Evidence map›Paper›PMID 25202920›Full record

ArticleJournal of acquired immune deficiency syndromes (1999)2014

Lack of pharmacokinetic interactions between pitavastatin and efavirenz or darunavir/ritonavir.

Carlos D Malvestutto, Qing Ma, Gene D Morse, James A Underberg, Judith A Aberg

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in Journal of acquired immune deficiency syndromes (1999), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01695954. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
2.5field-weighted citation impact, top 10% of its field
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.

NCT01695954 phase1completed

The Effect of Efavirenz and Ritonavir-boosted Darunavir on the Pharmacokinetics of the HMG CoA Reductase Inhibitor Pitavastatin

Ran2012Enrolled34Registered outcomes3Posted comparisons0ConditionsHIV, HyperlipidemiaArmsDarunavir, Efavirenz, Pitavastatin, Ritonavir
Open the trial in the graph
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pitavastatin to Prevent Cardiovascular Disease in HIV Infection.The New England journal of medicine · 2023 · on this map
    Trial
  4. Trial
  5. Trial
  6. Trial
  7. Review
  8. Review
  9. Review
  10. Article
  11. Review
  12. Article
  13. Article
  14. Review
  15. Evidence-based review of statin use in patients with HIV on antiretroviral therapy.Journal of clinical & translational endocrinology · 2017
    Review
  16. Review
  17. Statins to improve cardiovascular outcomes in treated HIV infection.Current opinion in infectious diseases · 2016
    Review
  18. Article
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

5 authors at 3 institutions in 1 country.

Carlos D Malvestutto*Division of Infectious Disease, Department of Medicine, New York University School of Medicine, New York, NY; †Division of Infectious Disease, Department of Medicine, Ohio State University Medical Center, Columbus, OH; ‡FACES Program, Nationwide Children's Hospital, Columbus, OH; §Translational Pharmacology Research Core, New York State Center of Excellence in Bioinformatics and Life Sciences, Buffalo, NY; ‖Department of Pharmacy Practice, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, Buffalo, NY; and ¶Division of Infectious Disease, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY.
Qing Ma
Gene D Morse
James A Underberg
Judith A Aberg
New York University · USUniversity at Buffalo, State University of New York · USNationwide Children's Hospital · US

Funding

INSTITUTIONAL CLINICAL AND TRANSLATIONAL SCIENCE AWARDUL1RR029893 · NCRR · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI CRONSTEIN, BRUCE NEIL · 2009 to 2011
$17.7M
Institutional Clinical and Translational Science AwardUL1TR000038 · NCATS · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI CRONSTEIN, BRUCE NEIL · 2012 to 2014
$16.8M
New York University HIV/AIDS Clinical Trial UnitU01AI069532 · NIAID · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI ABERG, JUDITH ANN · 2007 to 2011
$7.5M
New York University HIV/AIDS Clinical Trial UnitUM1AI069532 · NIAID · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI ABERG, JUDITH ANN · 2012 to 2014
$2.9M
Antiretroviral pharmacogenomics, pharmacokinetics and toxicity in neuroAIDSK08MH098794 · NIMH · STATE UNIVERSITY OF NEW YORK AT BUFFALO · PI MA, QING · 2012 to 2016
$599k
NCATS NIH HHS UL1 TR000038NCATS NIH HHS UL1TR000038NCRR NIH HHS 1UL1RR029893NCRR NIH HHS UL1 RR029893NIAID NIH HHS AI069532NIAID NIH HHS U01 AI069532NIAID NIH HHS UM1 AI069532NIMH NIH HHS K08 MH098794NIMH NIH HHS K08MH098794
6 · The paper itself

Abstract

backgroundThe drug-drug interactions between pitavastatin and darunavir/ritonavir (DRV/r) as well as pitavastatin and efavirenz (EFV) were examined in an open-label, parallel-arm, pharmacokinetic (PK) study in HIV-uninfected healthy volunteers.

methodsSubjects received a pitavastatin dose of 2 mg for 4 days, followed by either EFV 600 mg (n = 14) or DRV/r 800/100 mg (n = 14) daily for 10 days, and pitavastatin 2 mg coadministered with EFV 600 mg or DRV/r 800/100 mg for 4 days. Full PK profiles were determined for pitavastatin and its lactone metabolite on days 4 and 18 and for EFV or DRV on days 14 and 18.

resultsIn the EFV arm, the geometric mean area under the concentration time curve (AUC0-τ) and Cmax of pitavastatin were 85.3 ng·h·mL and 15.6 ng/mL, respectively, when given alone, versus 76 ng·h·mL and 18.8 ng/mL when coadministered with EFV. The geometric mean ratio for pitavastatin with EFV versus alone was 0.89 [90% confidence interval (CI): 0.73 to 1.09] for AUC0-τ and 1.20 (90% CI: 0.79 to 1.83) for Cmax. In the DRV/r arm, AUC0-τ and Cmax were 62.8 ng·h·mL and 24.0 ng/mL, respectively, when pitavastatin was administered alone, versus 56.9 ng·h·mL and 23.2 ng/mL when coadministered with DRV/r. The geometric mean ratio for pitavastatin with DRV/r versus alone was 0.91 (90% CI: 0.78 to 1.06) for AUC0-τ and 0.93 (90% CI: 0.72 to 1.19) for Cmax.

conclusionsThere were no significant PK interactions between pitavastatin and EFV or DRV/r. No significant safety issues or lipid changes were noted.

Indexed as

AdolescentAdultAlkynesAnti-HIV AgentsBenzoxazinesCyclopropanesDarunavirDrug InteractionsFemaleHIV Protease InhibitorsHumansHydroxymethylglutaryl-CoA Reductase InhibitorsMaleMiddle AgedQuinolinesRitonavirAlkynesAnti-HIV AgentsBenzoxazinesCyclopropanesDarunavirefavirenzHIV Protease InhibitorsHydroxymethylglutaryl-CoA Reductase InhibitorspitavastatinQuinolinesRitonavirSulfonamides

Identifiers

PMID25202920
PMCPMC4404408
OpenAlexW2317619427

What OpenQuestion holds

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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.