Beneficial Effects of Fixed-Dose Combination of Amlodipine and Atorvastatin in Patients with Concomitant Hypertension and Hypercholesterolemia: A Multi-Institutional Cohort Study

Background Blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) are important risk factors for cardiovascular (CV) diseases and treating these factors simultaneously is recommended by current guidelines but only short-term clinical results were available. The objective of this study was to examine the longer-term efficacy and safety of fixed-dose combination (FDC) versus free combination of amlodipine and atorvastatin in patients with concomitant hypertension and hypercholesterolemia. Methods Patients with hypertension and hypercholesterolemia were stratified into three groups (FDC of amlodipine 5 mg/atorvastatin 10 mg [Fixed 5/10], FDC of amlodipine 5 mg/atorvastatin 20 mg [Fixed 5/20], and free combination of amlodipine 5 mg/atorvastatin 10 mg [Free 5/10]). After inverse probability of treatment weighting, the composite CV outcome, liver function, BP, LDL-C and glycated hemoglobin (HbA1c) changes were compared. Results A total of 1,788 patients were eligible for analysis and the mean follow-up period was 1.7 year. There was no significant difference in the composite CV outcome among the three groups during the 30-month follow-up period (Fixed 5/10 6.1%, Fixed 5/20 6.3% and Free 5/10 6.0%). The LDL-C level was significantly reduced in the Fixed 5/20 group (-35.7 mg/dL) compared to the Fixed 5/10 (-23.6 mg/dL) and Free 5/10 (-10.3 mg/dL) groups (P=0.001 and <0.001, respectively). The changes in HbA1c were similar among the three groups. Conclusions FDC of amlodipine and atorvastatin, especially the regimen with higher dosage of statin, significantly reduced the mid-term LDL-C level compared to free combination in patients with concomitant hypertension and hypercholesterolemia. Blood sugar level during the follow-up period was not significantly changed by this aggressive treatment strategy.