Comparative study evaluating antihistamine versus leukotriene receptor antagonist as adjuvant therapy for rheumatoid arthritis.
Acetates
/ administration & dosage
Adult
Arthritis, Rheumatoid
/ drug therapy
Body Mass Index
C-Reactive Protein
/ drug effects
Clusterin
/ drug effects
Cyclopropanes
/ administration & dosage
Cyproheptadine
/ administration & dosage
Double-Blind Method
Drug Therapy, Combination
E-Selectin
/ drug effects
Egypt
Female
Histamine Antagonists
/ administration & dosage
Humans
Immunosuppressive Agents
/ administration & dosage
Interleukins
/ metabolism
Leukotriene Antagonists
/ administration & dosage
Male
Methotrexate
/ therapeutic use
Middle Aged
Quinolines
/ administration & dosage
Sulfides
/ administration & dosage
C-reactive protein
Dose-dependent effect
Montelukast
Platelet activation factor
Rheumatoid arthritis
Rupatadine
Journal
European journal of clinical pharmacology
ISSN: 1432-1041
Titre abrégé: Eur J Clin Pharmacol
Pays: Germany
ID NLM: 1256165
Informations de publication
Date de publication:
Dec 2021
Dec 2021
Historique:
received:
06
04
2021
accepted:
24
06
2021
pubmed:
5
7
2021
medline:
4
2
2022
entrez:
4
7
2021
Statut:
ppublish
Résumé
Investigating the efficacy and safety of rupatadine (RUP) versus montelukast (MON) as adjuvant therapy for patients with rheumatoid arthritis (RA). From December 2018 to December 2019, 75 patients with active RA were enrolled in this randomized double-blind placebo-controlled study. The patients were randomized into three groups (n = 25 in each group); methotrexate (MTX) group which received MTX 15-25 mg/week plus placebo tablet once daily; MTX/RUP group which received MTX plus RUP 10 mg once daily; and MTX/MON group which received MTX plus MON 10 mg once daily. The treatment duration was 3 months. At baseline and 3 months after treatment, blood samples were collected for the biochemical analysis of high-sensitivity C-reactive protein (hs-CRP), interleukins 8 and 17 (IL-8, IL-17), E-selectin, and clusterin (CLU) levels. Clinical and functional assessments using Disease Activity Score-CRP (DAS28-CRP) and Multidimensional Health Assessment Questionnaire (MDHAQ) were performed. Both RUP and MON produced clinical and functional improvements which were translated by significant improvements in DAS28-CRP score and MDHAQ. Rupatadine significantly reduced all measured parameters (P < 0.05) except for IL-17 and CLU. Montelukast significantly decreased all measured variables (P < 0.05) except for E-selectin. Interleukin-8 was positively correlated with IL-17 and CLU, while hs-CRP was positively correlated with E-selectin and body mass index (BMI). Both drugs were well tolerated; somnolence was the common side effect for RUP. No neuropsychiatric events were reported with MON. Rupatadine or montelukast may serve as a potential adjuvant therapy for patients with rheumatoid arthritis secondary to the preliminary evidence of efficacy and safety. ClinicalTrials.gov identifier NCT03770923, December 10, 2018.
Identifiants
pubmed: 34218304
doi: 10.1007/s00228-021-03181-2
pii: 10.1007/s00228-021-03181-2
doi:
Substances chimiques
Acetates
0
Clusterin
0
Cyclopropanes
0
E-Selectin
0
Histamine Antagonists
0
Immunosuppressive Agents
0
Interleukins
0
Leukotriene Antagonists
0
Quinolines
0
Sulfides
0
rupatadine
2AE8M83G3E
Cyproheptadine
2YHB6175DO
C-Reactive Protein
9007-41-4
montelukast
MHM278SD3E
Methotrexate
YL5FZ2Y5U1
Banques de données
ClinicalTrials.gov
['NCT03770923']
Types de publication
Comparative Study
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1825-1834Informations de copyright
© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.
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