Okamura Keisuke, Shirai Kazuyuki, Miyazaki Motoyasu, Okuda Tetsu, Takamiya Yosuke, Goto Miwa, Urata Hidenori
Department of Cardiovascular Diseases, Fukuoka University Chikushi Hospital, Chikushino, Japan.
Department of Pharmacy, Fukuoka University Chikushi Hospital, Chikushino, Japan.
J Clin Med Res. 2019 Feb;11(2):89-97. doi: 10.14740/jocmr3558. Epub 2019 Jan 5.
One of the treatment options for type 2 diabetes mellitus (DM) is a combination drug (CD) that contains the dipeptidyl peptidase-4 inhibitor (DPP4I) alogliptin (AG) together with pioglitazone (PG). This CD can improve impaired insulin secretion and insulin resistance, which are the two major pathologic factors for type 2 DM, and is also expected to increase adherence to treatment. We conducted a multicenter open-label prospective study to examine the usefulness of this CD for routine management of type 2 DM.
In type 2 DM patients with poor glycemic control who had been taking a DPP4I for ≥ 1 month, PG (15 mg/day) was added (first point). When the safety of PG was confirmed after 1 - 3 months, the DPP4I and PG were switched to the CD containing AG (25 mg) and PG (15 mg) (second point). Three months after switching to the CD was defined as the final point. Evaluation of objective findings, laboratory test results, and medication adherence was performed at these three points.
Nineteen subjects completed the study, but this was far short of the target (160 subjects). Compared to the first point, white blood cell count (WBC), aspartate aminotransferase (AST), alanine aminotransferase (ALT), γ-glutamyl transpeptidase (γ-GTP), and fasting blood glucose (FBG) all showed a significant decrease at both the second and final points. No change in medication adherence was observed throughout the study period. The most notable point about this study was the extremely small number of subjects enrolled. As a possible explanation, we considered whether the preferences of the study doctors for antidiabetic drugs differed between specialties. The study doctors were mainly gastroenterologists, followed by endocrinologists/diabetologists and cardiologists in equal numbers. As an additional investigation, we determined the percentages of specialist doctors prescribing DPP4Is, sodium-glucose cotransporter-2 inhibitors (SGLT2Is), PG, or biguanides (BGs) as the main treatment for DM in 1 month at our hospital. We found that a low percentage of endocrinologists/diabetologists prescribing PG compared to other drugs, while cardiologists prescribed PG frequently.
It was confirmed that the combination of DPP4I with PG was effective for the treatment of type 2 DM and improving metabolic function. Our data also showed that prescription of antidiabetic drugs differed between specialties, suggesting differences in their response to the results of various clinical studies and adverse reaction reports.
2型糖尿病（DM）的治疗选择之一是一种复方药物（CD），它含有二肽基肽酶-4抑制剂（DPP4I）阿格列汀（AG）和吡格列酮（PG）。这种复方药物可以改善胰岛素分泌受损和胰岛素抵抗，这是2型糖尿病的两个主要病理因素，并且有望提高治疗依从性。我们进行了一项多中心开放标签前瞻性研究，以检验这种复方药物用于2型糖尿病常规管理的有效性。
在血糖控制不佳且已服用DPP4I≥1个月的2型糖尿病患者中，添加PG（15毫克/天）（第一阶段）。在1 - 3个月确认PG的安全性后，将DPP4I和PG换成含有AG（25毫克）和PG（15毫克）的复方药物（第二阶段）。换成复方药物3个月后定义为最后阶段。在这三个阶段对客观检查结果、实验室检测结果和用药依从性进行评估。
19名受试者完成了研究，但这远低于目标人数（160名受试者）。与第一阶段相比，白细胞计数（WBC）、天冬氨酸转氨酶（AST）、丙氨酸转氨酶（ALT）、γ-谷氨酰转肽酶（γ-GTP）和空腹血糖（FBG）在第二阶段和最后阶段均显著下降。在整个研究期间未观察到用药依从性的变化。这项研究最显著的一点是入组的受试者数量极少。作为一种可能的解释，我们考虑了研究医生对抗糖尿病药物的偏好是否因专业不同而有所差异。研究医生主要是胃肠病学家，其次是内分泌科医生/糖尿病专家和心脏病专家，人数相当。作为一项补充调查，我们确定了我院专科医生在1个月内将DPP4I、钠-葡萄糖协同转运蛋白-2抑制剂（SGLT2Is）、PG或双胍类药物（BGs）作为糖尿病主要治疗药物的处方百分比。我们发现，与其他药物相比，内分泌科医生/糖尿病专家开具PG处方的比例较低，而心脏病专家经常开具PG处方。
证实了DPP4I与PG联合使用对治疗2型糖尿病和改善代谢功能有效。我们的数据还表明，不同专业的抗糖尿病药物处方存在差异，这表明他们对各种临床研究结果和不良反应报告的反应存在差异。
