Trial reportBritish journal of clinical pharmacology2012
Unexpected frequent hepatotoxicity of a prescription drug, flupirtine, marketed for about 30 years.
Trial report in British journal of clinical pharmacology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 1 of them a synthesis 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
31 citing papers in PubMed, 1 synthesis or guideline pooled it, 58 citations in OpenAlex.
- Signals from randomized clinical trials predicting hepatotoxicity of flupirtine: systematic review.European journal of clinical pharmacology · 2025Pooled it
- Quantitative systems toxicology (QST) reproduces species differences in PF-04895162 liver safety due to combined mitochondrial and bile acid toxicity.Pharmacology research & perspectives · 2019Trial
- Metabolic activation and analgesic effect of flupirtine in healthy subjects, influence of the polymorphic NAT2, UGT1A1 and GSTP1.British journal of clinical pharmacology · 2015Trial
- From Retigabine to Azetukalner: Reviving Voltage-Gated Potassium Channels for Epilepsy Therapy.Archiv der Pharmazie · 2026Review
- A Flupirtine Benzyl Carbamate Improves Neurocognitive Deficits and Molecular Pathology in theCells · 2026Article
- Mechanism-based nonopioid analgesic targets.The Journal of clinical investigation · 2025Review
- A high-throughput assay platform to discover small molecule activators of the phospholipase PLC-γ2 to treat Alzheimer's disease.The Journal of biological chemistry · 2025Article
- Carba Analogues of Flupirtine and Retigabine with Improved Oxidation Resistance and Reduced Risk of Quinoid Metabolite Formation.ChemMedChem · 2022Article
- Alternative Targets for Modulators of Mitochondrial Potassium Channels.Molecules (Basel, Switzerland) · 2022Review
- What Is New in Classification, Diagnosis and Management of Chronic Musculoskeletal Pain: A Narrative Review.Frontiers in pain research (Lausanne, Switzerland) · 2022Review
- Activation ofAmerican journal of physiology. Cell physiology · 2021Article
- Expert consensus of Chinese Association for the Study of Pain on the non-opioid analgesics for chronic musculoskeletal pain.World journal of clinical cases · 2021Review
- Activation of SGK1.1 Upregulates the M-current in the Presence of Epilepsy Mutations.Frontiers in molecular neuroscience · 2021Article
- PXR-mediated idiosyncratic drug-induced liver injury: mechanistic insights and targeting approaches.Expert opinion on drug metabolism & toxicology · 2020Review
- Detrusor Smooth Muscle KFrontiers in physiology · 2020Review
- Pharmacological Manipulation of KFrontiers in physiology · 2020Review
- Brain Distribution and Metabolism of Flupirtine, a Nonopioid Analgesic Drug with Antiseizure Effects, in Neonatal Rats.Pharmaceutics · 2018Article
- Flupirtine drug-induced liver injury in a patient developing acute liver failure.BMJ case reports · 2018Article
- Non-Specific Low Back Pain.Deutsches Arzteblatt international · 2017Review
- Quercetin prevents alcohol-induced liver injury through targeting of PI3K/Akt/nuclear factor-κB and STAT3 signaling pathway.Experimental and therapeutic medicine · 2017Article
Corrections and comments
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Authors and funding
5 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo determine efficacy of the analgesic flupirtine in the treatment of overactive bladder syndrome in a proof-of-concept study.
methodsDouble-blind, double-dummy, three-armed comparison of flupirtine extended release (400 mg/day, titrated to 600 mg/day), tolterodine extended release (4 mg/day) and placebo for 12 weeks.
resultsWhen major elevations of liver enzymes (more than three times the upper normal limit) were detected in several flupirtine-exposed patients, the study was prematurely discontinued. Based on study-end data, hepatotoxicity was detected in 31% of patients receiving flupirtine for ≥ 6 weeks.
conclusionsUnexpected frequent and relevant toxicity can occur when testing an established drug for a new indication.
Indexed as
Identifiers
What OpenQuestion holds
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.