Dataset Information

To what extent are we confident that tapentadol induces less constipation and other side effects than the other opioids in chronic pain patients? a confidence evaluation in network meta-analysis.

ABSTRACT:

Background

A confidence evaluation helps to make informed decisions about the results of meta-analyses. The goal of this work is to perform a confidence evaluation of results of a network meta-analysis (NMA) on the digestive side effects of tapentadol in patients with chronic pain.

Methods

An updated search in PubMed/Medline and Web of Science search until March 2020 was done to perform pairwise meta-analyses with NMA using random-effect models and confidence in network meta-analysis (CiNeMA) for the confidence analysis.

Results

Twenty-five studies were included in the final analyses. Pairwise and indirect comparisons showed a reduced risk of constipation with tapentadol compared to oxycodone. The confidence evaluation did not raise any concerns in terms of confidence for the oxycodone versus tapentadol comparisons. The oxycodone-naloxone versus tapentadol comparisons showed some concerns, particularly in terms of imprecision and incoherence. Regarding the overall risk of any side effects, the confidence evaluation showed a major concern regarding imprecision, but not for the comparison between tapentadol and oxycodone. However, this comparison showed a major heterogeneity.

Discussion and conclusions

A confidence evaluation in meta-analysis on the effect of tapentadol compared to other opioids in chronic pain showed possible imprecision, heterogeneity and/or incoherence. However, with a high level of confidence, tapentadol was associated with a lower incidence of constipation than oxycodone. Confidence analyses can help to get more information from meta-analyses.

SUBMITTER: Forget P

PROVIDER: S-EPMC8611300 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature

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Publications

To what extent are we confident that tapentadol induces less constipation and other side effects than the other opioids in chronic pain patients? a confidence evaluation in network meta-analysis.

Forget Patrice P Vermeersch Mathieu M

British journal of pain 20200803 4

<h4>Background</h4>A confidence evaluation helps to make informed decisions about the results of meta-analyses. The goal of this work is to perform a confidence evaluation of results of a network meta-analysis (NMA) on the digestive side effects of tapentadol in patients with chronic pain.<h4>Methods</h4>An updated search in PubMed/Medline and Web of Science search until March 2020 was done to perform pairwise meta-analyses with NMA using random-effect models and confidence in network meta-analy ...[more]

PMID: 34840785

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Project description:BACKGROUND: Chronic noncancer pain (CNCP) is a major health problem, for which opioids provide one treatment option. However, evidence is needed about side effects, efficacy, and risk of misuse or addiction. METHODS: This meta-analysis was carried out with these objectives: to compare the efficacy of opioids for CNCP with other drugs and placebo; to identify types of CNCP that respond better to opioids; and to determine the most common side effects of opioids. We searched MEDLINE, EMBASE, CENTRAL (up to May 2005) and reference lists for randomized controlled trials of any opioid administered by oral or transdermal routes or rectal suppositories for CNCP (defined as pain for longer than 6 mo). Extracted outcomes included pain, function or side effects. Methodological quality was assessed with the Jadad instrument; analyses were conducted with Revman 4.2.7. RESULTS: Included were 41 randomized trials involving 6019 patients: 80% of the patients had nociceptive pain (osteoarthritis, rheumatoid arthritis or back pain); 12%, neuropathic pain (postherpetic neuralgia, diabetic neuropathy or phantom limb pain); 7%, fibromyalgia; and 1%, mixed pain. The methodological quality of 87% of the studies was high. The opioids studied were classified as weak (tramadol, propoxyphene, codeine) or strong (morphine, oxycodone). Average duration of treatment was 5 (range 1-16) weeks. Dropout rates averaged 33% in the opioid groups and 38% in the placebo groups. Opioids were more effective than placebo for both pain and functional outcomes in patients with nociceptive or neuropathic pain or fibromyalgia. Strong, but not weak, opioids were significantly superior to naproxen and nortriptyline, and only for pain relief. Among the side effects of opioids, only constipation and nausea were clinically and statistically significant. INTERPRETATION: Weak and strong opioids outperformed placebo for pain and function in all types of CNCP. Other drugs produced better functional outcomes than opioids, whereas for pain relief they were outperformed only by strong opioids. Despite the relative shortness of the trials, more than one-third of the participants abandoned treatment.

Project description:Background and objectivesThe effectiveness and tolerability of tapentadol extended release (ER), a centrally acting analgesic with μ-opioid receptor agonist and norepinephrine (noradrenaline) reuptake inhibitor activities, have been demonstrated in patients with chronic pain, including those switching directly from prior opioid therapy. The objective of the current study was to evaluate the effectiveness and safety of conversion to oral tapentadol ER (50-250 mg twice daily) from previous around-the-clock strong opioid therapy in patients with moderate to severe, chronic malignant tumor-related cancer pain that was well-controlled.MethodsThis randomized, open-label, phase III study, which was conducted in Japan, included a 1- to 2-week screening period (on previous opioid) and an 8-week, open-label treatment period. Eligible patients, who were taking a strong opioid analgesic and had a mean pain intensity score <4 during the 3 days prior to randomization (adequate pain control on previous strong opioid), were randomized (1:1) to receive twice-daily treatment with tapentadol ER (100-500 mg/day) or morphine sustained release (SR; 20-140 mg/day; reference for assay sensitivity). Initial doses were estimated based on the conversion ratio of tapentadol ER:oxycodone:morphine:fentanyl = 10:2:3:0.03. The primary effectiveness endpoint was the proportion of patients who maintained pain control [change from baseline in mean pain intensity (11-point numerical rating scale) less than +1.5 for 3 consecutive days and no more than two doses of rescue medication per day for 3 consecutive days) during the first week of open-label treatment.ResultsIn the tapentadol ER group (n = 50), 84.0 % of patients (42/50; 95 % CI, 70.89-92.83) maintained pain control during Week 1. On the Patient Global Impression of Change, 2.1 % (1/48), 2.1 % (1/48), 22.9 % (11/48), and 50.0 % (24/48) of patients in the tapentadol ER group reported that their overall condition was "very much improved," "much improved," "minimally improved," and "not changed," respectively, at Week 1 compared with 0 %, 10.7 % (3/28), 28.6 % (8/28), and 53.6 % (15/28) reporting these ratings at Week 8. The sensitivity of effectiveness analyses was validated based on results using morphine SR; 98.0 % (49/50; 95 % CI, 89.35-99.95) of patients in the morphine SR group maintained pain control after 1 week of treatment. The overall safety profile was similar to that demonstrated in previous studies; tapentadol ER was associated with a lower incidence of gastrointestinal treatment-emergent adverse events than morphine SR [38.0 % (19/50) vs. 54.0 % (27/50)], including constipation [12.0 % (6/50) vs. 20.0 % (10/50)] and vomiting [6.0 % (3/50) vs. 26.0 % (13/50)].ConclusionsOverall, results indicate that conversion from previous strong opioids to tapentadol ER (50-250 mg twice daily) was successful and resulted in safe and effective pain control with improved gastrointestinal tolerability versus morphine SR in patients with moderate to severe cancer-related pain that was well-controlled on their previous opioid.

Project description:Memory conformity may develop when people are confronted with distinct memories reported by others in social situations and knowingly/unknowingly adhere to these exogenous memories. Earlier research on memory conformity suggests that (1) subjects were more likely to conform to confederate with high confidence; (2) subjects with low confidence on their memory accuracy were more likely to conform, and; (3) this subjective confidence could be adjusted by social manipulations. Nonetheless, it remains unclear how the confidence levels of ours and others may interact and produce a combined effect on our degree of conformity. More importantly, is memory conformity, defined by a complete adoption of the opposite side, the result of a gradual accumulation of subtler changes at the confidence level, i.e., a buildup of confidence conformity? Here, we followed participant's confidence transformation quantitatively over three confederate sessions in a memory test. After studying a set of human motion videos, participants had to answer simultaneously whether a target or lure video had appeared before by indicating their side (i.e., Yes/No) and their associated confidence rating. Participants were allowed to adjust their responses as they were being shown randomly-generated confederates' answers and confidence values. Results show that participants indeed demonstrated confidence conformity. Interestingly, they tended to become committed to their side early on and gain confidence gradually over subsequent sessions. This polarizing behaviour may be explained by two kinds of preferences: (1) Participant's confidence enhancement towards same-sided confederates was greater in magnitude compared to the decrement towards an opposite-sided confederate; and (2) Participants had the most effective confidence boost when the same-sided confederates shared similar, but not considerably different, confidence level to theirs. In other words, humans exhibit side- and similarity-biases during confidence conformity.

Project description:PurposeInvestigation of the efficacy and safety of tapentadol prolonged release (PR) compared with morphine PR for long-term treatment of pain in children.Patients and methodsChildren aged 6 to <18 years requiring long-term treatment with opioids were studied in a 12-month, 2-part, multi-center trial: Part 1, 14-day open-label, randomized, active-controlled, parallel group non-inferiority trial comparing twice daily tapentadol PR with morphine PR; Part 2, open-label treatment with tapentadol PR for up to 12 months or no treatment "safety observation period". Pain intensity was rated with visual analogue scale or Faces Pain Scale-Revised, and non-inferiority was assessed by comparison of "treatment responders" (those completing the 14-day treatment period and showing pre-defined changes in pain rating) in each group.ResultsTwenty-three of 48 centers enrolled 73 patients. In Part 1, 45 and 24 patients received tapentadol or morphine, respectively, of which 40 and 22 completed 14-day treatment. In Part 2, thirty-six and 58 patients entered the tapentadol PR or observation periods, respectively, with 20/36 completing at least 12 weeks of treatment; 10 of the 36 had received morphine in Part 1. Forty-four of the 58 patients in the safety observation period had received tapentadol. Tapentadol PR was non-inferior to morphine PR (lower limit of confidence interval above negative non-inferiority margin of -0.2) in Part 1. Rates of adverse events were as expected with nausea (22.2%) and constipation (15.6%) in the tapentadol PR group, and with vomiting (33.3%), nausea and constipation (each 16.7%) in the morphine PR group. No new safety issues were identified; the safety profile of tapentadol over the 12 months treatment and observation periods was comparable to that established in subjects >18 years old.ConclusionTapentadol PR was well tolerated and equivalent to morphine PR for both efficacy and safety in children (6 to <18 years old) requiring long-term treatment with opioids.

Project description:Purpose: High dose monotherapies or drug combinations are used to achieve sufficient analgesia for the treatment of severe chronic low back pain, before invasive therapy options are considered. In order to demonstrate an alternative for an empirical treatment approach, the authors' primary aim was to present an algorithm for the objective identification of treatment predictors. Additionally, the study identified baseline-characteristics in chronic low back pain patients prior to tapentadol PR treatment, as well as scrutinized those patients, either benefitting from a medium/high dose tapentadol PR monotherapy or a combination therapy (medium dose tapentadol PR + pregabalin). Patients and Methods: The statistical approach included data of a previously published randomized, double blind, phase 3b study which compared the effectiveness and safety of tapentadol PR vs. a combination of tapentadol PR and pregabalin. In total, 46 clinical parameters were included in the statistical prediction models which were applied separately either to 50 patients who already responded well during the titration period (i.e., medium dose tapentadol PR) or to 261 patients with in the comparative treatment period [i.e., monotherapy (high dose tapentadol PR) or combination therapy (medium dose tapentadol PR/pregabalin)]. Results: The first statistical model identified three co-variables (NRS-3, PDQ, SQ) with predictive effects on patients responding well ("optimal responders") to a medium dose tapentadol PR titration. Those patients presented low baseline pain intensity scores, good sleep quality and high painDETECT scores. The second statistical model identified eight co-variables (PDQ, numbness, SF-12 MCS, SF-12 PCS, VAS, HADS-A, HADS-D, SQ) with predictive effects on patients responding to high dose tapentadol PR monotherapy vs. a combination therapy (tapentadol PR + pregabalin). The high dose tapentadol PR responders indicated high painDETECT scores, little numbness and a good mental health status. Whereas, the combination therapy (tapentadol PR + pregabalin) responders were characterized by severe sleep disturbances and little anxiety. Conclusion: The statistical analysis characterized chronic low back pain patients and identified factors contributing to a treatment response. Thus, this retrospective statistical algorithm represents an elegant method, which may contribute to future strategies toward a more individualized and improved mechanism based pain therapy.

Dataset Information

To what extent are we confident that tapentadol induces less constipation and other side effects than the other opioids in chronic pain patients? a confidence evaluation in network meta-analysis.

Background

Methods

Results

Discussion and conclusions

Publications

To what extent are we confident that tapentadol induces less constipation and other side effects than the other opioids in chronic pain patients? a confidence evaluation in network meta-analysis.

Similar Datasets

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