: ACEI/ARB use is common in patients initiating PD and is associated with a lower risk of fatal CV outcomes.

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Section: Introductionmentioning

confidence: 99%

Angiotensin-converting enzyme inhibitor/angiotensin receptor blocker use and cardiovascular outcomes in patients initiating peritoneal dialysis

Shen

Saxena

Montez‐Rath

et al. 2016

Nephrol. Dial. Transplant.

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“…1 New findings from a study that assessed the effects of blocking the renin–angiotensin–aldosterone system (RAAS) on transplant outcomes concluded that use of the angiotensin-converting-enzyme (ACE) inhibitor, ramipril, did not reduce the risk of renal dysfunction or death in renal transplant recipients. 2 This study suffers from several shortcomings, however, including a failure to achieve their target sample size, which limits the conclusions that can be drawn from the study’s findings.…”

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confidence: 99%

“…have now reported the findings of a multi-centre, multinational controlled trial designed to resolve this controversy. 2 They performed a double-blind randomized controlled trial in which 213 kidney transplant recipients were randomly assigned to receive placebo or 5 mg ramipril once daily for up to 4 years. Participants were then followed for an extended period of up to 4 years.…”

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confidence: 99%

The role of RAAS blockade in kidney transplantation

Toto

2015

Nat Rev Nephrol

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“…A recent randomized, double-blind, placebo-controlled trial in kidney transplant recipients with proteinuria showed no significant reduction in the doubling of serum creatinine, end-stage renal disease, or death, with ramipril therapy compared with placebo. 349 Recent meta-analyses suggest that calcium channel blockers should be preferred over renin-angiotensin system (RAS) blockers for BP control, because RAS blockers are associated with progressive worsening of renal graft function without additional benefits in cardiovascular risk. 350,351 The KDIGO guidelines recommend a target of 130/80 mm Hg…”

Section: Hypertensionmentioning

confidence: 99%

Practical Recommendations for Long-term Management of Modifiable Risks in Kidney and Liver Transplant Recipients

et al. 2017

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Short-term patient and graft outcomes continue to improve after kidney and liver transplantation, with 1-year survival rates over 80%; however, improving longer-term outcomes remains a challenge. Improving the function of grafts and health of recipients would not only enhance quality and length of life, but would also reduce the need for retransplantation, and thus increase the number of organs available for transplant. The clinical transplant community needs to identify and manage those patient modifiable factors, to decrease the risk of graft failure, and improve longer-term outcomes. COMMIT was formed in 2015 and is composed of 20 leading kidney and liver transplant specialists from 9 countries across Europe. The group's remit is to provide expert guidance for the long-term management of kidney and liver transplant patients, with the aim of improving outcomes by minimizing modifiable risks associated with poor graft and patient survival posttransplant. The objective of this supplement is to provide specific, practical recommendations, through the discussion of current evidence and best practice, for the management of modifiable risks in those kidney and liver transplant patients who have survived the first postoperative year. In addition, the provision of a checklist increases the clinical utility and accessibility of these recommendations, by offering a systematic and efficient way to implement screening and monitoring of modifiable risks in the clinical setting. 12 Department of Gastroenterology and Hepatology, Erasmus MC, University Hospital Rotterdam, the Netherlands. 13 Department of Gastroenterology and Hepatology, University Hospitals KU Leuven, Belgium.14 Abdominal Transplant Surgery, Microbiology and Immunology Department, University Hospitals KU Leuven, Belgium. 15 Department of Hepatology and Liver Transplantation, Reina Sofía University Hospital, IMIBIC, CIBERehd, Spain. www.transplantjournal.com S1 S olid organ transplantation has evolved from an experimental procedure to an established treatment option for many types of end-stage organ failure. Both patient and graft outcomes are continuing to improve, and 1-year patient and graft survival currently exceed 80%.1,2 However, survival rates gradually decline over the long term. In kidney transplant, 5-and 10-year graft survival rates in Europe are 77% and 56%, and for liver transplant, 64% and 54% (Figures 1 and 2). 3,4 Although most European countries have seen an increase in both living and deceased donation, transplantation is not available to all who would benefit from the procedure, and there is considerable morbidity and mortality for those listed for transplant.6 Therefore, maximizing long-term graft survival and reducing the need for retransplantation is paramount, not only in improving outcomes for the recipients but also for those awaiting a graft. The improvement in outcomes is predominantly due to reduction in (Transplantation. 2017;101:S1-S41). The authors were approached by Astellas to discuss the practical implementation o...

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Ramipril versus placebo in kidney transplant patients with proteinuria: a multicentre, double-blind, randomised controlled trial

Cited by 97 publications

References 31 publications

Angiotensin-converting enzyme inhibitor/angiotensin receptor blocker use and cardiovascular outcomes in patients initiating peritoneal dialysis

Angiotensin-converting enzyme inhibitor/angiotensin receptor blocker use and cardiovascular outcomes in patients initiating peritoneal dialysis

The role of RAAS blockade in kidney transplantation

Practical Recommendations for Long-term Management of Modifiable Risks in Kidney and Liver Transplant Recipients

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