Clinical Trials Resource Center

Congenital Heart Disease

January 21, 2008

Merck and Schering-Plough reported negative results from a clinical trial of Vytorin for the treatment of Heterozygous Familial Hypercholesterolemia (HeFH). This multinational, randomized, double-blind, active comparator trial, dubbed ENHANCE (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia), enrolled seven hundred and twenty subjects with HeFH. The subjects were randomized to Vytorin (10 mg ezetimibe + 80 mg simvastatin) or simvastatin alone (80 mg) for two years. There was no statistically significant difference between the treatment groups on the primary endpoint, the mean change in the intima-media thickness (IMT), measured at three sites in the carotid arteries. The change from baseline in the mean carotid IMT was 0.0111 mm for the ezetimibe/simvastatin 10/80 mg group versus 0.0058 mm for the simvastatin 80 mg group (p =0.29). In addition, no statistically significant differences were observed in the key secondary imaging endpoints. There was a significant difference in low-density lipoprotein (LDL) cholesterol lowering seen between the treatment groups -- 58% LDL cholesterol lowering at twenty four months on ezetimibe/simvastatin 10/80 mg as compared to 41% at twenty four months on simvastatin 80mg alone, (p<0.01). The overall adverse events profile was similar between the two treatment groups. Additional post-marketing trials are currently underway.

October 28, 2002

MedImmune reported a large, multinational phase III trial investigating Synagis, was safe and effective in preventing respiratory syncytial virus (RSV) related hospitalizations in young children with congenital heart disease (CHD). The four-year study, beginning in 1998, was conducted at 76 sites in the U.S. and Europe. Designed to assess the safety and efficacy in children under two, the study randomly injected 1,287 subjects with either Synagis or placebo during the RSV season. Compared to placebo, the Synagis group had 45% fewer hospitalizations due to RSV. The data showed there were significantly fewer RSV-related hospital days and fewer days of increased oxygen usage in the treatment group than in the placebo group. Similar proportions of subjects in the placebo and Synagis groups experienced adverse events.

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