Evidence map›Paper›PMID 11453887›Full record

Trial reportBritish journal of clinical pharmacology2001

Pharmacokinetic-pharmacodynamic model for perindoprilat regional haemodynamic effects in healthy volunteers and in congestive heart failure patients.

E Bellissant, J F Giudicelli

Registry-linked trialOpen access · bronzeAbstract readClinical TrialComparative StudyRandomized 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. It is linked to trial NCT01682577 (Bioequivalence Study of 4 mg Perindopril Tablets Produced by PT Dexa Medica in Comparison With the Reference Tablets), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 45% 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.

NCT01682577 nacompletednot on this mapstarted 2008, after this paper: background citation

Bioequivalence Study of 4 mg Perindopril Tablets Produced by PT Dexa Medica in Comparison With the Reference Tablets (Prexum® 4 mg, Servier)Under Fasting Condition

TypeinterventionalSponsorDexa Medica GroupRan2008 to 2008Enrolled18ConditionsHealthyArmsPerindopril 4 mg tablets of PT Dexa Medica, Perindopril 4 mg tablets of Servier
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Review
  6. Understanding the hysteresis loop conundrum in pharmacokinetic/pharmacodynamic relationships.Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2014
    Article
  7. Review
  8. 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

2 authors at 2 institutions in 1 country.

E BellissantService de Pharmacologie Clinique, Hôpital de Bicêtre, Le Kremlin-Bicêtre, France.
J F Giudicelli
Bicêtre Hospital · FRCIC Rennes · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsWe compared the relationships between the plasma concentrations (C) of perindoprilat, active metabolite of the angiotensin I-converting enzyme inhibitor (ACEI) perindopril, and the effects (E) induced on plasma converting enzyme activity (PCEA) and brachial vascular resistance (BVR) in healthy volunteers (HV) and in congestive heart failure (CHF) patients after single oral doses of perindopril.

methodsSix HV received three doses of perindopril (4, 8, 16 mg) in a placebo-controlled, randomized, double-blind, crossover study whereas 10 CHF patients received one dose (4 mg) in an open study. Each variable was determined before and 6-12 times after drug intake. E (% variations from baseline) were individually related to C (ng ml(-1)) by the Hill model E=Emax x Cgamma/(CE50gamma + Cgamma). When data showed a hysteresis loop, an effect compartment was used.

results(means+/-s.d.) In HV, relationships between C and E were direct whereas in CHF patients, they showed hysteresis loops with optimal k(e0) values of 0.13 +/- 0.16 and 0.13 +/- 0.07 h(-1) for PCEA and BVR, respectively. For PCEA, with Emax set to -100%, CE50 = 1.87 +/- 0.60 and 1.36 +/- 1.33 ng ml(-1) (P = 0.34) and gamma = 0.90 +/- 0.13 and 1.11 +/- 0.47 (P = 0.23) in HV and CHF patients, respectively. For BVR, Emax= -41 +/- 14% and -60 +/- 7% (P = 0.02), CE50 = 4.95 +/- 2.62 and 1.38 +/- 0.85 ng ml(-1) (P = 0.02), and gamma = 2.25 +/- 1.54 and 3.06 +/- 1.37 (P = 0.32) in HV and CHF patients, respectively.

conclusionsWhereas concentration-effect relationships were similar in HV and CHF patients for PCEA blockade, they strongly differed for regional haemodynamics. This result probably expresses the different involvements, in HV and CHF patients, of angiotensinergic and nonangiotensinergic mechanisms in the haemodynamic effects of ACEIs.

Indexed as

AdultAngiotensin-Converting Enzyme InhibitorsBrachial ArteryCardiovascular AgentsCross-Over StudiesDouble-Blind MethodFemaleHeart FailureHemodynamicsHumansIndolesMaleMiddle AgedPeptidyl-Dipeptidase APerindoprilVascular ResistanceAngiotensin-Converting Enzyme InhibitorsCardiovascular AgentsIndolesPeptidyl-Dipeptidase APerindoprilperindoprilat

Identifiers

PMID11453887
PMCPMC2014509
OpenAlexW1711353201

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.