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Efficacy and safety of olmesartan medoxomil/amlodipine fixed-dose combination for hypertensive patients uncontrolled with monotherapy

Abstract

This study aimed to evaluate the efficacy and safety of olmesartan medoxomil (OM)/amlodipine (AML) 20/5 mg fixed-dose combination tablet in Chinese mild to moderately hypertensive patients with inadequate blood pressure (BP) control on monotherapy. Two multicenter, randomized, double-blind, double-dummy, active-controlled, parallel group clinical trials were conducted. After screening and a 2-week placebo run-in period, patients with 95 mmHg ≤ seated diastolic blood pressure (SeDBP) < 110 mmHg received monotherapy with OM 20 mg (in Study 1) or AML 5 mg (in Study 2), once daily for 4 weeks. Patients with 90 mmHg ≤ mean SeDBP < 110 mmHg at the end of the monotherapy period were randomized to receive OM/AML 20/5 mg treatment or continue with the monotherapy, once daily for 8 weeks. OM/AML (20/5 mg) treatment significantly lowered both systolic and diastolic BP at 4 and 8 weeks compared to 40 mg olmesartan or 5 mg AML. The incidence of drug-related adverse effects did not differ significantly between the groups. OM/AML 20/5 mg was superior to OM 40 mg or AML 5 mg monotherapy in lowering BP in Chinese mild to moderately hypertensive patients with inadequate BP control on monotherapy. No new or unexpected safety issues were identified with OM/AML combination therapy compared to monotherapy.

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Abbreviations

AML:

Amlodipine

ANCOVA:

Analysis of covariance

BP:

Blood pressure

CCB:

Calcium channel blocker

FAS:

Full analysis set

LSMEAN:

Least square mean

OM:

Olmesartan medoxomil

PPS:

Per protocol set

SD:

Standard deviation

SeDBP:

Seated diastolic blood pressure

SeSBP:

Seated systolic blood pressure

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Acknowledgements

The authors deeply appreciated the contributions of the study team which included but were not limited to Prof. Ge Junbo, Prof. Sun Ningling, Prof. Wu Zonggui,Prof Ke Yuannan, Prof. Zhao Xiuli, Prof Yang Xinchun, Prof Hua Qi, Prof. Zhao Shuiping, Prof. Yuan Hong, Prof. Ma Hong, Prof. Qi Guoxian, Prof. Li Zhanquan, Prof. Li Xiaodong, Prof. Jiang Yinong, Prof. Chen Yundai, Prof. Zhu Jianhua, Prof. Wang Jian’an, Prof. Lu Guoping.

Conflicts of interest

The authors have no conflicts of interest.

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Correspondence to Jun-Ren Zhu.

Additional information

Jun-Ren Zhu, Shu-Yang Zhang and Ping-Jin Gao have contributed equally to this study.

On the behalf of Olmesartan Medoxomil/Amlodipine 20/5 mg Study Group.

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Zhu, JR., Zhang, SY. & Gao, PJ. Efficacy and safety of olmesartan medoxomil/amlodipine fixed-dose combination for hypertensive patients uncontrolled with monotherapy. Arch. Pharm. Res. 37, 1588–1598 (2014). https://doi.org/10.1007/s12272-014-0446-x

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Keywords

  • Hypertension
  • Olmesartan medoxomil
  • Amlodipine
  • Fixed-dose combination