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Correlation between pain response and improvements in patient-reported outcomes and health-related quality of life in duloxetine-treated patients with diabetic peripheral neuropathic pain

Authors Ogawa K, Fujikoshi S, Montgomery W, Alev L

Received 30 April 2015

Accepted for publication 9 July 2015

Published 18 August 2015 Volume 2015:11 Pages 2101—2107


Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Miao Sun

Peer reviewer comments 3

Editor who approved publication: Professor Wai Kwong Tang

Kei Ogawa,1 Shinji Fujikoshi,2 William Montgomery,3 Levent Alev1

1Medical Science, 2Statistical Science, Eli Lilly Japan K.K., Kobe, Japan; 3Global Patient Outcomes and Real World Evidence, Eli Lilly Australia Pty Ltd, West Ryde, NSW, Australia

Objective: We assessed whether quality of life (QoL) improvement in duloxetine-treated patients with diabetic peripheral neuropathic pain (DPNP) correlates with the extent of pain relief.
Methods: Pooled data from three multicountry, double-blind, 12-week, placebo-controlled trials of duloxetine-treated (duloxetine 60 mg once daily; total number =335) patients with DPNP were analyzed. Based on improvement in 24-hour average pain scores, patients were stratified into four groups. Improvement in QoL, which was measured as the change from baseline in two patient-reported health outcome measures (Short Form [SF]-36 and five-dimension version of the EuroQol Questionnaire [EQ-5D]), was evaluated and compared among the four groups. Pearson’s correlation coefficient was calculated to assess the correlation between improvement in pain scores and improvement in QoL.
Results: The group with more pain improvement generally showed greater mean change from baseline in all of the SF-36 scale scores and on the EQ-5D index. Pearson’s correlation coefficients ranged from 0.114 to 0.401 for the SF-36 scale scores (P<0.05), and it was 0.271 for the EQ-5D (P<0.001).
Conclusion: Improvement in pain scores was positively correlated with improvement in QoL and patient-reported outcomes in duloxetine-treated patients.

Keywords: diabetic peripheral neuropathic pain, duloxetine, efficacy, function, quality of life

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