Rahman Sayeeda, Ismail Aziz Al-Shafi, Ismail Shaiful Bhari, Naing Nyi Nyi, Rahman Abdul Rashid Abdul
Department of Clinical Sciences, School of Life Sciences, University of Bradford, Bradford, UK.
Clin Pharmacol. 2010;2:83-7. doi: 10.2147/CPAA.S8863. Epub 2010 Apr 20.
The aim of the study is to investigate whether standard doses of rosiglitazone (4 mg/daily) and ramipril (5 mg/daily) can reverse pre-clinical macrovasculopathy in newly diagnosed never treated type 2 diabetes (T2DM) patients.
In this randomized, double-blind, placebo-controlled study, 33 T2DM patients were randomized to rosiglitazone (4 mg/daily) or ramipril (5 mg/daily) or placebo for 1 year. Hemodynamic variables were measured at 3 treatment phases and pulse wave velocity (PWV) and augmentation index (AI) were measured throughout the treatment period.
In diabetic patients, PWV (P = 0.037) and AI (P = 0.005) with ramipril and AI (P < 0.001) with rosiglitazone were significantly reduced during overall treatment period from the baseline; however, these differences were not significant in comparison to placebo.
The present study showed that treatment with standard doses of rosiglitazone and ramipril are not adequate to reverse pre-clinical vasculopathy in T2DM. The lack of benefit in newly diagnosed T2DM may be because of the relatively short-term intervention and/or the use of lower doses of rosiglitazone/ramipril. Further trials are needed for a longer period of time, possibly with higher doses, to show whether rosiglitazone/ramipril can reverse pre-clinical vasculopathy in T2DM (ClinicalTrials.gov number, NCT00489229).
本研究旨在调查标准剂量的罗格列酮（每日4毫克）和雷米普利（每日5毫克）能否逆转新诊断的未经治疗的2型糖尿病（T2DM）患者的临床前期大血管病变。
在这项随机、双盲、安慰剂对照研究中，33例T2DM患者被随机分为罗格列酮组（每日4毫克）、雷米普利组（每日5毫克）或安慰剂组，治疗1年。在3个治疗阶段测量血流动力学变量，并在整个治疗期间测量脉搏波速度（PWV）和增强指数（AI）。
在糖尿病患者中，在整个治疗期间，与基线相比，雷米普利治疗组的PWV（P = 0.037）和AI（P = 0.005）以及罗格列酮治疗组的AI（P < 0.001）显著降低；然而，与安慰剂相比，这些差异并不显著。
本研究表明，标准剂量的罗格列酮和雷米普利治疗不足以逆转T2DM患者的临床前期血管病变。新诊断的T2DM患者未获益处可能是由于干预时间相对较短和/或使用了较低剂量的罗格列酮/雷米普利。需要进行更长时间、可能更高剂量的进一步试验，以确定罗格列酮/雷米普利能否逆转T2DM患者的临床前期血管病变（ClinicalTrials.gov编号，NCT00489229）。
