Weber Michael A, Mansfield Traci A, Alessi Federica, Iqbal Nayyar, Parikh Shamik, Ptaszynska Agata
a SUNY Downstate College of Medicine , New York , NY , USA ;
b Bristol-Myers Squibb , Princeton , NJ , USA ;
Blood Press. 2016;25(2):93-103. doi: 10.3109/08037051.2015.1116258. Epub 2015 Dec 1.
Hypertension and type 2 diabetes mellitus (T2DM) are risk factors for cardiovascular disease. Dapagliflozin improves glycemic control and systolic blood pressure (SBP) in T2DM patients. This double-blind phase III study evaluated the effects of dapagliflozin on glycemic control and blood pressure in patients with inadequately controlled T2DM and hypertension, despite ongoing therapy with a renin-angiotensin system blocker. Patients were randomized to receive dapagliflozin 10 mg (n = 302) or placebo (n = 311) once daily for 12 weeks. Endpoints were change from baseline to week 12 in seated SBP and glycosylated hemoglobin (HbA1c); longitudinal repeated-measures analysis was performed. Additional endpoints included other hemodynamic measures, serum uric acid, fasting plasma glucose, body weight, blood lipids and heart rate. After 12 weeks, dapagliflozin-treated versus placebo-treated patients showed significant reductions in HbA1c (-0.6% vs -0.1%, p < 0.0001), mean seated SBP (-10.4 vs -7.3 mmHg, p = 0.0010) and mean 24 h ambulatory SBP (-9.6 vs -6.7 mmHg, p = 0.0043). Dapagliflozin also reduced body weight compared with placebo (-1.0 vs -0.3 kg). Dapagliflozin was well tolerated, with adverse events consistent with previous studies. Dapagliflozin improved glycemic control, and reduced SBP as well as body weight in patients with poorly controlled T2DM and hypertension.
高血压和2型糖尿病(T2DM)是心血管疾病的危险因素。达格列净可改善T2DM患者的血糖控制和收缩压(SBP)。这项双盲III期研究评估了达格列净对尽管正在接受肾素-血管紧张素系统阻滞剂治疗但血糖控制不佳和患有高血压的患者的血糖控制和血压的影响。患者被随机分配接受每日一次10mg达格列净(n = 302)或安慰剂(n = 311),持续12周。终点指标为坐位SBP和糖化血红蛋白(HbA1c)从基线到第12周的变化;进行纵向重复测量分析。其他终点指标包括其他血流动力学指标、血清尿酸、空腹血糖、体重、血脂和心率。12周后,接受达格列净治疗的患者与接受安慰剂治疗的患者相比,HbA1c显著降低(-0.6%对-0.1%,p < 0.0001),平均坐位SBP显著降低(-10.4对-7.3mmHg,p = 0.0010),平均24小时动态SBP显著降低(-9.6对-6.7mmHg,p = 0.0043)。与安慰剂相比,达格列净还减轻了体重(-1.0对-0.3kg)。达格列净耐受性良好,不良事件与先前研究一致。达格列净改善了血糖控制不佳且患有高血压的患者的血糖控制,降低了SBP和体重。