Drugs Reduce Cholesterol in Teens with Genetic Disorder
Simvastatin plus ezetimibe reduces low-density lipoprotein cholesterol better than simvastatin alone
TUESDAY, Oct. 14 (HealthDay News) -- Simvastatin plus ezetimibe is better than simvastatin alone in reducing low-density lipoprotein cholesterol (LDL-C) in adolescents with heterozygous familial hypercholesterolemia, an inherited disease characterized by abnormally high LDL-C levels, according to a report in the Oct. 21 issue of the Journal of the American College of Cardiology.
Anouk van der Graaf, M.D., from the University of Amsterdam in the Netherlands, and colleagues randomly assigned 248 adolescents with heterozygous familial hypercholesterolemia to simvastatin and ezetimibe in three steps. In the first step, which was double-blind, patients received 10, 20 or 40 mg/day simvastatin plus placebo or 10 mg/day ezetimibe for six weeks. In the second step, which was double-blind, patients received 40 mg/day simvastatin plus placebo or 10 mg/day ezetimibe for 27 weeks. In the third step, which was open-label, all patients received 10 or 20 mg/day simvastatin plus 10 mg/day ezetimibe for 20 weeks.
The researchers found that at the end of the first step, ezetimibe and simvastatin treatment was significantly better than placebo and simvastatin in the mean reduction in LDL-C from baseline (49.5 versus 34.4 percent), both in pooled dose groups and in individual doses. At the end of the second step, the mean reduction in LDL-C was also significantly better for ezetimibe and simvastatin (54 versus 38.1 percent). At the end of the third step, there was a pooled reduction in LDL-C of 49.1 percent. All treatments were well-tolerated throughout the 53-week study.
"Coadministration of ezetimibe with simvastatin was safe, well tolerated, and provided higher LDL-C reduction compared with simvastatin alone in adolescents with heterozygous familial hypercholesterolemia studied up to 53 weeks," van der Graaf and colleagues conclude.
The study was supported by Merck/Schering-Plough Pharmaceuticals. Several of the study authors report financial relationships with the pharmaceutical industry.