Cilostazol: a pilot study on safety and clinical efficacy in neuropathies of diabetes mellitus type 2 (ASCEND).

BACKGROUND

Diabetic polyneuropathy may have vascular and metabolic components in its pathophysiologic mechanism. Cilostazol, aside from its antiplatelet and vasodilatory properties, may increase nerve blood flow and potentially improve neuropathy.

OBJECTIVE

To assess the efficacy and safety of cilostazol in diabetic polyneuropathy.

METHODS

Forty-seven diabetic patients were randomized into placebo, low-dose (100 mg/d), and high-dose (200 mg/d) cilostazol groups. Primary efficacy parameter was a change in neuropathy symptom scores and secondary efficacy parameter was a change in walking speed from baseline to week 12. Safety parameters were changes in nerve conduction studies as well as reporting of adverse events.

RESULTS/CONCLUSION: Despite significant improvement in the neuropathy symptom scores in the overall motor and sensory categories of the 3 arms of the study from baseline to week 12, no significant differences were found among the groups, indicating nonsuperiority of cilostazol in regard to improvement of neuropathy symptoms over the short study span. However, cilostazol, at low dose, was effective in improving walking speed from baseline to week 12, implying an improved blood flow. No significant worsening nor improvement in motor and sensory nerve conduction parameters were observed, comparing the 3 study arms from baseline to weeks 4, 12, and 16, supporting cilostazol's safety. Overall, the adverse events of the 3 study arms did not significantly differ, and neither were there serious adverse events reported, also signifying safety and tolerability in our Filipino cohort of patients with neuropathy in diabetes mellitus treated with cilostazol.