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首页> 外文期刊>Advances in therapy. >Open-label study assessing the long-term efficacy and safety of triple olmesartan/amlodipine/hydrochlorothiazide combination therapy for hypertension
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Open-label study assessing the long-term efficacy and safety of triple olmesartan/amlodipine/hydrochlorothiazide combination therapy for hypertension

机译：评估奥美沙坦/氨氯地平/氢氯噻嗪三联疗法治疗高血压的长期疗效和安全性的开放标签研究

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Introduction: To reduce cardiovascular risk associated with hypertension, the majority of patients require at least two drugs to control their blood pressure (BP), and many require three or more. Methods: An open-label extension of a 10-week double-blind study assessed the long-term efficacy and safety of olmesartan/amlodipine/hydrochlorothiazide (OLM/AML/HCTZ) triple combination treatment in 2,509 patients with Grade 2-3 hypertension. After 8 weeks of single-blind OLM/AML/HCTZ 20/5/12.5 mg treatment, patients at BP goal [seated systolic/diastolic BP (SeSBP/SeDBP) <140/90 mmHg, or <130/80 mmHg for patients with diabetes, or chronic kidney or cardiovascular disease] entered open-label treatment for 36 weeks. Patients not at goal received 8 weeks of randomized, double-blind treatment before entering open-label treatment. During open-label treatment, patients received OLM/AML/HCTZ 20/5/12.5, 40/5/12.5, 40/5/25, 40/10/12.5 or 40/10/25 mg with up- or down-titration as needed to achieve BP goals. Results: During open-label treatment, mean SeSBP/SeDBP levels remained within the ranges 120-140 and 75-85 mmHg, respectively. At study end, significant reductions from baseline were seen in each group for SeSBP (37-43 mmHg) and SeDBP (22-27 mmHg), and 78.1% of patients overall achieved BP goal. Categorical analysis of patients by baseline SeSBP (150-159, 160-169, 170-179, 180-189, 190 to <200 mmHg) correlated with changes in SeSBP. Patients in the lowest baseline category (150-159 mmHg) showed a reduction of 34.3 mmHg, and those in the highest category (190 to <200 mmHg) showed a 59.4 mmHg reduction. At baseline, 90.8% of patients had Grade 2 or 3 hypertension, but at study end 91.9% had normal/high-normal BP. The incidence of adverse events was similar across the treatment groups. Conclusion: In patients with Grade 2-3 hypertension, long-term treatment with OLM/AML/HCTZ triple combination therapy was well tolerated and effective. A high level of BP control and a substantial reduction in the level of hypertension severity were achieved.
机译：简介：为了降低与高血压相关的心血管风险，大多数患者需要至少两种药物来控制其血压（BP），许多患者需要三种或更多种。方法：一项为期10周的双盲研究的开放标签扩展评估了奥美沙坦/氨氯地平/氢氯噻嗪（OLM / AML / HCTZ）三联疗法在2,509例2-3级高血压患者中的长期疗效和安全性。在单盲OLM / AML / HCTZ 20/5 / 12.5 mg治疗8周后，达到BP目标的患者[收缩压/舒张压BP（SeSBP / SeDBP）<140/90 mmHg，或对于患有以下疾病的患者<130/80 mmHg糖尿病，慢性肾脏或心血管疾病]进行了36周的开放标签治疗。未达到目标的患者在接受开放标签治疗之前接受了8周的随机双盲治疗。在开放标签治疗期间，患者接受OLM / AML / HCTZ 20/5 / 12.5、40 / 5 / 12.5、40 / 5 / 25、40 / 10 / 12.5或40/10/25毫克的滴定剂量根据需要实现BP目标。结果：在开放标签治疗期间，平均SeSBP / SeDBP水平分别保持在120-140和75-85 mmHg范围内。在研究结束时，每组的SeSBP（37-43 mmHg）和SeDBP（22-27 mmHg）均较基线显着降低，总体上达到BP目标的患者占78.1％。通过基线SeSBP（150-159、160-169、170-179、180-189、190至<200 mmHg）对患者进行的分类分析与SeSBP的变化相关。基线最低类别（150-159 mmHg）的患者减少了34.3 mmHg，而基线类别最高（190至<200 mmHg）的患者减少了59.4 mmHg。在基线时，90.8％的患者患有2级或3级高血压，但在研究结束时91.9％的患者具有正常/高正常血压。在各治疗组中，不良事件的发生率相似。结论：对于2-3级高血压患者，OLM / AML / HCTZ三联联合疗法的长期治疗耐受性良好且有效。实现了高水平的BP控制和高血压严重程度的显着降低。

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