Background incidence of liver chemistry abnormalities in a clinical trial population without underlying liver disease

Weil, J.; Bains, Chanchal; Linke, A; Clark, Douglas W.; Stirnadel, Heide A.; Hunt, Christine M.

doi:10.1016/j.yrtph.2008.06.001

Cited by 21 publications

(13 citation statements)

References 14 publications

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“…The elevation rates of ALT (1.09% > 3 × ULN) and ALP (1.41 > 2 × ULN) in the current analysis were higher than those previously reported from late phase clinical trials 7. This could be due to trial selection criteria.…”

Section: Resultscontrasting

confidence: 81%

Pretreatment data is highly predictive of liver chemistry signals in clinical trials

Cai

Bresell²,

Steinberg³

et al. 2012

DDDT

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PurposeThe goal of this retrospective analysis was to assess how well predictive models could determine which patients would develop liver chemistry signals during clinical trials based on their pretreatment (baseline) information.Patients and methodsBased on data from 24 late-stage clinical trials, classification models were developed to predict liver chemistry outcomes using baseline information, which included demographics, medical history, concomitant medications, and baseline laboratory results.ResultsPredictive models using baseline data predicted which patients would develop liver signals during the trials with average validation accuracy around 80%. Baseline levels of individual liver chemistry tests were most important for predicting their own elevations during the trials. High bilirubin levels at baseline were not uncommon and were associated with a high risk of developing biochemical Hy’s law cases. Baseline γ-glutamyltransferase (GGT) level appeared to have some predictive value, but did not increase predictability beyond using established liver chemistry tests.ConclusionIt is possible to predict which patients are at a higher risk of developing liver chemistry signals using pretreatment (baseline) data. Derived knowledge from such predictions may allow proactive and targeted risk management, and the type of analysis described here could help determine whether new biomarkers offer improved performance over established ones.

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Section: Resultscontrasting

confidence: 81%

Pretreatment data is highly predictive of liver chemistry signals in clinical trials

Cai

Bresell²,

Steinberg³

et al. 2012

DDDT

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“…Another US sample, in which the majority of individuals were overweight, reported the highest prevalence of abnormal ALT (>40 IU/l), with 39.4% [35]. Five studies presented the prevalence of abnormal LFTs for different reference ranges, highlighting the effects of different cutoff levels on the percentage prevalence [10,25,28,38,43]. Overall, male individuals were more likely to have abnormal LFTs.…”

Section: Prevalence Of Abnormal Liver Function Testsmentioning

confidence: 99%

A systematic review of the prevalence of mildly abnormal liver function tests and associated health outcomes

Radcke¹,

Dillon

Murray

2015

European Journal of Gastroenterology &Amp; Hepatology

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Liver function tests (LFTs) are commonly performed to investigate asymptomatic individuals or those with nonspecific symptoms. Understanding the prevalence of mildly abnormal LFTs in the general population and the prevalence of liver disease following abnormal LFTs has important implications for the planning of care pathways and the provision of healthcare services. A systematic review of the literature on the prevalence of abnormal LFTs in the general population and their respective health outcomes was conducted. A total of 37 studies reporting data on the prevalence of abnormal LFTs (published between 2000 and 2014) were identified from online database searches or were manually selected from article bibliographies. The prevalence of mildly abnormal LFTs, with one or more abnormal constituents in the LFT, was high at 10-21.7%. The prevalence of severe liver disease within cohorts with abnormal LFTs is relatively low (<5%), and a large proportion of abnormal LFTs remains unexplained. Among individuals with unexplained abnormal LFTs, risk factors include obesity and insulin resistance. Common aetiologies for abnormal LFTs were non-alcohol-related fatty liver disease (NAFLD), followed by alcohol use and viral infections. In addition, normal LFTs do not rule out liver disease. The prevalence of abnormal LFTs depends on the definition and population but is likely to be between 10 and 20% in the general population. Abnormal LFTs are associated with a range of health outcomes but are not necessarily strongly diagnostic of severe liver pathology. Important areas of future research include further studies on the prevalence and predictive ability of LFTs in large, population-representative samples.

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“…In comparison, these estimates are higher than the incidence of Hy's law reported in published literature for patients without cancer. Specifically, in a pooled analysis of 28 clinical trials studying nononcologic patients (irritable bowel syndrome, osteoporosis, and migraine), the authors reported that no patients experienced both an ALT ≥3× ULN and TBL ≥1.5× ULN among 18 672 patients (92% women) without underlying liver disease in over 70 000 person‐months of follow‐up . Even with less stringent criterion of TBL ≥1.5× ULN, rather than TBL >2× ULN per Hy's law criteria, the estimated incidence of Hy's law based on LLTs would be approximately <1 in 18 000 patients (~0.5 per 10 000 patients).…”

Section: Discussionmentioning

confidence: 66%

Incidence of liver injury among cancer patients receiving chemotherapy in an integrated health system

Yood

Bortolini

Casso³

et al. 2015

Pharmacoepidemiology and Drug

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Background incidence of liver chemistry abnormalities in a clinical trial population without underlying liver disease

Cited by 21 publications

References 14 publications

Pretreatment data is highly predictive of liver chemistry signals in clinical trials

Pretreatment data is highly predictive of liver chemistry signals in clinical trials

A systematic review of the prevalence of mildly abnormal liver function tests and associated health outcomes

Incidence of liver injury among cancer patients receiving chemotherapy in an integrated health system

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