Hilleman D E, Reyes A P, Wurdeman R L, Faulkner M
Creighton University School of Pharmacy and Allied Health Professions, 2500 California Plaza, Omaha, NE 68178, USA.
J Hum Hypertens. 2001 Aug;15(8):559-65. doi: 10.1038/sj.jhh.1001230.
Recent hypertension trials have demonstrated the importance of achieving goal blood pressures to reduce the risk of target organ damage. In patients with moderate to severe hypertension, the use of high-dose monotherapy and/or combinations of drugs are necessary to achieve these goals. Fixed-dose combination products may be useful in these patients by reducing the number of daily doses required to control blood pressure.
The objective of the present study was to evaluate the efficacy and safety of a therapeutic interchange between high-dose calcium channel blocker therapy and a fixed-dose combination of amlodipine/ benazepril (Lotrel; Novartis Pharmaceuticals, USA) in patients with moderate to severe hypertension.
A total of 75 patients were switched from amlodipine (n = 25), felodipine (n = 25), and nifedipine-GITS (n = 25) to amlodipine/benazepril. Twenty-eight of the 75 patients (37%) were taking either a beta-blocker or a diuretic in addition to the high-dose calcium channel blocker prior to the switch. Blood pressure control, side effects and the cost of the therapeutic interchange were evaluated in the year following the therapeutic interchange.
Sixty-six of the 75 (88%) patients were successfully switched with maintenance of blood pressure control and without the development of new dose-limiting side effects. Reasons for treatment failure after the therapeutic interchange included loss of blood pressure control in five patients and the development of new dose-limiting side effects in four patients. These side effects included cough in three patients and rash in one patient. After accounting for differences in drug acquisition cost and costs related to the switch (clinic and emergency room and laboratory tests), a cost savings of $16030 for all 75 patients was realised in the first year. The per patient-per year cost savings was $214.
Our data indicate that a therapeutic interchange from selected high-dose calcium channel blockers to a fixed-dose combination of amlodipine/ benazepril can be successfully accomplished in the majority of patients.
近期的高血压试验已证明达到目标血压对于降低靶器官损害风险的重要性。在中重度高血压患者中，使用高剂量单药治疗和/或联合用药对于实现这些目标是必要的。固定剂量复方制剂通过减少控制血压所需的每日用药次数，可能对这些患者有用。
本研究的目的是评估在中重度高血压患者中，高剂量钙通道阻滞剂治疗与氨氯地平/贝那普利固定剂量复方制剂（络活喜；美国诺华制药公司）之间进行治疗性换药的疗效和安全性。
总共75例患者从氨氯地平（n = 25）、非洛地平（n = 25）和硝苯地平控释片（n = 25）换用氨氯地平/贝那普利。75例患者中有28例（37%）在换药前除了服用高剂量钙通道阻滞剂外，还服用β受体阻滞剂或利尿剂。在治疗性换药后的一年中，评估血压控制情况、副作用以及治疗性换药的费用。
75例患者中有66例（88%）成功换药，血压得到控制且未出现新的剂量限制性副作用。治疗性换药后治疗失败的原因包括5例患者血压控制不佳以及4例患者出现新的剂量限制性副作用。这些副作用包括3例患者咳嗽和1例患者皮疹。在考虑药物采购成本以及与换药相关的成本（诊所、急诊室和实验室检查）差异后，75例患者在第一年共节省成本16030美元。每位患者每年节省成本214美元。
我们的数据表明，在大多数患者中，从选定的高剂量钙通道阻滞剂成功换用氨氯地平/贝那普利固定剂量复方制剂是可行的。
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