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      Comparison of the Efficacy of Duloxetine and Pregabalin in Pain Relief Associated with Diabetic Neuropathy

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          Abstract

          Introduction

          Painful diabetic peripheral neuropathy (PDPN) complicates 25% of type II diabetes mellitus. It has a profound impact on diabetes-related morbidity and worsens the quality of life. Both pregabalin and duloxetine may be indicated for PDPN. In this study, the efficacy of duloxetine and pregabalin was compared in patients with PDPN.

          Methods

          It was a single-centre open-label study conducted with patients of diabetes mellitus type II diagnosed with PDPN. Patients were randomized to receive 60 mg/daily duloxetine or 300 mg/daily pregabalin. Pain scores were recorded using visual analogue scale (VAS) on day 0, week 4, and week 12. Data was entered and analysed using SPSS version 22.0 (IBM Corp., Armonk, NY).

          Results

          In the duloxetine group, the mean VAS score decreased from 6.81 ± 0.91 to 4.01 ± 1.12 with 12 weeks of therapy (p <0.0001). In the pregabalin group, the mean VAS score decreased from 6.99 ± 1.12 to 4.91 ± 0.82 with 12 weeks of therapy (p <0.0001). At 12 weeks, duloxetine showed lower VAS scores than pregabalin (p <0.0001). In the duloxetine group, the mean change in VAS score over time was - 2.80 and in the pregabalin group, the mean change was - 2.80. Adverse events were reported in 17.9% of the participants. Lethargy/somnolence (8.1%) and peripheral edema (3.4%) were commonly reported in the pregabalin group and constipation (6.9%) and orthostatic hypotension (4.6%) were commonly reported in the duloxetine group.

          Conclusions

          Duloxetine at a daily fixed dose of 60 mg is efficacious in the relief of neuropathic pain. Pregabalin also showed a comparable outcome. Both duloxetine and pregabalin have a promising safety profile and are well-tolerated.

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          Most cited references14

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          Painful diabetic polyneuropathy: epidemiology, pain description, and quality of life.

          A prospective survey study was performed in patients with painful diabetic polyneuropathy (PDN) to assess the nature and scope of their pain. Pain associated with diabetic neuropathy is commonly encountered in clinical practice. Yet, little is known regarding the pain experience and impact on quality of life in persons with painful diabetic neuropathy. These 105 patients noted an average of 6/10 pain, most often described as 'burning', 'electric', 'sharp', and 'dull/ache', which, for most, is worse at night time and when tired or stressed. On average, patients reported that the pain caused substantial interference in sleep and enjoyment of life and moderate interference in recreational activities, normal work, mobility, general activity, social activities, and mood. Unexpectedly, a potential genetic predisposition to the development of painful neuropathy was suggested by the fact that a majority (56%) reported a family member with PDN. Thus, this study found that pain associated with diabetic neuropathy is a significant medical issue that has a substantial impact on the quality of life of many people with this condition.
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            Efficacy of pregabalin in neuropathic pain evaluated in a 12-week, randomised, double-blind, multicentre, placebo-controlled trial of flexible- and fixed-dose regimens.

            Pregabalin binds with high affinity to the alpha2-delta subunit protein of voltage-gated calcium channels and, thereby, reduces release of excitatory neurotransmitters. This 12-week randomised, double-blind, multicentre, placebo-controlled, parallel-group study evaluated the efficacy and safety of pregabalin in patients with chronic postherpetic neuralgia (PHN) or painful diabetic peripheral neuropathy (DPN). Patients were randomised to placebo (n=65) or to one of two pregabalin regimens: a flexible schedule of 150, 300, 450, and 600 mg/day with weekly dose escalation based on patients' individual responses and tolerability (n=141) or a fixed schedule of 300 mg/day for 1 week followed by 600 mg/day for 11 weeks (n=132). Both flexible- and fixed-dose pregabalin significantly reduced endpoint mean pain score (primary outcome) versus placebo (P=0.002, P<0.001) and were significantly superior to placebo in improving pain-related sleep interference (P<0.001). The most common adverse events (AEs) for pregabalin-treated patients were dizziness, peripheral oedema, weight gain (not affecting diabetes control), and somnolence. These results are consistent with previous studies' demonstrating pregabalin's efficacy, tolerability, and safety for treatment of chronic neuropathic pain associated with DPN or PHN. Pregabalin dosing aimed at optimal balance of efficacy and tolerability provides significant pain relief and may reduce risks for AEs and therapy discontinuation.
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              Diabetic peripheral neuropathy and quality of life.

              The quality of life (QOL) of 79 people with type 1 and type 2 diabetes and 37 non-diabetic controls was assessed using the Nottingham Health Profile (NHP). The NHP consists of six domains assessing energy, sleep, pain, physical mobility, emotional reactions and social isolation. Symptomatic diabetic neuropathy was present in 41 of the patients. The neuropathy patients had significantly higher scores (impaired QOL) in 5/6 NHP domains than either the other diabetic patients (p < 0.01) or the non-diabetic (p < 0.001) controls. These were: emotional reaction, energy, pain, physical mobility and sleep. The diabetic patients without neuropathy also had significantly impaired QOL for 4/6 NHP domains compared with the non-diabetic control group (p < 0.05) (energy, pain, physical mobility and sleep). This quantification of the detrimental effect on QOL of diabetes, and in particular of chronic symptomatic peripheral diabetic neuropathy, emphasizes the need for further research into effective management of these patients.
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                Author and article information

                Journal
                Cureus
                Cureus
                2168-8184
                Cureus
                Cureus (Palo Alto (CA) )
                2168-8184
                31 July 2019
                July 2019
                : 11
                : 7
                : e5293
                Affiliations
                [1 ] Internal Medicine, Jinnah Sindh Medical University, Karachi, PAK
                [2 ] Internal Medicine, Dow University of Health Sciences (DUHS), Karachi, PAK
                [3 ] Internal Medicine, Civil Hospital Karachi, Karachi, PAK
                [4 ] Internal Medicine, Australian Concept Infertility Medical Center, Karachi, PAK
                Author notes
                Article
                10.7759/cureus.5293
                6768616
                31579634
                a37eacf3-75bd-41ca-8dd8-352744cd5448
                Copyright © 2019, Shahid et al.

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 15 July 2019
                : 31 July 2019
                Categories
                Endocrinology/Diabetes/Metabolism
                Family/General Practice
                Internal Medicine

                duloxetine,pregabalin,diabetic neuropathy,efficacy,tolerability,open label trial,painful diabetic peripheral neuropathy,vas score

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