Evidence map›Paper›PMID 21927836›Full record

Trial reportEuropean journal of clinical pharmacology2012

The effect of different dosing regimens of levodopa/carbidopa/entacapone on plasma levodopa concentrations.

Kimmo Ingman, Tarja Naukkarinen, Mikko Vahteristo, Irja Korpela, Mikko Kuoppamäki, Juha Ellmén

Abstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of clinical pharmacology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.7field-weighted citation impact, top 16% 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

12 citing papers in PubMed, 27 citations in OpenAlex.

  1. Trial
  2. Effect of Opicapone on Levodopa Pharmacokinetics in Patients with Fluctuating Parkinson's Disease.Movement disorders : official journal of the Movement Disorder Society · 2022
    Trial
  3. Trial
  4. Trial
  5. Review
  6. Clinical Pharmacology of Entacapone (Comtan) From the FDA Reviewer.The international journal of neuropsychopharmacology · 2022
    Article
  7. Article
  8. Modern treatment in Parkinson's disease, a personal approach.Journal of neural transmission (Vienna, Austria : 1996) · 2016
    Review
  9. Article
  10. Article
  11. Review
  12. Therapy for Parkinson's disease: what is in the pipeline?Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2014
    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 2 countries.

Kimmo IngmanPhase I Unit, Orion Pharma, Orion Corporation, Espoo, Finland. kimmo.ingman@orionpharma.com
Tarja Naukkarinen
Mikko Vahteristo
Irja Korpela
Mikko Kuoppamäki
Juha Ellmén
Orion Corporation (Finland) · FI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRepeated dosing of levodopa/carbidopa/entacapone (LCE) has shown a favourable pharmacokinetic (PK) profile compared with levodopa/carbidopa (LC), but increases maximum plasma levodopa concentrations (C(max)) during the day. High levodopa concentrations are associated with peak-dose dyskinesias. PURPOSE: To determine whether administering LCE 75/18.5/200 and 125/31.5/200 mg (LCE 75 and LCE 125) following a morning dose of LCE 100/25/200 and 150/37.5/200 mg (LCE 100 and LCE 150), respectively, would avoid the increase in levodopa C(max) values observed during multiple dosing of LCE 100 and LCE 150.

methodsThis was an open, randomized, three-period, crossover PK trial in healthy volunteers (n = 19). Subjects were randomized to Group 1 or 2. Group 1 received in random sequence: LCE 150 followed by LCE 125 three times daily (tid); LCE 150 four times daily (qid); LC 150 qid. Group 2 received in random sequence: LCE 100 followed by LCE 75 tid; LCE 100 qid; LC 100 qid. Levodopa C(max), minimum plasma concentration (C(min)), area under the curve (AUC(0-14)) and peak-trough fluctuation (PTF) were calculated up to 14 h after the first dose.

resultsLevodopa C(max) was not increased when the LCE dose was decreased by 25 mg after the morning dose. In comparison to LC, levodopa C(min) levels and AUC(0-14) values for LCE were significantly higher, while the levodopa PTF was significantly smaller.

conclusionsReducing the dose of LCE by 25 mg following the first morning dose results in a more consistent levodopa C(max) profile, avoiding levodopa accumulation while maintaining significantly higher C(min) levels and AUC(0-14) values compared with LC.

Indexed as

AdultAntiparkinson AgentsArea Under CurveCarbidopaCatecholsCross-Over StudiesDopamine AgentsDrug CombinationsDrug InteractionsFemaleHumansLevodopaMaleNitrilesYoung AdultAntiparkinson AgentsCarbidopaCatecholsDopamine AgentsDrug CombinationsentacaponeLevodopaNitriles

Identifiers

PMID21927836
OpenAlexW2093513113

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.