SynthesisCardiovascular drugs and therapy2022
Five Years of Sacubitril/Valsartan-a Safety Analysis of Randomized Clinical Trials and Real-World Pharmacovigilance.
Synthesis in Cardiovascular drugs and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 3 syntheses or guidelines pooled it, 16 citations in OpenAlex.
- Ten years real-world experience with sacubitril/valsartan in patients with heart failure with reduced ejection fraction.ESC heart failure · 2026Pooled it
- Angiotensin-neprilysin inhibition in acute decompensated heart failure: a meta-analysis of randomized controlled trials.Future cardiology · 2026Pooled it
- Clinical practice guidelines for diagnostic and treatment of the chronic heart failure.Archivos de cardiologia de Mexico · 2024Guideline
- Impacts of Sacubitril-Valsartan versus Valsartan on Left Ventricular Remodeling and Cardiac Function in Patients with Ischemic Heart Failure and Reduced Ejection Fraction: A Randomized Double-blinded Controlled Trial.Cardiovascular & hematological disorders drug targets · 2026Trial
- Heterogeneous benefit of early sacubitril/valsartan initiation after PCI in elderly patients with left ventricular dysfunction: myocardial recovery and mid-term cardiovascular outcomes.Frontiers in cardiovascular medicine · 2026Article
- A real-world pharmacovigilance analysis of potential ototoxicity associated with sacubitril/valsartan based on FDA Adverse Event Reporting System (FAERS).Scientific reports · 2024Article
- Clinical drug interactions between linezolid and other antibiotics: For adverse drug event monitoring.Pharmacology research & perspectives · 2024Article
- A real-world disproportionality analysis of sacubitril/valsartan: data mining of the FDA adverse event reporting system.Frontiers in pharmacology · 2024Article
- Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems.Frontiers in drug safety and regulation · 2023Review
- Sacubitril/valsartan in heart failure: efficacy and safety in and outside clinical trials.ESC heart failure · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeIn PARADIGM-HF, sacubitril/valsartan showed a significant reduction in mortality and hospitalization for patients with heart failure with reduced ejection fraction. Despite proven efficacy, sacubitril/valsartan has moderate uptake in clinical practice. This study explores the safety profile of sacubitril/valsartan by comparing adverse events in RCT and real-world use.
methodsWe studied hypotension, renal dysfunction, hyperkalemia, and angioedema associated with sacubitril/valsartan in RCTs and pharmacovigilance databases. A random-effects meta-analysis was performed with six RCTs investigating sacubitril/valsartan vs. control/comparators in heart failure patients. WHO's VigiBase, FAERS, and EMA's EudraVigilance were mined to obtain spontaneously reported real-world adverse events. Disproportionality analysis was performed with the FDA's OpenVigil 2.0.
resultsSix RCTs enrolled 15,538 patients with heart failure with reduced and preserved ejection fractions. There was no statistical difference for the composite of hypotension, renal dysfunction, hyperkalemia, and angioedema between sacubitril/valsartan and its comparators viz. ACEi or ARBs (OR 1.23, CI 0.98-1.56; p = 0.08). A total of 103,038 adverse events were registered in the spontaneous reporting systems. Hypotension was the most reported adverse event. Proportions of composite adverse events were 20% in VigiBase, 17% in FAERS, and 39% with EudraVigilance. Disproportionality analysis showed a lower risk of adverse events with sacubitril/valsartan than other guideline-directed heart failure medications used in clinical practice.
conclusionWith increased uptake of sacubitril/valsartan, risks of hypotension, renal dysfunction, hyperkalemia, and angioedema appear low and acceptable in RCTs and global clinical practice.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.