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

Moo Yong Rhee, Taehoon Ahn, Kiyuk Chang, Shung Chull Chae, Tae Hyun Yang, Wan Joo Shim, Tae Soo Kang, Jae Kean Ryu, Deuk Young Nah, Tae Ho Park, In Ho Chae, Seung Woo Park, Hae Young Lee, Seung Jea Tahk, Young Won Yoon, Chi Young Shim, Dong Gu Shin, Hong Seog Seo, Sung Yun Lee, Doo Il KimJun Kwan, Seung Jae Joo, Myung Ho Jeong, Jin Ok Jeong, Ki Chul Sung, Seok Yeon Kim, Sang Hyun Kim, Kook Jin Chun, Dong Joo Oh

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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

Original languageEnglish
Article number2
JournalBMC Pharmacology and Toxicology
Volume18
Issue number1
DOIs
Publication statusPublished - 2017 Jan 5

Keywords

  • Fimasartan
  • Hypercholesterolemia
  • Hypertension
  • Rosuvastatin

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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    Rhee, M. Y., Ahn, T., Chang, K., Chae, S. C., Yang, T. H., Shim, W. J., Kang, T. S., Ryu, J. K., Nah, D. Y., Park, T. H., Chae, I. H., Park, S. W., Lee, H. Y., Tahk, S. J., Yoon, Y. W., Shim, C. Y., Shin, D. G., Seo, H. S., Lee, S. Y., ... Oh, D. J. (2017). The efficacy and safety of co-administration of fimasartan and rosuvastatin to patients with hypertension and dyslipidemia. BMC Pharmacology and Toxicology, 18(1), [2]. https://doi.org/10.1186/s40360-016-0112-7