Safety of Rupatadine Administered Over a Period of 1 Year in the Treatment of Persistent Allergic Rhinitis: A Multicentre Open-Label Study in Spain

• Published in: Drug safety 2009, Vol.32 (1), p.33-42
• Main Authors: Valero, Antonio, de la Torre, Fernando, Castillo, José Antonio, Rivas, Pilar, del Cuvillo, Alfonso, Antépara, Ignacio, Borja, Javier, Donado, Esther, Molà, Oriol, Izquierdo, Iñaki
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Allergic diseases; Analysis; Antihistamines; Biological and medical sciences; Child; Clinical trial. Drug monitoring; Complications and side effects; Cyproheptadine - adverse effects; Cyproheptadine - analogs & derivatives; Cyproheptadine - therapeutic use; Development and progression; Dosage and administration; Drug Safety and Pharmacovigilance; Drug therapy; Electrocardiography; Female; Follow-Up Studies; General pharmacology; Histamine H1 Antagonists - adverse effects; Histamine H1 Antagonists - therapeutic use; Humans; Immunopathology; Male; Medical sciences; Medication Adherence - statistics & numerical data; Medicine; Medicine & Public Health; Middle Aged; Non tumoral diseases; Original Research Article; Otorhinolaryngology. Stomatology; Patient compliance; Patient outcomes; Pharmacology. Drug treatments; Pharmacology/Toxicology; Respiratory and ent allergic diseases; Rhinitis; Rhinitis, Allergic, Perennial - drug therapy; Spain - epidemiology; Time Factors; Upper respiratory tract, upper alimentary tract, paranasal sinuses, salivary glands: diseases, semeiology; Young Adult
• ISSN: 0114-5916; 1179-1942
• DOI: 10.2165/00002018-200932010-00003

Background: Rupatadine (Rupafin®), a novel antihistamine approved recently in Europe for the treatment of allergic rhinitis (AR) and chronic idiopathic urticaria in patients aged ≥12 years, has been shown to be highly efficacious, and as safe and well tolerated as other commonly employed antihistamines in the treatment of allergic disease. There are, however, few data on the long-term safety of these antihistamines derived in accordance with the clinical safety recommendations of the European Agency for the Evaluation of Medicinal Products (EMEA) and the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use Guideline. Objective: To assess the safety and tolerability of treatment with rupatadine 10 mg/day for 12 months in subjects with persistent AR (PER). Methods: A multicentre, open-label, phase IV study in patients recruited from 33 centres in Spain, from September 2002 to November 2005. The study enrolled 324 male and female patients (aged 12–70 years) with a medical history of PER for at least 12 months and a documented positive skin-prick test to an appropriate allergen. On 4 of the 7 days prior to start of treatment, the patients were required to have a minimum total nasal symptom score (TNSS [for sneezing, rhinorrhoea, nasal obstruction/congestion and nasal itching]) of ≥5. Of the 324 eligible patients starting treatment, 120 needed to be treated for more than 6 months and were followed up until the end of 12 months. All patients received rupatadine 10 mg/day and were allowed to continue their normal concomitant medication for all conditions, other than rhinitis, for up to 6 or 12 months. Safety was assessed by means of adverse events (AEs) reported by patients or detected by investigators, scheduled centralized ECG with special attention to Bazzet corrected QT interval (QTcB) and standard laboratory investigations. Results: Assessment of treatment compliance rates indicated 90% and 83% of patients to be compliant during the 1–6 months and 1–12 months treatment periods, respectively, with compliance rates >80% being associated with the majority of the study population reporting at least one AE. Overall, 74.1% and 65.8% of the patients reported at least one AE during the 1–6 months and 1–12 months treatment periods, respectively, compared with 20.4% and 10.8% of patients reporting at least one treatment-related AE during these periods. Disorders of the nervous system and respirator