Trial reportEuropean journal of clinical pharmacology2007
The influence of hepatic impairment on the pharmacokinetics of the dipeptidyl peptidase IV (DPP-4) inhibitor vildagliptin.
Trial report in European journal of clinical pharmacology, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 1 synthesis or guideline pooled it, 64 citations in OpenAlex.
- Pooled it
- Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A State-of-the-Art Review.Journal of obesity & metabolic syndrome · 2023Review
- DPP-4 inhibitors for treating T2DM - hype or hope? an analysis based on the current literature.Frontiers in molecular biosciences · 2023Review
- Clinical Safety and Tolerability of Vildagliptin - Insights from Randomised Trials, Observational Studies and Post-marketing Surveillance.European endocrinology · 2017Review
- Vildagliptin and its metabolite M20.7 induce the expression of S100A8 and S100A9 in human hepatoma HepG2 and leukemia HL-60 cells.Scientific reports · 2016Article
- Role of dipeptidyl peptidase-4 inhibitors in new-onset diabetes after transplantation.The Korean journal of internal medicine · 2015Review
- Pharmacokinetics in patients with chronic liver disease and hepatic safety of incretin-based therapies for the management of type 2 diabetes mellitus.Clinical pharmacokinetics · 2014Review
- Review
- Comparative clinical pharmacokinetics of dipeptidyl peptidase-4 inhibitors.Clinical pharmacokinetics · 2012Review
- Clinical pharmacokinetics and pharmacodynamics of vildagliptin.Clinical pharmacokinetics · 2012Review
- Choosing between GLP-1 Receptor Agonists and DPP-4 Inhibitors: A Pharmacological Perspective.Journal of nutrition and metabolism · 2012Article
- Choosing a gliptin.Indian journal of endocrinology and metabolism · 2011Article
- Review
- Emerging treatment options for type 2 diabetes.British journal of clinical pharmacology · 2010Review
- The role of incretins in glucose homeostasis and diabetes treatment.Pharmacological reviews · 2008Review
- Incretin-based therapies in type 2 diabetes mellitus.The Journal of clinical endocrinology and metabolism · 2008Review
- Vildagliptin: a new oral treatment for type 2 diabetes mellitus.Vascular health and risk management · 2008Review
- The potential role of vildagliptin in the management and prevention of type 2 diabetes mellitus.Indian journal of pharmacology · 2008Article
- Consensus Statement on Dose Modifications of Antidiabetic Agents in Patients with Hepatic Impairment.Indian journal of endocrinology and metabolismReview
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 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveVildagliptin is a potent and selective dipeptidyl peptidase-IV (DPP-4) inhibitor that improves glycemic control in patients with type 2 diabetes mellitus by increasing alpha- and beta-cell responsiveness to glucose. This study investigated the pharmacokinetics of vildagliptin in patients with hepatic impairment compared with healthy subjects.
methodsThis was an open-label, parallel-group study in patients with mild (n = 6), moderate (n = 6) or severe (n = 4) hepatic impairment and healthy subjects (n = 6). All subjects received a single 100-mg oral dose of vildagliptin, and plasma concentrations of vildagliptin and its main pharmacologically inactive metabolite LAY151 were measured up to 36 h post-dose.
resultsExposure to vildagliptin (AUC(0-infinity) and C(max)) decreased non-significantly by 20 and 30%, respectively, in patients with mild hepatic impairment [geometric mean ratio (90% CI): AUC(0-infinity), 0.80 (0.60, 1.06), p = 0.192; C(max), 0.70 (0.46, 1.05), p = 0.149]. Exposure to vildagliptin was also decreased non-significantly in patients with moderate hepatic impairment [-8% for AUC(0-infinity), geometric mean ratio (90% CI): 0.92 (0.69, 1.23), p = 0.630; -23% for C(max), geometric mean ratio (90% CI): 0.77 (0.51, 1.17), p = 0.293]. In patients with severe hepatic impairment, C(max) was 6% lower than that in healthy subjects [geometric mean ratio (90% CI): 0.94 (0.59, 1.49), p = 0.285], whereas AUC(0-infinity) was increased by 22% [geometric mean ratio (90% CI): 1.22 (0.89, 1.68), p = 0.816). Across the hepatic impairment groups, LAY151 AUC(0-infinity) and C(max) were increased by 29-84% and 24-63%, respectively, compared with healthy subjects. The single 100-mg oral dose of vildagliptin was well tolerated by patients with hepatic impairment.
conclusionsThere was no significant difference in exposure to vildagliptin in patients with mild, moderate or severe hepatic impairment; therefore, no dose adjustment of vildagliptin is necessary in patients with hepatic impairment.
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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 Socratic graph.