Michel Martin C, Bohner Herbert, Köster Jürgen, Schäfers Rafael, Heemann Uwe
Department of Pharmacology and Pharmacotherapy, University of Amsterdam, Amsterdam, The Netherlands.
Drug Saf. 2004;27(5):335-44. doi: 10.2165/00002018-200427050-00005.
To determine whether age, gender, concomitant disease and/or previous or present antihypertensive medication affect the safety or antihypertensive efficacy of telmisartan in the treatment of arterial hypertension.
In this large-scale, open-label postmarketing surveillance study, German physicians systematically documented their observations concerning patients with essential hypertension on case report forms. Patients were treated for 6 months with telmisartan (40-80 mg once daily). Data were analysed using direct group comparisons and multiple linear regression analysis.
A total of 19 870 patients (52.3% males, mean age 59.1 years) were evaluated, of whom 47.6, 18.3, 13.2 and 2.1%, respectively, had concomitant hypercholesterolaemia, diabetes mellitus, congestive heart failure and renal insufficiency. In the overall group, adverse events were reported in 1.9% of patients. Global tolerability was rated as very good, good, moderate or poor, respectively, in 74.7, 22.1, 0.7 and 0.5% of patients; tolerability was similar across all subgroups of patients. Telmisartan treatment did not increase serum creatinine or potassium in any subgroup, including >400 patients with impaired renal function (basal creatinine 1.73 mg/dL). Telmisartan had no adverse effects on glucose, triglyceride or cholesterol levels. In the overall group, telmisartan reduced mean +/- SD systolic blood pressure from 171.3 +/- 16.4 mm Hg to 141.3 +/- 12.0 mm Hg and diastolic blood pressure from 99.0 +/- 9.4 mm Hg to 83.4 +/- 6.9 mm Hg. Reductions were very similar between genders, age groups and patients with and without comorbidities, and not dependent on prior or concomitant treatment with other antihypertensive drugs.
The safety and efficacy of telmisartan found in controlled studies is maintained in a large postmarketing population that included sizeable patient subgroups potentially at higher risk for adverse events.
确定年龄、性别、合并疾病和/或既往或当前的抗高血压药物是否会影响替米沙坦治疗动脉高血压的安全性或降压疗效。
在这项大规模、开放标签的上市后监测研究中，德国医生在病例报告表上系统地记录了他们对原发性高血压患者的观察结果。患者接受替米沙坦治疗6个月（每日一次，40 - 80毫克）。使用直接组间比较和多元线性回归分析对数据进行分析。
共评估了19870例患者（男性占52.3%，平均年龄59.1岁），其中分别有47.6%、18.3%、13.2%和2.1%的患者合并高胆固醇血症、糖尿病、充血性心力衰竭和肾功能不全。在整个研究组中，1.9%的患者报告了不良事件。分别有74.7%、22.1%、0.7%和0.5%的患者将总体耐受性评为非常好、好、中等或差；所有患者亚组的耐受性相似。替米沙坦治疗在任何亚组中均未增加血清肌酐或血钾水平，包括400多名肾功能受损患者（基础肌酐1.73毫克/分升）。替米沙坦对血糖、甘油三酯或胆固醇水平无不良影响。在整个研究组中，替米沙坦使平均±标准差收缩压从171.3±16.4毫米汞柱降至141.3±12.0毫米汞柱，舒张压从99.0±9.4毫米汞柱降至83.4±6.9毫米汞柱。不同性别、年龄组以及有无合并症的患者之间血压降低情况非常相似，且不依赖于先前或同时使用其他抗高血压药物。
在一项大型上市后人群研究中，替米沙坦在对照研究中所发现的安全性和疗效得以维持，该人群包括了可能发生不良事件风险较高的相当数量的患者亚组。
