评估阿齐沙坦在印度成年原发性高血压患者中的疗效和安全性：一项随机、III 期临床研究。

Evaluation of the Efficacy and Safety of Azilsartan in Adult Patients with Essential Hypertension: A Randomized, Phase-III Clinical Study in India.

机构信息

Hetero Group of Pharmaceutical Companies, Clinical Development and Medical Affairs, Hetero Corporate, Hyderabad, Telangana.

Cardiology Department, Mediciti Hospital, Hyderabad, Telangana.

出版信息

J Assoc Physicians India. 2021 Feb;69(2):35-39.

PMID:33527809

Abstract

BACKGROUND

Globally, women and men over the age of 25 years suffer from hypertension, the need for new treatment strategies to treat hypertension is due to the multi-faceted nature of the disease. Lack of optimal blood pressure control can lead to multiple complications. Therefore, this phase 3 study was conducted to assess the efficacy, safety and tolerability of potential product azilsartan hydrochloride for reduction in blood pressure in Indian patients with essential hypertension.

METHODS

This was a prospective, multicentre, randomized, comparative, parallel study of 303 participants over six weeks of treatment period with either azilsartan 40 mg or azilsartan 80 mg or telmisartan 40 mg in adult patients with essential hypertension. The primary endpoint was the change in mean trough sitting clinic systolic blood pressure (scSBP) from baseline to week 6. The secondary endpoints were the change in mean trough sitting clinic diastolic blood pressure (scDBP) from baseline and change in the 24-hour mean ambulatory systolic blood pressure (SBP)and diastolic blood pressure (DBP) from baseline.

RESULTS

The change in mean trough scSBP from baseline to week 6 was -27.2 ± 9.99, -28.2 ± 10.06 and -26.7 ± 9.72 (Per Patient (PP) Population) and -27.2 ± 9.93, -28.3 ± 10.01 and -26.7 ± 9.67 (Intent to Treat (ITT) Population) in the azilsartan 40mg, 80mg and telmisartan 40mg groups respectively. The lower limit of 95% CI of difference in change in mean systolic blood pressure was -2.35(Azilsartan 40mg) and 1.32 (Azilsartan 80mg) is less than the non-inferiority margin (i.e. 2.67). The change in mean trough scDBP from baseline to week 6 was -13.1 ± 8.46, -12.9 ± 7.20, and -13.0 ± 7.96 (PP) and -13.1 ± 8.42, -12.9 ± 7.16 and -13.0 ± 7.92 (ITT) in Azilsartna 40 mg, Azilsartan 80 mg and Telmisartan 40 mg respectively. The reduction in trough scDBP in Azilsartan 40 mg (p=0.9461: PP; p=0.9330: ITT) and Azilsartan 80 mg (p=0.9090: PP; p=0.9158: ITT) was not statistically significant compared to Telmisartan 40 mg. The difference in fall in the trough scSBP, scDBP and ambulatory SBP and DBP was similar between the groups from baseline to week 6 (P >0.05). Headache and dizziness were the most frequent treatmentrelated treatment-emergent adverse events.

CONCLUSION

Azilsartan is an effective blood pressure lowering drug and well tolerated and was non- inferior to telmisartan in its safety and efficacy.

摘要

背景

全球范围内，25 岁及以上的男性和女性都患有高血压，需要新的治疗策略来治疗高血压，这是由于疾病的多方面性质所致。血压控制不理想可能会导致多种并发症。因此，进行了这项 3 期研究，以评估潜在产品阿齐沙坦盐酸盐在降低印度原发性高血压患者血压方面的疗效、安全性和耐受性。

方法

这是一项前瞻性、多中心、随机、对照、平行研究，共纳入 303 名成年原发性高血压患者，在 6 周的治疗期间分别接受阿齐沙坦 40mg、阿齐沙坦 80mg 或替米沙坦 40mg 治疗。主要终点是从基线到第 6 周时平均谷值坐位诊所收缩压（scSBP）的变化。次要终点是从基线时平均谷值坐位诊所舒张压（scDBP）的变化和 24 小时平均动态收缩压（SBP）和舒张压（DBP）的变化。

结果

从基线到第 6 周时，阿齐沙坦 40mg、80mg 和替米沙坦 40mg 组的平均谷值 scSBP 变化分别为-27.2 ± 9.99、-28.2 ± 10.06 和-26.7 ± 9.72（患者人群）和-27.2 ± 9.93、-28.3 ± 10.01 和-26.7 ± 9.67（意向治疗人群）。平均收缩压变化的 95%置信区间下限差值为-2.35（阿齐沙坦 40mg）和 1.32（阿齐沙坦 80mg）小于非劣效性边界（即 2.67）。从基线到第 6 周时，阿齐沙坦 40mg、80mg 和替米沙坦 40mg 组的平均谷值 scDBP 变化分别为-13.1 ± 8.46、-12.9 ± 7.20 和-13.0 ± 7.96（患者人群）和-13.1 ± 8.42、-12.9 ± 7.16 和-13.0 ± 7.92（意向治疗人群）。与替米沙坦 40mg 相比，阿齐沙坦 40mg（p=0.9461：患者人群；p=0.9330：意向治疗人群）和阿齐沙坦 80mg（p=0.9090：患者人群；p=0.9158：意向治疗人群）的谷值 scDBP 降低无统计学意义。从基线到第 6 周，各组之间谷值 scSBP、scDBP 和动态 SBP 和 DBP 的下降差异无统计学意义（P>0.05）。头痛和头晕是最常见的治疗相关不良事件。