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Effectiveness and Safety of Ezetimibe Added to Statin Therapy in Patients with Primary Dyslipidaemia not Achieving the LDL- C Treatment Goal on Statin Monotherapy

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Abstract

Background and objective: Elevated serum low-density lipoprotein cholesterol (LDL-C) is a major cardiovascular risk factor. This study aimed to determine the efficacy and safety of co-administration of the cholesterol absorption inhibitor ezetimibe with an HMG-CoA reductase inhibitor (statin) in the treatment of Mexican patients with dyslipidaemia who had not attained the LDL-C treatment goal with statin monotherapy.

Material and methods: We studied 256 patients with elevated serum LDL-C (as defined by the US National Cholesterol Education Program Adult Treatment Panel III guidelines) despite statin therapy. All patients had lipid profiles performed at baseline and after 6–8 weeks of treatment with statin therapy plus ezetimibe 10 mg/day for 6–8 weeks.

Results: Addition of ezetimibe to statin treatment reduced mean serum LDL-C levels significantly (from 160 ± 42.8 to 100 ± 36 mg/dL; p < 0.001) after 6–8 weeks of treatment, with 61.7% of patients achieving LDL-C values below the goal established according to their coronary risk group. Serum LDL-C goals were achieved at the end of the study in 88.2% of the low-risk coronary group, 75.7% of the moderate-risk group and 47.8% of the high-risk group. Ezetimibe was well tolerated; no hepatic or muscle-related adverse events were observed.

Conclusion: Addition of ezetimibe to statin treatment was both efficacious and safe when used for further reduction of serum LDL-C in dyslipidaemic patients who had not reached their LDL-C treatment goal while taking statin monotherapy.

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Acknowledgements

This trial was supported by Schering-Plough S.A. de C.V. The authors thank Ernesto Rodriguera for his assistance in the preparation of this manuscript. The authors have no conflicts of interest that are directly relevant to the content of this study.

The study group consisted of the following investigators: Fernando Reyes, Melchor Alpízar, Roberto Barba, José L. García, Miguel A. Rivera, Arturo Guerra, Marco A. Alcocer, Marco Cruz, Marcos Ibarra, Julio Aspe, Jorge Carrillo, Alejandro Herrera, César Rodríguez, José M. Enciso, Raúl Velasco, Norberto Matadamas, Manuel Duarte, Odín De Los Ríos, Javier Marín, José A. Castro, Mario Benavides, Laura M. Castillón, Ma. Concepción Torres, Manuel González, Luis Manautou, Ernesto Cardona, Pedro Galván, Eddie Alfaro, Rafael Bustos, Leoncio Toledo, Sergio Islas, Alfredo Estrada, Armando García, Araceli Díaz, Armando Mansilla, Salvador Ocampo, Gerardo Carreón, Juan Parcero, Rogelio Peralta, José L. Arenas, Armando Cruz, Juan C. Ramírez, Miguel A. Ramírez, Mateo Porres, Roberto Rentería, Francisco Navarro, Argelia Medeiros, Angel González, José Rico, Ismael Hernández, Juan C. Necoechea, Juan Cerda, José L. Soto, Carlos Zamora, Guillermo Llamas, and Luis A. Elizondo.

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Authors and Affiliations

  1. Asociación Mexicana para la Prevención de la Aterosclerosis y sus Complicaciones A.C.(AMPAC), Mexico DF, Mexico

    Carlos A. González,  Alberto F. Rubio-Guerra, Abel Pavía, Francisco J. Redding, José L. Cervantes, José L. Zacarías, Rubén Yza, Jaime Carranza, Pedro Fernández, Enrique Morales, Francisco J. Robles, José L. Leyva & Leticia Rodríguez

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  1. Carlos A. González
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  2. Alberto F. Rubio-Guerra
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  3. Abel Pavía
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  4. Francisco J. Redding
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  5. José L. Cervantes
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  6. José L. Zacarías
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  7. Rubén Yza
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  8. Jaime Carranza
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  9. Pedro Fernández
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  10. Enrique Morales
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  11. Francisco J. Robles
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  12. José L. Leyva
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  13. Leticia Rodríguez
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Corresponding author

Correspondence to Alberto F. Rubio-Guerra.

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González, C.A., Rubio-Guerra, A.F., Pavía, A. et al. Effectiveness and Safety of Ezetimibe Added to Statin Therapy in Patients with Primary Dyslipidaemia not Achieving the LDL- C Treatment Goal on Statin Monotherapy. Clin. Drug Investig. 27, 333–337 (2007). https://doi.org/10.2165/00044011-200727050-00004

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  • DOI: https://doi.org/10.2165/00044011-200727050-00004

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