Evidence map›Paper›PMID 36970914›Full record

Trial reportJournal of Parkinson's disease2023

Dose Optimization of Apomorphine Sublingual Film for OFF Episodes in Parkinson's Disease: Is the Prophylactic Use of an Antiemetic Necessary?

Robert A Hauser, William G Ondo, Yi Zhang, Alyssa Bowling, Bradford Navia, Eric Pappert, Stuart H Isaacson, CTH-301 Study Investigators

Open access · diamondAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Journal of Parkinson's disease, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.4field-weighted citation impact, top 18% 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

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Review
  3. 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

8 authors at 3 institutions in 1 country.

Robert A HauserUniversity of South Florida, Tampa, FL, USA.
William G OndoMethodist Neurological Institute, Houston, TX, USA.
Yi ZhangSunovion Pharmaceuticals Inc., Marlborough, MA, USA.
Alyssa BowlingSunovion Pharmaceuticals Inc., Marlborough, MA, USA.
Bradford NaviaSunovion Pharmaceuticals Inc., Marlborough, MA, USA.
Eric PappertSunovion Pharmaceuticals Inc., Marlborough, MA, USA.
Stuart H IsaacsonUniversity of South Florida, Tampa, FL, USA.
CTH-301 Study Investigators
Sunovion (United States) · USUniversity of South Florida · USHouston Methodist · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNausea is common upon initiating dopamine agonists in patients with Parkinson's disease (PD); however, pretreatment with an antiemetic is recommended only when initiating apomorphine formulations.

objectiveEvaluate the need for prophylactic antiemetic use during dose optimization of apomorphine sublingual film (SL-APO).

methodsA post hoc analysis of a Phase III study evaluated nausea and vomiting treatment-emergent adverse events in patients with PD who underwent SL-APO dose optimization (10-35 mg; 5-mg increments) to achieve a tolerable FULL ON. Frequencies of nausea and vomiting were described for patients who did versus did not use an antiemetic during dose optimization and by patient subgroups based on extrinsic and intrinsic factors.

resultsOverall, 43.7% (196/449) of patients did not use an antiemetic during dose optimization; most of these patients (86.2% [169/196]) achieved an effective and tolerable SL-APO dose. In patients who did not use an antiemetic, nausea (12.2% [24/196]) and vomiting (0.5% [1/196]) were uncommon. An antiemetic was used in 56.3% (253/449) of patients, with 17.0% (43/253) and 2.4% (6/253) experiencing nausea and vomiting, respectively. All events of nausea (14.9% [67/449]) and vomiting (1.6% [7/449]) were of mild-to-moderate severity except for 1 event each. Irrespective of antiemetic use, among patients without baseline dopamine agonist use, nausea and vomiting rates were 25.2% (40/159) and 3.8% (6/159); in those already using dopamine agonists, rates were 9.3% (27/290) and 0.3% (1/290).

conclusionProphylactic treatment with an antiemetic is not necessary for most patients who initiate SL-APO for the treatment of OFF episodes in PD.

Indexed as

AntiemeticsParkinson DiseaseApomorphineDopamine AgonistsHumansNauseaVomitingAntiemeticsApomorphineDopamine AgonistsAntiemeticsapomorphinedomperidonenauseaParkinson’s diseasetreatmentvomiting

Identifiers

PMID36970914
PMCPMC10200146
OpenAlexW4360840743

What OpenQuestion holds

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Registered trials

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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.