Journal of diabetes and its complications · 2017
Predictors of response to treatment with actovegin for 6 months in patients with type 2 diabetes and symptomatic polyneuropathy.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Ziegler Dan, Edmundson Sally, Gurieva Irina, Mankovsky Boris, Papanas Nikolaos, Strokov Igor
Аннотация
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 6months 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.
METHODS: Response to 6-months treatment with actovegin or placebo was defined as a clinically meaningful decline from baseline to 6months 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.
Предметные рубрики MeSH
Administration, OralAngiotensin Receptor AntagonistsAngiotensin-Converting Enzyme InhibitorsCentral Nervous System StimulantsCohort StudiesDiabetes Mellitus, Type 2Diabetic NeuropathiesDouble-Blind MethodDrug Administration ScheduleDrug InteractionsDrug ResistanceFemaleHemeHumansInfusions, IntravenousIntention to Treat AnalysisMaleModels, NeurologicalPainPeripheral Nervous System DiseasesPolyneuropathiesSeverity of Illness IndexTablets