Efficacy and Safety of Inclisiran-An Assessment of the Consistency Between Randomized Controlled Trials and Real-World Evidence: A Systematic Review
Lin Y, Wang H, Yang H, Li Z
Reviews in cardiovascular medicine · 0 citas
Etiquetas de revisión
Financiación no declaradaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Revisión sistemática (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2026-05-26 · Rev Cardiovasc Med · vol. 27 · número 5 · pág. 48272
- Editorial
- IMR Press
- Citado
- 0 citas · más que el 34% de estudios similares · 0.0× el promedio de su campo
- Referencias
- 0 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY
- Áreas de investigación
- Lipoproteins and Cardiovascular Health · Antiplatelet Therapy and Cardiovascular Diseases · Cholesterol and Lipid Metabolism
- Palabras clave
- inclisiran, LDL cholesterol lowering, real-world evidence, randomized controlled trials, lipid-lowering drugs, hypercholesterolemia, diabetes mellitus, adverse events, injection site reactions, PCSK9 inhibition
4 autores
- Yaru Lin🇨🇳Shanxi Medical University
- Haixiong Wang🇨🇳 · autor de correspondenciaShanxi Medical University; Shanxi Cardiovascular Hospital
- Han Yang🇨🇳Shanxi Medical University
- Zekai Li🇨🇳Shanxi Medical University; Second Hospital of Shanxi Medical University
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
This study aimed to compare the consistency in low-density lipoprotein cholesterol (LDL-C) reduction and the safety profile of the novel lipid-lowering agent inclisiran between randomized controlled trials (RCTs) and real-world evidence (RWE).
Methods
A systematic search of the PubMed, Embase, and Web of Science databases (2022-2025) identified three RCTs (n = 1833) and five RWE studies (n = 805). LDL-C reduction in the RCTs at 540 days was compared with that observed at 90 days in the RWE studies. Subgroup analyses were performed for patients with and without diabetes.
Results
Four of the five RWE studies showed complete overlap of confidence intervals with the RCT results. Weighted regression analysis demonstrated a strong positive association between the reduction in LDL-C reported in the RCTs and RWE studies (R2 = 0.774; p = 0.004). The diabetic subgroup exhibited significantly greater LDL-C reduction than the overall RWE population (p = 0.003), with absolute differences ranging from 2.3% to 4.8% compared with corresponding RCTs. Safety profiles were comparable across study types, with differences in adverse event incidence of less than 5%. Injection-site reactions were the most frequently reported adverse events.
Conclusion
Inclisiran demonstrated highly consistent LDL-C-lowering efficacy and a comparable safety profile across both RCTs and real-world settings.
The prospero registration
CRD42024618982, URL: https://www.crd.york.ac.uk/PROSPERO/view/CRD42024618982.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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