title: The efficacy and safety of co-administration of fimasartan and rosuvastatin to patients with hypertension and dyslipidemia.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  This study demonstrated that the co-administration of fimasartan and rosuvastatin to patients with both hypertension and hypercholesterolemia was efficacious and safe.
  
  
  
  ClinicalTrials.gov Identifier: NCT02166814 . 16 June 2014.
authors.affiliation: Cardiovascular Center, Dongguk University Ilsan Hospital, Goyang, Republic of Korea.
authors.forename: Moo-Yong
authors.initials: MY
authors.lastname: Rhee
authors.affiliation: Division of Cardiology, Gachon University Gil Hospital, Incheon, Republic of Korea.
authors.forename: Taehoon
authors.initials: T
authors.lastname: Ahn
authors.affiliation: Division of Cardiology, Seoul St. Mary's Hospital, Seoul, Republic of Korea.
authors.forename: Kiyuk
authors.initials: K
authors.lastname: Chang
authors.affiliation: Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Republic of Korea.
authors.forename: Shung Chull
authors.initials: SC
authors.lastname: Chae
authors.affiliation: Division of Cardiology, Inje University Busan Paik Hospital, Busan, Republic of Korea.
authors.forename: Tae-Hyun
authors.initials: TH
authors.lastname: Yang
authors.affiliation: Division of Cardiology, Korea University Anam Hospital, Seoul, Republic of Korea.
authors.forename: Wan Joo
authors.initials: WJ
authors.lastname: Shim
authors.affiliation: Department of Cardiology, Dankook University Hospital, Cheonan, Republic of Korea.
authors.forename: Tae Soo
authors.initials: TS
authors.lastname: Kang
authors.affiliation: Department of Internal Medicine, Daegu Catholic University Hospital, Daegu, Republic of Korea.
authors.forename: Jae-Kean
authors.initials: JK
authors.lastname: Ryu
authors.affiliation: Division of Cardiology, Dongguk University Gyeongju Hospital, Gyeongju, Republic of Korea.
authors.forename: Deuk-Young
authors.initials: DY
authors.lastname: Nah
authors.affiliation: Department of Internal Medicine, Dong-A University College of Medicine, Busan, Republic of Korea.
authors.forename: Tae-Ho
authors.initials: TH
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.
authors.forename: In-Ho
authors.initials: IH
authors.lastname: Chae
authors.affiliation: Division of Cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Seung Woo
authors.initials: SW
authors.lastname: Park
authors.affiliation: Division of Cardiology, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Hae-Young
authors.initials: HY
authors.lastname: Lee
authors.affiliation: Department of Cardiology, Ajou University Hospital, Suwon, Republic of Korea.
authors.forename: Seung-Jea
authors.initials: SJ
authors.lastname: Tahk
authors.affiliation: Division of Cardiology, Gangnam Severance Hospital, Seoul, Republic of Korea.
authors.forename: Young Won
authors.initials: YW
authors.lastname: Yoon
authors.affiliation: Division of Cardiology, Severance Cardiovascular Hospital, Seoul, Republic of Korea.
authors.forename: Chi Young
authors.initials: CY
authors.lastname: Shim
authors.affiliation: Department of Cardiology, Yeungnam University Hospital, Daegu, Republic of Korea.
authors.forename: Dong-Gu
authors.initials: DG
authors.lastname: Shin
authors.affiliation: Division of Cardiology, Korea University Guro Hospital, 148, Gurodong-ro, Guro-gu, Seoul, 08308, Republic of Korea.
authors.forename: Hong Seog
authors.initials: HS
authors.lastname: Seo
authors.affiliation: Cardiac and Vascular Center, Inje University Ilsan Paik Hospital, Goyang, Republic of Korea.
authors.forename: Sung Yun
authors.initials: SY
authors.lastname: Lee
authors.affiliation: Department of Cardiology, Inje University Haeundae Paik Hospital, Busan, Republic of Korea.
authors.forename: Doo Il
authors.initials: DI
authors.lastname: Kim
authors.affiliation: Department of Cardiology, Inha University Hospital, Incheon, Republic of Korea.
authors.forename: Jun
authors.initials: J
authors.lastname: Kwan
authors.affiliation: Division of Cardiology, Jeju National University Hospital, Jeju, Republic of Korea.
authors.forename: Seung-Jae
authors.initials: SJ
authors.lastname: Joo
authors.affiliation: Department of Cardiovascular, Chonnam National University Hospital, Gwangju, Republic of Korea.
authors.forename: Myung Ho
authors.initials: MH
authors.lastname: Jeong
authors.affiliation: Division of Cardiology, Chungnam National University Hospital, Daejeon, Republic of Korea.
authors.forename: Jin-Ok
authors.initials: JO
authors.lastname: Jeong
authors.affiliation: Division of Cardiology, Department of Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Ki Chul
authors.initials: KC
authors.lastname: Sung
authors.affiliation: Department of Cardiology, Seoul Medical Center, Seoul, Republic of Korea.
authors.forename: Seok Yeon
authors.initials: SY
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Seoul Metropolitan Government Seoul National University Hospital Boramae Medical Center, Seoul, Republic of Korea.
authors.forename: Sang-Hyun
authors.initials: SH
authors.lastname: Kim
authors.affiliation: Cardiovascular Center, Pusan National University Yangsan Hospital, Yangsan, Republic of Korea.
authors.forename: Kook-Jin
authors.initials: KJ
authors.lastname: Chun
authors.affiliation: Division of Cardiology, Korea University Guro Hospital, 148, Gurodong-ro, Guro-gu, Seoul, 08308, Republic of Korea. ohdj@korea.ac.kr.
authors.forename: Dong Joo
authors.initials: DJ
authors.lastname: Oh
mesh_terms: D000328:Adult; D000368:Aged; D047228:Angiotensin II Type 1 Receptor Blockers / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000924:Anticholesteremic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001713:Biphenyl Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000150:complications / Q000188:drug therapy*; D006973:Hypertension / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011743:Pyrimidines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000068718:Rosuvastatin Calcium / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013777:Tetrazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D000924:Anticholesteremic Agents; D001713:Biphenyl Compounds; D011743:Pyrimidines; D013777:Tetrazoles; D000068718:Rosuvastatin Calcium; C558933:fimasartan
keywords: Fimasartan; Hypercholesterolemia; Hypertension; Rosuvastatin