Evidence map›Paper›PMID 11709322›Full record

Trial reportAntimicrobial agents and chemotherapy2001

Pharmacokinetic interactions between nelfinavir and 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors atorvastatin and simvastatin.

P H Hsyu, M D Schultz-Smith, J H Lillibridge, R H Lewis, B M Kerr

Open access · greenAbstract readClinical Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2001. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed
6.4field-weighted citation impact, top 3% 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.

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

31 citing papers in PubMed, 144 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Article
  7. Review
  8. Evidence-based review of statin use in patients with HIV on antiretroviral therapy.Journal of clinical & translational endocrinology · 2017
    Review
  9. Article
  10. Treatment of dyslipidemia in HIV.Current atherosclerosis reports · 2015
    Review
  11. Article
  12. Article
  13. Review
  14. Risk assessment of mechanism-based inactivation in drug-drug interactions.Drug metabolism and disposition: the biological fate of chemicals · 2012
    Article
  15. Article
  16. Review
  17. Article
  18. Article
  19. Clinical pharmacokinetics of darunavir.Clinical pharmacokinetics · 2007
    Review
  20. MDR- and CYP3A4-mediated drug-drug interactions.Journal of neuroimmune pharmacology : the official journal of the Society on NeuroImmune Pharmacology · 2006
    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

5 authors at 2 institutions in 1 country.

P H HsyuAgouron Pharmaceuticals Inc., A Pfizer Company, La Jolla, California, USA. poe.hsyu@agouron.com
M D Schultz-Smith
J H Lillibridge
R H Lewis
B M Kerr
Agouron Institute · USPfizer (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

3-Hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors are effective agents in lowering cholesterol and triglycerides and are being used by human immunodeficiency virus-positive patients to treat the lipid elevation that may be associated with antiretroviral therapy. Many HMG-CoA reductase inhibitors and protease inhibitors are metabolized by the same cytochrome P450 enzyme 3A4 (CYP3A4). In addition, many protease inhibitors are potent inhibitors of CYP3A4. Therefore, coadministration of these two classes of drugs may cause significant drug interactions. This open-label, multiple-dose study was performed to determine the interactions between nelfinavir, a protease inhibitor, and two HMG-CoA reductase inhibitors, atorvastatin and simvastatin, in healthy volunteers. Thirty-two healthy subjects received either atorvastatin calcium (10 mg once a day) or simvastatin (20 mg once a day) for the first 14 days of the study. Nelfinavir (1,250 mg twice a day) was added on days 15 to 28. Pharmacokinetic assessment was performed on days 14 and 28. The study drugs were well tolerated. Nelfinavir increased the steady-state area under the plasma concentration-time curve during one dosing period (AUC(tau)) of atorvastatin 74% and the maximum concentration (C(max)) of atorvastatin 122% and increased the AUC(tau) of simvastatin 505% and the C(max) of simvastatin 517%. Neither atorvastatin nor simvastatin appeared to alter the pharmacokinetics of nelfinavir. It is recommended that coadministration of simvastatin with nelfinavir should be avoided, whereas atorvastatin should be used with nelfinavir with caution.

Indexed as

AdultAnti-HIV AgentsArea Under CurveAtorvastatinDrug InteractionsFemaleHeptanoic AcidsHumansHydroxymethylglutaryl-CoA Reductase InhibitorsLipidsMaleNelfinavirPyrrolesSimvastatinAnti-HIV AgentsAtorvastatinHeptanoic AcidsHydroxymethylglutaryl-CoA Reductase InhibitorsLipidsNelfinavirPyrrolesSimvastatin

Identifiers

PMID11709322
PMCPMC90851
OpenAlexW2157402102

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.