Study summary · research use only
The time to develop treatments for diabetic neuropathy
Plain-language summary
Paraphrased from the published abstract below — not a verdict on whether anything works.
This review discusses diabetic neuropathy, describing it as affecting up to 50% of individuals with long standing diabetes, most commonly presenting as peripheral diabetic sensory neuropathy (DPN). The authors conducted a systematic review of PubMed literature and a targeted Google search on diagnostic and treatment topics related to DPN. The review describes a number of agents as having undergone unsuccessful trials for DPN treatment over the past half century, and notes that several approved agents exist for pain relief but do not address the underlying disease process. The authors attribute the lack of treatments to study design complexity and slow disease progression, and propose changes to the regulatory process to allow earlier introduction of agents with demonstrated safety and suggested benefit.
Abstract
Diabetic neuropathy is a multifaceted condition affecting up to 50% of individuals with long standing diabetes. The most common presentation is peripheral diabetic sensory neuropathy (DPN). We carried out a systematic review of papers dealing with diabetic neuropathy on Pubmed in addition to a targeted Google search.Search terms included small fiber neuropathy,diffuse peripheral neuropathy, quantitative sensory testing, nerve conduction testing, intra-epidermal nerve fiber density, corneal confocal reflectance microscopy, aldose reductase inhbitors, nerve growth factor, alpha-lipoic acid, ruboxistaurin, nerve growth factor antibody, and cibinetide. Over the past half century, there have been a number of agents undergoing unsuccessful trials for treatment of DPN.There are several approved agents for relief of pain caused by diabetic neuropathy, but these do not affect the pathologic process. The failure to find treatments for diabetic neuropathy can be ascribed to (1) the complexity of design of studies and (2) the slow progression of the condition, necessitating long duration trials to prove efficacy.We propose a modification of the regulatory process to permit early introduction of agents with demonstrated safety and suggestion of benefit as well as prolongation of marketing exclusivity while long term trials are in progress to prove efficacy.
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