Efficacy and safety of oral tapentadol extended release in Japanese and Korean patients with moderate to severe, chronic malignant tumor-related pain

Abstract

Objective:

This phase 3 study evaluated the efficacy and safety of tapentadol extended release (ER) compared with oxycodone controlled release (CR) for the management of moderate to severe, chronic malignant tumor-related cancer pain.

Research design and methods:

This randomized, double-blind, active-controlled study included Japanese and Korean patients with moderate to severe, chronic malignant tumor-related pain. Patients were randomized (1:1) to receive oral tapentadol ER (25–200 mg bid) or oral oxycodone HCl CR (5–40 mg bid) for 4 weeks of double-blind treatment.

ClinicalTrials.gov identifier:

ClinicalTrials.gov identifier: NCT01165281.

Main outcome measures:

This study was designed to evaluate the non-inferiority of the efficacy provided by tapentadol ER versus oxycodone CR, based on the mean change in average pain intensity (11 point numerical rating scale) from baseline to the last 3 days of study drug administration. Treatment-emergent adverse events (TEAEs) were recorded throughout the study.

Results:

Of the 374 patients who were screened, 343 were randomized and 236 completed treatment. The least-squares mean difference in the change in pain intensity from baseline to the last 3 days of study treatment between tapentadol ER and oxycodone CR was −0.06 (95% confidence interval [CI], −0.506 to 0.383). The upper limit of the 95% CI was <1 (the predefined threshold value for non-inferiority), indicating that tapentadol ER provided analgesic efficacy that was non-inferior to that of oxycodone CR. The percentage of patients reporting at least one TEAE was similar in the tapentadol ER (87.5% [147/168]) and oxycodone CR (90.1% [155/172]) treatment groups, but the incidence of gastrointestinal TEAEs was lower in the tapentadol ER group (55.4% [93/168]) than in the oxycodone CR group (67.4% [116/172]).

Conclusions:

Tapentadol ER (25–200 mg bid) provides analgesic efficacy that is non-inferior to that provided by oxycodone HCl CR (5–40 mg bid) for the management of moderate to severe, chronic malignant tumor-related pain, and is well tolerated overall, with a better gastrointestinal tolerability profile than oxycodone CR.

Keywords::

• Analgesia
• Cancer
• Chronic pain
• Tapentadol
• Tumor

Transparency

Declaration of funding

Janssen Research & Development, LLC funded this study.

Declaration of financial/other relationships

K.I. is an employee of Janssen Japan and a Johnson & Johnson stockholder. Y.T., M.O., M.W., K.H., and T.M. are employees of Janssen Japan. M.E. and I.V.H. are employees of Janssen Research & Development, LLC and Johnson & Johnson stockholders.

CMRO peer reviewers on this manuscript received honoraria from CMRO for their review work, but have no other relevant financial or other relationships to disclose.

Acknowledgments

Editorial support for the writing of this manuscript was provided by Megan Knagge, PhD, of MedErgy, and was funded by Janssen Research & Development, LLC. The authors retained full editorial control over the content of the manuscript.

Previous/planned presentations: These data will be presented in part at the 18th Congress of the Japanese Society for Palliative Medicine, 21–22 June 2013 in Yokohama, Japan and at the 51st Annual Meeting of the Japanese Society of Clinical Oncology, 24–26 October 2013 in Kyoto, Japan.