ArticleClinical drug investigation2015
A pooled analysis evaluating the efficacy and tolerability of tapentadol extended release for chronic, painful diabetic peripheral neuropathy.
Article in Clinical drug investigation, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 19 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized-Withdrawal Phase 3 Study Evaluating the Safety and Efficacy of CG5503 Extended Release (ER) in Subjects With Painful Diabetic Peripheral Neuropathy
A Randomized-Withdrawal, Placebo-Controlled, Study Evaluating the Efficacy, Safety, and Tolerability of Tapentadol Extended-Release (ER) in Subjects With Chronic, Painful Diabetic Peripheral Neuropathy (DPN)
Who cites it
19 citing papers in PubMed, 41 citations in OpenAlex.
- Treatment with α-Lipoic Acid over 16 Weeks in Type 2 Diabetic Patients with Symptomatic Polyneuropathy Who Responded to Initial 4-Week High-Dose Loading.Journal of diabetes research · 2015Trial
- Comprehensive Analysis of Strong Opioid Side Effects in Palliative Care Using the SIDER Database.Journal of clinical medicine · 2025Article
- Sex-Gender Differences Are Completely Neglected in Treatments for Neuropathic Pain.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Update on Treating Painful Diabetic Peripheral Neuropathy: A Review of Current US Guidelines with a Focus on the Most Recently Approved Management Options.Journal of pain research · 2024Review
- [Diabetic neuropathy and diabetic foot syndrome (update 2023)].Wiener klinische Wochenschrift · 2023Article
- Prevention and Management Strategies for Diabetic Neuropathy.Life (Basel, Switzerland) · 2022Review
- Pharmacotherapy of Painful Diabetic Neuropathy: A Clinical Update.Sisli Etfal Hastanesi tip bulteni · 2022Review
- An Insight into Potential Pharmacotherapeutic Agents for Painful Diabetic Neuropathy.Journal of diabetes research · 2022Review
- Comparison of opioid prescribing upon hospital discharge in patients receiving tapentadol versus oxycodone following orthopaedic surgery.International journal of clinical pharmacy · 2021Article
- Challenges of neuropathic pain: focus on diabetic neuropathy.Journal of neural transmission (Vienna, Austria : 1996) · 2020Review
- Guideline "diagnosis and non interventional therapy of neuropathic pain" of the German Society of Neurology (deutsche Gesellschaft für Neurologie).Neurological research and practice · 2020Article
- Spinal αBritish journal of pharmacology · 2019Review
- Tapentadol for neuropathic pain: a review of clinical studies.Journal of pain research · 2019Review
- An update on the diagnosis and treatment of diabetic somatic and autonomic neuropathy.F1000Research · 2019Review
- Diagnosing and managing diabetic somatic and autonomic neuropathy.Therapeutic advances in endocrinology and metabolism · 2019Review
- Review
- Does 'Strong Analgesic' Equal 'Strong Opioid'? Tapentadol and the Concept of 'µ-Load'.Advances in therapy · 2018Article
- Tapentadol Prolonged Release Reduces the Severe Chronic Ischaemic Pain and Improves the Quality of Life in Patients with Type 2 Diabetes.Journal of diabetes research · 2018Article
- The switch from buprenorphine to tapentadol: is it worth?Romanian journal of anaesthesia and intensive care · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveData from two similarly designed studies of tapentadol extended release (ER) for managing neuropathic pain associated with diabetic peripheral neuropathy (DPN; NCT00455520, NCT01041859) in adults were pooled for this analysis, allowing a detailed evaluation of efficacy in patient subgroups and secondary endpoints.
methodsIn each study, patients were titrated to their optimal dose of open-label tapentadol ER [100-250 mg twice daily (bid)] over 3 weeks. Patients with ≥1-point improvement in average pain intensity [11-point numerical rating scale (NRS)] were randomized (1:1) to receive placebo or tapentadol ER during a 12-week, double-blind maintenance period.
resultsMean (standard deviation [SD]) changes in pain intensity from baseline to week 12 of maintenance in the placebo (n = 343) and tapentadol ER (n = 360) groups, respectively, were 1.28 (2.41) and 0.08 (1.87) [least squares mean difference (LSMD): -1.14 (95 % confidence interval [CI]: -1.435, -0.838); P < 0.001, in favour of tapentadol ER]. Significant between-group differences were also observed in changes from the start of the double-blind treatment period to the double-blind endpoint for the Short Form-36 physical functioning, role-physical, bodily pain, social functioning and role-emotional subscale and physical component summary scores, and the EuroQol 5-Dimension health status index (all P < 0.05, in favour of tapentadol ER). No clinically relevant differences were observed in the efficacy of tapentadol ER across patient subgroups divided by age, sex, race, opioid experience and pain intensity. Incidences of treatment-emergent adverse events were 56.0 % (192/343) with placebo and 74.7 % (269/360) with tapentadol ER during maintenance.
conclusionResults of this pooled analysis indicate that tapentadol ER was effective for managing DPN-related pain, and provided consistent analgesic efficacy across different patient subgroups.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.