Sison Jorge, Assaad-Khalil Samir Helmy, Najem Robert, Kitchlew Asad Riaz, Cho Belong, Ueng Kwo-Chang, Shete Abhijit, Knap Ditte
Medical Center Manila , Manila , Philippines.
Curr Med Res Opin. 2014 Oct;30(10):1937-45. doi: 10.1185/03007995.2014.942415. Epub 2014 Jul 17.
The EXCITE (clinical EXperienCe of amlodIpine and valsarTan in hypErtension) study was designed to evaluate the effectiveness, tolerability and adherence of amlodipine/valsartan (Aml/Val) and amlodipine/valsartan/hydrochlorothiazide (Aml/Val/HCT) single-pill combination therapies in patients with hypertension from the Middle East and Asia studied in routine clinical practice.
This was a prospective, multinational, non-interventional real-world study in which adult patients with hypertension receiving treatment with Aml/Val or Aml/Val/HCT as part of routine clinical practice were observed for a period of 26 ± 8 weeks. Dosages in milligrams (prescribed in accordance with local prescribing information) were Aml/Val: 5/80, 5/160, 10/160, 5/320 or 10/320; Aml/Val/HCT: 5/160/12.5, 10/160/12.5, 5/160/25, 10/160/25 or 10/320/25.
Treatment effectiveness was assessed by change from baseline in mean sitting systolic blood pressure (BP)/diastolic BP (msSBP/msDBP), and the proportion of patients achieving therapeutic goal and BP response. Safety and tolerability were also assessed.
Of 9794 patients analyzed (mean age 53.2 years), 8603 received Aml/Val and 1191 Aml/Val/HCT. At study end (26 ± 8 weeks), overall msSBP (95% confidence interval [CI]) reductions from baseline were -31.0 (-31.42, -30.67) mmHg for Aml/Val and -36.6 (-37.61, -35.50) mmHg for Aml/Val/HCT; msDBP reductions from baseline were -16.6 (-16.79, -16.34) mmHg for Aml/Val and -17.8 (-18.41, -17.22) mmHg for Aml/Val/HCT. Meaningful reductions in BP from baseline were also consistently observed across all Aml/Val dosages and severities of hypertension. Adverse events (AEs) were reported in 11.2% and 6.1% of patients in the Aml/Val and Aml/Val/HCT groups, respectively. Most frequently reported AEs in the Aml/Val and Aml/Val/HCT groups were edema and peripheral edema. While the observational design of the study has inherent limitations, it enables collection of real-world data from a more naturalistic clinical setting, and the large size of the study increases the robustness of the study, as indicated by the narrow confidence intervals for the main study outcomes.
The EXCITE study provides evidence that Aml/Val and Aml/Val/HCT provide clinically meaningful BP reductions and are well tolerated in a large multi-ethnic hypertensive population studied in routine clinical practice.
EXCITE（氨氯地平和缬沙坦治疗高血压的临床经验）研究旨在评估氨氯地平/缬沙坦（Aml/Val）和氨氯地平/缬沙坦/氢氯噻嗪（Aml/Val/HCT）单片复方疗法在中东和亚洲高血压患者常规临床实践中的有效性、耐受性和依从性。
这是一项前瞻性、跨国、非干预性的真实世界研究，对作为常规临床实践一部分接受Aml/Val或Aml/Val/HCT治疗的成年高血压患者进行了为期26±8周的观察。以毫克为单位的剂量（根据当地处方信息规定）为：Aml/Val：5/80、5/160、10/160、5/320或10/320；Aml/Val/HCT：5/160/12.5、10/160/12.5、5/160/25、10/160/25或10/320/25。
通过平均坐位收缩压（BP）/舒张压（msSBP/msDBP）相对于基线的变化、达到治疗目标的患者比例以及血压反应来评估治疗效果。还评估了安全性和耐受性。
在分析的9794例患者（平均年龄53.2岁）中，8603例接受Aml/Val治疗，1191例接受Aml/Val/HCT治疗。在研究结束时（26±8周），Aml/Val组的平均坐位收缩压从基线降低了-31.0（-31.42，-30.67）mmHg，Aml/Val/HCT组降低了-36.6（-37.61，-35.50）mmHg；Aml/Val组的平均坐位舒张压从基线降低了-16.6（-16.79，-16.34）mmHg，Aml/Val/HCT组降低了-17.8（-18.41，-17.22）mmHg。在所有Aml/Val剂量和高血压严重程度组中，均持续观察到相对于基线有显著的血压降低。Aml/Val组和Aml/Val/HCT组分别有11.2%和6.1%的患者报告了不良事件（AE）。Aml/Val组和Aml/Val/HCT组最常报告的AE是水肿和外周水肿。虽然该研究的观察性设计存在固有局限性，但它能够从更自然的临床环境中收集真实世界的数据，并且研究规模较大增加了研究的稳健性，主要研究结果的置信区间较窄即表明了这一点。
EXCITE研究提供了证据，表明Aml/Val和Aml/Val/HCT可使血压在临床上显著降低，并且在常规临床实践中研究的大量多民族高血压人群中耐受性良好。
