Efficacy of Pregabalin Alone and in Combination with Lacosamide in Pain Management of Diabetic Neuropathy
DOI:
https://doi.org/10.52206/jsmc.2025.15.3.1129Abstract
Background: Neuropathy involves the progressive loss of peripheral nerve function, typically beginning with nerves that innervate the toes and advancing proximally. Diabetes mellitus is the leading cause of peripheral neuropathies globally. While pregabalin has been widely used for managing painful diabetic peripheral neuropathy (DPN), recent research suggests a potential role for lacosamide in enhancing pain control.
Objective: The aim of this study was to compare the effectiveness of pregabalin monotherapy versus a combination of pregabalin and lacosamide in the pain management of diabetic neuropathy.
Methodology: This randomized clinical trial included 134 patients divided equally into two groups: Group A received pregabalin 150 mg daily for six weeks, and Group B received pregabalin 100 mg combined with lacosamide 100 mg daily for the same duration.
Results: Group A consisted of 27 males (40.3%) and 40 females (59.7%), while Group B included 19 males (28.4%) and 48 females (71.6%). The mean age was 55.63 ± 12.76 years for Group A and 54.12 ± 11.14 years for Group B. Pre- and post-treatment Visual Analog Scale (VAS) scores showed significant improvement: Group A had a mean post-treatment score of 3.07 ± 1.32, and Group B had 2.30 ± 1.16 (p < 0.05). Treatment was effective in 58.2% of Group A and 80.6% of Group B (p < 0.05).
Conclusion: Both pregabalin alone and its combination with lacosamide were effective in reducing pain in DPN patients. However, the combination therapy showed greater efficacy, suggesting a potential benefit of adjunctive lacosamide. Further studies are needed to confirm these findings.
Keywords: Diabetic Peripheral Neuropathy, Lacosamide, Neuropathic Pain, Pregabalin, Visual Analog Scale.
References
Tokuço?lu F, Diniz G. Peripheral neuropathies. InClues for differential diagnosis of neuromuscular disorders 2023 Aug 23 (pp. 125-168). Cham: Springer International Publishing. https://doi.org/10.1007/978-3-031-33924-0_10
Castelli G, Desai KM, Cantone RE. Peripheral neuropathy: evaluation and differential diagnosis. American family physician. 2020 Dec 15;102(12):732-9.
Lehmann HC, Wunderlich G, Fink GR, Sommer C. Diagnosis of peripheral neuropathy. Neurological research and practice. 2020 Dec; 2:1-7. https://doi.org/10.1186/s42466-020-00064-2
So WZ, Wong NS, Tan HC, Lin MT, Lee IX, Mehta JS, et al. Diabetic corneal neuropathy as a surrogate marker for diabetic peripheral neuropathy. Neural Regeneration Research. 2022 Oct 1;17(10):2172-8. https://doi.org/10.4103/1673-5374.327364
Røikjer J, Ejskjaer N. Diabetic peripheral neuropathy: diagnosis and treatment. Current Drug Safety. 2021 Mar 1;16(1):2-16. https://doi.org/10.2174/1574886315666200731173113
Yang K, Wang Y, Li YW, Chen YG, Xing N, Lin HB, et al. Progress in the treatment of diabetic peripheral neuropathy. Biomedicine & Pharmacotherapy. 2022 Apr 1;148:112717. https://doi.org/10.1002/cbdv.202400910
Price R, Smith D, Franklin G, Gronseth G, Pignone M, David WS, et al. Oral and topical treatment of painful diabetic polyneuropathy: practice guideline update summary: report of the AAN guideline subcommittee. Neurology. 2022 Jan 4;98(1):31-43. https://doi.org/10.1212/WNL.0000000000013038
Khdour MR. Treatment of diabetic peripheral neuropathy: a review. Journal of Pharmacy and Pharmacology. 2020 Jul;72(7):863-72. https://doi.org/10.1111/jphp.13241
Jingxuan L, Litian M, Jianfang F. Different drugs for the treatment of painful diabetic peripheral neuropathy: a meta-analysis. Frontiers in Neurology. 2021 Oct 29;12:682244. https://doi.org/10.3389/fneur.2021.682244d
Hange N, Poudel S, Ozair S, Paul T, Nambakkam M, Shrestha R, et al. Managing chronic neuropathic pain: recent advances and new challenges. Neurology Research International. 2022;2022(1): 8336561. https://doi.org/10.1155/2022/8336561
Carmland ME, Kreutzfeldt MD, Holbech JV. The effect of lacosamide in peripheral neuropathic pain: A randomized, double?blind, placebo?controlled, phenotype?stratified trial. European Journal of Pain. 2024 Jan;28(1):105-19. https://doi.org/10.1002/ejp.2165
Merheb D, Dib G, Zerdan MB, Nakib CE, Alame S, Assi HI. Drug-induced peripheral neuropathy: diagnosis and management. Current Cancer Drug Targets. 2022 Jan 1;22(1):49-76. https://doi.org/10.2174/1568009621666210720142542
Alwash S, McIntyre D, Mamun A. The pre-pregnancy fasting blood glucose, glycated hemoglobin and lipid profiles as blood biomarkers for gestational diabetes mellitus: evidence from a multigenerational cohort study. The Journal of Maternal-Fetal & Neonatal Medicine. 2023 Dec 31;36(1):2195524. https://doi.org/10.1080/14767058.2023.2195524
Raja SN, Carr DB, Cohen M. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. Pain. 2020 Sep 1;161(9):1976-82. https://doi.org/10.1097/j.pain.0000000000001939
Comparison of the efficacy and safety of duloxetine and gabapentin in diabetic peripheral neuropathic pain: a meta-analysis. Jiang L, Xiong Y, Cui J. Contrast Media Mol Imaging. 2022; 2022:4084420. https://doi.org/10.1155/2022/4084420
Akhtar S, Hassan F, Saqlain SR, Ali A, Hussain S. The prevalence of peripheral neuropathy among the patients with diabetes in Pakistan: a systematic review and meta-analysis. Scientific Reports. 2023 Jul 20;13(1):11744. https://doi.org/10.1038/s41598-023-39037-1
Hunaifi I, Agustriadi IG, Asmara IG, Budyono C. The correlation between HbA1c and neuropathy disability score in type 2 diabetes. Acta Medica Indonesiana. 2021 Jul 11;53(2):164.
Davoudi M, Rezaei P, Rajaeiramsheh F, Ahmadi SM, Taheri AA. Predicting the quality of life based on pain dimensions and psychiatric symptoms in patients with Painful diabetic neuropathy: a cross-sectional prevalence study in Iranian patients. Health and Quality of Life Outcomes. 2021 Dec; 19:1-9. https://doi.org/10.1186/s12955-021-01697-w
Srinivasan A, Dutta P, Bansal D, Chakrabarti A, Bhansali AK, Hota D. Efficacy and safety of low?dose naltrexone in painful diabetic neuropathy: A randomized, double?blind, active?control, crossover clinical trial. Journal of Diabetes. 2021 Oct;13(10):770-8. https://doi.org/10.1111/1753-0407.13202
Pinzon RT, Wijaya VO, Veronica V. The benefits of add-on therapy of vitamin D 5000 IU to the vitamin D levels and symptoms in diabetic neuropathy patients: A randomized clinical trial. Journal of Pain Research. 2021 Dec 19:3865-75. https://doi.org/10.2147/JPR.S341862
Sun H, He M, Pang J, Guo X, Huo Y, Ma J. Continuous lumbar sympathetic blockade enhances the effect of lumbar sympatholysis on refractory diabetic neuropathy: a randomized controlled trial. Diabetes Therapy. 2020 Nov;11:2647-55. https://doi.org/10.1007/s13300-020-00918-7
Anwar S, Hassan MW, Tirmzi F, Saeed MU, Aslam M. Effectiveness of platelet rich plasma (PRP) treatment and its comparison with pregabalin in painful diabetic polyneuropathy: A randomized controlled clinical trial. Anaesthesia, Pain & Intensive Care. 2024 Feb 4;28(1):44-9. https://doi.org/10.35975/apic.v28i1.2280
Shah I, Ahmad W, Islam M, Jan B, Haq EU, Mahmood J, et al. A Prospective Observational Study Comparing the Efficacy and Safety of Duloxetine and Pregabalin in Diabetic Peripheral Neuropathic Pain. Cureus. 2022 Sep;14(9). https://doi.org/10.7759/cureus.28683
Mujeeb-ul-Rehman ZA, Mujtaba G, Ali A, Shah S, Singh J. Role of Lacosamide in Diabetic Neuropathy: An Experience at Tertiary Care Hospital in Rural Sindh. Pakistan Journal of Medical & Health Sciences. 2022 Dec 29;16(11):293-. https://doi.org/10.53350/pjmhs20221611293
Jingxuan L, Litian M, Jianfang F. Different drugs for the treatment of painful diabetic peripheral neuropathy: a meta-analysis. Frontiers in Neurology. 2021 Oct 29; 12:682244. https://doi.org/10.3389/fneur.2021.682244
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