Efficacy and safety study of olmesartan medoxomil, amlodipine, and hydrochlorothiazide combination therapy in patients with hypertension not controlled with olmesartan medoxomil and hydrochlorothiazide combination therapy

Results of a randomized, double-blind, multicenter trial

For the Investigators

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Background: This study was to evaluate the efficacy and safety of triple fixed-dose combination (FDC) therapy with olmesartan medoxomil (OM) 20 mg, amlodipine (AML) 5 mg, and hydrochlorothiazide (HCTZ) 12.5 mg (OM/ AML/HCTZ 20/5/12.5) in Korean patients with moderate hypertension not controlled with dual FDC therapy (OM/ HCTZ 20/12.5). Methods: In this multicenter, randomized, double-blind, parallel-group study, Korean patients aged 20 to 75 years with stage 2 hypertension who had a mean seated diastolic blood pressure (msDBP) ≥ 100 mmHg were enrolled when their BP was uncontrolled [mean seated systolic BP (msSBP)/msDBP > 140/90 mmHg or msSBP/msDBP > 130/80 mmHg with diabetes or chronic kidney disease] with 4-week dual FDC therapy (OM/HCTZ 20/12.5). The patients were randomized to receive either OM/AML/ HCTZ 20/5/12.5 or OM/HCTZ 20/12.5 once daily for 8 weeks. At the end of 8 weeks, patients with uncontrolled BP were assigned to receive either OM/AML/HCTZ 40/5/ 12.5 or OM/AML/HCTZ 20/5/12.5 in an additional 8-week open-label extension period. Results: A total of 623 patients received a 4-week run-in treatment with OM/HCTZ, 341 patients were randomized, and finally, 167 patients in the OM/AML/HCTZ group and 171 patients in the OM/HCTZ group were analyzed for the full analysis set. Non-responders after the 8 weeks of double-blind treatment continued the 8-week open-label treatment with OM/AML/HCTZ 40/5/12.5 mg (n = 32) or OM/AML/HCTZ 20/5/12.5 mg (n = 71). After 8 weeks of double-blind treatment, the changes in msDBP were -9.50 (8.46) mmHg in the OM/AML/HCTZ group and -4.23 (7.41) mmHg in the OM/HCTZ group (both p<0.0001 vs. baseline p<0.0001 between groups). The response rates for both msSBP and msDBP at week 8 were 65.27 % in the OM/AML/HCTZ group and 37.43 % in the OM/HCTZ group (p<0.0001 between groups). The response rates for both msSBP and msDBP at week 16 after open-label treatment were 18.75 % in the OM/AML/HCTZ 40/5/12.5 group and 46.48 % in the OM/AML/HCTZ 20/5/12.5 group (p = 0.0073 between groups). All medications were well tolerated. Conclusion: In Korean patients with moderate hypertension not controlled with dual FDC therapy (OM/HCTZ 20/12.5) as first-line therapy, switching to triple FDC therapy (OM/AML/HCTZ 20/5/12.5) was associated with significant BP reductions and greater achievement of BP goals, and was well tolerated (ClinicalTrials.gov Identifier: NCT01838850).

Original languageEnglish
Pages (from-to)129-138
Number of pages10
JournalAmerican Journal of Cardiovascular Drugs
Volume16
Issue number2
DOIs
Publication statusPublished - 2016 Dec 21

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Amlodipine
Hydrochlorothiazide
Multicenter Studies
Hypertension
Safety
Blood Pressure
Therapeutics
Olmesartan Medoxomil

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine
  • Pharmacology (medical)

Cite this

@article{94be93155e1244298168456e333996d5,
title = "Efficacy and safety study of olmesartan medoxomil, amlodipine, and hydrochlorothiazide combination therapy in patients with hypertension not controlled with olmesartan medoxomil and hydrochlorothiazide combination therapy: Results of a randomized, double-blind, multicenter trial",
abstract = "Background: This study was to evaluate the efficacy and safety of triple fixed-dose combination (FDC) therapy with olmesartan medoxomil (OM) 20 mg, amlodipine (AML) 5 mg, and hydrochlorothiazide (HCTZ) 12.5 mg (OM/ AML/HCTZ 20/5/12.5) in Korean patients with moderate hypertension not controlled with dual FDC therapy (OM/ HCTZ 20/12.5). Methods: In this multicenter, randomized, double-blind, parallel-group study, Korean patients aged 20 to 75 years with stage 2 hypertension who had a mean seated diastolic blood pressure (msDBP) ≥ 100 mmHg were enrolled when their BP was uncontrolled [mean seated systolic BP (msSBP)/msDBP > 140/90 mmHg or msSBP/msDBP > 130/80 mmHg with diabetes or chronic kidney disease] with 4-week dual FDC therapy (OM/HCTZ 20/12.5). The patients were randomized to receive either OM/AML/ HCTZ 20/5/12.5 or OM/HCTZ 20/12.5 once daily for 8 weeks. At the end of 8 weeks, patients with uncontrolled BP were assigned to receive either OM/AML/HCTZ 40/5/ 12.5 or OM/AML/HCTZ 20/5/12.5 in an additional 8-week open-label extension period. Results: A total of 623 patients received a 4-week run-in treatment with OM/HCTZ, 341 patients were randomized, and finally, 167 patients in the OM/AML/HCTZ group and 171 patients in the OM/HCTZ group were analyzed for the full analysis set. Non-responders after the 8 weeks of double-blind treatment continued the 8-week open-label treatment with OM/AML/HCTZ 40/5/12.5 mg (n = 32) or OM/AML/HCTZ 20/5/12.5 mg (n = 71). After 8 weeks of double-blind treatment, the changes in msDBP were -9.50 (8.46) mmHg in the OM/AML/HCTZ group and -4.23 (7.41) mmHg in the OM/HCTZ group (both p<0.0001 vs. baseline p<0.0001 between groups). The response rates for both msSBP and msDBP at week 8 were 65.27 {\%} in the OM/AML/HCTZ group and 37.43 {\%} in the OM/HCTZ group (p<0.0001 between groups). The response rates for both msSBP and msDBP at week 16 after open-label treatment were 18.75 {\%} in the OM/AML/HCTZ 40/5/12.5 group and 46.48 {\%} in the OM/AML/HCTZ 20/5/12.5 group (p = 0.0073 between groups). All medications were well tolerated. Conclusion: In Korean patients with moderate hypertension not controlled with dual FDC therapy (OM/HCTZ 20/12.5) as first-line therapy, switching to triple FDC therapy (OM/AML/HCTZ 20/5/12.5) was associated with significant BP reductions and greater achievement of BP goals, and was well tolerated (ClinicalTrials.gov Identifier: NCT01838850).",
author = "{For the Investigators} and Sohn, {Il Suk} and Kim, {Chong Jin} and Oh, {Byung Hee} and Hong, {Taek Jong} and Park, {Chang Gyu} and Kim, {Byung Soo} and Chung, {Woo Baek} and Nam, {Chang Wook} and Kim, {Cheol Ho} and Choi, {Dong Ju} and Baek, {Sang Hong} and Kim, {Woo Shik} and Ahn, {Tae Hoon} and Cho, {Jang Hyun} and Hwang, {Hweung Kon} and Shin, {Eun Seok} and Shin, {Joon Han} and Jeong, {Myung Ho} and Jeong, {Jin Ok} and Bae, {Jang Ho} and Seunghwan Lee and Rim, {Se Joong} and Rhew, {Jay Young} and Kim, {Doo Il} and Kim, {Dae Kyeong} and Kim, {Soon Kil} and Seo, {Hye Sun} and Kang, {Duk Hyun} and Kim, {Young Dae} and Kim, {Dong Woon} and Ha, {Jong Won} and Park, {Woo Jung} and Kim, {Tae Ho} and Kim, {Kee Sik} and Park, {Seung Woo} and Shim, {Wan Joo} and Yang, {Joo Young} and Choi, {Jae Woong} and Lee, {Sun Hwa} and Ahn, {Jeong Cheon} and Keun Lee",
year = "2016",
month = "12",
day = "21",
doi = "10.1007/s40256-015-0156-x",
language = "English",
volume = "16",
pages = "129--138",
journal = "American Journal of Cardiovascular Drugs",
issn = "1175-3277",
publisher = "Adis International Ltd",
number = "2",

}

TY - JOUR

T1 - Efficacy and safety study of olmesartan medoxomil, amlodipine, and hydrochlorothiazide combination therapy in patients with hypertension not controlled with olmesartan medoxomil and hydrochlorothiazide combination therapy

T2 - Results of a randomized, double-blind, multicenter trial

AU - For the Investigators

AU - Sohn, Il Suk

AU - Kim, Chong Jin

AU - Oh, Byung Hee

AU - Hong, Taek Jong

AU - Park, Chang Gyu

AU - Kim, Byung Soo

AU - Chung, Woo Baek

AU - Nam, Chang Wook

AU - Kim, Cheol Ho

AU - Choi, Dong Ju

AU - Baek, Sang Hong

AU - Kim, Woo Shik

AU - Ahn, Tae Hoon

AU - Cho, Jang Hyun

AU - Hwang, Hweung Kon

AU - Shin, Eun Seok

AU - Shin, Joon Han

AU - Jeong, Myung Ho

AU - Jeong, Jin Ok

AU - Bae, Jang Ho

AU - Lee, Seunghwan

AU - Rim, Se Joong

AU - Rhew, Jay Young

AU - Kim, Doo Il

AU - Kim, Dae Kyeong

AU - Kim, Soon Kil

AU - Seo, Hye Sun

AU - Kang, Duk Hyun

AU - Kim, Young Dae

AU - Kim, Dong Woon

AU - Ha, Jong Won

AU - Park, Woo Jung

AU - Kim, Tae Ho

AU - Kim, Kee Sik

AU - Park, Seung Woo

AU - Shim, Wan Joo

AU - Yang, Joo Young

AU - Choi, Jae Woong

AU - Lee, Sun Hwa

AU - Ahn, Jeong Cheon

AU - Lee, Keun

PY - 2016/12/21

Y1 - 2016/12/21

N2 - Background: This study was to evaluate the efficacy and safety of triple fixed-dose combination (FDC) therapy with olmesartan medoxomil (OM) 20 mg, amlodipine (AML) 5 mg, and hydrochlorothiazide (HCTZ) 12.5 mg (OM/ AML/HCTZ 20/5/12.5) in Korean patients with moderate hypertension not controlled with dual FDC therapy (OM/ HCTZ 20/12.5). Methods: In this multicenter, randomized, double-blind, parallel-group study, Korean patients aged 20 to 75 years with stage 2 hypertension who had a mean seated diastolic blood pressure (msDBP) ≥ 100 mmHg were enrolled when their BP was uncontrolled [mean seated systolic BP (msSBP)/msDBP > 140/90 mmHg or msSBP/msDBP > 130/80 mmHg with diabetes or chronic kidney disease] with 4-week dual FDC therapy (OM/HCTZ 20/12.5). The patients were randomized to receive either OM/AML/ HCTZ 20/5/12.5 or OM/HCTZ 20/12.5 once daily for 8 weeks. At the end of 8 weeks, patients with uncontrolled BP were assigned to receive either OM/AML/HCTZ 40/5/ 12.5 or OM/AML/HCTZ 20/5/12.5 in an additional 8-week open-label extension period. Results: A total of 623 patients received a 4-week run-in treatment with OM/HCTZ, 341 patients were randomized, and finally, 167 patients in the OM/AML/HCTZ group and 171 patients in the OM/HCTZ group were analyzed for the full analysis set. Non-responders after the 8 weeks of double-blind treatment continued the 8-week open-label treatment with OM/AML/HCTZ 40/5/12.5 mg (n = 32) or OM/AML/HCTZ 20/5/12.5 mg (n = 71). After 8 weeks of double-blind treatment, the changes in msDBP were -9.50 (8.46) mmHg in the OM/AML/HCTZ group and -4.23 (7.41) mmHg in the OM/HCTZ group (both p<0.0001 vs. baseline p<0.0001 between groups). The response rates for both msSBP and msDBP at week 8 were 65.27 % in the OM/AML/HCTZ group and 37.43 % in the OM/HCTZ group (p<0.0001 between groups). The response rates for both msSBP and msDBP at week 16 after open-label treatment were 18.75 % in the OM/AML/HCTZ 40/5/12.5 group and 46.48 % in the OM/AML/HCTZ 20/5/12.5 group (p = 0.0073 between groups). All medications were well tolerated. Conclusion: In Korean patients with moderate hypertension not controlled with dual FDC therapy (OM/HCTZ 20/12.5) as first-line therapy, switching to triple FDC therapy (OM/AML/HCTZ 20/5/12.5) was associated with significant BP reductions and greater achievement of BP goals, and was well tolerated (ClinicalTrials.gov Identifier: NCT01838850).

AB - Background: This study was to evaluate the efficacy and safety of triple fixed-dose combination (FDC) therapy with olmesartan medoxomil (OM) 20 mg, amlodipine (AML) 5 mg, and hydrochlorothiazide (HCTZ) 12.5 mg (OM/ AML/HCTZ 20/5/12.5) in Korean patients with moderate hypertension not controlled with dual FDC therapy (OM/ HCTZ 20/12.5). Methods: In this multicenter, randomized, double-blind, parallel-group study, Korean patients aged 20 to 75 years with stage 2 hypertension who had a mean seated diastolic blood pressure (msDBP) ≥ 100 mmHg were enrolled when their BP was uncontrolled [mean seated systolic BP (msSBP)/msDBP > 140/90 mmHg or msSBP/msDBP > 130/80 mmHg with diabetes or chronic kidney disease] with 4-week dual FDC therapy (OM/HCTZ 20/12.5). The patients were randomized to receive either OM/AML/ HCTZ 20/5/12.5 or OM/HCTZ 20/12.5 once daily for 8 weeks. At the end of 8 weeks, patients with uncontrolled BP were assigned to receive either OM/AML/HCTZ 40/5/ 12.5 or OM/AML/HCTZ 20/5/12.5 in an additional 8-week open-label extension period. Results: A total of 623 patients received a 4-week run-in treatment with OM/HCTZ, 341 patients were randomized, and finally, 167 patients in the OM/AML/HCTZ group and 171 patients in the OM/HCTZ group were analyzed for the full analysis set. Non-responders after the 8 weeks of double-blind treatment continued the 8-week open-label treatment with OM/AML/HCTZ 40/5/12.5 mg (n = 32) or OM/AML/HCTZ 20/5/12.5 mg (n = 71). After 8 weeks of double-blind treatment, the changes in msDBP were -9.50 (8.46) mmHg in the OM/AML/HCTZ group and -4.23 (7.41) mmHg in the OM/HCTZ group (both p<0.0001 vs. baseline p<0.0001 between groups). The response rates for both msSBP and msDBP at week 8 were 65.27 % in the OM/AML/HCTZ group and 37.43 % in the OM/HCTZ group (p<0.0001 between groups). The response rates for both msSBP and msDBP at week 16 after open-label treatment were 18.75 % in the OM/AML/HCTZ 40/5/12.5 group and 46.48 % in the OM/AML/HCTZ 20/5/12.5 group (p = 0.0073 between groups). All medications were well tolerated. Conclusion: In Korean patients with moderate hypertension not controlled with dual FDC therapy (OM/HCTZ 20/12.5) as first-line therapy, switching to triple FDC therapy (OM/AML/HCTZ 20/5/12.5) was associated with significant BP reductions and greater achievement of BP goals, and was well tolerated (ClinicalTrials.gov Identifier: NCT01838850).

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UR - http://www.scopus.com/inward/citedby.url?scp=84961214965&partnerID=8YFLogxK

U2 - 10.1007/s40256-015-0156-x

DO - 10.1007/s40256-015-0156-x

M3 - Article

VL - 16

SP - 129

EP - 138

JO - American Journal of Cardiovascular Drugs

JF - American Journal of Cardiovascular Drugs

SN - 1175-3277

IS - 2

ER -