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.
Bibliographical noteFunding Information:
Dr. Rhee has received lecture honoraria from Pfizer Inc., LG Life Sciences Ltd, Bayer Korea Ltd., Hanmi Pharm. Co. Ltd., Yuhan Co. Ltd., Boryung Pharmaceutical Co. Ltd., and research grant from Boryung Pharmaceutical Co. Ltd. and Dong-A Pharmaceutical Co., Ltd. Dr. Oh has received research grant from Boryung Pharmaceutical Co. Ltd. The authors have indicated that they have no other conflicts of interest with regard to the content of this article. The study drugs were supplied by Boryung Pharmaceutical Co. Ltd. ClinicalTrials.gov Identifier: NCT02166814.
This study was initiated and financially supported by Boryung Pharmaceutical Co. Ltd., Seoul, Republic of Korea (BR-FRC-CT-301). The sponsor supported the supply of study drug, laboratory test, data collection, and data analysis. The funding body had no role in data interpretation and the writing of the manuscript based on the data.
© 2017 The Author(s).
All Science Journal Classification (ASJC) codes
- Pharmacology (medical)