Evidence map›Paper›PMID 33415500›Full record

SynthesisEuropean journal of clinical pharmacology2021

Safety and efficacy of tolcapone in Parkinson's disease: systematic review.

Carlo Alberto Artusi, Lidia Sarro, Gabriele Imbalzano, Margherita Fabbri, Leonardo Lopiano

Open access · hybridAbstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in European journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
3.3field-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

22 citing papers in PubMed, 37 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Review
  13. Review
  14. Review
  15. Review
  16. A molecular basis for tetramer destabilization and aggregation of transthyretin Ala97Ser.Protein science : a publication of the Protein Society · 2023
    Article
  17. Review
  18. Article
  19. Review
  20. 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

5 authors at 3 institutions in 2 countries.

Carlo Alberto ArtusiDepartment of Neuroscience "Rita Levi Montalcini", University of Torino, Via Cherasco 15, 10126, Torino, Italy. caartusi@gmail.com.ORCID http://orcid.org/0000-0001-8579-3772
Lidia SarroDepartment of Neurology, Martini Hospital, ASL Città di Torino, Torino, Italy.
Gabriele ImbalzanoDepartment of Neuroscience "Rita Levi Montalcini", University of Torino, Via Cherasco 15, 10126, Torino, Italy.
Margherita FabbriDepartment of Neurosciences, Clinical Investigation Center CIC 1436, Parkinson Toulouse Expert Center, NS-Park/FCRIN Network and NeuroToul COEN Center, Toulouse University Hospital; INSERM; University of Toulouse 3, Toulouse, France.
Leonardo LopianoDepartment of Neuroscience "Rita Levi Montalcini", University of Torino, Via Cherasco 15, 10126, Torino, Italy.
University of Turin · ITInserm · FROspedale Martini · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTolcapone is an efficacious catechol-O-methyltransferase inhibitor for Parkinson's disease (PD). However, safety issues hampered its use in clinical practice. We aimed to provide evidence of safety and efficacy of tolcapone by a systematic literature review to support clinicians' choices in the use of an enlarging PD therapeutic armamentarium.

methodsWe searched PubMed for studies on PD patients treated with tolcapone, documenting the following outcomes: liver enzyme, adverse events (AEs), daily Off-time, levodopa daily dose, unified Parkinson's disease rating scale (UPDRS) part-III, quality of life (QoL), and non-motor symptoms. FAERS and EudraVigilance databases for suspected AEs were interrogated for potential additional cases of hepatotoxicity.

resultsThirty-two studies were included, for a total of 4780 patients treated with tolcapone. Pertaining safety, 0.9% of patients showed liver enzyme elevation > 2. Over 23 years, we found 7 cases of severe liver injury related to tolcapone, 3 of which were fatal. All fatal cases did not follow the guidelines for liver function monitoring. FAERS and EudraVigilance database search yielded 61 reports of suspected liver AEs possibly related to tolcapone. Pertaining efficacy, the median reduction of hours/day spent in Off was 2.1 (range 1-3.2), of levodopa was 108.9 mg (1-251.5), of "On" UPDRS-III was 3.6 points (1.1-6.5). Most studies reported a significant improvement of QoL and non-motor symptoms.

conclusionLiterature data showed the absence of relevant safety concerns of tolcapone when strict adherence to hepatic function monitoring is respected. Given its high efficacy on motor fluctuations, tolcapone is probably an underutilized tool in the therapeutic PD armamentarium.

Indexed as

Antiparkinson AgentsCatechol O-Methyltransferase InhibitorsChemical and Drug Induced Liver InjuryHumansLevodopaLiver Function TestsParkinson DiseaseQuality of LifeRandomized Controlled Trials as TopicSeverity of Illness IndexTolcaponeAntiparkinson AgentsCatechol O-Methyltransferase InhibitorsLevodopaTolcaponeCatechol-O-methyltransferaseEfficacyLiverParkinson’s diseaseSafetyTolcapone

Identifiers

PMID33415500
PMCPMC8128808
OpenAlexW3120323237

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.