Allergic Rhinitis and its Impact on Asthma - ARIA

Recommendations

Info

ALLERGIC RHINITIS AND ITS IMPACT ON ASTHMA GUIDELINES ● 2010 – V. 9/8/2010 Harms The most frequently reported adverse effect of intranasal H1-antihistamines was unpleasant taste with azelastine <strong>and</strong> olopatadine (see evidence profiles for question 14). There is an increased risk of somnolence (see evidence profiles for question 14) with an pooled estimate of relative risk of 2.44 (95% CI: 1.22 to 4.87) over 7 studies of azelastine, 2 studies of levocabastine, <strong>and</strong> 2 studies of olopatadine. Assuming a baseline risk of somnolence of 0.5% (observed in these studies) this relative effect would translate into an absolute risk increase of 7 more patients experiencing somnolence per 1000 patients receiving intranasal H1-antihistamine (95% CI: 1–19 more per 1000). Conclusions <strong>and</strong> research needs A net clinical benefit of intranasal H1-antihistamines is uncertain, because of imprecise estimates of the effects <strong>and</strong> poor reporting of many trials. Given the rare or mild adverse effects this class of agents may be beneficial in patients with seasonal allergic rhinitis. Answering this question requires an updated rigorously performed <strong>and</strong> reported (223, 224) systematic review of all intranasal H1-antihistamines versus placebo that provides information on all outcomes important to patients, including adverse effects. Well designed <strong>and</strong> rigorously executed r<strong>and</strong>omised trials of intranasal H1-antihistamines in patients with allergic rhinitis that measure <strong>and</strong> properly report (74, 75) patient-important outcomes, if done, are very likely to have important impact on this recommendation. Recommendation We suggest intranasal H1-antihistamines in adults with seasonal allergic rhinitis (conditional recommendation | low quality evidence) <strong>and</strong> in children with seasonal allergic rhinitis (conditional recommendation | very low quality evidence). In adults <strong>and</strong> children with perennial/persistent AR, we suggest that clinicians do not administer <strong>and</strong> patients do not use intranasal H1-antihistamines until more data on their relative efficacy <strong>and</strong> safety is available (conditional recommendation | very low quality evidence). Underlying values <strong>and</strong> preferences: The recommendation to use intranasal H1-antihistamines in patients with seasonal allergic rhinitis places a relatively high value on reduction of symptoms, <strong>and</strong> a relatively low value on the risk of rare or mild side effects. The recommendation not to use intranasal H1-antihistamines in patients with perennial/persistent allergic rhinitis places a relatively high value on their uncertain efficacy <strong>and</strong> possible side effects, <strong>and</strong> a relatively low value on possible small reduction in symptoms. Question 15 Should new generation oral H1-antihistamines versus intranasal H1antihistamines be used for treatment of allergic rhinitis? Summary of findings One recent systematic review assessed the relative effect of intranasal azelastine compared to new generation oral H1-antihistamine for the treatment of allergic rhinitis (244). However, we could not use it to inform this recommendation, since it did not provide a meaningful estimate of the effect for the outcomes of interest for this guideline. PAGE 50 OF 153
ALLERGIC RHINITIS AND ITS IMPACT ON ASTHMA GUIDELINES ● 2010 – V. 9/8/2010 We found 9 r<strong>and</strong>omised trials that compared intranasal H1-antihistamines to a new generation oral H1-antihistamines (255, 279-286). We did not consider studies that used old generation oral H1antihistamines as well as studies that used astemizole or terfenadine as comparator, since they have been removed from the market because of adverse effects <strong>and</strong> no longer represent a therapeutic option in allergic rhinitis. An additional article (287) reported the results of the same study that we already included (282). Seven studies compared intranasal versus oral H1-antihistamine in adults with seasonal allergic rhinitis (255, 280-284, 286), one study was done in adults with perennial allergic rhinitis (285), <strong>and</strong> one in children with perennial allergic rhinitis (279). All studies done in adults with seasonal allergic rhinitis used azelastine as intranasal medication, except for one that used levocabastine (286). Of trials that used azelastine, four used a dose of 0.56 mg/d (255, 281, 282, 284) <strong>and</strong> two used 1.12 mg/d (280, 283). Many of these studies did not report a measure of variability in the results, thus obtaining a combined estimate of the effects was not possible. However, based on the studies that properly reported their results <strong>and</strong> on the point estimates from the other studies, it is likely that intranasal <strong>and</strong> oral H1-antihistamines have a similar effect on nasal <strong>and</strong> ocular symptoms in adults with seasonal allergic rhinitis (see evidence profile 1 for question 15). Incidence of somnolence was lower in patients receiving intranasal than in those receiving oral H1-antihistamines (RR: 0.39, 95% CI: 0.16 to 0.98). However, these results are very uncertain, because of the small number of events. One study investigated the use of intranasal azelastine 0.56 mg/d compared to oral cetyrizine 10 mg in 40 adults with perennial allergic rhinitis (285). After 8 weeks of treatment mean total symprom score was lower in azelastine compared with cetirizine group, but authors reported neither the scale on which symptom score was measured nor the variability in these results. Rating of the efficacy of treatment by the investigators was also similar in azelastine <strong>and</strong> cetirizine treated patients (see evidence profile 2 for question 15). One study with serious limitations compared intranasal levocabastine to oral cetirizine in children with perennial allergic rhinitis (279). This study found no difference between the two treatments but <strong>its</strong> results were very imprecise <strong>and</strong> indirect (see evidence profile 3 for question 15). Benef<strong>its</strong> Intranasal H1-antihistamines seem to equally effectively improve nasal <strong>and</strong> ocular symptoms as new generation oral H1-antihistamines. However, these estimates are imprecise. Harms Intranasal <strong>and</strong> oral H1-antihistamines were well tolerated in these studies, but their adverse effects were reported inconsistently. The most common side effect with azelastine was bitter taste (up to 11% of patients). Somnolence was more frequent in the oral than in intranasal H1-antihistamine treated patients by the results were imprecise <strong>and</strong> it is likely that the oral H1-antihistamines differ in their potential of causing somnolence. Conclusions <strong>and</strong> research needs Intranasal H1-antihistamines appear to be equally beneficial as new generation oral H1antihistamines in patients with allergic rhinitis. The net benefit with intranasal versus newer oral H1-antihistamines may depend on patients’ preference regarding the route of administration. There PAGE 51 OF 153
Page 1 and 2: ALLERGIC RHINITIS AND ITS IMPACT ON
Page 49: ALLERGIC RHINITIS AND ITS IMPACT ON
Page 101 and 102:
ALLERGIC RHINITIS AND ITS IMPACT ON
Page 103 and 104:
Page 105 and 106:
Page 107 and 108:
Page 109 and 110:
Page 111 and 112:
Page 113 and 114:
Page 115 and 116:
Page 117 and 118:
Page 119 and 120:
Page 121 and 122:
Page 123 and 124:
Page 125 and 126:
Page 127 and 128:
Page 129 and 130:
Page 131 and 132:
Page 133 and 134:
Page 135 and 136:
Page 137 and 138:
Page 139 and 140:
Page 141 and 142:
Page 143 and 144:
Page 145 and 146:
Page 147 and 148:
Page 149 and 150:
Page 151 and 152:
Page 153:
show all

Allergic Rhinitis and its Impact on Asthma - ARIA

Create successful ePaper yourself

Delete template?

Save as template?