Department of Medicine/Cardiology, Cheil General Hospital, Kwandong University College of Medicine, 1-19 Mukjung-dong, Seoul 100-380, Korea.
Am J Cardiovasc Drugs. 2013 Feb;13(1):47-56. doi: 10.1007/s40256-013-0004-9.
Angiotensin II receptor blockers (ARBs) play a key role in hypertension therapy. Recently, fimasartan, the ninth ARB, was developed, but its safety and efficacy have not been well established.
The objective of this study was to determine whether age, sex, concomitant disease, and current antihypertensive medications affect the safety and efficacy of fimasartan in patients with arterial hypertension.
This was a large-scale, open-label observational study to determine the safety and efficacy of fimasartan in patients with hypertension. Patients who were treated for more than 2 months with fimasartan (60 or 120 mg, once daily) were recruited, and the data were systematically collected using electronic case report forms. Written informed consent forms were obtained from all patients.
A total of 14,151 patients (50.7 % males; mean age 59 ± 12 years) were evaluated, of whom 37.9 % were never treated with fimasartan, 53.5 % were switched to fimasartan, and 8.5 % had fimasartan added to their treatment. Overall, fimasartan reduced systolic blood pressure (SBP) from 145.4 ± 18.1 to 126.8 ± 12.6 mmHg and diastolic blood pressure (DBP) from 88.7 ± 11.8 to 79.0 ± 8.7 mmHg (all p < 0.001). The pulse rate decreased from 74.4 ± 10.3 to 71.9 ± 9.2 beats/min in comparison with before treatment (p < 0.001). The reductions were similar between sexes, age groups, and patients with and without co-morbidities, and were not dependent on prior or concomitant treatment with other antihypertensive drugs. Adverse events were reported in 3.31 % (treatment-emergent) and 2.35 % (drug-related) of patients; there were no dose differences for adverse events. The most frequent adverse events were dizziness (1.55 %) and headache (0.52 %); other adverse events were rare. The responder rate (DBP to <90 mmHg or a reduction of ≥10 mmHg) and the goal rate (combined SBP/DBP <140/90 mmHg) were 85.0 and 75.6 %, respectively. Global drug compliance was rated as excellent, very good, good, and poor in 68.1, 26.9, 3.4, and 1.7 % of patients, respectively.
The safety, efficacy, and compliance of fimasartan were found to be excellent in a large patient population that included patients potentially at higher risk for adverse events.
血管紧张素 II 受体阻滞剂（ARBs）在高血压治疗中起着关键作用。最近，开发了第九种 ARB，即飞米沙坦，但它的安全性和疗效尚未得到充分证实。
本研究旨在确定年龄、性别、合并症和当前降压药物是否会影响动脉高血压患者使用飞米沙坦的安全性和疗效。
这是一项大规模、开放性、观察性研究，旨在确定高血压患者使用飞米沙坦的安全性和疗效。招募了接受飞米沙坦（60 或 120mg，每日一次）治疗超过 2 个月的患者，并使用电子病例报告表系统地收集数据。所有患者均获得书面知情同意书。
共评估了 14151 名患者（50.7%为男性；平均年龄 59±12 岁），其中 37.9%从未使用过飞米沙坦，53.5%改用飞米沙坦，8.5%在治疗中添加了飞米沙坦。总的来说，飞米沙坦降低了收缩压（SBP）（从 145.4±18.1 降至 126.8±12.6mmHg，p<0.001）和舒张压（DBP）（从 88.7±11.8 降至 79.0±8.7mmHg，p<0.001）。与治疗前相比，脉搏率从 74.4±10.3 降至 71.9±9.2 次/分（p<0.001）。这些降低在性别、年龄组、有或无合并症的患者之间相似，并且不依赖于之前或同时使用其他降压药物。3.31%（治疗中出现）和 2.35%（与药物相关）的患者报告了不良事件；不良事件无剂量差异。最常见的不良事件是头晕（1.55%）和头痛（0.52%）；其他不良事件罕见。应答率（DBP<90mmHg 或降低≥10mmHg）和目标率（SBP/DBP<140/90mmHg）分别为 85.0%和 75.6%。68.1%、26.9%、3.4%和 1.7%的患者分别被评为药物依从性极好、很好、较好和差。
在包括可能有更高不良反应风险的患者在内的大量患者人群中，发现飞米沙坦的安全性、疗效和依从性极好。
