Bramlage Peter, Fronk Eva-Maria, Wolf Wolf-Peter, Smolnik Rüdiger, Sutton Gemma, Schmieder Roland E
Institut für Pharmakologie und präventive Medizin, Mahlow, Germany.
Daiichi Sankyo Europe GmbH, Munich, Germany.
Vasc Health Risk Manag. 2014 Dec 17;11:1-8. doi: 10.2147/VHRM.S75380. eCollection 2015.
Clinical trials indicate that the use of fixed-dose combinations (FDCs) is associated with a higher level of treatment adherence and prolonged blood pressure (BP) control. The aim of this study was to document the safety and effectiveness of the FDC olmesartan/amlodipine/hydrochlorothiazide in patients with essential hypertension in clinical practice.
This multicenter, prospective, 24-week, noninterventional study enrolled 5,831 patients from primary care offices in Germany and Austria. Inclusion criteria were a diagnosis of essential hypertension and newly initiated treatment with the FDC.
The mean age of patients was 63.5 years, almost 50% of patients had a time since diagnosis of essential hypertension of over 5 years, and approximately 70% of patients had at least one cardiovascular risk factor, including 29.4% of patients with diabetes mellitus. Following approximately 24 weeks of treatment, the mean reduction in systolic/diastolic BP was 29.0/14.0 mmHg, a BP response was observed by 94.2% of patients, and a target BP of <140/90 mmHg was attained in 67.5% of patients. At least one adverse drug reaction (ADR) was experienced by 1.2% of patients, with the most common being peripheral edema. Subanalyses demonstrated that the following factors did not have a significant influence on the ADR rate: age (<65 years versus ≥65 years), diabetes mellitus (no/yes), cardiovascular risk (low/high), and concomitant medication (no/yes).
This study demonstrates that in clinical practice, treatment with the three-drug combination as an FDC tablet resulted in a very high proportion of patients with a BP response and control, accompanied by a very low rate of ADRs.
临床试验表明，使用固定剂量复方制剂（FDC）与更高的治疗依从性水平以及延长的血压（BP）控制相关。本研究的目的是记录FDC奥美沙坦/氨氯地平/氢氯噻嗪在临床实践中治疗原发性高血压患者的安全性和有效性。
这项多中心、前瞻性、为期24周的非干预性研究纳入了来自德国和奥地利基层医疗诊所的5831名患者。纳入标准为原发性高血压诊断且新开始使用FDC治疗。
患者的平均年龄为63.5岁，近50%的患者自原发性高血压诊断以来的时间超过5年，约70%的患者至少有一项心血管危险因素，其中29.4%的患者患有糖尿病。经过约24周的治疗，收缩压/舒张压的平均降低值为29.0/14.0 mmHg，94.2%的患者观察到血压有反应，67.5%的患者达到了<140/90 mmHg的目标血压。1.2%的患者经历了至少一种药物不良反应（ADR），最常见的是外周水肿。亚组分析表明，以下因素对ADR发生率没有显著影响：年龄（<65岁与≥65岁）、糖尿病（无/有）、心血管风险（低/高）以及合并用药（无/有）。
本研究表明，在临床实践中，使用三种药物联合的FDC片剂进行治疗，导致很高比例的患者出现血压反应和得到控制，同时ADR发生率很低。
