Jeffers Barrett W, Bhambri Rahul, Robbins Jeffery
Pfizer Inc., New York, NY, USA.
Vasc Health Risk Manag. 2014 Nov 14;10:651-9. doi: 10.2147/VHRM.S64511. eCollection 2014.
Diabetic patients with hypertension are approximately twice as likely to develop cardiovascular disease as non-diabetic patients with hypertension. Given that hypertension affects ∼60% of patients with diabetes, effective blood pressure (BP) management is important in this high-risk population. This post-hoc analysis pooled data from six clinical studies to quantify additional BP efficacy achieved when titrating hypertensive diabetic patients from amlodipine 5 mg to 10 mg. Approximately half of the diabetic patients were male (44/98; 44.9%) with a mean (standard deviation [SD]) age of 60.6 (9.6) years and a baseline mean (standard error [SE]) systolic blood pressure/diastolic blood pressure (SBP/DBP) of 150.8 (1.30)/87.5 (0.94) mmHg while on amlodipine 5 mg (159.1 [1.40]/92.6 [0.94] mmHg prior to treatment). In comparison, 350/610 (57.4%) non-diabetic patients were male with a mean (SD) age of 58.7 (11.1) years and baseline mean (SE) SBP/DBP of 150.3 (0.62)/90.9 (0.41) mmHg while on amlodipine 5 mg (160.0 [0.67]/96.2 [0.45] mmHg prior to treatment). Increasing amlodipine from 5 mg to 10 mg lowered sitting SBP by -12.5 mmHg (95% confidence interval (CI): -15.5, -9.5; P<0.0001) and DBP by -6.0 mmHg (-7.4, -4.6; P<0.0001) in diabetic patients; and SBP by -12.4 mmHg (-13.5, -11.3; P<0.0001) and DBP by -7.3 mmHg (-8.0, -6.7; P<0.0001) in non-diabetic patients. In total, 12.0% (95% CI: 6.4, 20.0) of diabetic patients achieved their BP goal versus 46.4% (42.4, 50.4) of non-diabetic patients after titration to amlodipine 10 mg. Overall, 22.0% of diabetic patients experienced 31 adverse events (AEs) and 28.9% of non-diabetic patients experienced 282 AEs. Serious AEs were reported by one (1.0%) diabetic and five (0.8%) non-diabetic patients. In this analysis, increasing amlodipine from 5 mg to 10 mg produced a clinically significant reduction in the BP of diabetic hypertensive patients, similar to non-diabetic patients, highlighting the importance of optimizing amlodipine titration in this high-risk population.
患有高血压的糖尿病患者发生心血管疾病的可能性大约是非糖尿病高血压患者的两倍。鉴于高血压影响约60%的糖尿病患者，有效的血压（BP）管理对这一高危人群至关重要。这项事后分析汇总了六项临床研究的数据，以量化将高血压糖尿病患者从氨氯地平5毫克滴定至10毫克时额外获得的血压疗效。大约一半的糖尿病患者为男性（44/98；44.9%），平均（标准差[SD]）年龄为60.6（9.6）岁，服用氨氯地平5毫克时基线平均（标准误[SE]）收缩压/舒张压（SBP/DBP）为150.8（1.30）/87.5（0.94）毫米汞柱（治疗前为159.1[1.40]/92.6[0.94]毫米汞柱）。相比之下，350/610（57.4%）的非糖尿病患者为男性，平均（SD）年龄为58.7（11.1）岁，服用氨氯地平5毫克时基线平均（SE）SBP/DBP为150.3（0.62）/90.9（0.41）毫米汞柱（治疗前为160.0[0.67]/96.2[0.45]毫米汞柱）。将氨氯地平从5毫克增加到10毫克可使糖尿病患者的坐位SBP降低-12.5毫米汞柱（95%置信区间[CI]：-15.5，-9.5；P<0.0001），DBP降低-6.0毫米汞柱（-7.4，-4.6；P<0.0001）；非糖尿病患者的SBP降低-12.4毫米汞柱（-13.5，-11.3；P<0.0001），DBP降低-7.3毫米汞柱（-8.0，-6.7；P<0.0001）。滴定至氨氯地平10毫克后，总共12.0%（95%CI：6.4，20.0）的糖尿病患者达到了血压目标，而非糖尿病患者为46.4%（42.4，50.4）。总体而言，22.0%的糖尿病患者发生了31起不良事件（AE），28.9%的非糖尿病患者发生了282起AE。一名（1.0%）糖尿病患者和五名（0.8%）非糖尿病患者报告了严重AE。在这项分析中，将氨氯地平从5毫克增加到10毫克可使糖尿病高血压患者的血压在临床上显著降低，与非糖尿病患者相似，突出了在这一高危人群中优化氨氯地平滴定的重要性。
