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Outcomes of discontinuing renin-angiotensin system inhibitors: a study protocol for conducting systematic review and
Taihei Suzuki1, Hiroki Nishiwaki2, Yoshitaka Watanabe3
1Division of Nephrology, Department of Internal Medicine, Showa University Graduate School of Medicine, Shinagawa-ku, Japan taihei-s@med.showa-u.ac.jp.
Introduction:
Renin-angiotensin system (RAS) plays a key role in various types of cardiovascular disease and many kinds of RAS inhibitors have been developed. The effect of discontinuation of RAS inhibitors on clinical outcomes is still controversial. This study aims to evaluate the effects of discontinuing RAS inhibitor medication on the clinical outcomes of patients continuously taking these agents.
Methods And Analysis:
This article presents a systematic review protocol described in accordance with Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. We will include randomised controlled trials in which the effects of RAS inhibitor withdrawal were evaluated. Initially, four authors will search for eligible studies in MEDLINE, EMBASE, the Cochrane Database Trial Register, European trial registry and ClinicalTrials.gov. Abstracts and full-text screenings will be performed by the four authors with data extraction performed by each author independently. We will include patients taking RAS inhibitors-including ACE inhibitor, angiotensin receptor blocker and angiotensin receptor neprilysin inhibitor and exclude the patients undergoing renal replacement therapy (RRT), adolescents (under 18 years of age) and patients with acute infectious diseases. Our search will be performed on 1 May 2023. Studies in which the patients discontinued RAS inhibitors due to any reason will be included. Patients who continuously took RAS inhibitors under conditions in which the intervention group discontinued these agents will be considered eligible as the comparison group. Death (any cause), Death (cardiovascular disease (CVD)) and CVD events will be set as primary outcomes. Secondary outcomes will be set as RRT, acute kidney injury, renal function (analysis of the change in estimated glomerular filtration rate), hyperkalaemia, proteinuria and blood pressure.
Ethics And Dissemination:
Research ethics approval was not required in this study due to it being a systematic review, and any data belonging to individuals cannot be identified. The results of this study will be disseminated through peer-reviewed journals and conferences.
Trial Registration Number:
PROSPERO CRD42022300777.
Insights
Discontinuing renin-angiotensin system (RAS) inhibitors may impact patient outcomes, but evidence is debated. This systematic review will analyze randomized trials to clarify the effects of stopping RAS inhibitor medications on cardiovascular events and mortality.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Evidence-Based Medicine
Background:
- The renin-angiotensin system (RAS) is crucial in cardiovascular disease pathogenesis.
- Numerous RAS inhibitors are available, but their discontinuation effects remain controversial.
- Understanding the impact of stopping these medications is vital for patient management.
Purpose of the Study:
- To systematically review randomized controlled trials evaluating the clinical outcomes of discontinuing RAS inhibitor therapy.
- To assess the impact of RAS inhibitor withdrawal on mortality, cardiovascular events, and renal function.
Main Methods:
- Systematic review protocol adhering to PRISMA guidelines.
- Searches of MEDLINE, EMBASE, Cochrane, and clinical trial registries.
- Inclusion of randomized trials on RAS inhibitor withdrawal (ACE inhibitors, ARBs, ARNIs); exclusion of patients on renal replacement therapy, adolescents, and those with acute infections.
Main Results:
- Primary outcomes include all-cause mortality, cardiovascular death, and cardiovascular events.
- Secondary outcomes encompass renal replacement therapy, acute kidney injury, renal function (eGFR), hyperkalemia, proteinuria, and blood pressure.
- Data extraction and analysis will be performed independently by four authors.
Conclusions:
- This systematic review will provide crucial evidence on the clinical consequences of discontinuing RAS inhibitors.
- Findings will inform clinical practice regarding the management of patients on these essential cardiovascular medications.
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