RESUMEN
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).
Asunto(s)
Angina Estable/terapia , Enfermedad de la Arteria Coronaria/terapia , Endotelio Vascular/efectos de los fármacos , Molsidomina/uso terapéutico , Donantes de Óxido Nítrico/uso terapéutico , Intervención Coronaria Percutánea , Vasodilatación/efectos de los fármacos , Vasodilatadores/uso terapéutico , Anciano , Angina Estable/sangre , Angina Estable/diagnóstico , Angina Estable/fisiopatología , Bélgica , Biomarcadores/sangre , Terapia Combinada , Enfermedad de la Arteria Coronaria/sangre , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/fisiopatología , Método Doble Ciego , Endotelio Vascular/metabolismo , Endotelio Vascular/fisiopatología , Femenino , Humanos , Molécula 1 de Adhesión Intercelular/sangre , Masculino , Manometría , Persona de Mediana Edad , Molsidomina/efectos adversos , Donantes de Óxido Nítrico/efectos adversos , Intervención Coronaria Percutánea/efectos adversos , Peroxidasa/sangre , Factores de Tiempo , Resultado del Tratamiento , Vasodilatadores/efectos adversosRESUMEN
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.
Asunto(s)
Angina Estable/terapia , Vasos Coronarios/efectos de los fármacos , Endotelio Vascular/efectos de los fármacos , Molsidomina/uso terapéutico , Donantes de Óxido Nítrico/uso terapéutico , Intervención Coronaria Percutánea , Proyectos de Investigación , Angina Estable/diagnóstico , Angina Estable/fisiopatología , Bélgica , Protocolos Clínicos , Vasos Coronarios/fisiopatología , Método Doble Ciego , Quimioterapia Combinada , Endotelio Vascular/fisiopatología , Humanos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Proyectos Piloto , Stents , Factores de Tiempo , Resultado del TratamientoRESUMEN
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.