ArticlePain practice : the official journal of World Institute of Pain2015
A comprehensive drug safety evaluation of pregabalin in peripheral neuropathic pain.
Article in Pain practice : the official journal of World Institute of Pain, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05324059 (Confirmatory Study of Efficacy and Safety of the Pregabalin/Tramadol Combination Versus Pregabalin in the Management of Acute Pain of Neuropathic Origin.), which is not on this map. Cited by 27 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Confirmatory Study of Efficacy and Safety of the Pregabalin/Tramadol Combination Versus Pregabalin in the Management of Acute Pain of Neuropathic Origin.
Who cites it
27 citing papers in PubMed, 4 syntheses or guidelines pooled it, 83 citations in OpenAlex.
- Efficacy of gabapentin and pregabalin for treatment of post refractive surgery pain: a systematic review and meta-analysis.International ophthalmology · 2024Pooled it
- The efficacy of pregabalin for pain control after thoracic surgery: a meta-analysis.Journal of cardiothoracic surgery · 2024Pooled it
- The efficacy and safety of botulinum toxin type A in treatment of trigeminal neuralgia and peripheral neuropathic pain: A meta-analysis of randomized controlled trials.Brain and behavior · 2019Pooled it
- Benefits and harms of pregabalin in the management of neuropathic pain: a rapid review and meta-analysis of randomised clinical trials.BMJ open · 2019Pooled it
- Capsaicin 8% patch versus oral pregabalin in patients with peripheral neuropathic pain.European journal of pain (London, England) · 2016Trial
- Effect of the gastrointestinal prokinetic agent erythromycin on the pharmacokinetics of pregabalin controlled-release in healthy individuals: a phase I, randomized crossover trial.Clinical drug investigation · 2015Trial
- Pregabalin controlled-release pharmacokinetics in healthy volunteers: analysis of four multiple-dose randomized clinical pharmacology studies.Clinical drug investigation · 2014Trial
- Pharmacokinetics of pregabalin controlled-release in healthy volunteers: effect of food in five single-dose, randomized, clinical pharmacology studies.Clinical drug investigation · 2014Trial
- Decision-Making and Downstream Outcomes of the Gabapentinoid-Diuretic Prescribing Cascade.JAMA network open · 2025Article
- Calcium Channel αPain and therapy · 2025Review
- Gabapentinoids and Risk of Hip Fracture.JAMA network open · 2024Article
- Pregabalin for the Treatment of Neuropathic Pain: A Systematic Review of Patient-Reported Outcomes.Cureus · 2024Review
- Edema related to treatment with psychotropic drugs.Journal of neural transmission (Vienna, Austria : 1996) · 2024Article
- Pregabalin induced balance disorder, asthenia, edema, and constipation in an elderly adult: A case report.World journal of clinical cases · 2023Article
- Evaluation of in vitro transdermal permeation, mass spectrometric imaging, and in vivo analgesic effects of pregabalin using a pluronic lecithin organogel formulation in mice.Pharmacology research & perspectives · 2022Article
- Outpatient Oral Neuropathic Pain Management with Photobiomodulation Therapy: A Prospective Analgesic Pharmacotherapy-Paralleled Feasibility Trial.Antioxidants (Basel, Switzerland) · 2022Article
- Article
- Review
- Role of Perioperative Pregabalin in the Management of Acute and Chronic Post-Thoracotomy Pain.Open access Macedonian journal of medical sciences · 2019Article
- Pregabalin in the Management of Painful Diabetic Neuropathy: A Narrative Review.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Pregabalin is a commonly used therapy currently recommended as first-line treatment for a number of neuropathic pain (NeP) conditions. Since licensure, a number of clinical trials of pregabalin in different NeP conditions have been completed from which additional data on safety and tolerability can be drawn. In this analysis, patient-level data from 31 randomized clinical trials of pregabalin in peripheral NeP sponsored by Pfizer were pooled and assessed for incidence of adverse events (AEs). Incidence by age, disease condition, and race, together with risk differences and time to onset and resolution of AEs, was assessed. In total, 7,510 patients were included: 4,884 on pregabalin (representing 805 patient-years treatment) and 2,626 on placebo. Pregabalin vs. placebo risk analysis identified 9 AEs with a risk difference, for which the lower limit of the 95% confidence interval (CI) was > 1%: dizziness (risk difference [95% CI]: (17.0 [15.4 to 18.6]), somnolence (10.8 [9.5 to 12.1]), peripheral edema (5.4 [4.3 to 6.4]), weight increase (4.7 [3.9 to 5.5]), dry mouth (2.9 [2.1 to 3.8]), constipation (2.3 [1.5 to 3.2]), blurred vision (2.2 [1.6 to 2.9]), balance disorder (2.0 [1.5 to 2.5]), and euphoric mood (1.6 [1.2 to 2.0]). The most common AEs, dizziness and somnolence, typically emerged within the first 1 to 2 weeks of treatment and resolved 1 to 2 weeks later, without resulting in cessation of treatment. The data from this review provide information, indicating which AEs may be expected in patients treated with pregabalin, and suggest that careful dose titration to the highest tolerable dose is the most appropriate approach in clinical practice.
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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.