Volman Sergio, Benitez Fernando Nicolas, Cedenio Harold, Giorgi Mariano, Jaramillo Nicolas, Molina Nelys, Zilberman Judith
Novartis Argentina, Ramallo 1851-Grecia, Ciudad Autonoma de Buenos Aires-CABA, Buenos Aires 1429, Argentina.
Ther Adv Cardiovasc Dis. 2013 Aug;7(4):189-96. doi: 10.1177/1753944713485984. Epub 2013 May 30.
Hypertension (HTN) is one of the major risk factors for cardiovascular disease in Western countries, and disease control is of major relevance in order to reduce cardiovascular morbidity and mortality. Different approaches have shown efficacy, and one of the proven therapies for HTN control is the blockade of the renin-angiotensin-aldosterone system, which may be accomplished by means of various drugs with different modes of action. Aliskiren is a novel direct renin inhibitor that reduces both angiotensin I and II blood levels. Different randomized clinical trials (phase II and III) have shown its safety and efficacy either alone or in combination with hydrochlorothiazide. However, although aliskiren has been on the market for some years, reports on the post-marketing experience with aliskiren in the real-world setting are lacking.
The Aliskiren in Latin America Study (ALAS) was designed with the aim of describing the effectiveness of aliskiren at reducing blood pressure (BP) values by prospectively assessing BP control in outpatient clinics in different countries in Latin America. A total of 435 sites in 5 Latin American countries (Mexico, Ecuador, Colombia, Argentina, and Venezuela) enrolled 4588 patients who had just been initiated on aliskiren (either alone or in combination with hydrochlorothiazide) based on their treating physicians' discretion, and they were followed for a 6-month period. Prior antihypertensive drugs could be continued if their doses were not modified along the study.
At the end of the follow-up period, a statistically significant reduction in BP values was observed, with a mean systolic BP reduction of 29.2 mmHg and a mean diastolic BP reduction of 13.78 mmHg from baseline at the 6-month visit.
The BP reduction levels and the low adverse event rate demonstrate the adequate efficacy and safety profile of aliskiren (alone or with hydrochlorothiazide).
高血压（HTN）是西方国家心血管疾病的主要危险因素之一，控制该疾病对于降低心血管发病率和死亡率至关重要。不同的治疗方法已显示出疗效，而经证实的高血压控制疗法之一是阻断肾素-血管紧张素-醛固酮系统，这可以通过各种具有不同作用方式的药物来实现。阿利吉仑是一种新型直接肾素抑制剂，可降低血管紧张素I和II的血液水平。不同的随机临床试验（II期和III期）已显示其单独使用或与氢氯噻嗪联合使用的安全性和有效性。然而，尽管阿利吉仑已上市数年，但缺乏其在现实环境中的上市后经验报告。
拉丁美洲阿利吉仑研究（ALAS）旨在通过前瞻性评估拉丁美洲不同国家门诊诊所的血压控制情况，描述阿利吉仑降低血压（BP）值的有效性。拉丁美洲5个国家（墨西哥、厄瓜多尔、哥伦比亚、阿根廷和委内瑞拉）的435个研究点纳入了4588例患者，这些患者根据治疗医生的判断刚开始使用阿利吉仑（单独使用或与氢氯噻嗪联合使用），并对他们进行了为期6个月的随访。如果在研究过程中未改变先前抗高血压药物的剂量，则可以继续使用。
在随访期结束时，观察到血压值有统计学意义的降低，在6个月随访时，收缩压平均较基线降低29.2 mmHg，舒张压平均降低13.78 mmHg。
血压降低水平和低不良事件发生率证明了阿利吉仑（单独使用或与氢氯噻嗪联合使用）具有足够的疗效和安全性。
