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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Dose response and safety of telmisartan in patients with mild to moderate hypertension.
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Dose response and safety of telmisartan in patients with mild to moderate hypertension.

机译：轻中度高血压患者替米沙坦的剂量反应和安全性。

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摘要

This randomized, double-blind, double-dummy, placebo-controlled, parallel-group study evaluated the dose-response relationship of telmisartan in 207 patients with mild to moderate hypertension (diastolic blood pressure [DBP] 100 to 114 mmHg). After a 28-day placebo run-in period, patients were randomized to 28 days of once-daily, double-blind, double-dummy treatment with telmisartan 40, 80, or 120 mg; enalapril 20 mg; or placebo. Blood pressure (BP) was manually recorded for 12 hours after the first dose and after 24 hours at baseline (Day 0), Day 1, and Day 28 of double-blind treatment. Pharmacokinetic and pharmacodynamic parameters were assessed from telmisartan plasma concentrations. All doses of telmisartan and enalapril significantly reduced BP compared with placebo (p < or = 0.01). Mean +/- SE reductions in supine DBP after 28 days of treatment ranged between 7.9 +/- 1.3 mmHg and 9.8 +/- 1.3 mmHg in the telmisartan groups, 9.6 +/- 1.3 mmHg with enalapril, and 1.5 +/- 1.3 mmHg with placebo. Mean +/- SE reductions in supine systolic blood pressure (SBP) were between 10.0 +/- 2.2 mmHg and 15.5 +/- 2.2 mmHg with telmisartan versus 10.2 +/- 2.1 mmHg with enalapril; placebo increased supine SBP by 3.5 +/- 2.1 mmHg. The BP reductions after 4 weeks of treatment with telmisartan were no different from those achieved with enalapril. No significant linear trend in BP reduction was evident among telmisartan doses. Reductions in SBP and DBP were maintained over the 24-hour period at Day 28. Treatment did not affect supine heart rate. Trough/peak DBP ratios were > or = 85% for all telmisartan doses versus 65% for enalapril. High interpatient variability in telmisartan plasma concentrations was observed. For example, mean +/- SD values for Cmax were 159 +/- 104 ng/mL for telmisartan 40 mg, 693 +/- 606 ng/mL for telmisartan 80 mg, and 1635 +/- 1406 ng/mL for telmisartan 120 mg. Plasma concentration-effect analyses indicated that the antihypertensive effects of telmisartan 40, 80, and 120 mg are at the plateau region of the concentration-response curve. All active treatments were well tolerated, with tolerability profiles similar to placebo, and telmisartan did not produce any clinically relevant first-dose effects. These data confirm the antihypertensive efficacy and placebo-like tolerability of telmisartan.
机译：这项随机，双盲，双虚拟，安慰剂对照的平行组研究评估了替米沙坦在207例轻度至中度高血压（舒张压[DBP] 100至114 mmHg）中的剂量反应关系。经过28天的安慰剂磨合期后，将患者随机分配至28天的每日一次，替米沙坦40、80或120 mg双盲，双假治疗;依那普利20毫克;或安慰剂。手动记录血压（BP），在首次给药后12个小时，在基线（第0天），第1天和第28天第24天的24小时后记录。从替米沙坦血浆浓度评估药代动力学和药效学参数。与安慰剂相比，所有剂量的替米沙坦和依那普利均显着降低BP（p <或= 0.01）。替米沙坦组在治疗28天后平躺DBP的平均+/- SE降低范围在7.9 +/- 1.3 mmHg和9.8 +/- 1.3 mmHg之间，使用依那普利的9.6 +/- 1.3 mmHg和1.5 +/- 1.3 mmHg与安慰剂。替米沙坦组的仰卧平均收缩压（SBP）+/- +/-平均降低在10.0 +/- 2.2 mmHg和15.5 +/- 2.2 mmHg之间，而依那普利则为10.2 +/- 2.1 mmHg。安慰剂使仰卧SBP升高3.5 +/- 2.1 mmHg。替米沙坦治疗4周后的BP降低与依那普利达到的降低无差异。在替米沙坦剂量之间，血压降低没有明显的线性趋势。在第28天的24小时内，SBP和DBP均保持下降。治疗不影响仰卧心率。对于所有替米沙坦剂量，谷底/峰值DBP比率均大于或等于85％，而依那普利则为65％。观察到替米沙坦血浆浓度的高患者间差异。例如，替米沙坦40 mg的Cmax平均值+/- SD值为159 +/- 104 ng / mL，替米沙坦80 mg的平均值为693 +/- 606 ng / mL，替米沙坦120的1635 +/- 1406 ng / mL毫克血浆浓度效应分析表明，替米沙坦40、80和120 mg的降压作用在浓度-响应曲线的平稳区域。所有积极治疗的耐受性良好，耐受性与安慰剂相似，替米沙坦未产生任何临床相关的首剂作用。这些数据证实了替米沙坦的抗高血压功效和类似安慰剂的耐受性。

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