Human Genome Centre, School of Medical Sciences, Universiti Sains Malaysia, 16150, Kubang Kerian, Kelantan, Malaysia.
Department of Haematology, School of Medical Sciences, Universiti Sains Malaysia, 16150, Kubang Kerian, Kelantan, Malaysia.
Sci Rep. 2019 Mar 29;9(1):5389. doi: 10.1038/s41598-019-41854-2.
Pioglitazone, the only thiazolidinedione drug in clinical practice is under scrutiny due to reported adverse effects, it's unique insulin sensitising action provides rationale to remain as a therapeutic option for managing type 2 diabetes mellitus (T2DM). We conducted a systematic review and meta-analysis comparing pioglitazone monotherapy with monotherapies of other oral antidiabetic drugs for assessing its efficacy and safety in T2DM patients. Mean changes in glycated haemoglobin (HbA1c), and mean changes in fasting blood sugar (FBS) level, body weight (BW) and homeostasis model assessment-insulin resistance (HOMA-IR) were primary and secondary outcomes, respectively. Safety outcomes were changes in lipid parameters, blood pressure and incidences of adverse events. Metafor package of R software and RevMan software based on random-effects model were used for analyses. We included 16 randomised controlled trials. Pioglitazone monotherapy showed equivalent efficacy as comparators in reducing HbA1c by 0.05% (95% CI: -0.21 to 0.11) and greater efficacy in reducing FBS level by 0.24 mmol/l (95% CI: -0.48 to -0.01). Pioglitazone showed similar efficacy as comparators in reducing HOMA-IR (WMD: 0.05, 95% CI: -0.49 to 0.59) and increasing high-density lipoprotein level (WMD: 0.02 mmol/l, 95% CI: -0.06 to 0.10). Improved blood pressure (WMD: -1.05 mmHg, 95% CI: -4.29 to 2.19) and triglycerides level (WMD: -0.71 mmol/l, 95% CI: -1.70 to 0.28) were also observed with pioglitazone monotherapy. There was a significant association of pioglitazone with increased BW (WMD: 2.06 kg, 95% CI: 1.11 to 3.01) and risk of oedema (RR: 2.21, 95% CI: 1.48 to 3.31), though the risk of hypoglycaemia was absolutely lower (RR: 0.51, 95% CI: 0.33 to 0.80). Meta-analysis supported pioglitazone as an effective treatment option for T2DM patients to ameliorate hyperglycaemia, adverse lipid metabolism and blood pressure. Pioglitazone is suggested to prescribe following individual patient's needs. It can be a choice of drug for insulin resistant T2DM patients having dyslipidaemia, hypertension or history of cardiovascular disease.
吡格列酮是唯一一种在临床实践中应用的噻唑烷二酮类药物，由于其报道的不良反应，目前正受到审查，其独特的胰岛素增敏作用使其成为治疗 2 型糖尿病（T2DM）的一种治疗选择。我们进行了一项系统评价和荟萃分析，比较了吡格列酮单药治疗与其他口服降糖药物单药治疗 T2DM 患者的疗效和安全性。糖化血红蛋白（HbA1c）的平均变化和空腹血糖（FBS）水平、体重（BW）和稳态模型评估-胰岛素抵抗（HOMA-IR）的平均变化分别为主要和次要结局。安全性结局为血脂参数、血压和不良事件发生率的变化。使用 R 软件的 Metafor 包和基于随机效应模型的 RevMan 软件进行分析。我们纳入了 16 项随机对照试验。吡格列酮单药治疗在降低 HbA1c 方面与对照药物等效，降低 0.05%（95%CI：-0.21 至 0.11），在降低 FBS 水平方面更有效，降低 0.24mmol/l（95%CI：-0.48 至 -0.01）。吡格列酮在降低 HOMA-IR（WMD：0.05，95%CI：-0.49 至 0.59）和增加高密度脂蛋白水平（WMD：0.02mmol/l，95%CI：-0.06 至 0.10）方面与对照药物疗效相似。吡格列酮单药治疗还可改善血压（WMD：-1.05mmHg，95%CI：-4.29 至 2.19）和甘油三酯水平（WMD：-0.71mmol/l，95%CI：-1.70 至 0.28）。尽管低血糖风险绝对较低（RR：0.51，95%CI：0.33 至 0.80），但吡格列酮与 BW 增加（WMD：2.06kg，95%CI：1.11 至 3.01）和水肿风险增加（RR：2.21，95%CI：1.48 至 3.31）显著相关。荟萃分析支持吡格列酮作为 T2DM 患者改善高血糖、不良脂质代谢和血压的有效治疗选择。建议根据个体患者的需要开具吡格列酮。对于伴有血脂异常、高血压或心血管疾病史的胰岛素抵抗 T2DM 患者，它可以作为一种药物选择。
