Morning and evening efficacy evaluation of rupatadine (10 and 20 mg), compared with cetirizine 10 mg in perennial allergic rhinitis: a randomized, double-blind, placebo-controlled trial

Abstract

Background:

A circadian rhythm of symptoms has been reported in allergic rhinitis (AR). Severity of all major symptoms of AR, including runny nose, sneezing, and nasal congestion, is typically at its peak in the morning. The objective of this study was to explore the efficacy of the antihistamine and platelet activating factor (PAF) antagonist rupatadine in the morning and evening and to evaluate whether rupatadine provides effective symptom relief throughout the 24-hour dosing interval.

Methods:

A total of 308 patients ≥18 years of age with PAR was randomly assigned to once-daily rupatadine 10 mg, rupatadine 20 mg, or cetirizine 10 mg for 4 weeks in a placebo-controlled, double-blind study. The main outcome was the morning/evening reflective total symptom score (5TSS) over the treatment period. Secondary endpoints included morning/evening reflective nasal total symptom score (4NTSS), individual symptoms, Pdmax1 as percentage of days with daily severest symptom score ≤1, and subject/investigator evaluation of therapeutic response.

Results:

All active groups were significantly more effective than placebo in improving morning and evening evaluations of 5TSS (P < 0.001) and 4NTSS (P < 0.001) at 2 or 4 weeks. At morning evaluation, there was a significant reduction from baseline for 5TSS with rupatadine 10 mg (−36.8%, P < 0.01) and 20 mg (−46.3%, P < 0.01) compared with placebo. Similarly, 4NTSS was reduced significantly more with rupatadine 10 mg (−34%, P < 0.05) and 20 mg (−41%, P < 0.01) compared with placebo. In the cetirizine 10 mg group, the reduction was −32.7% and −32.2% for 5TSS and 4NTSS, respectively, but this reduction was not significant compared with placebo. The percentage reduction was greater at evening than at morning evaluation. 5TSS reduction with rupatadine 10 mg (−40.7%, P < 0.05) and 20 mg (−49.9%, P < 0.01) and cetirizine 10 mg (−40.1%, P < 0.05) was significantly better than with placebo. 4NTSS values for active groups were also significantly improved versus placebo. When individual symptoms were assessed, statistically significant differences for rhinorrhea (P < 0.01), nasal itching (P < 0.01), and sneezing (P < 0.01) were shown in all active groups compared with placebo at morning and evening evaluations. Pdmax1 index was significantly improved for all active groups and the overall efficacy assessed by patients or investigators showed a significant improvement (P < 0.01) versus placebo at 2 and 4 weeks. The incidence of somnolence was significantly greater in all active groups versus placebo.

Conclusion:

The sustained 24-hour action of rupatadine 10 mg provides an effective control of morning and evening symptoms in patients with PAR treated for up to 4 weeks.

Keywords:

• allergic rhinitis
• circadian rhythm
• morning and evening symptoms
• antihistamines
• rupatadine

View correction statement:

Morning and evening efficacy evaluation of rupatadine (10 and 20 mg), compared with cetirizine 10 mg in perennial allergic rhinitis: a randomized, double-blind, placebo-controlled trial [Corrigendum]

Acknowledgements

We would like to thank Teodoro Sanchez for help with the English editing of the paper.

This study was partially supported by the National Scientific research program of the Spanish Minister of Science and Technology.

Disclosure

Dr F Marmouz declares no conflicts of interests. Dr Iñaki Izquierdo and Josep Giralt are employees of J Uriach y Compañia, S.A.

Study participants

Paris: Farid Marmouz (Pontoise), Pascale Beaumont (Saint Maurdes Fosses), Madeleine Epstein (Paris), Dominique Ortolan (Villejuif), Caroline Sauvan (Paris), Dominique Château-Waquet (Paris), Micaela Dona (Paris), Brigitte Medina, (Paris), Véronique Thebault (Aubervilliers), Robert Blassin (Vicennes), Patrice Wurmser (Villeneuve Saint-Georges), Eliane Leriche (Levallois Perret). Bordeaux: Jean-Charles Farauz (Bordeaux), Monique Greciet-Sassoust (Bordeaux), Hervé Masson, (Bordeaux), Philippe Auriol (Bordeaux), Beatrice Michelena (Marmande), Maryse Beau-Besnard (Le Bouscat). Toulouse: Jacques Gayraud (Tarbes), Suzanne Carme (Albi), Jean-Claude Roca (Tarbes), François Malaquin (Albi). Nantes: François Wessel, Anton Michael. Tours: Marie Chantal Carre-Faure, Jean-Philippe Maffre, Charles Truche. Lyon: Françoise Bouteloup, Françoise Roitte-Flandrois (Le Peage de Roussillon), Roch Sanchez (Saint Priest), Marie-Claire Chaize (Venisseux), Lucile Courvoisier (Oullins), Elisabeth Gautier (Lyon), Martine Chouraqui (Lyon). Saint-Etienne: Colette Chappard, Pauline Lazar, Dominique Mounier, Charles Dzviga. Valence: Bernard San Juan. Limoges: Christine Bertin, Marie-Christine Brianchon. Montluçon: Philippe Chalmet. Poitiers: Katy Breuil, Hélène Pouvreau. Angôulême: Jacques Petit, Olivier Lagrange, Ghassan Haddad, Isabelle Bosse (la Rochelle). Nantes: Anne Bataille, Bruno Lebeaupin (Reze). Montpellier: Bernard Lirsac (Perpignan), Nicole Pueach (Lunel), Pierre Coulet, Robert Clavet. Strasbourg: Pierre Braun, Martin Schaller (Colmar), Sami Taieb (Selestat), Claude Schmitz (Colmar). Marseille: Marie-Françoise Fardeau (Les Milles), Jean-Pierre Marie (Aix en Provence), Yann Massabie.