Evidence map›Paper›PMID 11259986›Full record

Trial reportBritish journal of clinical pharmacology2001

The effects of lacidipine on the steady/state plasma concentrations of simvastatin in healthy subjects.

L Ziviani, L Da Ros, L Squassante, S Milleri, M Cugola, L E Iavarone

Open access · greenAbstract readClinical TrialRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2001. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
4.3field-weighted citation impact, top 6% 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

9 citing papers in PubMed, 23 citations in OpenAlex.

  1. Article
  2. Manipulating fenestrations in young and old liver sinusoidal endothelial cells.American journal of physiology. Gastrointestinal and liver physiology · 2019
    Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Simvastatin reduces VCAM-1 expression in human umbilical vein endothelial cells exposed to lipopolysaccharide.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2012
    Article
  9. 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

6 authors at 1 institution in 1 country.

L ZivianiGlaxo Wellcome, Medicine Research Centre, Verona, Italy. lz6673@glaxowellcome.co.uk
L Da Ros
L Squassante
S Milleri
M Cugola
L E Iavarone
Wellcome Library · GB

Funding

Wellcome Trust
6 · The paper itself

Abstract

aimsLacidipine, a long acting 2, 4-dihydropyridine calcium channel antagonist is frequently administered with cholesterol lowering agents, particularly in elderly populations. The effects of lacidipine on the pharmacokinetics of simvastatin were investigated, since they share the CYP3A4 pathway for metabolism.

methodsThe study was an open, randomised, two-way crossover design, with at least 7 days washout. Eighteen healthy subjects received simvastatin, 40 mg once daily, alone and together with lacidipine, 4 mg once daily, for 8 days. The pharmacokinetics of simvastatin were studied on the eighth day. Analysis was made of total simvastatin acid concentrations (naive simvastatin acid plus that derived from alkaline hydrolysis of the lactone).

resultsLacidipine increased the maximum concentration of simvastatin (Cmax) by approximately 70% (P=0.016) and the area under the plasma concentration-time curve AUC(0,24 h) by approximately 35% (P=0.001). The mean Cmax and AUC(0,24 h) of simvastatin (95% confidence interval) when given alone were 8.76 (6.72-11.41) ng ml(-1) and 60.36 (47.15-77.28) ng ml(-1) h. During treatment with lacidipine they were, respectively, 14.89 (10.77-20.58) ng ml(-1) and 80.96 (64.62-101.44) ng ml(-1) h. No significant differences were observed in either time to peak concentration (tmax was 1.0 h for simvastatin alone and 1.5 h for the combination) or in the half-life (t1/2,z was 8.5 h in both cases). The combination was safe and well tolerated.

conclusionsThe observed increased exposure to simvastatin 40 mg following coadministration of lacidipine is unlikely to be of clinical relevance.

Indexed as

AdultCalcium Channel BlockersCross-Over StudiesDihydropyridinesDrug InteractionsFemaleHumansHypolipidemic AgentsMaleSimvastatinCalcium Channel BlockersDihydropyridinesHypolipidemic AgentslacidipineSimvastatin

Identifiers

PMID11259986
PMCPMC2014440
OpenAlexW2042139205

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.