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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 Kim  ;  Jun 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 
 BMC PHARMACOLOGY & TOXICOLOGY, Vol.18(2) : 1-11, 2017 
Journal Title
Issue Date
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
Fimasartan ; Hypercholesterolemia ; Hypertension ; Rosuvastatin
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.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Shim, Chi Young(심지영) ORCID logo https://orcid.org/0000-0002-6136-0136
Yoon, Young Won(윤영원) ORCID logo https://orcid.org/0000-0002-0907-0350
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