Philip Elizabeth, Sundaram Meenakshi L, Das Rupam, Chauhan Sushil Kumar, Deshpande Sandeep, Ambhore Sanjay, Rathod Rahul, Manjrekar Pravin
Kuringi Hospital, Coimbatore, India.
LM Medical Centre, Chennai, Tamil Nadu, India.
Indian J Endocrinol Metab. 2013 Dec;17(Suppl 3):S674-9. doi: 10.4103/2230-8210.123565.
To investigate the efficacy and tolerability of the anti-diabetic agent acarbose (Glucobay(®)) as add-on or monotherapy in a range of patients with type-2 diabetes mellitus (T2DM), including those with cardiovascular morbidities in India.
This was a part of a prospective, non-interventional, non-controlled, multicentre, multinational, observational study. The study included patients of either gender if they were aged at least 18 years and had untreated or pre-treated type-2 diabetes mellitus (T2DM) or impaired glucose tolerance and no acarbose treatment within the 3 months before study inclusion.
In total, 1996 Indian patients were included in the effectiveness and 2010 in the safety analysis. Patients received acarbose (25-150 mg/day). The mean age of the patients was 50.1 years and the mean BMI was 27.2 kg/m(2). Mean 2-h post-prandial plasma glucose (PPG) value and fasting blood glucose (FBG) decreased from 243.9 to 169.5 mg/dl and 158.3 to 120.4 mg/dl, respectively after the last follow-up of 12.4 weeks. The mean HbA1c value at initial visit was 8.4% and was 7.4% at the last follow-up visit. FBG, PPG and HbA1c deceased in 90.6%, 94.4% and 52.4% patients respectively, by the last follow-up visit. The mean decrease in weight and waist circumference was 1.4 kg and 1.6 cm, respectively by the last follow-up visit. Physicians assessed the efficacy of drug as positive response in "very good to good" in 91.08%, "sufficient" in 7.92% and "insufficient" in 0.90% of patients. Also, continuation of Acarbose was reported in 97.09% of patients. Adverse events were reported in 2.74% and drug-related adverse events were reported in 2.19% of patients. Majority of them were gastrointestinal adverse events but were not serious.
Acarbose is effective and safe in Indian patients with T2DM. Further, it helps in weight reduction and has very good compliance in patients with T2DM.
研究抗糖尿病药物阿卡波糖（拜糖平®）作为二线治疗或一线治疗药物，在包括患有心血管疾病的各类2型糖尿病（T2DM）印度患者中的疗效和耐受性。
这是一项前瞻性、非干预性、非对照、多中心、跨国观察性研究的一部分。该研究纳入年龄至少18岁，患有未经治疗或经治疗的2型糖尿病（T2DM）或糖耐量受损，且在纳入研究前3个月内未接受过阿卡波糖治疗的任何性别患者。
有效性分析共纳入1996例印度患者，安全性分析纳入2010例。患者接受阿卡波糖治疗（25 - 150毫克/天）。患者的平均年龄为50.1岁，平均体重指数为27.2千克/平方米。在最后一次随访12.4周后，餐后2小时血浆葡萄糖（PPG）平均值和空腹血糖（FBG）分别从243.9降至169.5毫克/分升和从158.3降至120.4毫克/分升。初次就诊时的平均糖化血红蛋白（HbA1c）值为8.4%，最后一次随访时为7.4%。到最后一次随访时，空腹血糖、餐后2小时血糖和糖化血红蛋白分别在90.6%、94.4%和52.4%的患者中下降。到最后一次随访时，体重和腰围的平均下降分别为1.4千克和1.6厘米。医生评估药物疗效为“非常好到良好”的积极反应在91.08%的患者中，“足够”在7.92%的患者中，“不足”在0.90%的患者中。此外，97.09%的患者报告继续使用阿卡波糖。2.74%的患者报告了不良事件，2.19%的患者报告了与药物相关的不良事件。其中大多数是胃肠道不良事件，但并不严重。
阿卡波糖在印度2型糖尿病患者中有效且安全。此外，它有助于减轻体重，并且在2型糖尿病患者中具有很好的依从性。
