ArticleJournal of diabetes and metabolic disorders2019
Efficacy and safety of duloxetine and Pregabalin in Iranian patients with diabetic peripheral neuropathic pain: a double-blind, randomized clinical trial.
Article in Journal of diabetes and metabolic disorders, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed, 15 citations in OpenAlex.
- A randomized comparative study of methylcobalamin, methylcobalamin plus pregabalin and methylcobalamin plus duloxetine in patients of painful diabetic neuropathy.Indian journal of pharmacologyTrial
- Real-World Safety and Effectiveness of Mirogabalin in Chinese Adults with Diabetic Peripheral Neuropathic Pain: a Protocol of ReMIssion Study.Pain and therapy · 2026Article
- A Multicenter, Prospective, Observational, and Single-Arm Interventional Study of Mirogabalin in Diabetic Peripheral Neuropathic Pain: Rationale and Design of Dia-NeP.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2025Article
- A systematic review and meta-analysis of randomized controlled head-to-head trials of recommended drugs for neuropathic pain.Pain reports · 2024Review
- Expert Consensus on Ion Channel Drugs for Chronic Pain Treatment in China.Journal of pain research · 2024Review
- Antidepressants for pain management in adults with chronic pain: a network meta-analysis.The Cochrane database of systematic reviews · 2023Review
- Article
- Comparative Benefit-Risk Assessment for Lidocaine 700 mg Medicated Plaster and Pregabalin in Peripheral Neuropathic Pain Following a Structured Framework Approach.Pain and therapy · 2022Article
Corrections and comments
- Erratum issued
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeDiabetic peripheral neuropathic pain (DPNP) is one of the most sufferings, disabling, and dominant complications of diabetes. Duloxetine (DLX) and Pregabalin (PGB) are among first-line therapy and the most prescribed drugs for DPNP relief. The effectiveness-risk profile of drugs may differ from region to region due to variations in genetic and health situation of populations. This study aims to evaluate the efficacy and safety of DLX and PGB in a sample of Iranian population with DPNP.
methodsA double-blind, randomized clinical trial was conducted on 180 type-2 diabetic patients with DPNP≥40 mm according to Visual Analogue Scale (VAS), with other eligibility criteria throughout twelve weeks. We divided the patients randomly into two equal groups: DLX and PGB. Each patient received ten days placebo as a washout period, then blind capsules of DLX (group 1) or PGB (group 2). We assessed the efficacy and safety of drugs by VAS and recorded the Adverse Drug Reactions (ADRs) during the study.
resultsIn the DLX group, sixty-six and the PGB group, seventy-eight patients completed the study. The intensity of patients' pain was improved by both drugs significantly (p˂0.001), but there was no significant difference between the two groups. Average daily doses of DLX and PGB were 42.5 and 235.5 mg, respectively. In the DLX group, 74% of patients and the PGB group, 37% reported ADRs. The discontinuation rates due to ADRs were 19% and 7% correspondingly.
conclusionWe found that in Iranian patients, the mean effective doses of these drugs are different in comparison with several other studies. Surprisingly intolerance and discontinuation of DLX in our patients were attributed to mild and severe Serotonin Syndrome, which had not much occurred in other studies. Accordingly, despite the same efficacy, PGB was better tolerated than DLX in our patients. Thus we would recommend PGB for DPNP treatment in Iranian patients.
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