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 def...

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Bibliographic Details
Published in:Journal of diabetes and its complications 2017-07, Vol.31 (7), p.1181-1187
Main Authors: Ziegler, Dan, Edmundson, Sally, Gurieva, Irina, Mankovsky, Boris, Papanas, Nikolaos, Strokov, Igor
Format: Article
Language:English
Subjects:
Actovegin
Clinical trials
Diabetes
Diabetic neuropathy
Diabetic polyneuropathy
Drug therapy
Endocrinology & Metabolism
Foot diseases
Glucose
Hypertension
Metabolism
Neuropathic impairments
Neuropathic symptoms
Pain
Peptides
Predictors of treatment
Quality of life
Statistical analysis
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Summary: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.
ISSN:1056-8727
1873-460X
DOI:10.1016/j.jdiacomp.2017.03.012