Evidence map›Paper›PMID 36054749›Full record

ArticleJournal of clinical pharmacy and therapeutics2022

Level of therapeutic innovation from the registration studies of the new drugs for the prophylaxis of migraine.

Domenico Motola, Greta Santi Laurini, Giulia Bonaldo, Nicola Montanaro

Abstract read
In one paragraph

Article in Journal of clinical pharmacy and therapeutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. 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.

Domenico MotolaUnit of Pharmacology, Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.ORCID https://orcid.org/0000-0001-6253-4014
Greta Santi LauriniUnit of Pharmacology, Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.
Giulia BonaldoUnit of Pharmacology, Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.ORCID https://orcid.org/0000-0002-3302-1460
Nicola MontanaroDepartment of Pharmacology, Alma Mater Studiorum University di Bologna, Bologna, Italy.ORCID https://orcid.org/0000-0002-5710-8077

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

WHAT IS KNOWN AND

objectiveMigraine is one of the most prevalent and disabling medical illnesses. Preventive drugs are used to reduce the frequency, severity, and duration of attacks. Most patients were no longer on their medication due to contraindications or poor clinical response. Therefore, there is need for novel prophylactic agents for migraine. New preventive treatments are those of the class of calcitonin gene related peptide (CGRP)-targeting therapies. We aimed to assess the real level of therapeutic innovation of these new drugs.

methodsThe information on the new drugs was collected from several documents, including the European public assessment reports. The level of therapeutic innovation was assessed with the algorithm published by some of us in 2006.

resultsAll new approved drugs (eptinezumab, galcanezumab, fremanezumab, erenumab) are indicated for the prophylaxis of migraine in adults who have at least four migraine days for month. All these drugs have been tested only in comparison to placebo. Their level of therapeutic innovation was only modest, that is, the lowest value of our algorithm. DISCUSSION: The new monoclonal antibodies of the class of CGRP targeting therapies have been authorized with efficacy data only against placebo. They do not offer additional clinical benefits compared to available therapies for the prevention of migraine attacks, with the exception of a lower frequency of administration and a more rapid effect. All this assigns to these drugs only a modest role in therapy according to our algorithm for therapeutic innovation with a significantly higher cost than similar therapies.

Indexed as

Calcitonin Gene-Related PeptideMigraine DisordersAdultAlgorithmsCalcitonin Gene-Related Peptide Receptor AntagonistsHumansCalcitonin Gene-Related PeptideCalcitonin Gene-Related Peptide Receptor Antagonistsmigrainenew drugstherapeutic innovation

Identifiers

PMID36054749
PMCPMC10087688

What OpenQuestion holds

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LicenceCC BY-NC
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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.