Krupicka J, Ceypová K, Kristenová P, Hauser T
Kardiochirurgické oddelení Nemocnice Na Homolce, Praha.
Vnitr Lek. 2008 Nov;54(11):1031-8.
Losartan is the longest used angiotensin II receptor blocker in clinical practice. It is one of the first-line drugs for the treatment of hypertensive disease and there is enough data available today about its use in the treatment of the disease, including some specific situations (left ventricular hypertrophy, cerebrovascular accidents) and cases when the hypertension disease combines with another disease (e.g. diabetic nephropathy). The primary objective of the non-intervention multicentre prospective observational open clinical assessment NCT-CZ 14/04/LOZ was to verify on a large sample of patients the safety of Lozap and Lozap H in current clinical practice.
The six-month clinical study enrolled patients with recently diagnosed hypertension and/or poorly controlled hypertension [blood pressure > or = 140/90 mm Hg: 4432 patients (96%); blood pressure: < or = 139/89 mm Hg 84 patients (2%); value unspecified: 83 patients (2%)]. A standard form was used for data acquisition. A total of 4,599 patients was enrolled (of which 2,386 women, i.e. 51.9%) with mean age 61 +/- 12 years (18-95 years; median 60 years) with additional risk factors (cardiovascular diseases in 48%, diabetes mellitus in 33%, lipid metabolism disorder in 42%, obesity in 45% and smoking in 26% of cases, respectively). 2,631 patients (57%) had previously diagnosed hypertension. The average blood pressure (BP) at enrolment in the study was 159/95mm Hg (median 160/95 mm Hg), and the average heart rate was 76 strokes/min (median 76).
The most frequently used dose was 50 mg of losartan (Lozap or Lozap H)--in 4,006 patients (87%) at enrolment in the study and in 3,982 patients (87%) at the end of the study. Adverse effects related to the treatment during the study were reported in a total of 9 patients (0.2%). The therapy was assessed as well tolerated in 96% of patients (4,409), as fairly tolerated in 3% of patients (131) and as poorly tolerated in 0.1% of patients (4). Systolic and diastolic blood pressure decreased by 23mm Hg and 14mm Hg respectively to a mean value of 136/81 mm Hg (median 135/80mm Hg) (P < 0.001 for both systolic and diastolic BP). Improvement in patient status was recorded in 93% of cases (4,254 patients) and no change was recorded in 6% of cases (294 patients).
Losartan in the form of Lozap or Lozap is a safe and effective treatment of patients with hypertensive disease. It is effective and safe beginning with the dose of 50 mg and its combination with a diuretic represents a good and safe therapy in patients with insufficient BP response to a 50 mg dose of losartan alone. In case of poor blood pressure response the dose has to be titrated to 100 mg.
氯沙坦是临床实践中使用时间最长的血管紧张素II受体阻滞剂。它是治疗高血压疾病的一线药物之一，如今有足够的数据表明其在该疾病治疗中的应用情况，包括一些特定情况（左心室肥厚、脑血管意外）以及高血压疾病与其他疾病合并的病例（如糖尿病肾病）。非干预性多中心前瞻性观察性开放临床评估NCT-CZ 14/04/LOZ的主要目的是在大量患者样本中验证洛扎普（Lozap）和洛扎普H（Lozap H）在当前临床实践中的安全性。
这项为期六个月的临床研究纳入了近期诊断为高血压和/或血压控制不佳的患者[血压≥140/90 mmHg：4432例患者（96%）；血压＜139/89 mmHg：84例患者（2%）；未提及具体数值：83例患者（2%）]。采用标准表格进行数据采集。共纳入4599例患者（其中2386例为女性，即51.9%），平均年龄61±12岁（18 - 95岁；中位数60岁），伴有其他危险因素（心血管疾病占48%，糖尿病占33%，脂质代谢紊乱占42%，肥胖占45%，吸烟占26%）。2631例患者（57%）既往诊断为高血压。研究入组时的平均血压（BP）为159/95 mmHg（中位数160/95 mmHg），平均心率为76次/分钟（中位数76）。
最常用的剂量是50毫克氯沙坦（洛扎普或洛扎普H）——研究入组时4006例患者（87%）使用该剂量，研究结束时3982例患者（87%）使用该剂量。研究期间共9例患者（0.2%）报告了与治疗相关的不良反应。96%的患者（4409例）认为治疗耐受性良好，3%的患者（131例）认为耐受性尚可，0.1%的患者（4例）认为耐受性差。收缩压和舒张压分别下降23 mmHg和14 mmHg，平均降至136/81 mmHg（中位数135/80 mmHg）（收缩压和舒张压P均＜0.001）。93%的病例（4254例患者）记录到患者状况改善，6%的病例（294例患者）无变化。
洛扎普或洛扎普形式的氯沙坦是治疗高血压疾病患者的安全有效药物。从50毫克剂量开始即有效且安全，对于单独使用50毫克氯沙坦血压反应不足的患者，其与利尿剂联合使用是一种良好且安全的治疗方法。如果血压反应不佳，剂量需滴定至100毫克。
