Evaluation of clinical activity and safety of Daflon 500 mg in type 2 diabetic female patients.

BACKGROUND The incidence of cardiovascular disease in patients with type 2 diabetes mellitus is approximately twice as high as in the non-diabetic population. AIM To investigate the hypoglycemic and hypocholesterolemic effects of Daflon(®) 500 mg (DF) administration together with its tolerability and efficacy in reducing the cardiovascular metabolic risk factors in female patients with type 2 diabetes. METHODS In a well-adequate controlled single-blinded randomized parallel design the tolerability and the efficacy of Daflon(®) (500 mg) either alone or with oral hypoglycemic, twice daily for 45 days, was studied in 36 female patients with type 2 diabetes. RESULTS None of the patients in the studied groups were reported to have any adverse events throughout the treatment period (45 days), liver and kidney function tests were within normal limits and there was no significant difference between the pre-treatment (day 0) and post-treatment (day 45) values. Female patients receiving Daflon(®) either alone or with oral hypoglycemic showed significant decrease in serum glucose; fructosamine; total cholesterol; LDL-cholesterol; triglycerides; malondialdehydes (as index of lipid peroxidation) and C-reactive protein (CRB) levels along with increase in the levels of nitric oxide and blood glutathione. CONCLUSION This study has shown that Daflon(®) (500 mg, twice daily for 45 days) is helpful in reducing glucose level and the risk of cardiovascular disease in type 2 diabetic patients. RECOMMENDATION Further clinical trials are essential for strengthening the evidence base on the role of this drug in the cardiovascular risk in diabetic patients.