Volpe Massimo, de la Sierra Alejandro, Ammentorp Bettina, Laeis Petra
Division of Cardiology, Department of Clinical and Molecular Medicine, University of Rome "La Sapienza", Sant'Andrea Hospital, via di Grottarossa 1035, 00189, Rome, Italy,
Adv Ther. 2014 May;31(5):561-74. doi: 10.1007/s12325-014-0117-9. Epub 2014 Apr 24.
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.
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.
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.
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.
为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血压（BP），许多患者需要三种或更多药物。
一项为期10周的双盲研究的开放标签扩展研究评估了奥美沙坦/氨氯地平/氢氯噻嗪（OLM/AML/HCTZ）三联组合疗法在2509例2-3级高血压患者中的长期疗效和安全性。在接受8周单盲OLM/AML/HCTZ 20/5/12.5mg治疗后，血压达标的患者[坐位收缩压/舒张压（SeSBP/SeDBP）<140/90mmHg，糖尿病、慢性肾脏病或心血管疾病患者<130/80mmHg]进入36周的开放标签治疗。未达标的患者在进入开放标签治疗前接受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40/10/25mg治疗，并根据需要进行剂量上调或下调以实现血压目标。
在开放标签治疗期间，平均SeSBP/SeDBP水平分别保持在120-140mmHg和75-85mmHg范围内。在研究结束时，每组的SeSBP（37-43mmHg）和SeDBP（22-27mmHg）较基线均有显著降低，总体78.1%的患者实现了血压目标。根据基线SeSBP（150-159、160-169、170-179、180-189、190至<200mmHg）对患者进行分类分析与SeSBP的变化相关。基线类别最低（150-159mmHg）的患者SeSBP降低了34.3mmHg，最高类别（190至<200mmHg）的患者降低了59.4mmHg。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%的患者血压正常/高正常。各治疗组不良事件的发生率相似。
在2-3级高血压患者中，OLM/AML/HCTZ三联组合疗法的长期治疗耐受性良好且有效。实现了高水平的血压控制以及高血压严重程度的大幅降低。
