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.