PENDO-AMLODIPINE-ATORVASTATIN

Clinical Trial Adverse Drug Reactions For amlodipine besylate/atorvastatin calcium, itself Amlodipine besylate/atorvastatin calcium has been evaluated for safety in 1092 patients in two double-blind, placebo-controlled studies treated for co-morbid hypertension and dyslipidemia.

In these studies, no unexpected adverse experiences particular to this combination have been observed. Adverse experiences have been limited to those that were reported previously with amlodipine and/or atorvastatin. For the most part, adverse experiences with amlodipine besylate/atorvastatin calcium have been mild or moderate in severity.

0% of patients given placebo. The most common safety-related reasons for discontinuation from these studies in the combination treatment groups were headache and peripheral edema. In a double-blind, controlled clinical trial of all available amlodipine besylate/atorvastatin calcium doses (5/10 mg to 10/80 mg amlodipine/atorvastatin respectively), the incidences of treatment-emergent adverse events (all causalities) that occurred in at least 1% of all combination treatment groups, pooled across all the combination doses, are summarized below.

7) AML = amlodipine ATO = atorvastatin The incidence (%) of dose-related adverse events was consistent with those seen for amlodipine and/or atorvastatin. 0%). 1%) discontinued due to adverse safety experiences. Only 1 subject discontinued due to laboratory abnormalities.

4%), but these events led to the discontinuation of subjects in the combination treatment groups no more frequently than they did among subjects treated with either amlodipine alone or atorvastatin alone within this study. The following information is based on the clinical experience with the parent compounds, amlodipine besylate and atorvastatin calcium.

Amlodipine Amlodipine besylate has been administered to 1 714 patients (805 hypertensive and 909 angina patients) in controlled clinical trials, when compared to placebo alone or active comparators. Most adverse reactions reported during therapy were of mild to moderate severity.

9% of patients. 3%). 5%). 7%). 5%). 5%). 7%). 4%). 5%). 5%). 5% of patients and required discontinuation of therapy due […]