Gatlin Marjorie, Jarrett Wentworth G, Nwose Oliseyenum M
Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Private Practice, Miami, Florida, USA.
Curr Ther Res Clin Exp. 2004 Mar;65(2):138-48. doi: 10.1016/S0011-393X(04)90028-8.
The LOGIC (LOtrel: Gauging Improved Control) study assessed the efficacy and tolerability of switching from amlodipine besylate monotherapy to fixed-dose combination therapy with amlodipine besylate/benazepril hydrochloride (HCI) in patients who were experiencing uncontrolled blood pressure (BP) or edema with monotherapy.
This article reports the efficacy and tolerability of amlodipine besylate/benazepril HCI combination therapy in the predefined African-American population of the LOGIC study.
This multicenter (1518 centers across the United States), practice-based, open-label, clinical trial enrolled patients with mild to moderate essential hypertension. Patients in group 1 had uncontrolled BP (sitting diastolic BP [DBP] ≥90 mm Hg and ≤110 mm Hg) during treatment with amlodipine besylate monotherapy 5 or 10 mg/d, and those in group 2 had controlled BP (sitting DBP ⩽90 mm Hg), but also had experienced edema during amlodipine besylate monotherapy. Participants were instructed to discontinue amlodipine besylate and were given amlodipine besylate/benazepril HCl 5/10 mg/d or 5/20 mg/d for 4 weeks. For group 1, the primary efficacy outcome was the change in mean sitting DBP (MSDBP) from baseline to week 4; a secondary efficacy outcome was the change in mean sitting systolic BP (MSSBP) from baseline to week 4. The primary efficacy outcome for group 2 was the percentage of patients whose edema improved with the switch to combination therapy. The secondary efficacy variables in group 2 were the changes in MSDBP and MSSBP from baseline to week 4. Patients in groups 1 and 2 were questioned about any adverse events that may have occurred since the previous visit. At both study visits, medications were reviewed, and the level of edema was assessed.
A total of 2055 African-American patients were enrolled in the study. At study end, African-American patients in group 1 (n = 1422 assessable patients) experienced significant reductions in MSSBP (13.9 mm Hg) and MSDBP (10.4 mm Hg) from those achieved during amlodipine besylate monotherapy (both P < 0.001). In group 2 (n = 266 assessable patients), 81% of African-American patients reported improvement in edema, and BP remained well controlled.
In this study of an African-American subpopulation of patients with mild to moderate essential hypertension who had uncontrolled BP while receiving amlodipine besylate monotherapy, switching from amlodipine besylate monotherapy to fixed-dose amlodipine besylate/benazepril HCl combination therapy reduced BP to a greater extent than with amlodipine besylate alone, and reduced the incidence of edema in patients who were edematous but who had controlled BP. Fixed-dose combination therapy with amlodipine besylate/benazepril HCI has the potential to improve BP control, leading to improved clinical outcomes and enhanced treatment compliance.
LOGIC（络活喜：评估改善控制情况）研究评估了在接受苯磺酸氨氯地平单药治疗血压（BP）未得到控制或出现水肿的患者中，从苯磺酸氨氯地平单药治疗转换为苯磺酸氨氯地平/盐酸贝那普利固定剂量联合治疗的疗效和耐受性。
本文报告LOGIC研究中预先定义的非裔美国人群中苯磺酸氨氯地平/盐酸贝那普利联合治疗的疗效和耐受性。
这项多中心（美国各地1518个中心）、基于实践、开放标签的临床试验纳入了轻度至中度原发性高血压患者。第1组患者在接受5或10mg/d苯磺酸氨氯地平单药治疗期间血压未得到控制（坐位舒张压[DBP]≥90mmHg且≤110mmHg），第2组患者血压得到控制（坐位DBP≤90mmHg），但在苯磺酸氨氯地平单药治疗期间也出现了水肿。参与者被指示停用苯磺酸氨氯地平，并给予5/10mg/d或5/20mg/d的苯磺酸氨氯地平/盐酸贝那普利治疗4周。对于第1组，主要疗效指标是从基线到第4周平均坐位DBP（MSDBP）的变化；次要疗效指标是从基线到第4周平均坐位收缩压（MSSBP）的变化。第2组的主要疗效指标是转换为联合治疗后水肿改善的患者百分比。第2组的次要疗效变量是从基线到第4周MSDBP和MSSBP的变化。第1组和第2组的患者被询问自上次就诊以来可能发生的任何不良事件。在两次研究就诊时，对用药情况进行了审查，并评估了水肿程度。
共有2055名非裔美国患者参加了该研究。在研究结束时，第1组（n = 1422名可评估患者）的非裔美国患者的MSSBP（13.9mmHg）和MSDBP（10.4mmHg）较苯磺酸氨氯地平单药治疗期间有显著降低（均P < 0.001）。在第2组（n = 266名可评估患者）中，81%的非裔美国患者报告水肿有所改善，且血压仍得到良好控制。
在这项针对轻度至中度原发性高血压的非裔美国亚组患者的研究中，这些患者在接受苯磺酸氨氯地平单药治疗时血压未得到控制，从苯磺酸氨氯地平单药治疗转换为固定剂量的苯磺酸氨氯地平/盐酸贝那普利联合治疗比单独使用苯磺酸氨氯地平能更大程度地降低血压，并降低了有水肿但血压得到控制的患者的水肿发生率。苯磺酸氨氯地平/盐酸贝那普利固定剂量联合治疗有可能改善血压控制，从而改善临床结局并提高治疗依从性。
