Efficacy and safety of rupatadine for allergic rhino-conjunctivitis: a systematic review of randomized, double-blind, placebo-controlled studies with meta-analysis.

Background: Allergic rhinitis is a complex inflammatory disease whose pathophysiology involves local and systemic mechanisms. Rupatadine, a molecule with intense antihistaminic activity and with antagonist PAF effects through its interaction with specific receptors, is indicated for the treatment of intermittent or persistent allergic rhinitis and urticaria.

Scope: This systematic review was aimed at identifying in the most important databases, up to January 2013, the double-blind placebo-controlled randomized trials administering rupatadine in allergic rhinitis. No restriction was introduced for treatment duration and dose, study design, population age, allergen exposition and disease classification. The methodological quality of included studies and risk of bias were systematically assessed. Meta-analysis was performed when possible to summarize information.

Findings: Seventeen of 413 initially identified records were fully assessed for eligibility. Ten trials involving 2573 patients overall met the inclusion criteria and entered the analysis. Their internal validity was satisfactory. Data synthesis showed that rupatadine is superior to placebo in relieving the overall allergy symptoms on reflective (SMD: -0.37, 95% CI -0.46 to -0.27; p < 0.00001) and instantaneous (SMD: -0.41, 95% CI -0.71 to -0.11; p = 0.007) assessment, the nasal symptoms considered together (reflective SMD: -0.36, 95% CI -0.48 to -0.25; p < 0.00001; instantaneous SMD: -0.39, 95% CI -0.61 to -0.17; p = 0.0004) or individually and ocular symptoms. Inter-study heterogeneity was low for the main outcomes and the risk of publication bias was judged as unlikely. A number of secondary endpoints were favorably affected by rupatadine. No difference was observed in the incidence of total adverse reactions between rupatadine and placebo (OR 1.23, 95% CI 0.95 to 1.59; p = 0.12).

Conclusion: Randomized double-blind controlled trials show a favorable risk-benefit ratio in rupatadine for the treatment of allergic rhino-conjunctivitis. This evidence is strengthened when data are pooled in the form of meta-analysis, where accurate and robust effect estimations are derived from a large population.