Higher efficacy of rupatadine 20 mg and 10 mg versus placebo in patients with perennial allergic rhinitis: a pooled responder analysis
Abstract Background The clinical efficacy of rupatadine in terms of responders has not been previously explored in perennial allergic rhinitis (PAR). Methods This pooled analysis included data from 6 randomised, double-blind, placebo-controlled trials conducted in PAR patients treated with rupatadin...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2020-04-01
|
| Series: | Allergy, Asthma & Clinical Immunology |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13223-020-00425-1 |
| _version_ | 1818684626516836352 |
|---|---|
| author | Antonio Valero Iñaki Izquierdo Marek L. Kowalski Glenis K. Scadding Jean Bousquet Joaquim Mullol |
| author_facet | Antonio Valero Iñaki Izquierdo Marek L. Kowalski Glenis K. Scadding Jean Bousquet Joaquim Mullol |
| author_sort | Antonio Valero |
| collection | DOAJ |
| description | Abstract Background The clinical efficacy of rupatadine in terms of responders has not been previously explored in perennial allergic rhinitis (PAR). Methods This pooled analysis included data from 6 randomised, double-blind, placebo-controlled trials conducted in PAR patients treated with rupatadine 10 mg or 20 mg, or placebo. Participants were aged ≥ 18 years, with diagnosis of PAR and a Total 4 Nasal Symptom Score (T4NSS) ≥ 5. We evaluated the T4NSS and Total 5 Symptom Score (T5SS) for 28 days of treatment, the responder proportion (50% and 75% response), and the time to response. Results Efficacy data from 1486 patients were analysed: 585 received placebo, 682 rupatadine 10 mg, and 219 rupatadine 20 mg. Compared with placebo, rupatadine promoted greater symptom improvements and higher responder proportions (50% and 75% response) for T4NSS and T5SS over 28 days. Symptom improvements and responder proportions were higher in the rupatadine 20 mg group vs the 10 mg group. The time to response was shorter in the rupatadine 20 mg group vs the 10 mg group for T4NSS (16 and 9 days for the 50% and 75% responses, respectively) and for T5SS (13 and 8 days for the 50% and 75% responses, respectively). Conclusions Rupatadine was efficacious in reducing allergic rhinitis symptoms, showing high responder proportions. The faster and stronger effect of rupatadine 20 mg may suggest its use in patients with severe PAR or not responding to the standard dose. |
| first_indexed | 2024-12-17T10:53:37Z |
| format | Article |
| id | doaj.art-b0f869890ab54d42801973f4bc75cfaf |
| institution | Directory Open Access Journal |
| issn | 1710-1492 |
| language | English |
| last_indexed | 2024-12-17T10:53:37Z |
| publishDate | 2020-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Allergy, Asthma & Clinical Immunology |
| spelling | doaj.art-b0f869890ab54d42801973f4bc75cfaf2022-12-21T21:51:53ZengBMCAllergy, Asthma & Clinical Immunology1710-14922020-04-011611910.1186/s13223-020-00425-1Higher efficacy of rupatadine 20 mg and 10 mg versus placebo in patients with perennial allergic rhinitis: a pooled responder analysisAntonio Valero0Iñaki Izquierdo1Marek L. Kowalski2Glenis K. Scadding3Jean Bousquet4Joaquim Mullol5Allergy Section, Pneumology and Allergy Department, Hospital Clínic de Barcelona, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)Department of Clinical Development & Medical Adviser, Biohorm, Grupo UriachDepartment of Immunology and Allergy, Medical University of LodzDepartment of Allergy and Rhinology, Royal National Ear, Nose and Throat HospitalMACVIA-France, Contre les Maladies Chroniques Pour un VIeillissement Actif en France European Innovation Partnership on Active and Healthy Ageing Reference SiteCIBER de Enfermedades Respiratorias (CIBERES)Abstract Background The clinical efficacy of rupatadine in terms of responders has not been previously explored in perennial allergic rhinitis (PAR). Methods This pooled analysis included data from 6 randomised, double-blind, placebo-controlled trials conducted in PAR patients treated with rupatadine 10 mg or 20 mg, or placebo. Participants were aged ≥ 18 years, with diagnosis of PAR and a Total 4 Nasal Symptom Score (T4NSS) ≥ 5. We evaluated the T4NSS and Total 5 Symptom Score (T5SS) for 28 days of treatment, the responder proportion (50% and 75% response), and the time to response. Results Efficacy data from 1486 patients were analysed: 585 received placebo, 682 rupatadine 10 mg, and 219 rupatadine 20 mg. Compared with placebo, rupatadine promoted greater symptom improvements and higher responder proportions (50% and 75% response) for T4NSS and T5SS over 28 days. Symptom improvements and responder proportions were higher in the rupatadine 20 mg group vs the 10 mg group. The time to response was shorter in the rupatadine 20 mg group vs the 10 mg group for T4NSS (16 and 9 days for the 50% and 75% responses, respectively) and for T5SS (13 and 8 days for the 50% and 75% responses, respectively). Conclusions Rupatadine was efficacious in reducing allergic rhinitis symptoms, showing high responder proportions. The faster and stronger effect of rupatadine 20 mg may suggest its use in patients with severe PAR or not responding to the standard dose.http://link.springer.com/article/10.1186/s13223-020-00425-1PAF antagonistPerennial allergic rhinitisResponder analysisRupatadineSecond-generation H1-antihistamines |
| spellingShingle | Antonio Valero Iñaki Izquierdo Marek L. Kowalski Glenis K. Scadding Jean Bousquet Joaquim Mullol Higher efficacy of rupatadine 20 mg and 10 mg versus placebo in patients with perennial allergic rhinitis: a pooled responder analysis Allergy, Asthma & Clinical Immunology PAF antagonist Perennial allergic rhinitis Responder analysis Rupatadine Second-generation H1-antihistamines |
| title | Higher efficacy of rupatadine 20 mg and 10 mg versus placebo in patients with perennial allergic rhinitis: a pooled responder analysis |
| title_full | Higher efficacy of rupatadine 20 mg and 10 mg versus placebo in patients with perennial allergic rhinitis: a pooled responder analysis |
| title_fullStr | Higher efficacy of rupatadine 20 mg and 10 mg versus placebo in patients with perennial allergic rhinitis: a pooled responder analysis |
| title_full_unstemmed | Higher efficacy of rupatadine 20 mg and 10 mg versus placebo in patients with perennial allergic rhinitis: a pooled responder analysis |
| title_short | Higher efficacy of rupatadine 20 mg and 10 mg versus placebo in patients with perennial allergic rhinitis: a pooled responder analysis |
| title_sort | higher efficacy of rupatadine 20 mg and 10 mg versus placebo in patients with perennial allergic rhinitis a pooled responder analysis |
| topic | PAF antagonist Perennial allergic rhinitis Responder analysis Rupatadine Second-generation H1-antihistamines |
| url | http://link.springer.com/article/10.1186/s13223-020-00425-1 |
| work_keys_str_mv | AT antoniovalero higherefficacyofrupatadine20mgand10mgversusplaceboinpatientswithperennialallergicrhinitisapooledresponderanalysis AT inakiizquierdo higherefficacyofrupatadine20mgand10mgversusplaceboinpatientswithperennialallergicrhinitisapooledresponderanalysis AT mareklkowalski higherefficacyofrupatadine20mgand10mgversusplaceboinpatientswithperennialallergicrhinitisapooledresponderanalysis AT gleniskscadding higherefficacyofrupatadine20mgand10mgversusplaceboinpatientswithperennialallergicrhinitisapooledresponderanalysis AT jeanbousquet higherefficacyofrupatadine20mgand10mgversusplaceboinpatientswithperennialallergicrhinitisapooledresponderanalysis AT joaquimmullol higherefficacyofrupatadine20mgand10mgversusplaceboinpatientswithperennialallergicrhinitisapooledresponderanalysis |