Management of severe chronic pain with tapentadol prolonged release – long-term data from pain specialists

Abstract

Background and objective:

Clinical trials have documented the efficacy and good tolerability of tapentadol prolonged released (PR) for severe chronic pain. This study investigated routine long-term administration by pain specialists.

Methods:

The effectiveness analysis included prospective data collected over a 3 month period (cohort I, n = 1457, mean age 61.2 ± 13 years) and over a 12 month period (cohort II, n = 588, 60.1 ± 13.2 years) regarding previous and concomitant analgesic treatment, tapentadol dosage, pain intensity, sleep and quality of life parameters, and tolerability.

Results:

Most patients (>77%) had suffered from severe chronic pain for ≥2 years with low back pain the main pain diagnosis (82%); 91% had already received analgesic long-term treatment prior to initiation of tapentadol therapy (42% of those received strong opioids). After 3 month tapentadol treatment, cohort I had experienced a mean pain reduction of 2.4 points (from 6.8 ± 1.6 at baseline) and improvements of 2.1 points in quality of sleep (from 5.8 ± 2.5) and quality of life (from 6.5 ± 2; all p ≤ 0.001). The 12 month tapentadol treatment (cohort II) reduced the mean pain intensity by 3.2 points from 6.7 ± 1.6 at baseline (NRS-11; p ≤ 0.001); 57% of the patients experienced clinically relevant pain relief of ≥50%. At end of observation, 92% attained either their intended pain reduction and/or an additional individual treatment target, both predefined at start of tapentadol therapy. This was accompanied by a significant reduction in pain-related impairments in daily activities and an improvement in quality of life (all p ≤ 0.001). Most frequent side-effects were nausea (6.3% of patients) and dizziness (3.8%) for cohort I, and nausea (1.5%) and constipation (1.2%) for cohort II.

Conclusion:

Tapentadol PR is effective and well tolerated and can be considered an alternative to classical strong opioids in long-term chronic pain therapy.

Limitations:

The study lacks a control group; assessment under routine practice conditions, however, reflects daily practice clinical management conditions.

Keywords::

• Daily clinical pain specialist practice
• Non-interventional study
• Pain treatment
• Severe chronic pain
• Tapentadol PR

Transparency

Declaration of funding

This study was supported by Grünenthal GmbH, Aachen, Germany.

Declaration of financial/other relationships

V.S. has disclosed that he is an advisor for Grünenthal GmbH. He participated in this study and received financial recompense for complete documentation of patients.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

The author thanks all participating physicians, and Elke Grosselindemann and Birgit Brett for writing and editorial assistance. All costs in connection with the preparation of the manuscript were met by Grünenthal GmbH.

Previous presentation: Part of the manuscript data was presented in two posters at the German Pain Conference, Hamburg, 23–26 October 2013: Friedrich J, Lehmann U, Schwenke K. Tapentadol PR in daily clinical practice – long-term data from pain specialists (in German). Schmerz 2013;27(Suppl 1):114; Lehmann U, Friedrich J, Waldmann-Rex S, Schwenke K. Tapentadol PR in daily clinical practice – treatment success in general practice, pain practice and orthopedic practice (in German). Schmerz 2013;27(Suppl 1):114

Notes

*Palexia retard is a registered trademark of Grünenthal GmbH, Aachen, Germany