Adis, a Wolters Kluwer Business, Auckland, New Zealand.
Am J Cardiovasc Drugs. 2010;10(6):401-12. doi: 10.2165/11204880-000000000-00000.
Telmisartan/amlodipine is a single-pill combination of telmisartan, an angiotensin II receptor antagonist, and amlodipine, a dihydropyridine calcium channel antagonist, which is taken orally once daily for the treatment of hypertension. In the US and the EU, single-pill telmisartan/amlodipine can be used as a replacement for separate telmisartan and amlodipine tablets, and by patients not achieving BP goals with amlodipine monotherapy. In addition, the US indication includes patients not achieving BP goals with telmisartan (or another angiotensin II receptor antagonist or calcium channel antagonist other than amlodipine) alone, and as initial therapy in patients considered likely to require multiple drugs to achieve their BP goals. In an 8-week, randomized, double-blind, factorial-design, placebo-controlled, multicenter study in adult patients with hypertension (n = 1461), mean DBP was reduced from baseline to a significantly greater extent in recipients of telmisartan 40 or 80 mg/day plus amlodipine 5 or 10 mg/day than in those receiving equivalent dosages of telmisartan or amlodipine monotherapy. Single-pill telmisartan/amlodipine recipients had significantly greater reductions in BP than telmisartan or amlodipine monotherapy recipients in an 8-week, randomized, double-blind, multicenter study in adult patients with severe hypertension (n = 858), and in four 8-week, randomized, double-blind, multicenter trials in patients who had not responded to amlodipine (n = 1097, 947, and 531) or telmisartan (n = 314) monotherapy. Telmisartan/amlodipine was generally well tolerated in clinical trials, including two 36-week follow-up studies.
替米沙坦/氨氯地平是一种单片复方制剂，由血管紧张素 II 受体拮抗剂替米沙坦和二氢吡啶类钙通道拮抗剂氨氯地平组成，每日口服一次，用于治疗高血压。在美国和欧盟，单一片剂的替米沙坦/氨氯地平可替代替米沙坦和氨氯地平的单独片剂，也可用于单药氨氯地平治疗血压未达标的患者。此外，美国的适应证还包括单药替米沙坦（或其他血管紧张素 II 受体拮抗剂或除氨氯地平以外的钙通道拮抗剂）治疗血压不达标的患者，以及初始治疗时预计需要多种药物才能达到血压目标的患者。在一项 8 周、随机、双盲、析因设计、安慰剂对照、多中心研究中，纳入了高血压成年患者（n=1461），结果显示，接受替米沙坦 40 或 80mg/天加氨氯地平 5 或 10mg/天治疗的患者，其舒张压从基线到治疗后的下降幅度明显大于接受替米沙坦或氨氯地平单药治疗的患者。在一项 8 周、随机、双盲、多中心研究中，纳入了严重高血压的成年患者（n=858），结果显示，接受替米沙坦/氨氯地平治疗的患者的血压降低幅度明显大于接受替米沙坦或氨氯地平单药治疗的患者；在四项 8 周、随机、双盲、多中心研究中，纳入了对氨氯地平（n=1097、947 和 531）或替米沙坦（n=314）单药治疗无应答的患者，结果也显示，接受替米沙坦/氨氯地平治疗的患者的血压降低幅度明显大于接受替米沙坦或氨氯地平单药治疗的患者。替米沙坦/氨氯地平在临床试验中一般耐受性良好，包括两项 36 周随访研究。
