Kobalava Z D, Kotovskaya Y V, Villevalde S V, Moiseev V S
Russian Peoples' Friendship University, Moscow, Russian Federation.
Curr Med Res Opin. 2009 Sep;25(9):2229-37. doi: 10.1185/03007990903157531.
Insufficient use of diuretics in combination antihypertensive therapy is a main cause of poor blood pressure (BP) control in Russia. The objective of the ARGUS-2 study was to demonstrate that a rational use of a thiazide-like diuretic, indapamide sustained release (SR), alone or in combination, improves BP control in patients with arterial hypertension difficult to control due to isolated systolic hypertension (ISH), diabetes mellitus (DM), chronic nephropathy, or metabolic syndrome.
The open-label, non-comparative, 3-month study without preliminary washout included 1438 hypertensive patients (mean age: 57.3 +/- 10.7 years, mean BP: 158.8 +/- 14.2/93.4 +/- 10.0 mmHg), with difficult-to-control arterial hypertension and who had never been treated with diuretics previously. Throughout the study, patients received indapamide SR 1.5 mg OD. BP control was defined as <140/90 mmHg for all patients and <130/80 mmHg for those with diabetes mellitus or chronic nephropathy.
Indapamide SR was given as initiation monotherapy to 13.7% of the patients, as substitutive monotherapy to 6.8% of the patients uncontrolled by a previous monotherapy, as additive therapy to 31.9% of the patients uncontrolled by previous monotherapy, and as additive therapy to 47.6% uncontrolled by previous combination therapy without a diuretic. Among included patients 75.7% received also an ACE inhibitor or an angiotensin II receptors blocker, 43.9% a calcium channel blocker, and 32.8% a beta-blocker. In 3 months after indapamide SR administration, average BP level decreased to 131.8 +/- 9.7/80.5 +/- 6.9 mmHg and 84.5% of the study population achieved BP control. BP was controlled in 91.9% of patients with ISH (n = 477), 74.8% of those with diabetes (n = 214), 75.6% of those with chronic nephropathy (n = 82), and 85.1% of patients with metabolic syndrome (n = 745). No case of hypokalemia was reported.
The study demonstrates the value of including the thiazide-like diuretic indapamide SR in a combined antihypertensive regimen to control BP in hypertensive patients with added cardiovascular risk factors whose hypertension is difficult to treat. Methodological limitations of this study are its open-label design and the possibility of a change in concomitant antihypertensive treatment during the study.
在俄罗斯，联合抗高血压治疗中利尿剂使用不足是血压（BP）控制不佳的主要原因。ARGUS - 2研究的目的是证明合理使用噻嗪类利尿剂吲达帕胺缓释片（SR），单独使用或联合使用，可改善因单纯收缩期高血压（ISH）、糖尿病（DM）、慢性肾病或代谢综合征导致难以控制的动脉高血压患者的血压控制情况。
这项开放标签、非对照、为期3个月且无预洗脱期的研究纳入了1438例高血压患者（平均年龄：57.3±10.7岁，平均血压：158.8±14.2/93.4±10.0 mmHg），这些患者患有难以控制的动脉高血压且此前从未接受过利尿剂治疗。在整个研究过程中，患者每日服用1.5 mg吲达帕胺缓释片。所有患者的血压控制定义为<140/90 mmHg，糖尿病或慢性肾病患者的血压控制定义为<130/80 mmHg。
13.7%的患者起始使用吲达帕胺缓释片进行单药治疗，6.8%的患者在先前单药治疗未控制血压的情况下使用吲达帕胺缓释片进行替代单药治疗，31.9%的患者在先前单药治疗未控制血压的情况下使用吲达帕胺缓释片进行联合治疗，47.6%的患者在先前无利尿剂的联合治疗未控制血压的情况下使用吲达帕胺缓释片进行联合治疗。纳入研究的患者中，75.7%还接受了血管紧张素转换酶抑制剂或血管紧张素II受体阻滞剂治疗，43.9%接受了钙通道阻滞剂治疗，32.8%接受了β受体阻滞剂治疗。在服用吲达帕胺缓释片3个月后，平均血压水平降至131.8±9.7/80.5±6.9 mmHg，84.5%的研究人群实现了血压控制。ISH患者（n = 477）中91.9%的患者血压得到控制，糖尿病患者（n = 214）中74.8%的患者血压得到控制，慢性肾病患者（n = 82）中75.6%的患者血压得到控制，代谢综合征患者（n = 745）中85.1%的患者血压得到控制。未报告低钾血症病例。
该研究证明了在联合抗高血压方案中加入噻嗪类利尿剂吲达帕胺缓释片对控制伴有心血管危险因素且高血压难以治疗的高血压患者血压的价值。本研究的方法学局限性在于其开放标签设计以及研究期间联合抗高血压治疗可能发生变化。
