The Evaluation of Nifedipine and Cerivastatin on the Recovery of Endothelial Function (ENCORE) was a randomised, double-blind, placebo-controlled trial in patients with coronary artery disease (CAD). The trial compared the effects of Adalat® (nifedipine GITS), cerivastatin or the combination of Adalat® and cerivastatin on coronary endothelial function, as measured by the acetylcholine test.
ENCORE included 343 CAD patients who were randomised to placebo, cerivastatin alone, Adalat® alone or Adalat® and cerivastatin in combination. The effect of each treatment on the constriction of coronary arteries in response to acetylcholine was investigated. In CAD patients, due to endothelial dysfunction, acetylcholine does not cause vasodilation of the affected coronary arteries, but instead causes vasoconstriction through activation of vascular smooth muscle cell muscarinic receptors. The primary endpoint was the change from baseline in the mean lumen diameter after 6 months of treatment, as determined by the acetylcholine test in the most constricting coronary segment.
ENCORE demonstrated that Adalat® treatment significantly improved endothelial function in the most constricting coronary artery segment. This supports the hypothesis that Adalat® treatment has benefits on the vascular system, as indicated by the INSIGHT side-arm study results.
ENCORE Investigators. Circulation 2003;107:422-8.