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Background: Fexofenadine emerged as one of the most representative second generation histamine H1 antagonist drugs since the 1990s, with an outstanding efficacy and appreciable safety for the treatment of allergic patients. While allergic rhino-conjunctivitis represents the most frequent atopic disease globally, an update of fexofenadine efficacy and safety on this entity was proposed as a surrogate of allergic condition. Methods: Double blind, placebo controlled, randomized clinical trials investigating the efficacy and safety of fexofenadine for the treatment of Allergic Rhinitis were searched in 5 major global databases. Eligibility criteria and characteristics, risk of bias, and validity assessment, data extraction and heterogeneity evaluation are described. Primary outcome selected corresponded to 12-reflective and instantaneous total symptom scores (TSS), besides morning instantaneous TSS and the frequency of reported adverse events (AEs); analysis was planned on the intention-to-treat population.Standardized mean differences of scoring systems were analyzed, and Cochran's Q statistic test and the I2 test were assessed for heterogeneity. Results: From the initial 83 identified records, 12 eligible studies were selected. In the evaluated patients, individuals receiving fexofenadine (1910) showed a significant reduction of TSS compared with those who received placebo (1777), change from baseline: standardized mean difference (SMD) -0.33; 95% CI-0.47 to -0.18, p < 0.0001. Morning instantaneous TSS also demonstrated lower symptoms (change from baseline: SMS -1.42; 95% CI -2.22 to -0.62, p = 0.0005). Heterogeneity was found across selected studies.Frequency of AEs was similar compared to placebo (OR = 1.04; 0.88-1.21), with no detection of heterogeneity across these 12 studies. Conclusions: According to this new evidence, fexofenadine maintains its beneficial profile on signs and symptoms of patients with allergic conditions, as well as its attributes as one of the major candidates for an ideal antihistamine medication (including special conditions such as pregnancy and pre-school age), providing support to its over-the-counter condition in several countries.
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Epidemiologic studies suggest that the prevalence of allergic rhinitis (AR) is rising worldwide. Several reports, in fact, indicate increasing trends in the prevalence of AR especially in developing countries, likely related to the environment and climate changes and the adoption of an urbanized Western lifestyle. The primary objective of the present study was to collect information about management in real-life settings, including a characterization of typical patients' profile referring to physicians, the disease features, the common approaches to diagnostic assessments and therapeutic decisions. This was an international, multicenter, cross-sectional study conducted in adults or children (≥6 years) suffering from rhinitis confirmed by physician's diagnosis for at least one year. The 234 physicians who participated in the study included a total of 2778 patients in Egypt, Mexico, Brazil, Colombia, Guatemala, Iran, Venezuela, Argentina, Israel, Kuwait and United Arab Emirates. It was found that clinical history was the selected tool to diagnose and categorize AR patients (97.1%), with less than half of patients undergoing allergy testing, may be explaining the scarce use of immunotherapy on management of disease. Out of 2776 patients, 93.4% had somehow received a recommendation to avoid allergens and irritant agent exposure. Notably, 91.4% were receiving at least one treatment at the time of the survey, mostly oral antihistamines (79.7%) and intranasal corticosteroids (66.3%). Oral antihistamines, intranasal steroids and decongestants were considered both safe and effective by patients and physicians, preferring oral and nasal route of administration. The ISMAR registry was designed according to the most accepted epidemiological recommendations, and provides interesting information regarding the management of rhinitis from a patient and physician points of view, with many similarities between the participating countries. Further efforts are required to better manage AR and its comorbidities.
RESUMO
OBJECTIVE: To perform a structured analysis of the latest scientific evidence obtained for the clinical efficacy of sublingual immunotherapy (SLIT) in children. DATA SOURCES: PubMed, Embase, reference lists from reviews, and personal databases were reviewed for original articles on clinical trials with SLIT in patients younger than 18 years published from January 1, 2009, through December 31, 2012, using broad search and medical subject heading terms. STUDY SELECTIONS: Clinical trials, irrespective of their design, of SLIT in the treatment of respiratory and food allergy in patients 18 years or younger were selected. Clinical outcomes (symptom scores, medication use, provocation tests, pulmonary function tests, skin prick tests, and adverse events) and immunologic changes were tabulated. Quality of each trial and total quality of compounded evidence was analyzed with the Grading of Recommendations Assessment, Development and Evaluation system. RESULTS: Of 56 articles, 29 met the inclusion criteria. New evidence is robust for the precoseasonal tablet and drop grass pollen SLIT efficacy in allergic rhinitis and scarce for seasonal asthma. Some evidence for Alternaria SLIT efficacy is appearing. For house dust mite (HDM) SLIT in asthma, there is high-quality evidence for medication reduction while maintaining symptom control; evidence for HDM SLIT efficacy in allergic rhinitis is of moderate-low quality. There is moderate evidence for efficacy of dual grass pollen-HDM SLIT after 12 months of treatment and 1 year after discontinuation. Specific provocation test results (nasal, skin) improve with grass pollen and HDM SLIT but nonspecific bronchial provocation testing does not. Food oral immunotherapy is more promising than food SLIT. Possible new surrogate markers have been reported. No anaphylaxis was found among 2469 treated children. CONCLUSION: Evidence for efficacy of SLIT in children with respiratory or food allergy is growing.