In type 2 diabetes (T2DM), cardiomiopathy is characterized by an impairment of diastolic performance resulting in ventricular hypertrophy and dilatation. Heart remodelling leads to an increase in its angle of torsion, measurable by innovative cine-magnetic resonance imaging (MRI). To evaluate the impact of phosphodiesterase 5 inhibitors (PDE5i) on cardiovascular performance in T2DM, we designed a randomized, placebo-controlled, double blind (subject/outcome assessor) study on chronic treatment (3 months) with high dose of Sildenafil (100 mg/in 3 daily doses). The study has been registered at US NIH clinicaltrial.gov (identifier NCT00692237). We have enrolled 50 diabetic men (3575 years), metabolically controlled; 27 subjects have already ended the study; 2 patients drop out the study (1 for dyspepsia, 1 for non-compliance). Safety monitoring was taken monthly at follow-up visits. Primary outcome is the analysis of left ventricular torsion (cineMRI). Secondary outcomes reveals: (1) a significant improvement of heart remodelling parameter: end diastolic volume, ejection fraction and hypocynetic areas. (2) A significant improvement of cardiovascular risk parameters: reduction of post prandial glycemia from 178±49 to 156±48; HbA1c from 7.8±1 to 7.1±0.9; waist to hip ratio and increase of HDL cholesterol from 39±7 to 43±9. (3) A significant reduction of P selectina on activated plateletmonocytes interaction (cytofluorometry), involved in atheromatous process. 4) A significant reduction of systolic (136±12 to 131±12) and diastolic blood pressure (78±9 to 76±7) (Holter 24 h). Our study documents the safety of prolonged chronic sildenafil treatment on the adaptative endothelial changes affecting cardiovascular response in T2DM.
25 - 29 Apr 2009
European Society of Endocrinology