The efficacy and safety of co-administration of fimasartan and rosuvastatin to patients with hypertension and dyslipidemia

Abstract

Background Hypertension and dyslipidemia are major risk factors of cardiovascular disease (CVD) events. The objective of this study was to evaluate the efficacy and safety of the co-administration of fimasartan and rosuvastatin in patients with hypertension and hypercholesterolemia.

Methods We conducted a randomized double-blind and parallel-group trial. Patients who met eligible criteria after 4weeks of therapeutic life change were randomly assigned to the following groups. 1) co-administration of fimasartan 120mg/rosuvastatin 20mg (FMS/RSV), 2) fimasartan 120mg (FMS) alone 3) rosuvastatin 20mg (RSV) alone. Drugs were administered once daily for 8weeks.

Results Of 140 randomized patients, 135 for whom efficacy data were available were analyzed. After 8weeks of treatment, the FMS/RSV treatment group showed greater reductions in sitting systolic (siSBP) and diastolic (siDBP) blood pressures than those in the group receiving RSV alone (both p < 0.001). Reductions in siSBP and siDBP were not significantly different between the FMS/RSV and FMS alone groups (p = 0.500 and p = 0.734, respectively). After 8weeks of treatment, FMS/RSV treatment showed greater efficacy in percentage reduction of low-density lipoprotein cholesterol (LDL-C) level from baseline than that shown by FMS alone treatment (p < 0.001). The response rates of siSBP with FMS/RSV, FMS alone, and RSV alone treatments were 65.22, 55.56, and 34.09%, respectively (FMS/RSV vs. RSV, p = 0.006). The LDL-C goal attainment rates with FMS/RSV, RSV alone, and FMS alone treatments were 80.43%, 81.82%, and 15.56%, respectively (FMS/RSV vs. FMS, p < 0.001). Incidence of adverse drug reactions with FMS/RSV treatment was 8.33%, which was similar to those associated with FMS and RSV alone treatments.

Conclusion This study demonstrated that the co-administration of fimasartan and rosuvastatin to patients with both hypertension and hypercholesterolemia was efficacious and safe.

Trial registration ClinicalTrials.gov Identifier: NCT0216681. 16 June 2014