DISCONTINUATION OF RENIN-ANGIOTENSIN SYSTEM INHIBITORS AND CLINICAL OUTCOMES: A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CONTROLLED TRIAL

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Abstract Title *

DISCONTINUATION OF RENIN-ANGIOTENSIN SYSTEM INHIBITORS AND CLINICAL OUTCOMES: A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CONTROLLED TRIAL

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Co-author 1

Taihei Suzuki taihei-s@med.showa-u.ac.jp Showa Medical University Nephrology Tokyo Japan * Showa Medical University Institute of Clinical Epidemiology (iCE) Tokyo Japan

Co-author 2

Hiroki Nishiwaki nwacky1978@med.showa-u.ac.jp Showa Medical University Fujigaoka Hospital Nephrology Kanagawa Japan - Showa Medical University Institute of Clinical Epidemiology (iCE) Tokyo Japan

Co-author 3

Yoshifusa Abe yoshifusa@med.showa-u.ac.jp Showa Medical University Koto Toyosu Hospital Children's Medical Center Tokyo Japan -

Co-author 4

Yoshitaka Watanabe y.nabe29@med.showa-u.ac.jp Showa Medical University Northern Yokohama Hospital Children's Medical Center Kanagawa Japan -

Co-author 5

Shunsuke Yoshida syoshida1993@med.showa-u.ac.jp Showa Medical University Nephrology Tokyo Japan -

Co-author 6

Nobuhiro Kanazawa nkanazawa@med.showa-u.ac.jp Showa Medical University Nephrology Tokyo Japan -

Co-author 7

Hisashi Noma noma@ism.ac.jp The Institute of Statistical Mathematics Interdisciplinary Statistical Mathematics Tokyo Japan -

Co-author 8

Erika Ota ota@slcn.ac.jp St.Luke's International University Global Health Nursing Tokyo Japan -

Co-author 9

Hirokazu Honda hondah@med.showa-u.ac.jp Showa Medical University Nephrology Tokyo Japan -

Co-author 10

Takeshi Hasegawa tahasegawa@med.showa-u.ac.jp Showa Medical University Nephrology Tokyo Japan - Showa Medical University Institute of Clinical Epidemiology (iCE) Tokyo Japan Showa Medical University Fujigaoka Hospital Nephrology Tokyo Japan

Co-author 11

Co-author 12

Co-author 13

Co-author 14

Co-author 15

Introduction

The renin-angiotensin system inhibitors (RASi), such as angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers, angiotensin receptor-neprilysin inhibitor, and mineral corticoid receptor antagonist are sometime discontinued because of their adverse events in clinical practice. However, the effects of RASi withdrawal have not been elucidated fully. We performed systematic review and meta-analysis using the RCTs data from large database and registry archives to comprehensively examine the current landscape of the effects of RASi discontinuation.

Methods

We performed a systematic review and meta-analysis including only RCTs. We searched MEDLINE, EMBASE, CENTRAL, ClinicalTrials.gov, and EU Clinical Trials Register for the full text review analysis on 21 September 2025. Primary outcomes included all-cause death and cardiovascular (CVD) events. Risk of bias was assessed using version 2 of the Cochrane Risk of bias tool, and the certainty of evidence was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation approach.

Results

Among the seven included RCTs (n = 928), four studies (n = 745) reported all-cause mortality and two studies (n = 697) reported CVD events. The meta-analysis did not show a difference in all-cause mortality (RR 0.95, 95% CI 0.54–1.65; I² = 0%) and cardiovascular events (RR 1.22, 95% CI 1.00–1.50; I² = 0%) between the intervention and control groups. The certainty of evidence was rated as very low for both outcomes because of risk of bias, imprecision, and clinical heterogeneity.

Conclusion

This systematic review and meta-analysis did not identify a statistical difference in the risk of all-cause mortality or CVD events following RASi discontinuation compared with continuation. However, the point estimates suggested a potential increase in cardiovascular risk after discontinuation, which may be mediated by changes in blood pressure. The certainty of evidence was very low; thus, the results should be interpreted with caution. Further high-quality RCTs are warranted to clarify the clinical implications.

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