Tapentadol prolonged-release for moderate-to-severe chronic osteoarthritis knee pain: a double-blind, randomized, placebo- and oxycodone controlled release-controlled study

Serrié, Alain; Lange, Bernd; Steup, Achim

doi:10.1080/03007995.2017.1335189

Cited by 25 publications

(48 citation statements)

References 30 publications

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“…These two studies [19, 20] are supported by a pooled analysis [26] of all three phase 3 trials [18–20] (see Table 1 for key outcomes). Moreover, in a post hoc pooled subgroup analysis of these three studies, tapentadol PR, unlike oxycodone CR, provided significant ( p < 0.01) pain relief versus placebo in elderly patients (aged ≥ 75 years; n = 210), as measured by the least-squares mean (LSM) change from baseline to week 15 in pain intensity [27].…”

Section: Therapeutic Efficacymentioning

confidence: 85%

“…Tapentadol PR was compared with placebo in adults with moderate to severe non-malignant musculoskeletal pain in three 15-week, randomized, double-blind, phase 3 trials [18–20]. Each study had a 3-week titration period and a 12-week maintenance period and included oxycodone CR as a reference drug for assay sensitivity (Table 1).…”

Section: Therapeutic Efficacymentioning

confidence: 99%

“…Each study had a 3-week titration period and a 12-week maintenance period and included oxycodone CR as a reference drug for assay sensitivity (Table 1). However, as one of the trials [18] did not demonstrate significant benefit with oxycodone CR over placebo for primary endpoint measures (Table 1), it was considered to have failed and is not discussed further, except as part of pooled analyses. The two positive studies enrolled adults with chronic lower back pain [19] or osteoarthritic knee pain [20] requiring analgesics (opioid or non-opioid) for the last ≥ 3 months.…”

Section: Therapeutic Efficacymentioning

confidence: 99%

“…Mean pain intensity score at BL (over last 72 h) was 7.3–7.5 [18–20, 26] (graph estimate [20]) on NRS (0 = no pain; 10 = worst pain) BL baseline, OXY CR oxycodone controlled release 20–50 mg twice daily, NRS numerical rating scale, PL placebo, pts patients, TAP PR tapentadol prolonged release 100–250 mg twice daily, wk(s) week(s)* p < 0.05, ** p < 0.005, *** p < 0.001 vs. PL † p < 0.05, †† p < 0.005, ††† p < 0.001 vs. OXY CR a Average intensity of pain over last 12 h rated twice daily on 11-point NRS b Primary endpoint in EU and other non-USA regions c Primary endpoint in USA d TAP PR was noninferior to OXY CR [26], with a pre-planned additional analysis indicating TAP PR was superior to OXY CR ( p = 0.037) for the mean change in average pain intensity over 12 weeks of maintenance [32]…”

Section: Therapeutic Efficacymentioning

confidence: 99%

“…Mean pain intensity score at BL (over last 72 h) was 7.3–7.5 [18–20, 26] (graph estimate [20]) on NRS (0 = no pain; 10 = worst pain)…”

Section: Therapeutic Efficacymentioning

confidence: 99%

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Tapentadol Prolonged Release: A Review in Pain Management

Deeks

2018

Drugs

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Tapentadol prolonged release (tapentadol PR) [Palexia® SR in EU] is a long-acting tablet formulation of the strong central analgesic tapentadol, which acts as both a μ-opioid receptor (MOR) agonist and a noradrenaline reuptake inhibitor. Tapentadol PR is approved for chronic pain in various countries, with its EU indication (severe chronic pain manageable only with opioid analgesics) being the focus here. Well-designed trials and clinical practice data support tapentadol PR use in this setting. Short term, tapentadol PR was an effective and generally well tolerated analgesic for moderate to severe pain of varying aetiologies, including neuropathic pain. It provided analgesia at least as good as that of conventional strong opioids and appeared more favourable in terms of gastrointestinal tolerability, likely due to less potent MOR binding. Severe back pain with a neuropathic component responded well to moderate-dose tapentadol PR in some patients, while for others, an increase to the maximum recommended tapentadol PR dosage provided analgesia at least as good as that of moderate-dose tapentadol PR plus pregabalin and appeared to have some CNS tolerability benefits. Data also support the use of tapentadol PR in opioid rotation, including when conventional opioids are intolerable. Longer-term data in musculoskeletal pain conditions indicate continued benefit over up to 2 years’ treatment with tapentadol PR with no evidence of tolerance. Thus, tapentadol PR is a useful option for the management of severe chronic pain.

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Section: Therapeutic Efficacymentioning

confidence: 85%

Section: Therapeutic Efficacymentioning

confidence: 99%

Section: Therapeutic Efficacymentioning

confidence: 99%

Section: Therapeutic Efficacymentioning

confidence: 99%

“…Mean pain intensity score at BL (over last 72 h) was 7.3–7.5 [18–20, 26] (graph estimate [20]) on NRS (0 = no pain; 10 = worst pain)…”

Section: Therapeutic Efficacymentioning

confidence: 99%

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Tapentadol Prolonged Release: A Review in Pain Management

Deeks

2018

Drugs

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Opioids for Chronic Noncancer Pain

Busse

Wang

Kamaleldin

et al. 2018

JAMA

490

216

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IMPORTANCE Harms and benefits of opioids for chronic noncancer pain remain unclear. OBJECTIVE To systematically review randomized clinical trials (RCTs) of opioids for chronic noncancer pain. DATA SOURCES AND STUDY SELECTION The databases of CENTRAL, CINAHL, EMBASE, MEDLINE, AMED, and PsycINFO were searched from inception to April 2018 for RCTs of opioids for chronic noncancer pain vs any nonopioid control. DATA EXTRACTION AND SYNTHESIS Paired reviewers independently extracted data. The analyses used random-effects models and the Grading of Recommendations Assessment, Development and Evaluation to rate the quality of the evidence. MAIN OUTCOMES AND MEASURES The primary outcomes were pain intensity (score range, 0-10 cm on a visual analog scale for pain; lower is better and the minimally important difference [MID] is 1 cm), physical functioning (score range, 0-100 points on the 36-item Short Form physical component score [SF-36 PCS]; higher is better and the MID is 5 points), and incidence of vomiting. RESULTS Ninety-six RCTs including 26 169 participants (61% female; median age, 58 years [interquartile range, 51-61 years]) were included. Of the included studies, there were 25 trials of neuropathic pain, 32 trials of nociceptive pain, 33 trials of central sensitization (pain present in the absence of tissue damage), and 6 trials of mixed types of pain. Compared with placebo, opioid use was associated with reduced pain (weighted mean difference [WMD], −0.69 cm [95% CI, −0.82 to −0.56 cm] on a 10-cm visual analog scale for pain; modeled risk difference for achieving the MID, 11.9% [95% CI, 9.7% to 14.1%]), improved physical functioning (WMD, 2.04 points [95% CI, 1.41 to 2.68 points] on the 100-point SF-36 PCS; modeled risk difference for achieving the MID, 8.5% [95% CI, 5.9% to 11.2%]), and increased vomiting (5.9% with opioids vs 2.3% with placebo for trials that excluded patients with adverse events during a run-in period). Low-to moderate-quality evidence suggested similar associations of opioids with improvements in pain and physical functioning compared with nonsteroidal anti-inflammatory drugs (pain: WMD, −0.60 cm [95% CI, −1.54 to 0.34 cm]; physical functioning: WMD, −0.90 points [95% CI, −2.69 to 0.89 points]), tricyclic antidepressants (pain: WMD, −0.13 cm [95% CI, −0.99 to 0.74 cm]; physical functioning: WMD, −5.31 points [95% CI, −13.77 to 3.14 points]), and anticonvulsants (pain: WMD, −0.90 cm [95% CI, −1.65 to −0.14 cm]; physical functioning: WMD, 0.45 points [95% CI, −5.77 to 6.66 points]). CONCLUSIONS AND RELEVANCE In this meta-analysis of RCTs of patients with chronic noncancer pain, evidence from high-quality studies showed that opioid use was associated with statistically significant but small improvements in pain and physical functioning, and increased risk of vomiting compared with placebo. Comparisons of opioids with nonopioid alternatives suggested that the benefit for pain and functioning may be similar, although the evidence was from studies of only low to moderate quality.

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Is There Any Role for Opioids in the Management of Knee and Hip Osteoarthritis? A Systematic Review and Meta‐Analysis

Osani

Lohmander

Bannuru

2021

Arthritis Care & Research

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Objective Opioids have long been prescribed for chronic pain conditions, including osteoarthritis (OA). However, there is little information about their temporal efficacy, or differences in efficacy and safety between opioids with strong versus weak/intermediate μ opioid receptor–binding affinity. To explore these research questions, we conducted a systematic review and meta‐analyses of randomized controlled trials (RCTs) conducted in patients with knee and/or hip OA. Methods We searched Medline, Embase, PubMed Central, and the Cochrane Central Register of Controlled Trials from inception to December 2019 and sought unpublished data. Placebo‐controlled RCTs of oral opioids in patients with knee and/or hip OA were included. Standardized mean differences (SMDs) were calculated for pain and function at 2, 4, 8, and 12 weeks. Subgroup analyses for strong and weak/intermediate opioids were conducted. Meta‐regression was performed to assess the impact of dosage (morphine equivalency) on pain relief. Risk ratios were calculated for safety at the final follow‐up. Results A total of 18 RCTs (9,283 participants) were included. Opioids demonstrated small benefits on pain at each time point, with SMDs ranging from –0.28 (95% confidence interval [95% CI] –0.38, –0.17) to –0.19 (95% CI –0.29, –0.08); similar effects were observed for function. Strong opioids demonstrated consistently inferior efficacy and overall worse safety than weak/intermediate opioids. Meta‐regression revealed that incremental pain relief achieved beyond 20–50‐mg doses was not substantial in the context of increased safety risks. Conclusion Opioids provide minimal relief of OA symptoms within a 12‐week period, and they are known to cause discomfort in a majority of patients. Clinicians and policy makers should reconsider the utility of opioids in the management of OA.

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Tapentadol prolonged-release for moderate-to-severe chronic osteoarthritis knee pain: a double-blind, randomized, placebo- and oxycodone controlled release-controlled study

Abstract: The study did not demonstrate assay sensitivity. The finding that both primary end-points for tapentadol PR were not met can, thus, not be interpreted. Tapentadol PR was better tolerated than oxycodone CR, largely due to fewer gastrointestinal side-effects.

Cited by 25 publications

References 30 publications

Tapentadol Prolonged Release: A Review in Pain Management

Tapentadol Prolonged Release: A Review in Pain Management

Opioids for Chronic Noncancer Pain

Is There Any Role for Opioids in the Management of Knee and Hip Osteoarthritis? A Systematic Review and Meta‐Analysis

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