Evidence map›Paper›PMID 31624533›Full record

ArticleClinical and translational allergy2019

Clinically relevant effect of rupatadine 20 mg and 10 mg in seasonal allergic rhinitis: a pooled responder analysis.

Joaquim Mullol, Iñaki Izquierdo, Kimihiro Okubo, Giorgio Walter Canonica, Jean Bousquet, Antonio Valero

Open access · goldAbstract read
In one paragraph

Article in Clinical and translational allergy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.1field-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.

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

6 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. [A preliminary study on the biomarkers of local inflammation in allergic rhinitis].Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology head and neck surgery · 2021
    Article
  5. Review
  6. Higher efficacy of rupatadine 20 mg and 10 mg versus placebo in patients with perennial allergic rhinitis: a pooled responder analysis.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2020
    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

6 authors at 5 institutions in 3 countries.

Joaquim Mullol *1Unitat de Rinologia, & Clínica de l'Olfacte, ENT Department, Hospital Clínic de Barcelona, C/Villarroel, 170, 08036 Barcelona, Catalonia Spain.
Iñaki Izquierdo *Department of Clinical Development & Medical Adviser, Biohorm, Grupo Uriach, Avinguda Camí Reial, 51-57, 08184 Barcelona, Catalonia Spain.
Kimihiro Okubo6Department of Otolaryngology-Head and Neck Surgery, Nippon Medical School, Tokyo, Japan.
Giorgio Walter Canonica7Personalized Medicine Clinic Asthma & Allergy, Humanitas University, Humanitas Research Hospital, Rozzano, Milan, Italy.
Jean BousquetMACVIA-France, Contre les Maladies Chroniques Pour un VIeillissement Actif en France European Innovation Partnership on Active and Healthy Ageing Reference Site, Montpellier, France.
Antonio Valero2Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
Centro de Investigación Biomédica en Red de Enfermedades Respiratorias · ESConsorci Institut D'Investigacions Biomediques August Pi I Sunyer · ESHumanitas University · ITNippon Medical School · JPUriach (Spain) · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDifferent clinical trials showed the superior efficacy of rupatadine compared to placebo at improving seasonal allergic rhinitis (SAR) symptoms, but no study has assessed if the response promoted is clinically meaningful.

methodsThis study is a pooled analysis of data of seven randomized, double-blind, placebo-controlled SAR studies comparing responder proportions upon treatment with rupatadine (10 or 20 mg) or placebo. We evaluated the following symptom scores at baseline (Visit 1) and over 14 days of treatment: Total 4 Nasal Symptom Score (T4NSS), Total 2 Ocular Symptom Score (T2OSS) and Total 6 Symptom Score (T6SS). The proportion of responders (50% and 75% response) and the time to response were compared between groups on days 7 (Visit 2) and 14 (Visit 3). Responder rates were compared between groups on days 7 and 14 for the complete/near-to-complete response for T4NSS (TN4SS score ≤ 2 and each symptom score ≤ 1) and T6SS (T6SS score ≤ 3 and each symptom score ≤ 1).

resultsData from 1470 patients were analyzed: 332 treated with placebo, 662 with rupatadine 10 mg and 476 with rupatadine 20 mg. The reduction in T4NSS, T2OSS and T6SS over 14 days of treatment relative to baseline was statistically higher in rupatadine groups vs the placebo group, with greater improvements in the 20 mg group. A statistically higher proportion of patients reached the 50% and 75% response for T4NSS, T2OSS and T6SS in rupatadine groups compared to the placebo group across the visits. Among rupatadine-treated patients, those receiving 20 mg compared favourably for both cut-off responses. The time to achieve a proportion of responders was shorter in the rupatadine 20 mg group than in the rupatadine 10 mg and placebo groups for all the symptom scores. The number of patients who achieved a complete/near-to-complete response for both symptom scores was higher in rupatadine groups than in the placebo group, with higher proportions in the 20 mg group.

conclusionsThis responder analysis confirms the superior efficacy of rupatadine vs placebo to treat SAR. Rupatadine promoted higher proportions of responders according to stringent response criteria and in a dose-dependent manner, with faster and higher response rates in the 20 mg group.

Indexed as

Meaningful responseNasal symptomsOcular symptomsResponder analysisRupatadineSeasonal allergic rhinitis

Identifiers

PMID31624533
PMCPMC6784348
OpenAlexW2979790154

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.