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WIN OVER研究:奥美沙坦在印度高血压患者中的疗效与安全性:一项开放标签、非对照、多中心、上市后观察性研究的结果

WIN OVER study: Efficacy and safety of olmesartan in Indian hypertensive patients: results of an open label, non-comparative, multi-centric, post marketing observational study.

作者信息

Kumbla D K, Kumar S, Reddy Y V, Trailokya A, Naik M

机构信息

Consultant Clinical & Interventional Cardiologist, Jupiter Hospital, Thane, India.

Consultant Cardiologist, AMRI Hospital, Kolkata, India.

出版信息

Indian Heart J. 2014 May-Jun;66(3):340-4. doi: 10.1016/j.ihj.2014.05.002.

DOI:10.1016/j.ihj.2014.05.002
PMID:24973841
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4121764/
Abstract

BACKGROUND

Hypertension is a global health problem. Multiple classes of drugs including angiotensin receptor blockers (ARBs) are available for the treatment of hypertension. Olmesartan is a relatively newer ARB used in hypertension management.

OBJECTIVE

To assess the efficacy and safety of WIN-BP (Olmesartan 20 mg/40 mg) tablet in Indian patients with hypertension.

MATERIAL AND METHODS

An open label, non-comparative, multi-centric, real world post marketing observational study included Indian adult hypertensive patients who were treated with olmesartan 20 mg/40 mg tablet once daily for six months. The primary outcome was reduction of systolic blood pressure (SBP) to <140 mmHg and diastolic BP (DBP) to <90 mmHg at 3 and 6 months after initiation of treatment with olmesartan. All reported adverse events were recorded.

RESULTS

A total of 8940 patients were enrolled in this study. Baseline SBP of 164 mmHg was reduced to 153, 145, 134 and 130 mmHg at the end of 15 days, 1, 3 and 6 months respectively. Similarly, baseline DBP of 100 mmHg was reduced to 93, 89, 84 and 82 mmHg at the end of 15 days, 1, 3 and 6 months respectively. The reduction in both systolic and diastolic blood pressure from day 15 to month 6 was statistically significant (p < 0.0001) with olmesartan treatment. The percentage of responders for both systolic and diastolic blood pressure increased consistently from day 15 to month 6. Only 0.08% patients reported the adverse events. No serious adverse event was reported in the study.

CONCLUSION

Olmesartan 20 mg/40 mg is effective and well tolerated without any serious adverse events in patients with hypertension.

摘要

背景

高血压是一个全球性的健康问题。包括血管紧张素受体阻滞剂(ARB)在内的多种药物可用于治疗高血压。奥美沙坦是一种相对较新的用于高血压管理的ARB。

目的

评估WIN-BP(奥美沙坦20毫克/40毫克)片剂对印度高血压患者的疗效和安全性。

材料与方法

一项开放标签、非对照、多中心、真实世界上市后观察性研究,纳入印度成年高血压患者,他们每天服用一次奥美沙坦20毫克/40毫克片剂,持续六个月。主要结局是在开始使用奥美沙坦治疗3个月和6个月时,收缩压(SBP)降至<140 mmHg,舒张压(DBP)降至<90 mmHg。记录所有报告的不良事件。

结果

本研究共纳入8940例患者。基线收缩压164 mmHg在第15天、1个月、3个月和6个月末分别降至153 mmHg、145 mmHg、134 mmHg和130 mmHg。同样,基线舒张压100 mmHg在第15天、1个月、3个月和6个月末分别降至93 mmHg、89 mmHg、84 mmHg和82 mmHg。奥美沙坦治疗后,从第15天到第6个月,收缩压和舒张压均显著降低(p<0.0001)。从第15天到第6个月,收缩压和舒张压的达标患者百分比持续增加。仅0.08%的患者报告了不良事件。该研究未报告严重不良事件。

结论

奥美沙坦20毫克/40毫克对高血压患者有效且耐受性良好,未发生任何严重不良事件。

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Olmesartan in the treatment of hypertension in elderly patients: a review of the primary evidence.奥美沙坦治疗老年高血压患者的疗效评价:主要证据回顾。
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