Roca-Cusachs Alejandro, Schmieder Roland E, Triposkiadis Filippos, Wenzel René R, Laurent Stéphane, Kohlmann Osvaldo, Fogari Roberto
Santa Creu I Sant Pau Hospital, Barcelona, Spain.
J Hypertens. 2008 Apr;26(4):813-8. doi: 10.1097/HJH.0b013e3282f3b5f0.
Hypertension markedly increases the already high risk for cardiovascular complications in patients with diabetes mellitus. Less than one in eight patients with hypertension and type 2 diabetes have adequately controlled blood pressure. As a result, antihypertensive combinations are now widely used in management of hypertension associated with diabetes.
This double-blind study investigated efficacy of a new fixed dose combination of a calcium antagonist, manidipine 10 mg, and an angiotensin-converting enzyme inhibitor, delapril 30 mg, compared with a combination of an angiotensin receptor blocker, losartan 50 mg, and a diuretic, hydrochlorothiazide 12.5 mg. Patients with hypertension (blood pressure > or = 130/80 mmHg) with controlled type 2 diabetes (HbA1c < or = 7.5%) were randomized to manidipine/delapril (n = 153) or losartan/hydrochlorothiazide (n = 161), administered once daily for 12 weeks. Patients underwent ambulatory blood pressure monitor evaluation at baseline and end of treatment.
Mean decreases in 24-h systolic blood pressure were seen with both manidipine/delapril (-9.3 mmHg) and losartan/hydrochlorothiazide (-10.7 mmHg) combinations. The mean (95% confidence interval) treatment difference was -1.4 (-4.5/1.8) mmHg, demonstrating noninferiority of the manidipine/delapril combination. Reduction in 24-h diastolic blood pressure (-4.6 versus -4.5 mmHg) and daytime (systolic blood pressure -10.5 versus -11.1 mmHg) and night-time (systolic blood pressure -7.1 versus -9.3 mmHg) blood pressure were also not significantly different between treatments. Compliance and adverse events were comparable for both groups.
The study demonstrated that the combination of manidipine and delapril is as effective as losartan and hydrochlorothiazide in treatment of hypertension in type 2 diabetes.
高血压显著增加了糖尿病患者已有的心血管并发症高风险。高血压合并2型糖尿病的患者中，每八人不到一人的血压得到充分控制。因此，抗高血压联合用药目前广泛用于糖尿病相关高血压的治疗。
这项双盲研究调查了一种新的固定剂量组合（钙拮抗剂马尼地平10毫克和血管紧张素转换酶抑制剂地拉普利30毫克）与血管紧张素受体阻滞剂氯沙坦50毫克和利尿剂氢氯噻嗪12.5毫克的组合相比的疗效。高血压（血压≥130/80 mmHg）且2型糖尿病得到控制（糖化血红蛋白≤7.5%）的患者被随机分为马尼地平/地拉普利组（n = 153）或氯沙坦/氢氯噻嗪组（n = 161），每日给药一次，持续12周。患者在基线和治疗结束时接受动态血压监测评估。
马尼地平/地拉普利组（-9.3 mmHg）和氯沙坦/氢氯噻嗪组（-10.7 mmHg）的24小时收缩压均出现平均下降。平均（95%置信区间）治疗差异为-1.4（-4.5/1.8）mmHg，表明马尼地平/地拉普利组合不劣于其他组合。治疗之间的24小时舒张压降低（-4.6对-4.5 mmHg）以及白天（收缩压-10.5对-11.1 mmHg）和夜间（收缩压-7.1对-9.3 mmHg）血压降低也无显著差异。两组的依从性和不良事件相当。
该研究表明，马尼地平与地拉普利的组合在治疗2型糖尿病高血压方面与氯沙坦和氢氯噻嗪一样有效。
