Evidence map›Paper›PMID 19667285›Full record

Trial reportAntimicrobial agents and chemotherapy2009

Differential effects of tipranavir plus ritonavir on atorvastatin or rosuvastatin pharmacokinetics in healthy volunteers.

P A Pham, C J L la Porte, L S Lee, R van Heeswijk, J P Sabo, M M Elgadi, P J Piliero, P Barditch-Crovo, E Fuchs, C Flexner and 1 more

Open access · greenAbstract readClinical Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
2.1field-weighted citation impact, top 13% 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

21 citing papers in PubMed, 66 citations in OpenAlex.

  1. Trial
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  11. Transcription factor-mediated regulation of the BCRP/Expert opinion on drug metabolism & toxicology · 2020
    Review
  12. Article
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  14. Evidence-based review of statin use in patients with HIV on antiretroviral therapy.Journal of clinical & translational endocrinology · 2017
    Review
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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

11 authors at 6 institutions in 2 countries.

P A PhamJohns Hopkins University School of Medicine, Baltimore, Maryland, USA. vpham@jhmi.edu
C J L la Porte
L S Lee
R van Heeswijk
J P Sabo
M M Elgadi
P J Piliero
P Barditch-Crovo
E Fuchs
C Flexner
D W Cameron
Johns Hopkins University · USBoehringer Ingelheim (United States) · USJohns Hopkins Medicine · USOttawa Hospital · CABoehringer Ingelheim (Canada) · CAUniversity of Ottawa · CA

Funding

ZINC AND CA EDTA THERAPY OF PLUMBISMM01RR000052 · NCRR · JOHNS HOPKINS UNIVERSITY · PI BELCHER, HAROLYN MILLICENT EDITH · 1985 to 2007
$37.3M
NCRR NIH HHS M01 RR000052NCRR NIH HHS RR-00052
6 · The paper itself

Abstract

To identify pharmacokinetic (PK) drug-drug interactions between tipranavir-ritonavir (TPV/r) and rosuvastatin and atorvastatin, we conducted two prospective, open-label, single-arm, two-period studies. The geometric mean (GM) ratio was 1.37 (90% confidence interval [CI], 1.15 to 1.62) for the area under the concentration-time curve (AUC) for rosuvastatin and 2.23 (90% CI, 1.83 to 2.72) for the maximum concentration of drug in serum (Cmax) for rosuvastatin with TPV/r at steady state versus alone. The GM ratio was 9.36 (90% CI, 8.02 to 10.94) for the AUC of atorvastatin and 8.61 (90% CI, 7.25 to 10.21) for the Cmax of atorvastatin with TPV/r at steady state versus alone. Tipranavir PK parameters were not affected by single-dose rosuvastatin or atorvastatin. Mild gastrointestinal intolerance, headache, and mild reversible liver enzyme elevations (grade 1 and 2) were the most commonly reported adverse drug reactions. Based on these interactions, we recommend low initial doses of rosuvastatin (5 mg) and atorvastatin (10 mg), with careful clinical monitoring of rosuvastatin- or atorvastatin-related adverse events when combined with TPV/r.

Indexed as

AdolescentAdultAgedAnti-HIV AgentsAtorvastatinDrug InteractionsFemaleFluorobenzenesHeptanoic AcidsHumansMaleMiddle AgedPyridinesPyrimidinesPyronesPyrrolesAnti-HIV AgentsAtorvastatinFluorobenzenesHeptanoic AcidsPyridinesPyrimidinesPyronesPyrrolesRitonavirRosuvastatin CalciumSulfonamidestipranavir

Identifiers

PMID19667285
PMCPMC2764168
OpenAlexW2121928714

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.