Patient-relevant outcomes and health-related quality of life in patients with chronic, severe, noncancer pain treated with tapentadol prolonged release—Using criteria of health technology assessment

Johannes FX Hofmann, PhD; Arun Lal, MSc, MBA; Maike Steffens; Robert Boettger

doi:10.5055/jom.2016.0349

Authors

Johannes FX Hofmann, PhD
Arun Lal, MSc, MBA
Maike Steffens
Robert Boettger

DOI:

https://doi.org/10.5055/jom.2016.0349

Keywords:

tapentadol, chronic nonmalignant pain, evidence-based medicine, health-related quality of life

Abstract

Objective: To perform a systematic comparison of tapentadol prolonged release (PR) and oxycodone controlled release (CR) using patient-relevant endpoints of efficacy, safety, and health-related quality of life (HRQoL) according to criteria used in health technology assessment. To derive a minimal important difference (MID) for the EQ-5D from three pivotal trials to measure patient-relevant changes in HRQoL.

Design: Randomized, double-blind, placebo and active controlled.

Setting: Outpatient primary care.

Participants: Patients with severe chronic osteoarthritis pain (two pivotal studies) and severe lower-back pain (one pivotal study) were enrolled. The intent-to-treat population of the three studies comprised a total of 2,968 patients (tapentadol PR arms: 978, oxycodone CR arms: 999, and in the placebo arms: 991).

Interventions: Tapentadol PR (100-250 mg bid), oxydodone CR (20-50 mg bid), or placebo over a period of 15 weeks (3 weeks titration plus 12 weeks maintenance).

Outcome Measures: Patient-relevant endpoints of efficacy, safety, tolerability, and HRQoL.

Results: Tapentadol PR demonstrated significant added benefits as compared to oxycodone CR in meta-analyses of the patient-relevant outcomes 30 percent pain relief (Realtive risk [RR]: 0.80 [0.75, 0.87]), treatment discontinuations (RR: 0.55 [0.363, 0.825]), safety (RR: 0.652 [0.599, 0.710]), and HRQoL (RR: 0.78 [0.64, 0.96]) based on a MID derived for the EQ-5D summary index.

Conclusions: Added benefit of tapentadol in all endpoint categories suggests that it may be beneficial to initiate treatment of chronic severe nonmalignant pain with tapentadol rather than oxycodone.

Author Biographies

Johannes FX Hofmann, PhD

HS Value and Dossier GmbH, Eschborn, Germany.

Arun Lal, MSc, MBA

Gruenenthal GmbH, Aachen, Germany

Maike Steffens

Health Economist, Gruenenthal GmbH, Aachen, Germany

Robert Boettger

Health Economist, Gruenenthal GmbH, Aachen, Germany

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