Effect of ranolazine on A1C and glucose levels in hyperglycemic patients with non-ST elevation acute coronary syndrome.

Effect of ranolazine on A1C and glucose levels in hyperglycemic patients with non-ST elevation acute coronary syndrome.
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DOI:
10.2337/dc09-2334
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发表时间:
2010-06
期刊:
影响因子:
16.2
通讯作者:
Belardinelli L
Belardinelli L
中科院分区:
医学1区
文献类型:
--
作者:
Chisholm JW;Goldfine AB;Dhalla AK;Braunwald E;Morrow DA;Karwatowska-Prokopczuk E;Belardinelli L

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在MERLIN-TIMI-36(MERLIN)研究中,我们确定了接受糖尿病标准治疗并随机接受雷诺嗪或安慰剂治疗的糖尿病患者随机分组时的A1 C、合并降糖治疗与A1 C和空腹血糖(FPG)变化之间的关系。雷诺嗪是一种新药,首次被批准用于治疗心绞痛。使用Spotfire和SAS 9.1版软件分析MERLIN的随机化和4个月血糖和降糖药物使用数据。在随机化时A1 C ≥8-10%的糖尿病患者中(n = 171),雷诺嗪组A1 C绝对降低1.2%(95%CI −1.4至−1.0),雷诺嗪组安慰剂校正后(n = 182)A1 C降低0.59%(95%CI −0.99至−0.20,P < 0.001)。在随机分组时FPG为150-400 mg/dl的患者中,雷诺嗪(n = 131)与安慰剂(n = 147)相比使FPG降低25.7 mg/dl(95% CI-43.3至-8.1,P = 0.001)。当A1 C或FPG的变化与随机化时的A1 C或FPG相关时,雷诺嗪组的斜率显著大于安慰剂组(A1 C,P = 0.046; FPG,P < 0.001),表明雷诺嗪降低A1 C和FPG与随机化时的高血糖相关。与安慰剂相比,雷诺嗪与严重的低血糖事件无关,与同时抗糖尿病治疗的显著变化无关,或依赖于心绞痛病史。雷诺嗪,当添加到同时抗糖尿病治疗,降低FPG和A1 C的心血管疾病和控制不佳的糖尿病患者。
We determined the relationships between glycemia at randomization, concurrent antidiabetic therapy, and change in A1C and fasting plasma glucose (FPG) in patients with diabetes receiving standard treatment for diabetes and randomized to ranolazine or placebo within the MERLIN-TIMI-36 (MERLIN) study. Ranolazine is a novel first-in-class drug approved for treating angina pectoris. Randomization and 4-month glycemic and antidiabetes drug usage data from MERLIN were analyzed using Spotfire and SAS version 9.1 software. In patients with diabetes and A1C of ≥8–10% at randomization (n = 171), there was an absolute A1C reduction in the ranolazine group of 1.2% (95% CI −1.4 to −1.0), and the placebo-adjusted (n = 182) decrease in A1C by ranolazine was 0.59% (95% CI −0.99 to −0.20, P < 0.001). In patients with FPG of 150–400 mg/dl at randomization, ranolazine (n = 131) compared with placebo (n = 147) reduced FPG by 25.7 mg/dl (95% CI −43.3 to −8.1, P = 0.001). When changes in either A1C or FPG were correlated to A1C or FPG at randomization, the slopes were significantly steeper for ranolazine than placebo (A1C, P = 0.046; FPG, P < 0.001), indicating that lowering of A1C and FPG by ranolazine is related to hyperglycemia at randomization. Ranolazine, compared with placebo, was not associated with serious hypoglycemic events, associated with significant changes in concurrent antidiabetic therapy, or dependent on a history of angina. Ranolazine, when added to concurrent antidiabetes treatment, lowers FPG and A1C in patients with cardiovascular disease and poorly controlled diabetes.
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