Tanaka Atsushi, Komukai Sho, Shibata Yoshisato, Yokoi Hiroyoshi, Iwasaki Yoshihiro, Kawasaki Tomohiro, Horiuchi Kenji, Nakao Koichi, Ueno Takafumi, Nakashima Hitoshi, Tamashiro Masahiro, Hikichi Yutaka, Shimomura Mitsuhiro, Tago Motoko, Toyoda Shigeru, Inoue Teruo, Kawaguchi Atsushi, Node Koichi
Department of Cardiovascular Medicine, Saga University, 5-5-1 Nabeshima, Saga, Japan.
Clinical Research Center, Saga University Hospital, Saga, Japan.
Heart Vessels. 2018 Sep;33(9):965-977. doi: 10.1007/s00380-018-1143-3. Epub 2018 Feb 27.
Pioglitazone has superior antiatherosclerotic effects compared with other classes of antidiabetic agents, and there is substantial evidence that pioglitazone improves cardiovascular (CV) outcomes. However, there is also a potential risk of worsening heart failure (HF). Therefore, it is clinically important to determine whether pioglitazone is safe in patients with type 2 diabetes mellitus (T2DM) who require treatment for secondary prevention of CV disease, since they have an intrinsically higher risk of HF. This prospective, multicenter, open-label, randomized study investigated the effects of pioglitazone on cardiometabolic profiles and CV safety in T2DM patients undergoing elective percutaneous coronary intervention (PCI) using bare-metal stents or first-generation drug-eluting stents. A total of 94 eligible patients were randomly assigned to either a pioglitazone or conventional (control) group, and pioglitazone was started the day before PCI. Cardiometabolic profiles were evaluated before PCI and at primary follow-up coronary angiography (5-8 months). Pioglitazone treatment reduced HbA1c levels to a similar degree as conventional treatment (pioglitazone group 6.5 to 6.0%, P < 0.01; control group 6.5 to 5.9%, P < 0.001), without body weight gain. Levels of high-molecular weight adiponectin increased more in the pioglitazone group than the control group (P < 0.001), and the changes were irrespective of baseline glycemic control. Furthermore, pioglitazone significantly reduced plasma levels of natriuretic peptides and preserved cardiac systolic and diastolic function (assessed by echocardiography) without incident hospitalization for worsening HF. The incidence of clinical adverse events was also comparable between the groups. These results indicate that pioglitazone treatment before and after elective PCI may be tolerable and clinically safe and may improve cardiometabolic profiles in T2DM patients.
与其他类别的抗糖尿病药物相比，吡格列酮具有更优的抗动脉粥样硬化作用，并且有大量证据表明吡格列酮可改善心血管（CV）结局。然而，吡格列酮也存在使心力衰竭（HF）恶化的潜在风险。因此，对于需要进行心血管疾病二级预防治疗的2型糖尿病（T2DM）患者而言，确定吡格列酮是否安全具有重要的临床意义，因为这类患者本身发生HF的风险更高。这项前瞻性、多中心、开放标签、随机研究调查了吡格列酮对接受裸金属支架或第一代药物洗脱支架的择期经皮冠状动脉介入治疗（PCI）的T2DM患者心脏代谢指标和CV安全性的影响。总共94例符合条件的患者被随机分配至吡格列酮组或传统（对照）组，吡格列酮在PCI前一天开始使用。在PCI前以及首次随访冠状动脉造影（5 - 8个月）时评估心脏代谢指标。吡格列酮治疗使糖化血红蛋白（HbA1c）水平降低的程度与传统治疗相似（吡格列酮组从6.5%降至6.0%，P < 0.01；对照组从6.5%降至5.9%，P < 0.001），且未出现体重增加。吡格列酮组高分子量脂联素水平的升高幅度大于对照组（P < 0.001），且这些变化与基线血糖控制情况无关。此外，吡格列酮显著降低了利钠肽的血浆水平，并保留了心脏收缩和舒张功能（通过超声心动图评估），且未因HF恶化而发生住院事件。两组之间临床不良事件的发生率也相当。这些结果表明，择期PCI前后使用吡格列酮治疗可能是可耐受的且临床安全的，并且可能改善T2DM患者的心脏代谢指标。
