Long-term effect of molsidomine, a direct nitric oxide donor, as an add-on treatment, on endothelial dysfunction in patients with stable angina pectoris undergoing percutaneous coronary intervention: results of the MEDCOR trial

Atherosclerosis. 2015 Jun;240(2):351-4. doi: 10.1016/j.atherosclerosis.2015.03.045. Epub 2015 Apr 7.

Abstract

Objective: The MEDCOR trial is a double-blind, randomized study aiming at demonstrating the superiority of molsidomine (direct NO donor) over placebo, used as add-on treatments, on improving endothelial function (EF) after 12 months, in stable angina patients undergoing percutaneous coronary intervention.

Methods: EF was assessed by peripheral vasodilator response (i.e. Endoscore) using arterial tonometry and by several biomarkers, in terms of changes versus baseline after a one-year treatment.

Results: The change in Endoscore was +75 ± 130% in placebo group and +39 ± 145% in molsidomine group (p = 0.143). There was a decrease in sICAM-1 with molsidomine (-6%) and an increase with placebo (+6%). The MPO activity/antigen ratio slightly increased with placebo (+9%) and strongly decreased with molsidomine (-42%) (p = 0.020).

Conclusion: The MEDCOR trial was not able to demonstrate significant differences between molsidomine and placebo for all parameters, except the MPO activity/antigen ratio which significantly decreased with molsidomine (p = 0.020 versus placebo).

Trial registration: ClinicalTrials.gov NCT01363661.

Keywords: Atherosclerosis; Biomarkers; Molsidomine; Nitric oxide donor; Percutaneous coronary intervention; Reactive hyperemia-peripheral arterial tonometry; Stable angina.

Publication types

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

MeSH terms

  • Aged
  • Angina, Stable / blood
  • Angina, Stable / diagnosis
  • Angina, Stable / physiopathology
  • Angina, Stable / therapy*
  • Belgium
  • Biomarkers / blood
  • Combined Modality Therapy
  • Coronary Artery Disease / blood
  • Coronary Artery Disease / diagnosis
  • Coronary Artery Disease / physiopathology
  • Coronary Artery Disease / therapy*
  • Double-Blind Method
  • Endothelium, Vascular / drug effects*
  • Endothelium, Vascular / metabolism
  • Endothelium, Vascular / physiopathology
  • Female
  • Humans
  • Intercellular Adhesion Molecule-1 / blood
  • Male
  • Manometry
  • Middle Aged
  • Molsidomine / adverse effects
  • Molsidomine / therapeutic use*
  • Nitric Oxide Donors / adverse effects
  • Nitric Oxide Donors / therapeutic use*
  • Percutaneous Coronary Intervention* / adverse effects
  • Peroxidase / blood
  • Time Factors
  • Treatment Outcome
  • Vasodilation / drug effects*
  • Vasodilator Agents / adverse effects
  • Vasodilator Agents / therapeutic use*

Substances

  • Biomarkers
  • ICAM1 protein, human
  • Nitric Oxide Donors
  • Vasodilator Agents
  • Intercellular Adhesion Molecule-1
  • Molsidomine
  • Peroxidase

Associated data

  • ClinicalTrials.gov/NCT01363661