Effect of rosiglitazone/ramipril on preclinical vasculopathy in newly diagnosed, untreated diabetes and IGT patients: 1-year randomised, double-blind, placebo-controlled study

Eur J Clin Pharmacol. 2007 Aug;63(8):733-41. doi: 10.1007/s00228-007-0315-3. Epub 2007 Jun 13.

Abstract

Objective: To investigate whether pharmacological interventions with rosiglitazone/ramipril can reverse preclinical vasculopathy in newly diagnosed untreated patients with type 2 diabetes (T2DM) and impaired glucose tolerance (IGT).

Methods: In this randomised, double-blind, placebo-controlled study, 33 T2DM and 33 IGT patients were randomised to 4 mg rosiglitazone or 5 mg ramipril or placebo for 1 year. The subjects were newly diagnosed, untreated, normotensive, nonobese, nonsmoker, and nonhyperlipidaemic. Haemodynamic variables were measured at three treatment phases and pulse wave velocity (PWV) and augmentation index (AI) were measured throughout the treatment period.

Results: Rosiglitazone showed a significant reduction in PWV (p=0.039) and AI (p=0.031) and ramipril demonstrated a significant reduction of AI (p=0.025) in IGT in comparison to placebo on the 12th month of treatment. No significant difference was observed in PWV and AI in T2DM with rosiglitazone/ramipril in comparison to placebo during overall treatment period.

Conclusions: Rosiglitazone significantly reversed preclinical vasculopathy in IGT as evident by significant decrease in PWV and AI after 1 year of treatment. Ramipril also reduced large artery stiffness as shown by significant decrease of AI after 1 year of treatment in IGT. Further trials are needed for a longer period of time, maybe with higher doses, to show whether rosiglitazone/ramipril can reverse preclinical vasculopathy in T2DM.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Angiotensin-Converting Enzyme Inhibitors / administration & dosage
  • Angiotensin-Converting Enzyme Inhibitors / pharmacology
  • Angiotensin-Converting Enzyme Inhibitors / therapeutic use*
  • Arteries / drug effects
  • Arteries / physiopathology
  • Diabetes Mellitus, Type 2 / complications
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetic Angiopathies / drug therapy
  • Diabetic Angiopathies / etiology
  • Diabetic Angiopathies / physiopathology
  • Double-Blind Method
  • Glucose Intolerance / complications
  • Glucose Intolerance / drug therapy*
  • Humans
  • Hypoglycemic Agents / administration & dosage
  • Hypoglycemic Agents / pharmacology
  • Hypoglycemic Agents / therapeutic use*
  • Middle Aged
  • Pulsatile Flow / drug effects
  • Ramipril / administration & dosage
  • Ramipril / pharmacology
  • Ramipril / therapeutic use*
  • Rosiglitazone
  • Stroke Volume
  • Thiazolidinediones / administration & dosage
  • Thiazolidinediones / pharmacology
  • Thiazolidinediones / therapeutic use*
  • Vascular Diseases / drug therapy*
  • Vascular Diseases / etiology

Substances

  • Angiotensin-Converting Enzyme Inhibitors
  • Hypoglycemic Agents
  • Thiazolidinediones
  • Rosiglitazone
  • Ramipril