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      Duloxetine in patients with diabetic peripheral neuropathic pain in Japan: a randomized, doubleblind, noninferiority comparative study with pregabalin

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          Duloxetine and pregabalin are recommended as first-line treatments for diabetic peripheral neuropathic pain (DPNP). However, studies have not reported a direct comparison between duloxetine and pregabalin. We conducted a postmarketing, randomized, double-blind study to assess the noninferiority of duloxetine compared with pregabalin after 12 weeks of treatment in adult patients with DPNP in Japan (NCT02417935).

          Patients and methods

          Patients (N = 303) with distal symmetrical DPNP were randomized to and were administered duloxetine (40–60 mg/day) or pregabalin (300–600 mg/day). The primary endpoint was the change from baseline in weekly mean of the 24-hour average pain score (numeric rating scale [NRS]). Noninferiority of duloxetine compared with pregabalin was assessed with the primary endpoint at week 12. Secondary measures, including night pain and worst pain, Brief Pain Inventory-Severity and Interference rating short form (BPI-SF), Clinical Global Impression of Improvement (CGI-I), Patient Global Impression of Improvement (PGI-I), and Neuropathic Pain Symptom Inventory (NPSI), health outcome measures (EuroQol 5-Dimension index and VAS), and safety were also assessed.


          For the 24-hour NRS average pain score, the difference between the duloxetine and pregabalin groups was 0.072 (95% CI: – 0.295, 0.439), and the upper bound of the 95% CI (0.439) did not exceed the predefined noninferiority margin (0.51), at the end of the study period. For secondary outcome measures (night pain, worst pain, BPI-SF, CGI-I, PGI-I, NPSI) and health outcome measures, both the duloxetine and pregabalin treatment groups showed an improvement from baseline with no significant between-group difference. Duloxetine and pregabalin were well tolerated and the safety profiles were consistent with previously reported results.


          This study demonstrated the noninferior efficacy of duloxetine compared with pregabalin in the treatment of adult patients with DPNP. The safety analyses showed an acceptable tolerability based on safety profiles of duloxetine and pregabalin.

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          Most cited references 18

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          Rationale and usefulness of newly devised abbreviated diagnostic criteria and staging for diabetic polyneuropathy.

          In order to establish a diagnostic criteria for diabetic polyneuropathy (DP) for daily practice, usefulness of the abbreviated diagnostic criteria proposed by Diabetic Neuropathy Study Group in Japan was examined in 131 diabetic patients in admission and outpatient clinic. The prerequisite condition includes: (1) diagnosed as diabetes and (2) other neuropathies than diabetic neuropathy can be excluded. The criteria should meet any of the following three items: (1) sensory symptoms considered to be due to DP, (2) bilaterally decreased or absent ankle reflex and (3) decreased vibratory sensation in bilateral medial malleoli. Using this criteria, sensitivity (68%) and specificity (74%) were obtained by evaluating nerve conduction study as gold standard, suggesting usefulness of the criteria for diagnosis of DP especially for daily practice. Staging of DP is now sought to establish the consensus for the specific therapy for its stage. Thirty-one diabetic patients in admission was evaluated to examine usefulness of the newly devised staging system of DP. Staging was almost consistent between the new staging system and Dyck's staging (gold standard) and nerve function deteriorated with increasing stage, suggesting that usefulness and rationale of this staging system is well substantiated.
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            Efficacy and safety of pregabalin for treating neuropathic pain associated with diabetic peripheral neuropathy: a 14 week, randomized, double-blind, placebo-controlled trial.

             J Satoh,  S Yagihashi,  M Baba (2011)
            To evaluate the efficacy, safety and pharmacokinetics of pregabalin in treating neuropathic pain associated with diabetic peripheral neuropathy in Japanese patients.
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              • Article: not found

              Pharmacologic interventions for painful diabetic neuropathy: An umbrella systematic review and comparative effectiveness network meta-analysis.

              Multiple treatments for painful diabetic peripheral neuropathy are available.

                Author and article information

                J Pain Res
                J Pain Res
                Journal of Pain Research
                Journal of Pain Research
                Dove Medical Press
                13 September 2018
                : 11
                : 1857-1868
                [1 ]Bio-Medicine, Medicines Development Unit, Eli Lilly Japan K. K, Tokyo, Japan, enomoto_hiroyuki@ 123456lilly.com
                [2 ]Foundation of Shiga Health Research Center, Shiga, Japan
                [3 ]Project Management, Global Development Division, Shionogi & Co. Ltd., Osaka, Japan
                [4 ]Statistical Science, Medicines Development Unit, Eli Lilly Japan K.K., Kobe, Japan
                [5 ]Biostatistics, Biostatistics Department, Shionogi & Co. Ltd., Osaka, Japan
                [6 ]Clinical Research Development, Shionogi & Co. Ltd., Osaka, Japan
                [7 ]Medical Affairs Department, Shionogi & Co., Ltd., Osaka, Japan
                [8 ]Scientific Communications, Medicines Development Unit, Eli Lilly Japan K. K, Kobe, Japan
                [9 ]Eli Lilly, Medical Department, Lilly Turkey, Istanbul, Turkey
                Author notes
                Correspondence: Hiroyuki Enomoto, Medical Science, Eli Lilly Japan K.K., 4-15-1-13F, Akasaka, Minato-ku, Tokyo 107-0052, Japan, Tel +8135 574 9143, Fax +8135 574 9979, Email enomoto_hiroyuki@ 123456lilly.com
                © 2018 Enomoto et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

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