OBJECTIVE: To assess the effect of ranolazine on systemic vascular function in patients with type II diabetes mellitus (T2DM). METHODS: We randomized 30 consecutive T2DM patients with no evidence of cardiovascular disease and no insulin therapy to receive one of the following 3 forms of treatment in a blinded fashion: ranolazine, 375 mg bid for 3 weeks (group 1); ranolazine, 375 mg bid for 2 weeks, followed by placebo bid for 1 week (group 2); placebo bid for 3 weeks (group 3). Flow-mediated dilation (FMD) and nitrate-mediated dilation (NMD) of the right brachial artery were assessed at baseline and after 48 h, and 2 and 3 weeks. RESULTS:FMD and NMD were similar among groups at baseline. Compared to the basal value, FMD significantly improved after 2 weeks in group 1 and in group 2 (p < 0.01 for both), but not in group 3. At 3 weeks, FMD remained improved, compared to baseline, in group 1 (p < 0.05), whereas returned to basal values in group 2 (p = 0.89 vs. baseline). No changes in NMD were observed in any group. CONCLUSIONS: In this controlled study, ranolazine was able to improve endothelial function in T2DM patients.
RCT Entities:
OBJECTIVE: To assess the effect of ranolazine on systemic vascular function in patients with type II diabetes mellitus (T2DM). METHODS: We randomized 30 consecutive T2DM patients with no evidence of cardiovascular disease and no insulin therapy to receive one of the following 3 forms of treatment in a blinded fashion: ranolazine, 375 mg bid for 3 weeks (group 1); ranolazine, 375 mg bid for 2 weeks, followed by placebo bid for 1 week (group 2); placebo bid for 3 weeks (group 3). Flow-mediated dilation (FMD) and nitrate-mediated dilation (NMD) of the right brachial artery were assessed at baseline and after 48 h, and 2 and 3 weeks. RESULTS:FMD and NMD were similar among groups at baseline. Compared to the basal value, FMD significantly improved after 2 weeks in group 1 and in group 2 (p < 0.01 for both), but not in group 3. At 3 weeks, FMD remained improved, compared to baseline, in group 1 (p < 0.05), whereas returned to basal values in group 2 (p = 0.89 vs. baseline). No changes in NMD were observed in any group. CONCLUSIONS: In this controlled study, ranolazine was able to improve endothelial function in T2DM patients.