Evidence map›Paper›PMID 27681702›Full record

Trial reportDrugs & aging2016

Effects of Renal Impairment on Steady-State Plasma Concentrations of Rivastigmine: A Population Pharmacokinetic Analysis of Capsule and Patch Formulations in Patients with Alzheimer's Disease.

Gilbert Lefèvre, Francesca Callegari, Sandro Gsteiger, Yuan Xiong

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Drugs & aging, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00099242 (Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.6field-weighted citation impact, top 24% 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.

NCT00099242 phase3completednot on this map

Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease

TypeinterventionalSponsorNovartis PharmaceuticalsRan2003 to 2006Enrolled1,040ConditionsAlzheimer's Disease, Dementia, Alzheimer TypeArmsrivastigmine transdermal patch
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 15 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. 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 2 institutions in 1 country.

Gilbert LefèvreWSJ-386.12.48.10, Novartis Institutes for Biomedical Research, Translational Medicine, Clinical PK/PD, 4002, Basel, Switzerland. gilbert.lefevre@novartis.com.
Francesca CallegariNovartis Pharma AG, 4002, Basel, Switzerland.
Sandro GsteigerNovartis Pharma AG, 4002, Basel, Switzerland.
Yuan XiongNovartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, USA.
Novartis (Switzerland) · CHNovartis Institutes for BioMedical Research

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe glomerular filtration rate (GFR), a measure of renal function, decreases by approximately 10 mL/min every 10 years after the age of 40 years, which could lead to the accumulation of drugs and/or renal toxicity. Pharmacokinetic studies of drugs excreted both renally and non-renally are desirable in patients with impaired renal function, defined by parameters including estimated GFR (eGFR) and creatinine clearance (CL

objectiveWe describe here a population pharmacokinetic analysis of the possible effects of renal impairment on steady-state plasma concentrations of rivastigmine and its metabolite NAP226-90 after rivastigmine patch (5 cm

methodsThe data used to conduct the current pharmacokinetic analysis were obtained from the pivotal phase III, 24-week, multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group study (IDEAL). One blood sample was collected from each patient at steady-state to measure plasma concentrations of rivastigmine and NAP226-90 using a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The steady-state plasma concentrations of rivastigmine and NAP226-90 were plotted against CL

resultsThe two groups (mild/no renal impairment vs. moderate/severe/end-stage renal impairment) showed comparable demographic covariates for all patch sizes and capsule doses. No correlation was observed between CL

conclusionThe results of this study show that renal function does not affect rivastigmine or NAP226-90 steady-state plasma concentrations, and no dose adjustment in patients with renal impairment is required. CLINICALTRIALS.GOV: NCT00099242.

Indexed as

AgedAlzheimer DiseaseCapsulesDouble-Blind MethodFemaleGlomerular Filtration RateHumansMaleMiddle AgedNeuroprotective AgentsPhenethylaminesPhenolsRenal InsufficiencyRivastigmineTandem Mass SpectrometryTransdermal Patch3-(1-dimethylaminoethyl)phenolCapsulesNeuroprotective AgentsPhenethylaminesPhenolsRivastigmine

Identifiers

PMID27681702
PMCPMC5075013
OpenAlexW2525205867

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.