A pooled analysis of patient-specific factors and efficacy and tolerability of tapentadol extended release treatment for moderate to severe chronic pain

Mila Etropolski, MD; Bernd Lange, MD, MSc; Jutta Goldberg, PhD; Achim Steup, Dipl.-Stat.; Christine Rauschkolb, MD, PhD

doi:10.5055/jom.2013.0177

Authors

Mila Etropolski, MD
Bernd Lange, MD, MSc
Jutta Goldberg, PhD
Achim Steup, Dipl.-Stat.
Christine Rauschkolb, MD, PhD

DOI:

https://doi.org/10.5055/jom.2013.0177

Keywords:

tapentadol, chronic pain, low back pain, osteoarthritis pain, BMI, opioid experience, baseline pain intensity, gender

Abstract

Objective: To evaluate via retrospective analysis the efficacy and tolerability of tapentadol extended release (ER; 100-250 mg bid) based on patient-specific factors, including baseline pain intensity, prior opioid experience, gender, and body mass index (BMI).

Design: Data were pooled from three randomized, double-blind phase III studies of similar design that evaluated the efficacy and tolerability of tapentadol ER for the management of moderate to severe, chronic osteoarthritis knee pain (NCT00421928, NCT00486811) or low back pain (NCT00449176).

Setting: In the original trials, patients were recruited at primary, secondary, and tertiary care centers, institutional settings, and private practices in North America, Europe, Australia, and New Zealand.

Patients: Data were analyzed separately for groups of patients divided by baseline pain intensity, prior opioid experience, gender, and BMI.

Interventions: Patients received twice-daily placebo, tapentadol ER (100-250 mg), or oxycodone HCl controlled release (CR; 20-50 mg) for a 3-week titration and 12-week maintenance period.

Main outcome measures: Changes from baseline in average pain intensity (11-point numerical rating scale) at week 12 of the maintenance period and for the overall maintenance period.

Results: Efficacy and tolerability were evaluated in 2,968 and 2,974 patients, respectively. The efficacy of tapentadol ER was shown in subpopulations divided by baseline pain intensity, prior opioid experience, gender, and BMI. Tapentadol ER was also shown to be well tolerated and associated with better gastrointestinal tolerability than oxycodone CR in the evaluated subpopulations (divided by prior opioid experience and gender).

Conclusions: Results suggest that tapentadol ER (100-250 mg bid) provides similar pain relief and tolerability, regardless of baseline pain intensity, prior opioid experience, gender, or BMI.

Author Biographies

Mila Etropolski, MD

Senior Director/Clinical Leader, Janssen Research & Development, LLC, Raritan, New Jersey

Bernd Lange, MD, MSc

Associate International Clinical Lead, Grünenthal GmbH, Aachen, Germany

Jutta Goldberg, PhD

Associate International Clinical Lead, Grünenthal GmbH, Aachen, Germany

Achim Steup, Dipl.-Stat.

Project Biostatistician, Global Biometrics-Biostatistics, Grünenthal GmbH, Aachen, Germany

Christine Rauschkolb, MD, PhD

Vice President/Compound Development Team Leader, Janssen Research & Development, LLC, Raritan, New Jersey

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