Real-World Evidence Evaluation on the Lipid Profile, Therapeutic Goals, and Safety of the Fixed-Dose Combination of Rosuvastatin/Ezetimibe (Trezete®) in Dyslipidemia Patients

Introduction. Cardiovascular diseases are the leading cause of death worldwide. The combination of statins and cholesterol-absorption inhibitors promotes the decrease in risk factors, such as high concentrations of LDL (low-density lipoproteins). The aim of the study was to evaluate changes in the l...

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Main Authors: Joel Rodríguez-Saldaña, Francisco Padilla-Padilla, Ernesto G. Cardona-Muñoz, Yulia Romero-Antonio, María Marcela Arguedas-Núñez, José G. Sander-Padilla, Alberto Martínez-Muñoz, Laura A. Lugo-Sánchez, Ileana C. Rodríguez-Vazquez, Jorge González-Canudas
Format: Article
Language:English
Published: Wiley 2022-01-01
Series:Cardiology Research and Practice
Online Access:http://dx.doi.org/10.1155/2022/9464733
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author Joel Rodríguez-Saldaña
Francisco Padilla-Padilla
Ernesto G. Cardona-Muñoz
Yulia Romero-Antonio
María Marcela Arguedas-Núñez
José G. Sander-Padilla
Alberto Martínez-Muñoz
Laura A. Lugo-Sánchez
Ileana C. Rodríguez-Vazquez
Jorge González-Canudas
author_facet Joel Rodríguez-Saldaña
Francisco Padilla-Padilla
Ernesto G. Cardona-Muñoz
Yulia Romero-Antonio
María Marcela Arguedas-Núñez
José G. Sander-Padilla
Alberto Martínez-Muñoz
Laura A. Lugo-Sánchez
Ileana C. Rodríguez-Vazquez
Jorge González-Canudas
author_sort Joel Rodríguez-Saldaña
collection DOAJ
description Introduction. Cardiovascular diseases are the leading cause of death worldwide. The combination of statins and cholesterol-absorption inhibitors promotes the decrease in risk factors, such as high concentrations of LDL (low-density lipoproteins). The aim of the study was to evaluate changes in the lipid profile and the effect on therapeutic goals, as well as the safety of dyslipidemia patients treated with Rosuvastatin/Ezetimibe (Trezete®). Materials and Methods. A real-world evidence study was conducted with retrospective data collection through a review of clinical records from dyslipidemia patients treated with Trezete® in routine medical practice. Clinical records included results of biochemical markers before treatment and at least one follow up between weeks 8 and 16. Results. The study included 103 patients’ clinical records (55.4% men) with a mean age of 56.0 ± 13.0 years. More than 57% of the patients had mixed dyslipidemia and a median disease progression of 3.1 (IQR, 1.5; 9.1) years. Regarding LDL concentrations, 72.8% of the patients achieved therapeutic goals according to cardiovascular risk (CVR), which was statistically significant. Similarly, 94.1% achieved goals for total cholesterol (<200 mg/dL) and 56.0% for triglycerides (<150 mg/dL), a p value <0.001. No cardiovascular events were observed. Conclusion. Trezete® shows an important clinical impact on CVR-related target markers during the treatment of dyslipidemia patients. It is relevant to mention that a significant percentage of patients achieved therapeutic goals during the first months of treatment. Fixed-dose combination therapy has shown to be as safe as monotherapy treatment. ClinicalTrials.gov Identifier: NCT04862962.
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spelling doaj-art-aa57b867c2774f289b66a05271ac24f22025-02-03T01:22:59ZengWileyCardiology Research and Practice2090-05972022-01-01202210.1155/2022/9464733Real-World Evidence Evaluation on the Lipid Profile, Therapeutic Goals, and Safety of the Fixed-Dose Combination of Rosuvastatin/Ezetimibe (Trezete®) in Dyslipidemia PatientsJoel Rodríguez-Saldaña0Francisco Padilla-Padilla1Ernesto G. Cardona-Muñoz2Yulia Romero-Antonio3María Marcela Arguedas-Núñez4José G. Sander-Padilla5Alberto Martínez-Muñoz6Laura A. Lugo-Sánchez7Ileana C. Rodríguez-Vazquez8Jorge González-Canudas9Resultados Médicos Desarrollo e Investigación S.C.Clinical and Interventional CardiologyPrivate PracticeLaboratorios Silanes S.A. de C.V.Laboratorios Silanes S.A. de C.V.Laboratorios Silanes S.A. de C.V.Laboratorios Silanes S.A. de C.V.Laboratorios Silanes S.A. de C.V.Laboratorios Silanes S.A. de C.V.Laboratorios Silanes S.A. de C.V.Introduction. Cardiovascular diseases are the leading cause of death worldwide. The combination of statins and cholesterol-absorption inhibitors promotes the decrease in risk factors, such as high concentrations of LDL (low-density lipoproteins). The aim of the study was to evaluate changes in the lipid profile and the effect on therapeutic goals, as well as the safety of dyslipidemia patients treated with Rosuvastatin/Ezetimibe (Trezete®). Materials and Methods. A real-world evidence study was conducted with retrospective data collection through a review of clinical records from dyslipidemia patients treated with Trezete® in routine medical practice. Clinical records included results of biochemical markers before treatment and at least one follow up between weeks 8 and 16. Results. The study included 103 patients’ clinical records (55.4% men) with a mean age of 56.0 ± 13.0 years. More than 57% of the patients had mixed dyslipidemia and a median disease progression of 3.1 (IQR, 1.5; 9.1) years. Regarding LDL concentrations, 72.8% of the patients achieved therapeutic goals according to cardiovascular risk (CVR), which was statistically significant. Similarly, 94.1% achieved goals for total cholesterol (<200 mg/dL) and 56.0% for triglycerides (<150 mg/dL), a p value <0.001. No cardiovascular events were observed. Conclusion. Trezete® shows an important clinical impact on CVR-related target markers during the treatment of dyslipidemia patients. It is relevant to mention that a significant percentage of patients achieved therapeutic goals during the first months of treatment. Fixed-dose combination therapy has shown to be as safe as monotherapy treatment. ClinicalTrials.gov Identifier: NCT04862962.http://dx.doi.org/10.1155/2022/9464733
spellingShingle Joel Rodríguez-Saldaña
Francisco Padilla-Padilla
Ernesto G. Cardona-Muñoz
Yulia Romero-Antonio
María Marcela Arguedas-Núñez
José G. Sander-Padilla
Alberto Martínez-Muñoz
Laura A. Lugo-Sánchez
Ileana C. Rodríguez-Vazquez
Jorge González-Canudas
Real-World Evidence Evaluation on the Lipid Profile, Therapeutic Goals, and Safety of the Fixed-Dose Combination of Rosuvastatin/Ezetimibe (Trezete®) in Dyslipidemia Patients
Cardiology Research and Practice
title Real-World Evidence Evaluation on the Lipid Profile, Therapeutic Goals, and Safety of the Fixed-Dose Combination of Rosuvastatin/Ezetimibe (Trezete®) in Dyslipidemia Patients
title_full Real-World Evidence Evaluation on the Lipid Profile, Therapeutic Goals, and Safety of the Fixed-Dose Combination of Rosuvastatin/Ezetimibe (Trezete®) in Dyslipidemia Patients
title_fullStr Real-World Evidence Evaluation on the Lipid Profile, Therapeutic Goals, and Safety of the Fixed-Dose Combination of Rosuvastatin/Ezetimibe (Trezete®) in Dyslipidemia Patients
title_full_unstemmed Real-World Evidence Evaluation on the Lipid Profile, Therapeutic Goals, and Safety of the Fixed-Dose Combination of Rosuvastatin/Ezetimibe (Trezete®) in Dyslipidemia Patients
title_short Real-World Evidence Evaluation on the Lipid Profile, Therapeutic Goals, and Safety of the Fixed-Dose Combination of Rosuvastatin/Ezetimibe (Trezete®) in Dyslipidemia Patients
title_sort real world evidence evaluation on the lipid profile therapeutic goals and safety of the fixed dose combination of rosuvastatin ezetimibe trezete r in dyslipidemia patients
url http://dx.doi.org/10.1155/2022/9464733
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