Fascinating data from Moscow and Germany in this month’s Diabetes Care:
Treatment of Symptomatic Polyneuropathy with Actovegin in Type 2 Diabetic Patients.
Objective: To evaluate the efficacy and safety of Actovegin in patients with diabetic polyneuropathy. Research design and methods: In this multicenter, randomized, double-blind trial, 567 patients with type 2 diabetes received 20 IV infusions of Actovegin (2000 mg/day) (n=281) or placebo (n=286) once daily followed by three tablets of Actovegin (1800 mg/day) or placebo three times daily for 140 days. Total Symptom Score (TSS) of the lower limbs and vibration perception threshold (VPT) were used as co-primary outcome measures, computed as the area under the curve (AUC) from repeated scores and divided by duration of exposure. Secondary endpoints included individual TSS symptoms, Neuropathy Impairment Score of the Lower Limbs (NIS-LL), and quality of life (SF-36). Results: TSS was significantly improved during Actovegin treatment compared with placebo as assessed by AUC (-0.56 points, 95% CI: -0.85, -0.27;p=0.0003) and from baseline to 160 days (-0.86 points, 95% CI: -1.22, -0.50;p