Rosenstock J, Goldstein B J, Vinik A I, O'neill M Colleen, Porter L E, Heise M A, Kravitz B, Dirani R G, Freed M I
Dallas Diabetes and Endocrine Center, Dallas, TX 75230, USA.
Diabetes Obes Metab. 2006 Jan;8(1):49-57. doi: 10.1111/j.1463-1326.2005.00541.x.
To compare the efficacy, safety and tolerability of adding rosiglitazone (RSG) vs. sulphonylurea (SU) dose escalation in older type 2 diabetes mellitus (T2DM) patients inadequately controlled on SU therapy.
A total of 227 T2DM patients from 48 centres in the USA and Canada, aged > or =60 years, were randomized to receive RSG (4 mg) or placebo once daily in combination with glipizide 10 mg twice daily for 2 years in a double-blind, parallel-group study. Previous SU monotherapy was (1/4) to (1/2) maximum recommended dose for > or =2 months prior to screening with fasting plasma glucose (FPG) > or =7.0 and < or =13.9 mmol/l. Treatment options were individualized, and escalation of study medication was specifically defined.
Disease progression (time to reach confirmed FPG > or =10 mmol/l while on maximum doses of both glipizide and study medication or placebo) was reported in 28.7% of patients uptitrating SU plus placebo compared with only 2.0% taking RSG and SU combination (p < 0.0001). RSG + SU significantly decreased HbA(1c), FPG, insulin resistance, plasma free fatty acids and medical care utilization and improved treatment satisfaction compared with uptitrated SU.
Addition of RSG to SU in older T2DM patients significantly improved glycaemic control and reduced disease progression compared with uptitrated SU alone but without increasing hypoglycaemia. These benefits were associated with increased patient treatment satisfaction and reduced medical care utilization with regards to emergency room visits and length of hospitalization. Early addition of RSG is an effective treatment option for older T2DM patients inadequately controlled on submaximal SU monotherapy.
比较在接受磺脲类药物（SU）治疗但控制不佳的老年2型糖尿病（T2DM）患者中，加用罗格列酮（RSG）与增加SU剂量在疗效、安全性和耐受性方面的差异。
在美国和加拿大48个中心选取了227例年龄≥60岁的T2DM患者，在一项双盲、平行组研究中，随机分组，一组每日一次接受RSG（4毫克）或安慰剂，同时每日两次接受10毫克格列吡嗪，共治疗2年。在筛查前≥2个月，先前的SU单药治疗剂量为最大推荐剂量的（1/4）至（1/2），空腹血糖（FPG）≥7.0且≤13.9毫摩尔/升。治疗方案个体化，且明确规定了研究药物的剂量递增方式。
在增加SU剂量加用安慰剂的患者中，28.7%报告疾病进展（在格列吡嗪和研究药物或安慰剂最大剂量时达到确诊FPG≥10毫摩尔/升的时间），而接受RSG与SU联合治疗的患者中这一比例仅为2.0%（p<0.0001）。与增加SU剂量相比，RSG+SU显著降低糖化血红蛋白（HbA1c）、FPG、胰岛素抵抗、血浆游离脂肪酸水平，减少医疗保健利用，并提高治疗满意度。
在老年T2DM患者中，与单纯增加SU剂量相比，加用RSG可显著改善血糖控制，减少疾病进展，且不增加低血糖风险。这些益处与患者治疗满意度提高以及急诊就诊和住院时间方面的医疗保健利用减少相关。对于接受次最大剂量SU单药治疗控制不佳的老年T2DM患者，早期加用RSG是一种有效的治疗选择。
