Evidence map›Paper›PMID 16133549›Full record

Trial reportEuropean journal of clinical pharmacology2005

Pharmacodynamic evaluation of warfarin and rosuvastatin co-administration in healthy subjects.

Daisy Jindal, Monika Tandon, Sanjay Sharma, K K Pillai

Abstract readClinical TrialRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of clinical pharmacology, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact, top 81% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Statin use decreases coagulation in users of vitamin K antagonists.European journal of clinical pharmacology · 2016
    Trial
  3. Article
  4. Article
  5. 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

4 authors at 1 institution in 1 country.

Daisy JindalApollo Hospital, New Delhi, India. jindal_daisy@yahoo.com
Monika Tandon
Sanjay Sharma
K K Pillai
Jamia Hamdard · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo determine whether co-administration of rosuvastatin alters the pharmacodynamics of warfarin, thereby requiring additional monitoring of the anticoagulant effects of warfarin.

methodsIn this open-labeled, placebo-controlled, randomized, two-period, crossover trial with a washout period of 15 days, 12 healthy male volunteers were administered daily oral doses of 5 mg warfarin for 14 days. Either rosuvastatin 40 mg/day (treatment A) or placebo (treatment B) was concomitantly administered on days 8-14. The pharmacodynamic parameters prothrombin time (PT) and international normalized ratio (INR) were evaluated on all 14 days pre-dose during both study periods. On the 8th, 10th, 12th, and 14th days of each study period, PT and INR were also measured at 4 h post-dose of rosuvastatin or placebo. Bleeding time and clotting time were assessed on the 1st, 8th, and 14th days pre-dose.

resultsData of 10 subjects have been analyzed. No significant effect of rosuvastatin was seen on the steady-state pharmacodynamics of warfarin during concomitant administration.

conclusionRosuvastatin did not significantly alter the anticoagulant effects of warfarin in this study.

Indexed as

Administration, OralAdultAnticoagulantsBlood CoagulationCross-Over StudiesDrug InteractionsDrug Therapy, CombinationFluorobenzenesHumansHydroxymethylglutaryl-CoA Reductase InhibitorsInternational Normalized RatioMaleProthrombin TimePyrimidinesRosuvastatin CalciumSulfonamidesAnticoagulantsFluorobenzenesHydroxymethylglutaryl-CoA Reductase InhibitorsPyrimidinesRosuvastatin CalciumSulfonamidesWarfarin

Identifiers

PMID16133549
OpenAlexW2160559640

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.