Evidence map›Paper›PMID 30949874›Full record

ArticleClinical pharmacokinetics2019

Pharmacokinetics of the BCL-2 Inhibitor Venetoclax in Subjects with Hepatic Impairment.

Ahmed Hamed Salem, Nimita Dave, Thomas Marbury, Beibei Hu, Dale Miles, Suresh K Agarwal, Orlando F Bueno, Rajeev M Menon

Abstract readClinical Trial, Phase IMulticenter Study
PubMed Publisher
In one paragraph

Article in Clinical pharmacokinetics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Article
  7. Review
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Review
  16. Article
  17. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Ahmed Hamed SalemAbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA. ahmed.salem@abbvie.com.
Nimita DaveAbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA.
Thomas MarburyOrlando Clinical Research Center, Orlando, FL, 32809-3017, USA.
Beibei HuAbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA.
Dale MilesGenentech Inc., South San Francisco, CA, 94080, USA.
Suresh K AgarwalAbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA.
Orlando F BuenoAbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA.
Rajeev M MenonAbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionVenetoclax is a selective B cell lymphoma-2 inhibitor. It is approved for treatment of chronic lymphocytic leukemia and is being investigated for other hematological malignancies. Venetoclax is predominantly eliminated by the liver; therefore, there is a need to investigate the effect of hepatic insufficiency on venetoclax pharmacokinetics.

methodsA phase I study was carried out in 24 women with normal hepatic function or mild, moderate, or severe hepatic impairment (based on Child-Pugh scores), who received a single 50 mg dose of venetoclax with a low-fat meal. Blood samples were collected up to 120 h after venetoclax administration. Pharmacokinetic parameters were estimated using non-compartmental methods.

resultsVenetoclax maximum observed plasma concentration (C

conclusionsNo venetoclax dosage adjustment is required in subjects with mild or moderate hepatic impairment. In subjects with severe hepatic impairment, a 50% dose reduction of venetoclax is recommended to account for higher exposures and the longer half-life.

Indexed as

Administration, OralAgedAntineoplastic AgentsBridged Bicyclo Compounds, HeterocyclicCase-Control StudiesFemaleHalf-LifeHepatic InsufficiencyHumansLeukemia, Lymphocytic, Chronic, B-CellMiddle AgedProto-Oncogene Proteins c-bcl-2SafetySulfonamidesAntineoplastic AgentsBridged Bicyclo Compounds, HeterocyclicProto-Oncogene Proteins c-bcl-2Sulfonamidesvenetoclax

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.