title: Blood Pressure and Cholesterol-lowering Efficacy of a Fixed-dose Combination With Irbesartan and Atorvastatin in Patients With Hypertension and Hypercholesterolemia: A Randomized, Double-blind, Factorial, Multicenter Phase III Study.
abstract: A fixed-dose combination of a stain and an antihypertensive drug may be useful for the treatment of patients with hypertension and hyperlipidemia. It may also improve patient drug compliance to help control risk factors of cardiovascular disease. This study was designed to evaluate the blood pressure-lowering and cholesterol-lowering effect of a fixed-dose combination of irbesartan-atorvastatin compared with monotherapy by either agent over an 8-week treatment period.
  
  
  
  Patients with comorbid hypertension and hypercholesterolemia were screened for this randomized, double-blind, Phase III study. Eligible study patients were randomly assigned to test groups receiving a combination of irbesartan 300 mg and atorvastatin 40 mg or 80 mg (IRB300 + ATO40 and IRB300 + ATO80). Comparator groups comprised monotherapy groups with irbesartan 300 mg (IRB300) or atorvastatin 40 mg (ATO40) or atorvastatin 80 mg (ATO80), or placebo. Patients who were eligible at screening were subjected to a 4- to 6-week washout period before commencing 8 weeks of therapy per their assigned group. The primary efficacy end points were percent change in LDL-C and sitting diastolic blood pressure (DBP) levels from baseline to end of therapy. Tolerability profiles of combination therapy were compared with other groups.
  
  
  
  A total of 733 patients with comorbid hypertension and hypercholesterolemia were screened for this study; 230 eligible patients were randomized to treatment. The mean age of patients was 58.9 (8.5) years, and their mean body mass index was 25.8 (3.2) kg/m2. More than two thirds (70.9%) of the study patients were male. Mean LDL-C and sitting DBP levels at baseline were 149.54 (29.19) mg/dL and 92.32 (6.03) mm Hg, respectively. Percent reductions in LDL-C after 8 weeks were 46.74% (2.06%) in the IRB300 + ATO40 group and 48.98% (2.12%) in the IRB300 + ATO80 group; these values were 47.13% (3.21%) and 48.30% (2.98%) in the ATO40 and ATO80 comparator groups. Similarly, a reduction in sitting DBP after 8 weeks was -8.50 (1.06) mm Hg in the IRB300 + ATO40 group and 10.66 (1.08) mm Hg in the IRB300 + ATO80 group compared with 8.40 (1.65) mm Hg in the IRB300 group. The incidence rate for treatment-emergent adverse events was 22.27% and was similar between the monotherapy and combination groups.
  
  
  
  A once-daily combination product of irbesartan and atorvastatin provided an effective, safe, and more compliable treatment for patients with coexisting hypertension and hyperlipidemia. ClinicalTrials.gov identifier: NCT01442987.
authors.affiliation: Seoul Boramae Hospital, Seoul, Republic of Korea; Seoul National University College of Medicine, Seoul, Republic of Korea.
authors.forename: Sang-Hyun
authors.initials: SH
authors.lastname: Kim
authors.affiliation: Hallym University Sacred Hospital, Pyeongchon, Republic of Korea.
authors.forename: Sang-Ho
authors.initials: SH
authors.lastname: Jo
authors.affiliation: Samsung Seoul Hospital, Seoul, Republic of Korea.
authors.forename: Sang-Cheol
authors.initials: SC
authors.lastname: Lee
authors.affiliation: Baek University Ilsan Hospital, Goyang, Republic of Korea.
authors.forename: Sung-Yoon
authors.initials: SY
authors.lastname: Lee
authors.affiliation: Ajou University Hospital, Goyang, Republic of Korea.
authors.forename: Myung-Ho
authors.initials: MH
authors.lastname: Yoon
authors.affiliation: Seoul Bukbu Hospital, Seoul, Republic of Korea.
authors.forename: Hyang-Lim
authors.initials: HL
authors.lastname: Lee
authors.affiliation: Sooncheonhyang University Bucheon Hospital, Bucheon, Republic of Korea.
authors.forename: Nae-Hee
authors.initials: NH
authors.lastname: Lee
authors.affiliation: Yonsei University Severance Hospital, Seoul, Republic of Korea.
authors.forename: Jong-Won
authors.initials: JW
authors.lastname: Ha
authors.affiliation: Hallym University Gangnam Sacred Hospital, Seoul, Republic of Korea.
authors.forename: Nam-Ho
authors.initials: NH
authors.lastname: Lee
authors.affiliation: Chungbook University Hospital, Cheongju, Republic of Korea.
authors.forename: Dong-Woon
authors.initials: DW
authors.lastname: Kim
authors.affiliation: Hallym University Gangdong Sacred Hospital, Seoul, Republic of Korea.
authors.forename: Gyu-Rok
authors.initials: GR
authors.lastname: Han
authors.affiliation: Sooncheonhyang University Seoul Hospital, Seoul, Republic of Korea.
authors.forename: Min-Su
authors.initials: MS
authors.lastname: Hyon
authors.affiliation: Gwandong University Myungji Hospital, Seoul, Republic of Korea.
authors.forename: Deok-Gyu
authors.initials: DG
authors.lastname: Cho
authors.affiliation: Korea University Guro Hospital, Seoul, Republic of Korea.
authors.forename: Chang-Gyu
authors.initials: CG
authors.lastname: Park
authors.affiliation: Dong-A University Hospital, Busan, Republic of Korea.
authors.forename: Young-Dae
authors.initials: YD
authors.lastname: Kim
authors.affiliation: Hallym University Dongtan Sacred Hospital, Hwaseong, Republic of Korea.
authors.forename: Gyu-Hyung
authors.initials: GH
authors.lastname: Ryu
authors.affiliation: Seoul National University College of Medicine, Seoul, Republic of Korea; Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
authors.forename: Cheol-Ho
authors.initials: CH
authors.lastname: Kim
authors.affiliation: Keimyung University Hospital, Daegu, Republic of Korea.
authors.forename: Kee-Sik
authors.initials: KS
authors.lastname: Kim
authors.affiliation: Cheonnam University Hospital, Gwangju, Republic of Korea.
authors.forename: Myung-Ho
authors.initials: MH
authors.lastname: Chung
authors.affiliation: Gyungbook University Hospital, Daegu, Republic of Korea.
authors.forename: Sung-Chul
authors.initials: SC
authors.lastname: Chae
authors.affiliation: Catholic University Seoul St Mary Hospital, Seoul, Republic of Korea.
authors.forename: Ki-Bae
authors.initials: KB
authors.lastname: Seung
authors.affiliation: Seoul National University College of Medicine, Seoul, Republic of Korea; Seoul National University Hospital, Seoul, Republic of Korea. Electronic address: ohbhmed@snu.ac.kr.
authors.forename: Byung-Hee
authors.initials: BH
authors.lastname: Oh
mesh_terms: D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage; D000069059:Atorvastatin / Q000008:administration & dosage*; D001713:Biphenyl Compounds / Q000008:administration & dosage*; D001794:Blood Pressure / Q000187:drug effects; D002784:Cholesterol / Q000097:blood; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000188:drug therapy*; D006973:Hypertension / Q000188:drug therapy*; D000077405:Irbesartan; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D013777:Tetrazoles / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D001713:Biphenyl Compounds; D004338:Drug Combinations; D013777:Tetrazoles; D002784:Cholesterol; D000069059:Atorvastatin; D000077405:Irbesartan
keywords: atorvastatin; combination; hyperlipidemia; hypertension; irbesartan