PMID- 19132803
OWN - NLM
STAT- MEDLINE
DCOM- 20090407
LR  - 20211020
IS  - 0114-5916 (Print)
IS  - 0114-5916 (Linking)
VI  - 32
IP  - 1
DP  - 2009
TI  - Safety of rupatadine administered over a period of 1 year in the treatment of 
      persistent allergic rhinitis: a multicentre, open-label study in Spain.
PG  - 33-42
LID - 10.2165/00002018-200932010-00003 [doi]
AB  - BACKGROUND: Rupatadine (Rupafin), a novel antihistamine approved recently in 
      Europe for the treatment of allergic rhinitis (AR) and chronic idiopathic 
      urticaria in patients aged>or=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 >or=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 respiratory thoracic and mediastinal 
      system, in particular headache, somnolence and catarrh, were the three most 
      common AEs reported by >5% of the patients during both treatment periods. 
      Detailed ECG assessments demonstrated no clinically relevant abnormal ECG 
      findings, nor any QTcB increases >60 msec or QTcB values>470 msec for any patient 
      at any time during treatment. Serious AEs were reported in seven patients, of 
      whom six were considered as unlikely to be related to rupatadine treatment, 
      whereas one involving increased blood enzyme levels was considered as possibly 
      related to rupatadine treatment. CONCLUSION: This study confirmed the good 
      long-term safety and tolerability of rupatadine at the therapeutic dose of 10 
      mg/day in patients with PER.
FAU - Valero, Antonio
AU  - Valero A
AD  - Department of Pneumology and Respiratory Allergy, Hospital Clinic i Provincial, 
      Barcelona, Spain.
FAU - de la Torre, Fernando
AU  - de la Torre F
FAU - Castillo, Jose Antonio
AU  - Castillo JA
FAU - Rivas, Pilar
AU  - Rivas P
FAU - del Cuvillo, Alfonso
AU  - del Cuvillo A
FAU - Antepara, Ignacio
AU  - Antepara I
FAU - Borja, Javier
AU  - Borja J
FAU - Donado, Esther
AU  - Donado E
FAU - Mola, Oriol
AU  - Mola O
FAU - Izquierdo, Inaki
AU  - Izquierdo I
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - Drug Saf
JT  - Drug safety
JID - 9002928
RN  - 0 (Histamine H1 Antagonists)
RN  - 2AE8M83G3E (rupatadine)
RN  - 2YHB6175DO (Cyproheptadine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Child
MH  - Cyproheptadine/adverse effects/*analogs & derivatives/therapeutic use
MH  - Electrocardiography
MH  - Female
MH  - Follow-Up Studies
MH  - Histamine H1 Antagonists/*adverse effects/therapeutic use
MH  - Humans
MH  - Male
MH  - Medication Adherence/*statistics & numerical data
MH  - Middle Aged
MH  - Rhinitis, Allergic, Perennial/*drug therapy
MH  - Spain/epidemiology
MH  - Time Factors
MH  - Young Adult
EDAT- 2009/01/10 09:00
MHDA- 2009/04/08 09:00
CRDT- 2009/01/10 09:00
PHST- 2009/01/10 09:00 [entrez]
PHST- 2009/01/10 09:00 [pubmed]
PHST- 2009/04/08 09:00 [medline]
AID - 3 [pii]
AID - 10.2165/00002018-200932010-00003 [doi]
PST - ppublish
SO  - Drug Saf. 2009;32(1):33-42. doi: 10.2165/00002018-200932010-00003.