Littlejohn Thomas W, Majul Claudio R, Olvera R, Seeber Mary, Kobe Maureen, Guthrie Robert, Oigman Wille
Piedmont Medical Research Associates, Winston-Salem, NC 27103, USA.
Postgrad Med. 2009 Mar;121(2):5-14. doi: 10.3810/pgm.2009.03.1972.
Patients with moderate-to-severe hypertension frequently require > or = 2 antihypertensives to achieve blood pressure (BP) control. An angiotensin receptor blocker (ARB) plus a calcium channel blocker (CCB) seems particularly attractive for these difficult-to-control patients.
Patients with Stage 1 or 2 hypertension were randomized to telmisartan 0, 20, 40, or 80 mg plus amlodipine 0, 2.5, 5, or 10 mg for 8 weeks. Only those with a diastolic BP (DBP) > or = 100 mm Hg at baseline were included in this subgroup analysis. The primary endpoint was the change in the in-clinic seated trough cuff DBP from baseline to study end for combination versus respective monotherapies. Secondary endpoints included the change in the in-clinic seated trough systolic BP (SBP), BP response, and control rates.
A total of 1078 patients (mean [standard deviation] baseline in-clinic BP: 154.7 +/- 11.7/103.5 +/- 3.5 mm Hg) were analyzed. In-clinic DBP and SBP reductions were significantly greater with combination therapies than respective monotherapies. The greatest least-square mean (standard error) SBP/DBP reductions (-26.5 +/- 1.2/-21 +/- 0.8 mm Hg) were observed with telmisartan 80 mg plus amlodipine 10 mg; 77% and 85% of patients in this treatment group achieved BP control (< 140/90 mm Hg) and DBP control (< 90 mm Hg), respectively. Peripheral edema was reported in 17.2% of patients in the amlodipine 10 mg group; however, this was substantially lower when telmisartan was used in combination: 7% (telmisartan 40 mg/amlodipine 10 mg) and 9.5% (telmisartan 80 mg/ amlodipine 10 mg).
Telmisartan plus amlodipine provides effective BP lowering at all clinically relevant doses (up to -26.5 mm Hg SBP), and almost 9 out of 10 patients may achieve DBP control. Peripheral edema is up to 59% less when telmisartan 40 mg is used in combination with amlodipine 10 mg compared with amlodipine 10 mg monotherapy alone.
中重度高血压患者通常需要两种或两种以上抗高血压药物才能实现血压控制。血管紧张素受体阻滞剂（ARB）加钙通道阻滞剂（CCB）对这些难以控制的患者似乎特别有吸引力。
将1或2期高血压患者随机分为替米沙坦0、20、40或80mg加氨氯地平0、2.5、5或10mg，治疗8周。本亚组分析仅纳入基线舒张压（DBP）≥100mmHg的患者。主要终点是联合治疗与各自单药治疗相比，从基线到研究结束时诊室坐位谷值袖带DBP的变化。次要终点包括诊室坐位谷值收缩压（SBP）的变化、血压反应和控制率。
共分析了1078例患者（平均[标准差]基线诊室血压：154.7±11.7/103.5±3.5mmHg）。联合治疗组的诊室DBP和SBP降低幅度明显大于各自的单药治疗组。替米沙坦80mg加氨氯地平10mg组观察到最大的最小二乘均值（标准误）SBP/DBP降低幅度（-26.5±1.2/-21±0.8mmHg）；该治疗组分别有77%和85%的患者实现了血压控制（<140/90mmHg）和DBP控制（<90mmHg）。氨氯地平10mg组有17.2%的患者报告有外周水肿；然而，当与替米沙坦联合使用时，外周水肿发生率显著降低：7%（替米沙坦40mg/氨氯地平10mg）和9.5%（替米沙坦80mg/氨氯地平10mg）。
替米沙坦加氨氯地平在所有临床相关剂量下均能有效降低血压（SBP降低幅度高达-26.5mmHg），几乎十分之九的患者可实现DBP控制。与氨氯地平10mg单药治疗相比，替米沙坦40mg与氨氯地平10mg联合使用时外周水肿发生率降低多达59%。
