Effectiveness and safety of ezetimibe added to statin therapy in patients with primary dyslipidaemia not achieving the LDL-C treatment goal on statin monotherapy.
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.


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.


CONCLUSIONS
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.
González
Carlos A
CA
Asociación Mexicana para la Prevención de la Aterosclerosis y sus Complicaciones A.C. (AMPAC), Mexico DF, Mexico.
Rubio-Guerra
Alberto F
AF
Pavía
Abel
A
Redding
Francisco J
FJ
Cervantes
José L
JL
Zacarías
José L
JL
Yza
Rubén
R
Carranza
Jaime
J
Fernández
Pedro
P
Morales
Enrique
E
Robles
Francisco J
FJ
Leyva
José L
JL
Rodríguez
Leticia
L
D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D001384:Azetidines / Q000627:therapeutic use*; D008078:Cholesterol, LDL / Q000097:blood*; D004359:Drug Therapy, Combination; D050171:Dyslipidemias / Q000097:blood / Q000188:drug therapy*; D000069438:Ezetimibe; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
D000924:Anticholesteremic Agents; D001384:Azetidines; D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000069438:Ezetimibe