Predictors of Response to Treatment with Actovegin for 6 Months in Patients with Type 2 Diabetes and Symptomatic Polyneuropathy

Abstract Aims To evaluate two definitions of response and the predictive value of baseline covariates for response to actovegin treatment in type 2 diabetic patients with symptomatic diabetic sensorimotor polyneuropathy (DSPN). Methods Response to 6-months treatment with actovegin or placebo was defined as a clinically meaningful decline from baseline to 6 months in (1) both Neuropathy Impairment Score of Lower Limbs (NIS-LL) ≥ 2 points and Total Symptom Score (TSS) > 50% and (2) NIS-LL ≥ 2 points only. Nineteen baseline covariates were evaluated using separate logistic regression models and either both NIS-LL and TSS or NIS-LL response definitions. Results Intention-to-treat analysis included 567 patients. Actovegin treatment compared to placebo was associated with better odds of response (OR [95% CI] of 1.73 [1.21–2.48] for definition 1 and 1.94 [1.33–2.84] for definition 2). Significant interaction with actovegin treatment was noted only for baseline use of angiotensin receptor blockers (ARBs)/angiotensinogen converting enzyme inhibitors (ACEIs), resulting in a reduced treatment response (P = 0.03). Conclusions Actovegin treatment was associated with a clinically meaningful response in neuropathic symptoms and/or impairments in patients with symptomatic DSPN. Since only one predictor of response to actovegin treatment was identified, this drug seems an appropriate therapy for the majority of patients with DSPN.