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).
Subject(s)
Angina, Stable/therapy , Coronary Artery Disease/therapy , Endothelium, Vascular/drug effects , Molsidomine/therapeutic use , Nitric Oxide Donors/therapeutic use , Percutaneous Coronary Intervention , Vasodilation/drug effects , Vasodilator Agents/therapeutic use , Aged , Angina, Stable/blood , Angina, Stable/diagnosis , Angina, Stable/physiopathology , Belgium , Biomarkers/blood , Combined Modality Therapy , Coronary Artery Disease/blood , Coronary Artery Disease/diagnosis , Coronary Artery Disease/physiopathology , Double-Blind Method , Endothelium, Vascular/metabolism , Endothelium, Vascular/physiopathology , Female , Humans , Intercellular Adhesion Molecule-1/blood , Male , Manometry , Middle Aged , Molsidomine/adverse effects , Nitric Oxide Donors/adverse effects , Percutaneous Coronary Intervention/adverse effects , Peroxidase/blood , Time Factors , Treatment Outcome , Vasodilator Agents/adverse effectsABSTRACT
The effects of molsidomine (a direct nitric oxide donor) on the endothelial dysfunction have never been evaluated using reactive hyperemia peripheral arterial tonometry (RH-PAT). The objective of the MEDCOR double-blind trial will be to demonstrate the superiority of molsidomine (Coruno® 16 mg, once daily) over placebo, on improving the endothelial function (Endoscore by RH-PAT) after 12 months of treatment in stable angina patients undergoing elective percutaneous coronary intervention (PCI). Study design will take care of the real-life situation, in which patients are being offered PCI and stent placement (drug-eluting or bare metal), but also gold standard medical therapy (beta-blockers, statins, angiotensin-converting enzyme inhibitors (ACEIs), and/or calcium antagonists). Demonstrating clinical and statistical superiority of the study drug over placebo will be a real challenge. Therefore, a sequential approach has been designed with a pilot phase aiming at recruiting 50 patients. Upon evaluation of the results by an independent data steering committee, a larger sample size phase will eventually be considered.
Subject(s)
Angina, Stable/therapy , Coronary Vessels/drug effects , Endothelium, Vascular/drug effects , Molsidomine/therapeutic use , Nitric Oxide Donors/therapeutic use , Percutaneous Coronary Intervention , Research Design , Angina, Stable/diagnosis , Angina, Stable/physiopathology , Belgium , Clinical Protocols , Coronary Vessels/physiopathology , Double-Blind Method , Drug Therapy, Combination , Endothelium, Vascular/physiopathology , Humans , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/instrumentation , Pilot Projects , Stents , Time Factors , Treatment OutcomeABSTRACT
Porcine circovirus type 2 systemic infection was diagnosed in 2 slaughter-weight pigs based on postmortem examination. The infection was associated with unusual central nervous system lesions characterized by a multifocal lymphohistiocytic to granulomatous meningoencephalomyelitis with giant cell formation. The role of these nervous system lesions in the development of the clinical signs in these pigs remains uncertain.