氨氯地平/缬沙坦或氨氯地平/缬沙坦/氢氯噻嗪单片复方制剂在巴基斯坦高血压患者中的实际疗效、安全性及耐受性
Real-life effectiveness, safety, and tolerability of amlodipine/valsartan or amlodipine/valsartan/hydrochlorothiazide single-pill combination in patients with hypertension from Pakistan.
作者信息
Khan Waheed, Moin Nasir, Iktidar Somia, Sakrani Javed, Abid Rizwan, Afzal Javed, Maheshwary Neeta, Kumar Kishore, Siddiqi Ahson, Qadir Murad
机构信息
Adil Hospital Lahore, Lahore, Pakistan.
出版信息
Ther Adv Cardiovasc Dis. 2014 Apr;8(2):45-55. doi: 10.1177/1753944714525496. Epub 2014 Feb 20.
OBJECTIVE
EXCITE (clinical EXperienCe of amlodIpine and valsarTan in hypErtension) evaluated the real-life effectiveness, safety, and tolerability of single-pill combinations (SPCs) of amlodipine/valsartan (Aml/Val) and amlodipine/valsartan/hydrochlorothiazide (Aml/Val/HCTZ) in patients with hypertension from 13 countries in the Middle East and Asia. Here, we present data from Pakistan.
METHODS
This was a 26-week observational, multicenter, prospective, open-label study. At week 26, change from baseline in mean sitting systolic (msSBP) and diastolic blood pressure (msDBP) and the proportion of patients achieving BP goal (SBP/DBP <140/90 mmHg; <130/80 mmHg in patients with diabetes) and response rates (SBP <140 mmHg [130 mmHg for patients with diabetes] or reduction of ≥20 mmHg; DBP <90 mmHg [80 mmHg for patients with diabetes] or reduction of ≥10 mmHg), were evaluated. Incidence of adverse events (AEs) and serious AEs (SAEs) was recorded as safety variables. Subjective assessment of effectiveness, compliance and tolerability was done by the physician.
RESULTS
A total of 500 patients with hypertension (mean age of 48 years) were prescribed Aml/Val (n = 471, 94%) or Aml/Val/HCTZ (n = 29, 6%); 439 (87.8%) patients completed the study. At week 26, the mean BP decreased from 153.4/91.1 mmHg at baseline to 128.9/78.4 mmHg in the Aml/Val cohort (-24.5/-12.7 mmHg; p < 0.0001) and from 171.6/99.3 mmHg at baseline to 127.7/77.4 mmHg (-43.9/-21.9 mmHg; p < 0.0001) in the Aml/Val/HCTZ cohort. BP goals were achieved by 57% and 55.2% of patients in the Aml/Val and Aml/Val/HCTZ cohorts, respectively. A total of 40 (8%) patients reported at least one AE during the study period. Most common AEs included nausea (1.6%), headache (1.2%), vomiting (1.2%), and edema (1.2%). Most patients in Aml/Val cohort and all patients in Aml/Val/HCTZ cohort rated the effectiveness, compliance and tolerability as 'good' or 'very good'.
CONCLUSIONS
Aml/Val with or without HCTZ in a SPC was effective and well-tolerated for BP reduction in this cohort of patients with hypertension from Pakistan.
目的
EXCITE（氨氯地平与缬沙坦治疗高血压的临床经验）评估了氨氯地平/缬沙坦（Aml/Val）和氨氯地平/缬沙坦/氢氯噻嗪（Aml/Val/HCTZ）单片复方制剂（SPC）在中东和亚洲13个国家高血压患者中的实际疗效、安全性和耐受性。在此，我们展示来自巴基斯坦的数据。
方法
这是一项为期26周的观察性、多中心、前瞻性、开放标签研究。在第26周时，评估平均坐位收缩压（msSBP）和舒张压（msDBP）相对于基线的变化、达到血压目标（收缩压/舒张压<140/90 mmHg；糖尿病患者<130/80 mmHg）的患者比例以及反应率（收缩压<140 mmHg[糖尿病患者为<130 mmHg]或降低≥20 mmHg；舒张压<90 mmHg[糖尿病患者为<80 mmHg]或降低≥10 mmHg）。记录不良事件（AE）和严重不良事件（SAE）的发生率作为安全性变量。医生对疗效、依从性和耐受性进行主观评估。
结果
共有500例高血压患者（平均年龄48岁）被处方Aml/Val（n = 471，94%）或Aml/Val/HCTZ（n = 29，6%）；439例（87.8%）患者完成了研究。在第26周时，Aml/Val组的平均血压从基线时的153.4/91.1 mmHg降至128.9/78.4 mmHg（-24.5/-12.7 mmHg；p < 0.0001），Aml/Val/HCTZ组从基线时的171.6/99.3 mmHg降至127.7/77.4 mmHg（-43.9/-21.9 mmHg；p < 0.0001）。Aml/Val组和Aml/Val/HCTZ组分别有57%和55.2%的患者达到了血压目标。共有40例（8%）患者在研究期间报告了至少一次AE。最常见的AE包括恶心（1.6%）、头痛（1.2%）、呕吐（1.2%）和水肿（1.2%）。Aml/Val组的大多数患者以及Aml/Val/HCTZ组的所有患者对疗效、依从性和耐受性的评价为“良好”或“非常良好”。
结论
在巴基斯坦的这组高血压患者中，含或不含HCTZ的Aml/Val SPC在降低血压方面有效且耐受性良好。
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