Efficacy and safety of oral tapentadol extended release in Japanese and Korean patients with moderate to severe, chronic malignant tumor-related pain. (October 2013)

• Record Type: Journal Article
• Authors: Imanaka, Keiichiro; Tominaga, Yushin; Etropolski, Mila; van Hove, Ilse; Ohsaka, Masaki; Wanibe, Mikio; Hirose, Keiichiro; Matsumura, Taka
• Is Part Of: Current medical research and opinion. Volume 29:Number 10(2013:Oct.)
• Page Start: 1399
• Page End: 1409
• Publication Date: 2013-10
• Subjects: Clinical medicine -- Periodicals; Therapeutics -- Periodicals; 615.5
• DOI: 10.1185/03007995.2013.831816
• Languages: English
• ISSNs: 0300-7995

Abstract

<abstract> <title>Abstract</title> <sec id="ss1"> <title>Objective:</title> <p>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.</p> </sec> <sec id="ss2"> <title>Research design and methods:</title> <p>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.</p> </sec> <sec id="ss3"> <title>ClinicalTrials.gov identifier:</title> <p>NCT01165281.</p> </sec> <sec id="ss4"> <title>Main outcome measures:</title> <p>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.</p> </sec> <sec id="ss5"> <title>Results:</title> <p>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]).</p> </sec> <sec id="ss6"> <title>Conclusions:</title> <p>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.</p> </sec> </abstract>