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ASSA13-14-9 Efficacy and Safety of Olmesartan and Olmesartan Plus Hydrochlorothiazide Combined with Amlodipine in Chinese Patients with Mild to Moderate Essential Hypertension
  1. Li Hongwei1,
  2. Mei Kezhi2,
  3. Hua Qi3,
  4. Dai Qiuyan4,
  5. Peng Xiaoling5,
  6. Ding Hong6,
  7. Pi Lin7,
  8. Jin Zhimin8,
  9. Zhang Daifu9,
  10. Lv Ke10,
  11. Guo Xingui11,
  12. Xu Hui12,
  13. You Hua13,
  14. Yin Pengfei14,
  15. Yu Licheng15,
  16. Yang Ming16,
  17. Yu Xiaowei17,
  18. Ikegami Naotaka18,
  19. Zhou Shuxian19,
  20. Gao Pingjin20
  1. 1Beijing Friendship Hospital, Capital Medical University, Beijing, China
  2. 2Guangzhou Red Cross Hospital, Guangzhou, China
  3. 3Xuanwu Hospital, Capital Medical University, Beijing, China
  4. 4Shanghai First People’s Hospital, Shanghai, China
  5. 5Shenzhen Sun Yat-Sen Cardiovascular Hospital, Shenzhen, China
  6. 6Wuxi Second People’s Hospital, Wuxi, China
  7. 7Beijing Chuiyangliu Hospital, Beijing, China
  8. 8Shanghai Songjiang District Central Hospital, Shanghai, China
  9. 9Shanghai Pudong District Peoples Hospital, Shanghai, China
  10. 10Suzhou Municipal Hospital, China
  11. 11Shanghai Huadong Hospital, Shanghai, Chinam
  12. 12Shanghai Changning District Central Hospital, Shanghai, China
  13. 13Wujiang First People’s Hospital, China
  14. 14Shijitan Hospital, Capital Medical University, Beijing, China
  15. 15Beijing Haidian Hospital, Beijing, China
  16. 16Fuxing Hospital, Capital Medical University, Bejing, China
  17. 17Beijing Daxing District People’s Hospital, Beijing, China
  18. 18R & D Division, Daiichi Sankyo Pharmaceutical (Shanghai) Co., Ltd, Shanghai, China
  19. 19Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China
  20. 20Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

Abstract

Objective To evaluate the efficacy and safety of olmesartan (OLM) and olmesartan plus hydrochlorothiazide (fixed-dose combination of OLM/HCTZ 20 mg/12.5 mg) combined with amlodipine (AML) in Chinese patients with mild to moderate essential hypertension who had insufficient response for AML mono-therapy.

Methods This was an open label, non-comparative, multicenter clinical trial. The patients who had not achieved targeted BP (defined as DBP < 90mmHg, DBP < 80mmHg if DM subjects) after more than 4 weeks of AML mono-therapy (5 mg/day) were enrolled, and administrated combination of OLM (20 mg/day) and AML (5 mg/day). The possible up-titration points were at the end of week 8 and week 12. The subjects who achieved target BP maintained the treatment. If not, the subjects were up-titrated OLM to 40mg/day or changed OLM to OLM/HCTZ. The treatment selections were decided by the investigators. The total treatment duration was 16 weeks. The primary endpoint was the rate of the responders at the end of week 16 which was defined as 10 mmHg, or the mean SBP reduction > 20 mmHg.

Results In the intent-to-treat analysis (n = 409), the rate of the responders at the end of week 4, 8, 12, 16 was 76.3%, 86.3%, 95.4%, 97.1%, respectively. In terms of DM subjects (n = 54), the rate was 88.9% at the end of treatment. The mean changes of blood pressure from baseline in all subjects at week 4, 8, 12 and 16 were as below.

Abstract ASSA13-14-9 Table 1

Only one SAE (no drug related) was reported during the study period.

Conclusions In Chinese hypertensive patients with insufficient response for AML mono-therapy, OLM and OLM plus HCTZ combined with AML are efficacious in lowering BP and have an acceptable safety and tolerability profile.

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