부산대학교 도서관

Diabetic peripheral neuropathy (DPN) is a highly prevalent chronic complication in type 2 diabetes (T2D) for which no effective treatment is available. In this multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial in China, patients with T2D with DPN received acetyllevocarnitine hydrochloride (ALC; 1,500 mg/day; n = 231) or placebo (n = 227) for 24 weeks, during which antidiabetic therapy was maintained. A significantly greater reduction in modified Toronto clinical neuropathy score (mTCNS) as the primary end point occurred in the ALC group (−6.9 ± 5.3 points) compared with the placebo group (−4.7 ± 5.2 points; P < 0.001). Effect sizes (ALC 1.31 and placebo 0.85) represented a 0.65-fold improvement in ALC treatment efficacy. The mTCNS values for pain did not differ significantly between the two groups (P = 0.066), whereas the remaining 10 components of mTCNS showed significant improvement in the ALC group compared with the placebo group (P < 0.05 for all). Overall results of electrophysiological measurements were inconclusive, with significant improvement in individual measurements limited primarily to the ulnar and median nerves. Incidence of treatment-emergent adverse events was 51.2% in the ALC group, among which urinary tract infection (5.9%) and hyperlipidemia (7.9%) were most frequent. Article Highlights: The prevalence of diabetic peripheral neuropathy (DPN) in adults with diabetes is ∼50%, with clinical manifestations of burning, tingling, pain, and progressive numbness. Carnitine insufficiency is associated with increased risk of type 2 diabetes complications, and carnitine therapy reduces fasting plasma glucose and hemoglobin A1c concentrations. Adult patients with DPN were treated with acetyllevocarnitine hydrochloride (ALC) orally while receiving concomitant antidiabetic therapy, which resulted in improved modified Toronto clinical neuropathy scores. Dietary ALC supplementation provides at least some incremental improvement in DPN-related symptoms. [ABSTRACT FROM AUTHOR]