A long-term safety study of caduet combination tablet in japanese patients with either concurrent hypertension and hypercholeresterolemia or concurrent angina pectoris and hypercholesterolemia

We examined safety and efficacy of treatment with Caduet 1 Ban (2.5 mg/5 mg, dose of amlodipine/dose of atorvastatin), 2 Ban (2.5 mg/10 mg), 3 Ban (5 mg/5 mg) or 4 Ban (5 mg/10 mg) combination tablets for 52 weeks in Japanese patients with hypertension and hypercholesterolemia or angina pectoris and hypercholesterolemia. There were no deaths throughout the study period. All serious adverse events which occurred in the study were not related to Caduet. Most adverse events were mild or moderate with only 1 severe event (ischemic colitis). All treatment-related adverse events were mild and the only event which occurred in more than 2 patients was abdominal pain. In efficacy, Caduet favorably controlled systolic blood pressure (SBP), as well as diastolic blood pressure (DBP) with lower levels than the baseline throughout the treatment period. The low-density lipoprotein cholesterol (LDL-C) level showed approximately 10% reduction at Week 4 from baseline and maintained its level throughout the period. The LDL-C level in patients who were treated with the same dose of atorvastatin at the observational period (m = 116) maintained the same level at baseline throughout the study period. The LDL-C level in patients without any treatment on hypercholesterolemia (m = 40) greatly reduced. As to changes of the other lipid parameters except LDL-C, the percent changes from baseline of both total cholesterol and apolipoprotein B and both LDL-C and high density lipoprotein cholesterol (HDL-C) and TC, and the change from baseline of HDL-C gradually reduced until Week 4 and then maintained this reduced level. HDL-C level slightly increased throughout the study period except at Week 24. However, the triglyceride level did not show any change until Week 52. From the above results, it is considered the long-term safety of Caduet in Japanese patients is well-tolerated. The controls of BP and LDL-C treated with Caduet are favorable, in particular Caduet showed good improvement of LDL-C levels in patients without any treatment to hypercholesterolemia at baseline. This suggests that Caduet allows patients with hypercholesterolemia further intervention to their serum lipid.