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Additive Duloxetine for Cancer-Related Neuropathic Pain Nonresponsive or Intolerant to Opioid-Pregabalin Therapy: A Randomized Controlled Trial (JORTC-PAL08).

Abstract：

CONTEXT:Although opioids and pregabalin are widely used for cancer-related neuropathic pain (CNP), no clinical trials exist to determine which medications are effective when an opioid-pregabalin combination therapy fails. OBJECTIVES:We investigated the efficacy of duloxetine for CNP nonresponsive or intolerant to opioid-pregabalin combination therapy. METHODS:A multicenter, randomized, double-blind, placebo-controlled trial was performed at 12 specialized palliative care services in Japan. Patients with CNP average pain scores (Brief Pain Inventory [BPI]-Item 5) ≥ 4 in the previous 24 hours and nonresponsive or intolerant to opioid-pregabalin combination therapy were eligible. Patients with chemotherapy-induced peripheral neuropathies were excluded. Patients were administered duloxetine 20 mg/day titrated to 40 mg/day or placebo for 10 days. The primary endpoint was BPI-Item 5 on Day 10. Responder analysis measured proportions of patients with 30% and 50% pain decreases. RESULTS:Seventy patients were enrolled. Complete case analysis revealed mean BPI-Item 5 on Day 10 of 4.03 for Group D vs. 4.88 for Group P (P = 0.053). Baseline observation carried forward analysis revealed mean BPI-Item 5 on Day 10 of 4.06 and 4.91 for Groups D and P, respectively (P = 0.048). Clinically meaningful pain improvement (≥30%) was reported by 44.1% (n = 15) of patients in Group D vs. 18.2% (n = 6) in Group P (P = 0.02); 32.4% (n = 11) vs. 3.0% (n = 1) of patients in Groups D and P, respectively, reported pain reduction ≥ 50% (P = 0.002). CONCLUSION:Adding duloxetine to opioid-pregabalin therapy might have clinical benefit in alleviating refractory CNP. Further studies are needed to conclude the efficacy of adding duloxetine.

journal_name

J Pain Symptom Manage

journal_title

Journal of pain and symptom management

authors

Matsuoka H,Iwase S,Miyaji T,Kawaguchi T,Ariyoshi K,Oyamada S,Satomi E,Ishiki H,Hasuo H,Sakuma H,Tokoro A,Shinomiya T,Otani H,Ohtake Y,Tsukuura H,Matsumoto Y,Hasegawa Y,Kataoka Y,Otsuka M,Sakai K,Matsuda Y,Morita

doi

10.1016/j.jpainsymman.2019.06.020

subject

Has Abstract

pub_date

2019-10-01 00:00:00

pages

645-653

issue

eissn

0885-3924

issn

1873-6513

pii

S0885-3924(19)30364-1

journal_volume

pub_type

杂志文章,多中心研究,随机对照试验

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Additive Duloxetine for Cancer-Related Neuropathic Pain Nonresponsive or Intolerant to Opioid-Pregabalin Therapy: A Randomized Controlled Trial (JORTC-PAL08).