Assaad-Khalil Samir Helmy, Najem Robert, Sison Jorge, Kitchlew Asad Riaz, Cho Belong, Ueng Kwo-Chang, DiTommaso Shelley, Shete Abhijit
Department of Diabetology, Lipidology and Metabolism, Alexandria Faculty of Medicine, Alexandria University, Alexandria, Egypt.
Lebanese University Hospital, Beirut, Lebanon.
Vasc Health Risk Manag. 2015 Jan 21;11:71-8. doi: 10.2147/VHRM.S76599. eCollection 2015.
The clinical EXCITE (EXperienCe of amlodIpine and valsarTan in hypErtension) study reported clinically relevant blood pressure (BP) reductions across all doses of amlodipine/valsartan (Aml/Val) and Aml/Val/hydrochlorothiazide (HCT) single-pill combinations. The study prospectively observed a multiethnic population of hypertensive patients for 26 weeks who were treated according to routine clinical practice. Here, we present the results in high-risk subgroups including the elderly, obese patients, and patients with diabetes or isolated systolic hypertension. In addition, we present a post hoc analysis as per prior antihypertensive monotherapy and dual therapy.
Patients prescribed Aml/Val or Aml/Val/HCT were assessed in this 26±8 week, noninterventional, multicenter study across 13 countries in the Middle East and Asia. Changes in mean sitting systolic BP, mean sitting diastolic BP, and overall safety were assessed.
Of a total of 9,794 patients analyzed, 8,603 and 1,191 patients were prescribed Aml/Val and Aml/Val/HCT, respectively. Among these, 15.5% were elderly, 32.5% were obese, 31.3% had diabetes, and 9.8% had isolated systolic hypertension. Both Aml/Val and Aml/Val/HCT single-pill combinations, respectively, were associated with clinically relevant and significant mean sitting systolic/diastolic BP reductions across all subgroups: elderly patients (-32.2/-14.3 mmHg and -38.5/-16.5 mmHg), obese patients (-32.2/-17.9 mmHg and -38.5/-18.4 mmHg), diabetic patients (-30.3/-16.1 mmHg and -34.4/-16.6 mmHg), and patients with isolated systolic hypertension (-25.5/-4.1 mmHg and -30.2/-5.9 mmHg). Incremental BP reductions with Aml/Val or Aml/Val/HCT single-pill combinations were also observed in patients receiving prior monotherapy or dual therapy for hypertension. Overall, both Aml/Val and Aml/Val/HCT were generally well tolerated.
This large, multiethnic study supports the evidence that Aml/Val and Aml/Val/ HCT single-pill combinations are effective in diverse and clinically important subgroups of patients with hypertension.
临床EXCITE（氨氯地平和缬沙坦治疗高血压的经验）研究报告了氨氯地平/缬沙坦（氨氯地平/缬沙坦）和氨氯地平/缬沙坦/氢氯噻嗪（HCT）单一片剂组合的所有剂量在临床上均能显著降低血压（BP）。该研究前瞻性观察了按照常规临床实践治疗的多民族高血压患者群体26周。在此，我们展示了在包括老年人、肥胖患者以及糖尿病或单纯收缩期高血压患者在内的高危亚组中的研究结果。此外，我们还根据先前的抗高血压单药治疗和联合治疗进行了事后分析。
在这项为期26±8周、非干预性、多中心研究中，对中东和亚洲13个国家中开具氨氯地平/缬沙坦或氨氯地平/缬沙坦/氢氯噻嗪处方的患者进行了评估。评估了平均坐位收缩压、平均坐位舒张压的变化以及总体安全性。
在总共分析的9794例患者中，分别有8603例和1191例患者开具了氨氯地平/缬沙坦和氨氯地平/缬沙坦/氢氯噻嗪的处方。其中，15.5%为老年人，32.5%为肥胖患者，31.3%患有糖尿病，9.8%患有单纯收缩期高血压。氨氯地平/缬沙坦和氨氯地平/缬沙坦/氢氯噻嗪单一片剂组合在所有亚组中均与临床上显著的平均坐位收缩压/舒张压降低相关：老年患者（-32.2/-14.3 mmHg和-38.5/-16.5 mmHg）、肥胖患者（-32.2/-17.9 mmHg和-38.5/-18.4 mmHg）、糖尿病患者（-30.3/-16.1 mmHg和-34.4/-16.6 mmHg）以及单纯收缩期高血压患者（-25.5/-4.1 mmHg和-30.2/-5.9 mmHg）。在先前接受高血压单药治疗或联合治疗的患者中，也观察到氨氯地平/缬沙坦或氨氯地平/缬沙坦/氢氯噻嗪单一片剂组合能进一步降低血压。总体而言，氨氯地平/缬沙坦和氨氯地平/缬沙坦/氢氯噻嗪的耐受性普遍良好。
这项大型多民族研究支持了以下证据，即氨氯地平/缬沙坦和氨氯地平/缬沙坦/氢氯噻嗪单一片剂组合在高血压患者的不同且临床上重要的亚组中是有效的。
