Bhansali A, Masoodi S R
Department of Endocrinology and Metabolism, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
J Assoc Physicians India. 2005 May;53:441-5.
The extended-release formulation of metformin (MXR) prolongs drug absorption in the upper gastrointestinal tract and permits once-daily dosing in patients with type 2 diabetes mellitus (T2DM). This newer formulation may enhance patient compliance with oral therapy compared to conventional immediate-release metformin (MIR) in T2DM.
To analyse whether a switch from thrice daily MIR to once or twice daily MXR wouldachieve comparable degrees of glycemic control in patients with type 2 diabetes mellitus (T2DM).
We conducted an open study of the efficacy and tolerability of MXR in 40 patients with T2DM who had achieved moderate or good glycemic control with MIR alone or in combination with other antihyperglycemic agents. After a lead in period of 3 months patients were switched over to a specific brand of MIR at baseline (Visit 0). Patients were subsequently followed for 4 more visits. These visits were done monthly, after taking MIR in a dose of 1-2 g/day (Visit 1); MXR as a single dose at dinner but 0.5 g less than baseline dose of MIR (Visit 2); MXR, 1-2 g/day as a single dose at bedtime, with strength same as that of baseline dose of MIR (Visit 3); and MXR, 1-2 g/day in two divided doses keeping dose same as baseline MIR (Visit 4). Glycemic control was assessed by a four-point glucose profile (fasting and three postprandial levels) at each visit.
At visit 2, when patients had been on 500 mg lesser dose of MXR for 1 month, glucose profile worsened. However, glycemic control, at visit 3, returned to earlier levels when dose of MXR was increased back to original dose. Overall the MXR formulation was well tolerated with minor gastrointestinal adverse effects, reported by only 3 patients.
Patients with T2DM who had been receiving thrice-daily MIR achieved comparable glycemic control when therapy was switched to once- or twice-daily MXR at the same total daily dose.
二甲双胍缓释制剂(MXR)可延长药物在上消化道的吸收时间,并允许2型糖尿病(T2DM)患者每日给药一次。与传统的二甲双胍速释制剂(MIR)相比,这种新型制剂可能会提高T2DM患者口服治疗的依从性。
分析从每日三次MIR转换为每日一次或两次MXR是否能使2型糖尿病(T2DM)患者达到相当程度的血糖控制。
我们对40例T2DM患者进行了一项关于MXR疗效和耐受性的开放性研究,这些患者单独使用MIR或与其他降糖药物联合使用已实现中度或良好的血糖控制。在3个月的导入期后,患者在基线期(访视0)转换为特定品牌的MIR。随后对患者进行另外4次访视。这些访视每月进行一次,在服用1-2 g/天的MIR后(访视1);晚餐时服用单剂量MXR,但比MIR的基线剂量少0.5 g(访视2);睡前服用1-2 g/天的单剂量MXR,强度与MIR的基线剂量相同(访视3);以及分两次服用1-2 g/天的MXR,剂量与基线MIR相同(访视4)。每次访视时通过四点血糖谱(空腹和三个餐后水平)评估血糖控制情况。
在访视2时,患者服用剂量比MXR少500 mg达1个月,血糖谱恶化。然而,在访视3时,当MXR剂量增加回到原始剂量时,血糖控制恢复到早期水平。总体而言,MXR制剂耐受性良好,只有3例患者报告有轻微胃肠道不良反应。
接受每日三次MIR治疗的T2DM患者,当治疗转换为每日一次或两次、总日剂量相同 的MXR时,可实现相当的血糖控制。