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

Sang Hyun Kim, Sang Ho Jo, Sang Cheol Lee, Sung Yoon Lee, Myung Ho Yoon, Hyang Lim Lee, Nae Hee Lee, Jong Won Ha, Nam Ho Lee, Dong Woon Kim, Gyu Rok Han, Min Su Hyon, Deok Gyu Cho, Chang Gyu Park, Young Dae Kim, Gyu Hyung Ryu, Cheol Ho Kim, Kee Sik Kim, Myung Ho Chung, Sung Chul Chae & 2 others Ki Bae Seung, Byung Hee Oh

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Purpose 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. Methods 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. Findings 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. Implications 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.

Original languageEnglish
Pages (from-to)2171-2184
Number of pages14
JournalClinical Therapeutics
Volume38
Issue number10
DOIs
Publication statusPublished - 2016 Oct 1

Fingerprint

irbesartan
Hypercholesterolemia
Cholesterol
Blood Pressure
Hypertension
Therapeutics
Hyperlipidemias
Atorvastatin Calcium

Keywords

  • atorvastatin
  • combination
  • hyperlipidemia
  • hypertension
  • irbesartan

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

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. / Kim, Sang Hyun; Jo, Sang Ho; Lee, Sang Cheol; Lee, Sung Yoon; Yoon, Myung Ho; Lee, Hyang Lim; Lee, Nae Hee; Ha, Jong Won; Lee, Nam Ho; Kim, Dong Woon; Han, Gyu Rok; Hyon, Min Su; Cho, Deok Gyu; Park, Chang Gyu; Kim, Young Dae; Ryu, Gyu Hyung; Kim, Cheol Ho; Kim, Kee Sik; Chung, Myung Ho; Chae, Sung Chul; Seung, Ki Bae; Oh, Byung Hee.

In: Clinical Therapeutics, Vol. 38, No. 10, 01.10.2016, p. 2171-2184.

Research output: Contribution to journalArticle

Kim, SH, Jo, SH, Lee, SC, Lee, SY, Yoon, MH, Lee, HL, Lee, NH, Ha, JW, Lee, NH, Kim, DW, Han, GR, Hyon, MS, Cho, DG, Park, CG, Kim, YD, Ryu, GH, Kim, CH, Kim, KS, Chung, MH, Chae, SC, Seung, KB & Oh, BH 2016, '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', Clinical Therapeutics, vol. 38, no. 10, pp. 2171-2184. https://doi.org/10.1016/j.clinthera.2016.09.005
Kim, Sang Hyun ; Jo, Sang Ho ; Lee, Sang Cheol ; Lee, Sung Yoon ; Yoon, Myung Ho ; Lee, Hyang Lim ; Lee, Nae Hee ; Ha, Jong Won ; Lee, Nam Ho ; Kim, Dong Woon ; Han, Gyu Rok ; Hyon, Min Su ; Cho, Deok Gyu ; Park, Chang Gyu ; Kim, Young Dae ; Ryu, Gyu Hyung ; Kim, Cheol Ho ; Kim, Kee Sik ; Chung, Myung Ho ; Chae, Sung Chul ; Seung, Ki Bae ; Oh, Byung Hee. / 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. In: Clinical Therapeutics. 2016 ; Vol. 38, No. 10. pp. 2171-2184.
@article{0b13813b5a9d44079b98eb41b1a4e65c,
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 = "Purpose 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. Methods 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. Findings 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. Implications 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.",
keywords = "atorvastatin, combination, hyperlipidemia, hypertension, irbesartan",
author = "Kim, {Sang Hyun} and Jo, {Sang Ho} and Lee, {Sang Cheol} and Lee, {Sung Yoon} and Yoon, {Myung Ho} and Lee, {Hyang Lim} and Lee, {Nae Hee} and Ha, {Jong Won} and Lee, {Nam Ho} and Kim, {Dong Woon} and Han, {Gyu Rok} and Hyon, {Min Su} and Cho, {Deok Gyu} and Park, {Chang Gyu} and Kim, {Young Dae} and Ryu, {Gyu Hyung} and Kim, {Cheol Ho} and Kim, {Kee Sik} and Chung, {Myung Ho} and Chae, {Sung Chul} and Seung, {Ki Bae} and Oh, {Byung Hee}",
year = "2016",
month = "10",
day = "1",
doi = "10.1016/j.clinthera.2016.09.005",
language = "English",
volume = "38",
pages = "2171--2184",
journal = "Clinical Therapeutics",
issn = "0149-2918",
publisher = "Excerpta Medica",
number = "10",

}

TY - JOUR

T1 - Blood Pressure and Cholesterol-lowering Efficacy of a Fixed-dose Combination With Irbesartan and Atorvastatin in Patients With Hypertension and Hypercholesterolemia

T2 - A Randomized, Double-blind, Factorial, Multicenter Phase III Study

AU - Kim, Sang Hyun

AU - Jo, Sang Ho

AU - Lee, Sang Cheol

AU - Lee, Sung Yoon

AU - Yoon, Myung Ho

AU - Lee, Hyang Lim

AU - Lee, Nae Hee

AU - Ha, Jong Won

AU - Lee, Nam Ho

AU - Kim, Dong Woon

AU - Han, Gyu Rok

AU - Hyon, Min Su

AU - Cho, Deok Gyu

AU - Park, Chang Gyu

AU - Kim, Young Dae

AU - Ryu, Gyu Hyung

AU - Kim, Cheol Ho

AU - Kim, Kee Sik

AU - Chung, Myung Ho

AU - Chae, Sung Chul

AU - Seung, Ki Bae

AU - Oh, Byung Hee

PY - 2016/10/1

Y1 - 2016/10/1

N2 - Purpose 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. Methods 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. Findings 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. Implications 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.

AB - Purpose 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. Methods 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. Findings 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. Implications 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.

KW - atorvastatin

KW - combination

KW - hyperlipidemia

KW - hypertension

KW - irbesartan

UR - http://www.scopus.com/inward/record.url?scp=84992663718&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84992663718&partnerID=8YFLogxK

U2 - 10.1016/j.clinthera.2016.09.005

DO - 10.1016/j.clinthera.2016.09.005

M3 - Article

VL - 38

SP - 2171

EP - 2184

JO - Clinical Therapeutics

JF - Clinical Therapeutics

SN - 0149-2918

IS - 10

ER -