Allergic Rhinitis and its Impact on Asthma - ARIA

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ALLERGIC RHINITIS AND ITS IMPACT ON ASTHMA GUIDELINES ● 2010 – V. 9/8/2010 Summary of findings One systematic review addressed the question of the efficacy of oral H1-antihistamines in reducing the symptom of nasal obstruction in adults with persistent allergic rhinitis (126). Another systematic review of the effect of desloratadine in allergic rhinitis requires updating <strong>and</strong> could not be used to inform this recommendation (127). One systematic review investigated the use of astemizole in allergic rhinitis <strong>and</strong> urticaria (128), but since astemizole <strong>and</strong> terfenadine have been withdrawn from the market <strong>and</strong> the review had considerable methodological limitations we did not consider it for this recommendation. We did not identify any other systematic review of efficacy or safety of oral H1-antihistamines compared to placebo in allergic rhinitis. The ARIA guideline group has identified 78 trials of different oral H1-antihistamines compared to placebo in patients with allergic rhinitis, that were published until the first quarter of 2007 (129- 205). Because no systematic review comparing oral H1-antihistamines to placebo in patients with seasonal allergic rhinitis is available, we based the judgement about the quality of supporting evidence on an assumption that at least for two critical outcomes – quality of life <strong>and</strong> adverse effects – available evidence would be inconsistent <strong>and</strong> there would be a probability of publication <strong>and</strong> reporting bias. This assumption is based on the results of systematic reviews of trials that compared oral H1-antihistamines to active treatments (not to placebo) in allergic rhinitis. Benef<strong>its</strong> A systematic review found that oral H1-antihistamines compared to placebo were more effective for nasal obstruction in patients with persistent allergic rhinitis (126). Since we could not identify any systematic review of the effectiveness of oral H1-antihistamines compared to placebo in patients with seasonal allergic rhinitis overall effect <strong>and</strong> <strong>its</strong> magnitude are currently uncertain. Harms In the systematic review by Hore <strong>and</strong> colleagues (126) headache was the most common adverse event, but there was no statistically significant difference between the groups. The effect on fatigue was inconsistent across studies. In the absence of any other systematic review investigating the safety of oral H1-antihistamines compared to placebo it is currently not feasible to estimate the magnitude of the risk of adverse effects. Based on unsystematic observations there is, however, concern about somnolence, headache, appetite stimulation, weight gain, QT interval prolongation, <strong>and</strong> altering of drug metabolism with some oral H1-antihistamines, particularly those interacting with cytochrome P450 <strong>and</strong> P-glycoprotein (206-222). Terfenadine <strong>and</strong> astemizole were withdrawn from the market in many countries because of serious cardiac adverse effects. Therefore, they were not considered for this recommendation. Conclusions <strong>and</strong> research needs Oral H1-antihistamines may be of net clinical benefit in treatment of allergic rhinitis, but in absence of a systematic review the overall magnitude of the effect for both desirable <strong>and</strong> undesirable effects is not known. The only available systematic review of oral H1-antihistamines in patients with PAGE 44 OF 153
ALLERGIC RHINITIS AND ITS IMPACT ON ASTHMA GUIDELINES ● 2010 – V. 9/8/2010 allergic rhinitis focused exclusively on nasal obstruction ignoring other outcomes important to patients. A complete rigorously performed <strong>and</strong> reported (223, 224) systematic review of all individual oral H1-antihistamines versus placebo in adults <strong>and</strong> children that provides information on all outcomes important to patients, including adverse effects, is required for the next update of the ARIA guidelines. We based our current judgements on a less systematic evaluation of the evidence by the ARIA guideline panel members. The ARIA guideline panel strongly supports that new generation oral H1-antihistamines be available worldwide, in particular in low to middle income countries. Recommendation In patients with AR, we recommend new generation oral H1-antihistamines that do not cause sedation <strong>and</strong> do not interact with cytochrome P450 (strong recommendation | low quality evidence). In patients with AR, we suggest new generation oral H1-antihistamines that cause some sedation <strong>and</strong>/or interact with cytochrome P450 (conditional recommendation | low quality evidence). Underlying values <strong>and</strong> preferences: The recommendation to use new generation oral H1antihistamines that cause some sedation <strong>and</strong>/or interact with cytochrome P450 places a relatively high value on a reduction of symptoms of AR, <strong>and</strong> a relatively low value on side effects of these medications. Remarks: Astemizole <strong>and</strong> terfenadine were removed from the market due to cardiotoxic side effects. Question 12 Should new generation oral H1-antihistamines versus old generation oral H1-antihistamines be used for the treatment of allergic rhinitis? See the note on classification <strong>and</strong> terminology for question 11 above. Summary of findings One health technology report addressed the relative efficacy <strong>and</strong> safety of new generation (―nonsedating‖) compared to old generation (―sedating‖) oral H1-antihistamines (225). Ten out of twelve r<strong>and</strong>omised trials included in this review investigated terfenadine or astemizole as ―non-sedating‖ oral H1-antihistamines. Because both medications were withdrawn from the market in many countries for safety reasons, it was not possible to rely on the report by Long <strong>and</strong> colleagues to inform this recommendation. One systematic review examined sedation <strong>and</strong> performance impairment with new generation H1antihistamines compared to old generation oral H1-antihistamine – diphenhydramine (226). We identified 13 r<strong>and</strong>omised trials that directly compared new generation (referred to as ―nonsedating‖) to old generation (referred to as ―sedating‖) oral H1-antihistamines in patients with allergic rhinitis. Three trials compared desloratadine with diphenhydramine (193, 227, 228), two compared fexofenadine with diphenhydramine (229) or hydroxizine (230), two compared cetirizine with chlorphenamine (231) or ketotifen (232), <strong>and</strong> six compared loratadine with chlorphenamine (233), diphenhydramine (234), brompheniramine (235), azatadine (236), <strong>and</strong> clemastine (149, 173, PAGE 45 OF 153
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