AMSUB 1 Abstracts S16-S18
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. SELECTED ABSTRACTS . The following abstracts, from medical journals containing literature on allergic rhinitis, were selected for their relevance to this Special Report. Preclinical and Clinical Evidence of Intranasal Corticosteroids Examined This article reviewed preclinical and clinical evidence of intranasal steroids to answer 2 questions: 1) How well do topical glucocorticoids measure up to expectations as to their reduced potential for systemic side effects, increased potency, and quick onset of action? 2) Can they be safely used for the treatment of allergic rhinitis and sinusitis? Available data were analyzed for several agents, including beclomethasone dipropionate, budesonide, flunisolide, fluticasone propionate, mometasone furoate, and triamcinolone acetonide. Owing to its GR-binding affinity and its transactivation potential, mometasone furoate appeared to be the most potent intranasal steroid studied. Mometasone furoate offered strong anti-inflammatory activity related to the inhibition of IL-4 and IL-5 that was equivalent to that of fluticasone propionate and superior to that of budesonide, beclomethasone dipropionate, tri- amcinolone acetonide, and betamethasone phosphate. In a previous study, treatment with mometasone furoate had been associated with statistically significant 30-minute reduction in nasal lavage histamine levels compared with placebo. The onset of action of mometasone furoate and fluticasone propionate occurs as early as 12 hours. Both have been safely administered for up to 12 months, and their low systemic availability resulted in fewer side effects than that experienced with systemically administered steroids. The newer corticosteroids are quick-acting, have gen- erally localized actions, and rapid elimination. Mometasone furoate has the highest relative binding affinity for glu- cocorticoid receptors and transcriptional activation, which leads to target-gene expression. Unlike fluticasone pro- pionate, mometasone furoate does not contain benzalkonium chloride and, therefore, does not adversely affect growth velocity in children. Lumry WR. A review of the preclinical and clinical data of newer intranasal steroids used in the treatment of allergic rhinitis. J Allergy Clin Immunol 1999;104:S150-S158. Comparison of Intranasal Corticosteroids for Allergic Rhinitis Despite the demonstrated efficacy of intranasal steroids, some physicians have remained reluctant to prescribe them owing to potential local and systemic adverse effects. This article compares intranasal glucocorticoid compounds with regard to topical potency, lipophilicity, systemic bioavailability, onset of action, and the potential for local and systemic adverse effects. Use of the McKenzie assay, which measures the topical potency of glucocorticoids, has shown that mometasone furoate and fluticasone propionate are more potent than other intranasal corticosteroids. Both were equally and highly effective in preventing the release of IL-4 and IL-5, which accounts for their substan- tial degree of activity over other compounds tested. Both offered higher degrees of lipid solubility compared with the other compounds. Neither mometasone furoate nor fluticasone propionate were readily absorbed by the gas- trointestinal tract, owing to extremely low oral bioavailability (<0.1% and <2%, respectively). Recent clinical stud- ies have demonstrated clinical improvement within 1 to 2 days of the first dose. Mometasone furoate demonstrated relief of symptoms in as few as 12 hours in 28% of patients treated with active therapy compared with 13% of patients in the placebo group. The median time to symptomatic relief for mometasone furoate and placebo was 36 and 72 hours, respectively. Greater potency of intranasal corticosteroids does not appear to increase the risk of local side effects. Mometasone furoate did not show any reduction in growth velocity at dosages of either 100 µg or 200 µg once daily. Extrapolating data from trials of fluticasone propionate, twice-daily use at 100 µg may not result in significant alterations in growth velocity. Differences among agents in children with asthma who are also being treat- ed with an inhaled steroid preparation must be determined to establish safety. However, the new agents appear to offer reasonable choices for the treatment of young children. Corren J. Intranasal corticosteroids for allergic rhinitis: How do different agents compare? J Allergy Clin Immunol 1999;104:S144-S149. S16 THE AMERICAN JOURNAL OF MANAGED CARE JANUARY 2000 . SELECTED ABSTRACTS . Loratadine Does Not Confer Additional Benefit When Added to Fluticasone Propionate This study compared the efficacy, safety, and impact on quality of life of fluticasone propionate intranasal spray (200 µg once daily), loratadine (10 mg once daily), combination therapy (fluticasone propionate plus loratadine), and placebo (an aqueous nasal spray plus tablet) in the treatment of seasonal allergic rhinitis during the mountain cedar allergy season in south central Texas. A total of 569 patients completed the study. Approximately 90% of study participants had not received previous care for their rhinitis symptoms. After 1 week of therapy, clinician-rated total nasal symptom scores were significantly lower in the fluticasone propionate and fluticasone propionate plus lorata- dine groups compared with the loratadine-only or placebo groups. After 2 weeks, total nasal symptoms were further reduced in all treatment groups. Significantly lower scores were recorded in the fluticasone propionate and combi- nation therapy groups compared with the placebo group. At 1 week and 2 weeks, loratadine did not differ from placebo in efficacy, and combination therapy did not differ from fluticasone propionate monotherapy. At day 14, fluticasone propionate and combination therapy proved equivalent in efficacy and were significantly more effective than placebo or loratadine monotherapy. There was no difference observed between the loratadine and placebo treatment groups. Quality-of-life scores were significantly improved from baseline to day 14 in patients receiving fluticasone propionate and in the combination therapy group. No mean change in baseline scores regarding quali- ty of life occurred in the loratadine-only or placebo groups. Safety was comparable in the 3 treatment groups with only 5% to 8% of patients in each group experiencing an event related to treatment. The most commonly reported adverse events were blood in the nasal mucus (1% to 2% in active treatment groups, 3% in the placebo group), epis- taxis (1% for all treatment groups), and xerostomia (2%) for all treatment groups. Fluticasone propionate was superior to loratadine alone and to placebo. Adding loratadine to the treatment regimen did not confer additional protection against symptoms. Ratner PH, van Bavel JH, Martin BG, et al. A comparison of the efficacy of fluticasone propionate aqueous nasal spray and loratadine, alone and in combination, for the treatment of seasonal allergic rhinitis. J Fam Pract 1998;47:118-125. Targeted Intervention Programs: Creating a Customized Practice Model to Improve the Treatment of Allergic Rhinitis in a Managed Care Population The article examines the process of developing an intervention program to improve health outcomes among patients with allergic rhinitis in a managed care environment. The Episodes of Care (EOC) team at Lovelace Health Systems selected allergic rhinitis for an intervention program because it was identified as one of the top 10 reasons for visits to primary care clinics. The EOC team researched literature and current practices and then identified inconsisten- cies in diagnostic and treatment patterns. Based on this research, the team developed guidelines and a provider edu- cation program. Intervention strategies were structured around decision points in a treatment protocol. More than 500 patients were monitored throughout the allergy season by using written and telephone surveys, symptom diaries, and encounter data. Measurable outcomes were established for provider and patient behavior. Patient outcomes were derived from a preventive behavior index and administrative data reporting usage of 5 classes of medication. Approximately 50% of providers altered their practice patterns as a result of the intervention program. Patient out- comes showed a decrease in the use of rescue medications, particularly antibiotics, and an increase in preventive measures in the treatment group compared with the control group. The EOC model resulted in positive changes in provider and patient behavior. The multidisciplinary approach resulted in broad provider participation. Gregory C, Cifaldi M, Tanner LA. Targeted intervention programs: Creating a customized practice model to improve the treatment of aller- gic rhinitis in a managed care population. Am J Manag Care 1999;5:485-496. VOL. 6, NO. 1, SUP. THE AMERICAN JOURNAL OF MANAGED CARE S17 . SELECTED ABSTRACTS . Medical Care Costs of Patients With Allergic Rhinitis and Asthma This study examined medical care costs for patients with both asthma and allergic rhinitis and compared it with costs for patients with asthma alone. A previously identified cohort of 1245 patients with asthma confirmed by medical review records was used to help establish the frequency of coexisting asthma and allergic rhinitis. A total of 653 patients also had documented allergic rhinitis: 23.9% had only seasonal allergic rhinitis; 6.4% had perennial aller- gic rhinitis; and 5.9% had nonallergic rhinitis. Men were slightly more likely than