IngentaConnect Effectiveness and Safety of Ezetimibe Added to Statin Therapy in ...

Authors: González, Carlos A.¹; Rubio-Guerra, Alberto F.¹; Pavía, Abel¹; Redding, Francisco J.¹; Cervantes, José L.¹; Zacarías, José L.¹; Yza, Rubén¹; Carranza, Jaime¹; Fernández, Pedro¹; Morales, Enrique¹; Robles, Francisco J.¹; Leyva, José L.¹; Rodríguez, Leticia¹

Source: Clinical Drug Investigation, Volume 27, Number 5, 2007 , pp. 333-337(5)

Publisher: Adis International

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.

Keywords: Cholesterol absorption inhibitors; Ezetimibe; HMG CoA reductase inhibitors; Lipid metabolism disorders

Document Type: Research article

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

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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