Louisville Metabolic and Atherosclerosis Research Center, Louisville, Kentucky, USA.
Diabetes Metab Syndr Obes. 2012;5:125-34. doi: 10.2147/DMSO.S32018. Epub 2012 May 28.
To evaluate the long-term safety, tolerability, and efficacy of colesevelam HCl (colesevelam) in type 2 diabetes mellitus patients receiving metformin monotherapy or metformin combination therapy.
This post-hoc subgroup analysis examined data from type 2 diabetes mellitus patients aged 18 to 75 years with a hemoglobin A(1c) of 7.5% to 9.5%, who received metformin as part of their treatment via their participation in one of three randomized, double-blind base studies wherein colesevelam (3.75 g/day) or a placebo was added to existing metformin-, insulin-, or sulfonylurea-based treatment. After completing the base studies, the subjects who initially received blinded colesevelam (n = 196) or the placebo (n = 166) entered a 52-week extension study wherein they received open-label colesevelam (3.75 g/day).
This analysis describes the 362 patients receiving background metformin therapy who also received open-label colesevelam (3.75 g/day) during a 1-year extension study. From a safety perspective, hypoglycemia was reported by 11 patients (3.0%; none severe). Drug-related adverse events (AEs) occurred in 38 patients (10.5%). At least one serious AE occurred in 35 patients (9.7%), with only one being assessed by investigators as drug related (exacerbation of diverticulitis). Twenty-four patients (6.6%) discontinued open-label treatment because of an AE (10 due to a drug-related AE). Compared with baseline values obtained prior to the start of both the base and extension studies, colesevelam improved and maintained improvement in hemoglobin A(1c) and various lipid parameters.
This analysis found colesevelam to be generally safe and effective for long-term therapy in type 2 diabetes mellitus patients with inadequately controlled glucose while treated with metformin monotherapy or metformin combination therapy.
评估盐酸考来维仑（考来维仑）在接受二甲双胍单药或二甲双胍联合治疗的 2 型糖尿病患者中的长期安全性、耐受性和疗效。
本事后亚组分析检查了年龄在 18 至 75 岁之间、糖化血红蛋白（HbA1c）为 7.5%至 9.5%、接受二甲双胍治疗的 2 型糖尿病患者的数据，这些患者参与了三项随机、双盲基础研究中的一项，其中考来维仑（3.75 g/天）或安慰剂被添加到现有的二甲双胍、胰岛素或磺脲类药物治疗中。完成基础研究后，最初接受盲法考来维仑（n = 196）或安慰剂（n = 166）的受试者进入为期 52 周的扩展研究，在该研究中他们接受开放标签考来维仑（3.75 g/天）。
本分析描述了在为期 1 年的扩展研究中接受背景二甲双胍治疗并同时接受开放标签考来维仑（3.75 g/天）的 362 名患者。从安全性角度来看，有 11 名患者（3.0%；均不严重）报告发生低血糖。发生药物相关不良事件（AE）的有 38 名患者（10.5%）。至少发生一次严重 AE 的有 35 名患者（9.7%），只有 1 例被研究者评估为与药物相关（憩室炎恶化）。24 名患者（6.6%）因 AE（10 例因药物相关 AE）停止开放标签治疗。与基础研究开始前的基线值相比，考来维仑改善并维持了糖化血红蛋白（HbA1c）和各种血脂参数的改善。
本分析发现，对于接受二甲双胍单药或二甲双胍联合治疗血糖控制不佳的 2 型糖尿病患者，考来维仑长期治疗通常是安全有效的。
