ArticleAdvances in therapy2018
Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment.
Article in Advances in therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.
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, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial of Pregabalin Versus Placebo in the Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
A 14-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study To Evaluate The Safety And Efficacy Of Pregabalin (150mg-600mg/Day) Using A Flexible Optimal Dose Schedule In Patients With Painful Diabetic Peripheral Neuropathy (DPN).
A 13 Week, Double-Blind, Placebo-Controlled Phase 4 Trial of Pregabalin (CI-1008, 600 mg/Day) for Relief of Pain in Subjects With Painful Diabetic Peripheral Neuropathy
Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin (CI-1008) In The Treatment For Pain Associated With Diabetic Peripheral Neuropathy
Who cites it
1 citing paper in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.
- Moving towards the use of artificial intelligence in pain management.European journal of pain (London, England) · 2025Pooled it
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionPrediction of final clinical outcomes based on early weeks of treatment can enable more effective patient care for chronic pain. Our goal was to predict, with at least 90% accuracy, 12- to 13-week outcomes for pregabalin-treated painful diabetic peripheral neuropathy (pDPN) patients based on 4 weeks of pain and pain-related sleep interference data.
methodsWe utilized active treatment data from six placebo-controlled randomized controlled trials (n = 939) designed to evaluate efficacy of pregabalin for reducing pain in patients with pDPN. We implemented a three-step, trajectory-focused analytics approach based upon patient responses collected during the first 4 weeks using monotonicity, path length, frequency domain (FD), and k-nearest neighbor (kNN) methods. The first two steps were based on combinations of baseline pain, pain at 4 weeks, weekly monotonicity and path length during the first 4 weeks, and assignment of patients to one of four responder groups (based on presence/absence of 50% or 30% reduction from baseline pain at 4 and at 12/13 weeks). The third step included agreement between prediction of logistic regression of daily FD amplitudes and assignment made from kNN analyses.
resultsStep 1 correctly assigned 520/939 patients from the six studies to a responder group using a 3-metric combination approach based on unique assignment to a 50% responder group. Step 2 (applied to the remaining 419 patients) predicted an additional 121 patients, using a blend of 50% and 30% responder thresholds. Step 3 (using a combination of FD and kNN analyses) predicted 204 of the remaining 298 patients using the 50% responder threshold. Our approach correctly predicted 90.0% of all patients.
conclusionBy correctly predicting 12- to 13-week responder outcomes with 90% accuracy based on responses from the first month of treatment, we demonstrated the value of trajectory measures in predicting pDPN patient response to pregabalin.
trial registrationwww.clinicaltrials.gov identifiers, NCT00156078/NCT00159679/NCT00143156/NCT00553475.
fundingPfizer. Plain language summary available for this article.
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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.