Management of the New H1 Antihistamines in Allergic Rhinitis – General Practitioner Perspective patients.100
Cardiotoxicity manifesting as tachyarrhythmias has been a feature of some antihistamines; a randomised trial involving rupatadine and moxifloxacin (positive control) showed that rupatadine at doses of 10 and 100 mg resulted in no signal changes in QTc following single and repeated administration.101
Several clinical trials of rupatadine have compared its safety and efficacy with various second-generation antihistamines in the treatment of SAR. For example, 339 SAR patients were randomised to either rupatadine 10 or 20 mg or loratadine 10 mg. The mean total daily symptom score (mTDSS) was significantly lower in both rupatadine groups compared with the loratadine group, with significantly milder symptoms including sneezing and itching.96
In another prospective
randomised, double-blind multicentre trial that included 249 patients, rupatadine treatment was observed to have a faster, more persistent resolution of acute symptoms in the first week of treatment than cetirizine, but this difference was less noticeable in the second week of therapy.102
These studies suggest that rupatadine is a safe and effective symptomatic treatment of SAR.
However, there were no differences between ebastine and rupatadine treatments. Comparison of rupatadine, cetirizine and placebo in 543 patients as part of a randomised, double-blind clinical trial in the treatment of PAR demonstrated that rupatadine significantly relieves symptoms of PAR providing rapid onset of action with maintenance over the 12-week treatment period. Rupatadine, but not cetirizine, significantly reduced baseline scores in the instantaneous total symptom score (see Figure 4).103
Rupatadine was reported to have significant improvements in severity of total symptom score and nasal symptom score compared with placebo.95
Levocetirizine possesses pharmacodynamically and pharmacokinetically favourable characteristics. It has been proven safe and effective for the treatment of AR and has minimal side effects.104,105
Clinical studies examining the chronic condition, PAR, have demonstrated that rupatadine significantly relieves symptoms, providing rapid onset of action and maintenance of therapeutic effect. In a randomised, double-blind clinical trial involving 223 patients with reported PAR, rupatadine was compared with ebastine over a four-week period.95
symptoms (p<0.001), disease severity (p<0.0001) and HRQoL (p<0.001) compared with baseline.107
This was assessed using the AR-specific
ESPRINT questionnaire (EsQ-15) that provided an AR severity categorisation which the authors suggest is a valuable new instrument in classifying patient populations, more accurately assessing severity of AR symptoms and helping develop more focused disease management strategies and treatments.108,109
Conclusions and Future Trends In a randomised,
open-label clinical study involving 60 patients with SAR, rupatadine demonstrated superiority when compared with levocetirizine.106
Both
eosinophil differential and absolute counts and IgE levels were significantly decreased in the rupatadine treatment groups. Furthermore, rupatadine significantly reduced both the Total Nasal Symptom Score and the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) compared with levocetirizine in SAR patients.106
When developing guidelines for the treatment of AR, careful assessment of clinical trial data is required to ensure that the guidelines reflect entire populations rather than highly selected patient subsets in clinical trials.110
The last decade has witnessed a global increase in the prevalence of AR, the symptoms of which cause significant impairment of HRQoL. Recommendations regarding diagnosis, prevention and treatment of AR need to be effectively disseminated to both clinicians and patients to improve outcomes and reduce the burden of the disease.56 Implementation of the ARIA guidelines for treatment provides a significant improvement in AR compared with the non-standardised regimens.7
Many patients with AR continue to go Recently published results from a
study of a cohort of 360 patients with AR show that rupatadine treatment in routine daily practice significantly improved the control of nasal
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undetected or use first-generation antihistamines that have limited efficacy and significant side effects. Improving efficacy and tolerance of the medication is vital to improving treatment and outcome in AR patients. Rupatadine is well tolerated by patients with AR and has a benign cardiac safety profile with no arrhythmogenic effects and no effects on driving performance. Rupatadine compares favourably with other second-generation antihistamines. These properties make rupatadine a suitable first-line treatment for AR and are likely to help address an increasingly important clinical need. n
7. Bousquet J, Schunemann HJ, Zuberbier T, et al., Development and implementation of guidelines in allergic rhinitis - an ARIA- GA2LEN paper, Allergy, 2010;65:1212–21.
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14. Asher MI, Montefort S, Bjorksten B, et al., Worldwide time trends in the prevalence of symptoms of asthma, allergic rhinoconjunctivitis, and eczema in childhood: ISAAC Phases One and Three repeat multicountry cross-sectional surveys, Lancet, 2006;368:733–43.
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17. Dykewicz MS, Fineman S, Nicklas R, et al., Joint Task Force
Figure 4: Change in Instantaneous Total Symptom Score From Baseline in Allergic Rhinitis During Weeks Four, Eight and 12 of Treatment With Rupatadine, Cetirizine or Placebo
-50 -40 -30 -20 -10 0
-60 4 weeks Placebo
*p<0.05; **p<0.01. Source: Fantin et al., 2008.103
8 weeks Cetirizine 12 weeks Rupatadine
*
**
*
* **
EUROPEAN RESPIRATORY DISEASE
115
Improvement Mean change from baseline
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