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

BMC Pharmacol Toxicol. 2017 Jan 5;18(1):2. doi: 10.1186/s40360-016-0112-7.

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 4 weeks of therapeutic life change were randomly assigned to the following groups. 1) co-administration of fimasartan 120 mg/rosuvastatin 20 mg (FMS/RSV), 2) fimasartan 120 mg (FMS) alone 3) rosuvastatin 20 mg (RSV) alone. Drugs were administered once daily for 8 weeks.

Results: Of 140 randomized patients, 135 for whom efficacy data were available were analyzed. After 8 weeks 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 8 weeks 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: NCT02166814 . 16 June 2014.

Keywords: Fimasartan; Hypercholesterolemia; Hypertension; Rosuvastatin.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Angiotensin II Type 1 Receptor Blockers / administration & dosage
  • Angiotensin II Type 1 Receptor Blockers / adverse effects
  • Angiotensin II Type 1 Receptor Blockers / therapeutic use*
  • Anticholesteremic Agents / administration & dosage
  • Anticholesteremic Agents / adverse effects
  • Anticholesteremic Agents / therapeutic use*
  • Biphenyl Compounds / administration & dosage
  • Biphenyl Compounds / adverse effects
  • Biphenyl Compounds / therapeutic use*
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Humans
  • Hypercholesterolemia / complications
  • Hypercholesterolemia / drug therapy*
  • Hypertension / complications
  • Hypertension / drug therapy*
  • Male
  • Middle Aged
  • Pyrimidines / administration & dosage
  • Pyrimidines / adverse effects
  • Pyrimidines / therapeutic use*
  • Rosuvastatin Calcium / administration & dosage
  • Rosuvastatin Calcium / adverse effects
  • Rosuvastatin Calcium / therapeutic use*
  • Tetrazoles / administration & dosage
  • Tetrazoles / adverse effects
  • Tetrazoles / therapeutic use*
  • Young Adult

Substances

  • Angiotensin II Type 1 Receptor Blockers
  • Anticholesteremic Agents
  • Biphenyl Compounds
  • Pyrimidines
  • Tetrazoles
  • Rosuvastatin Calcium
  • fimasartan

Associated data

  • ClinicalTrials.gov/NCT02166814