Gary Gross

Inhaled salmeterol and fluticasone: a study comparing monotherapy and combination therapy in asthma.

BACKGROUNDnThe current stepwise approach to pharmacotherapy in the treatment of asthma includes the initiation of an inhaled corticosteroid with the addition of a long-acting inhaled bronchodilator if low dose inhaled corticosteroid fails to control asthma symptoms.nnnOBJECTIVEnTo determine whether initiation of salmeterol and fluticasone propionate treatment together improves asthma control greater than initiation of monotherapy with the individual agents alone with no additional safety risk in patients with asthma who had not previously been treated with inhaled corticosteroids.nnnMETHODSnA total of 136 male and female patients at least 12 years of age with asthma [forced expiratory volume in 1 second (FEV) between 50% and 80% of predicted] were randomized to twice daily salmeterol 42 microg, fluticasone propionate 88 microg, fluticasone propionate 220 microg, salmeterol 42 microg plus fluticasone propionate 88 microg, salmeterol 42 microg plus fluticasone propionate 220 microg, or placebo for 4 weeks.nnnRESULTSnPatients treated with salmeterol combined with fluticasone propionate had improvements over baseline in FEV at endpoint that were at least twice as great (0.6 to 0.7 L) as improvements in patients treated with salmeterol (0.3 L) or fluticasone propionate alone (0.3 L) (P < .05). Patient-rated data (peak expiratory flow, asthma symptom scores, percent of days with no asthma symptoms) confirmed greater (P < .05) mean change from baseline improvements after combined treatment compared with fluticasone propionate alone. No clinically significant differences were noted between treatment groups in any safety measurement.nnnCONCLUSIONnInitiation of maintenance therapy with salmeterol and fluticasone propionate in patients with asthma treated with short-acting beta2-agonists alone provides greater improvements in pulmonary function and symptom control than initiation of maintenance therapy with fluticasone propionate alone.

Allergy immunotherapy among Medicaid-enrolled children with allergic rhinitis: Patterns of care, resource use, and costs

BACKGROUNDnAlthough research demonstrates that allergy immunotherapy (IT) improves allergic rhinitis (AR) outcomes, little is known about IT patterns of care and associated resource use and costs among US children with diagnoses of AR.nnnOBJECTIVEnWe sought to examine characteristics associated with receiving IT, patterns of IT care, and health care use and costs incurred in the 6 months before versus after IT.nnnMETHODSnWe performed retrospective Florida Medicaid claims data (1997-2004) analysis of children (<18 years of age) given new diagnoses of AR.nnnRESULTSnOf 102,390 patients with new diagnoses of AR, 3048 (3.0%) received IT. Male patients, Hispanic patients, and those with concomitant asthma were significantly more likely to receive IT. Approximately 53% completed less than 1 year and 84% completed less than 3 years of IT. Patients who received IT used significantly less pharmacy (12.1 vs 8.9 claims, P < .0001), outpatient (30.7 vs 22.9 visits, P < .0001), and inpatient (1.2 vs 0.4 admissions, P = .02) resources in the 6 months after versus before IT. Pharmacy (

The effects of triamcinolone acetonide aqueous nasal spray on adrenocortical function in children with allergic rhinitis

330 vs

Comparative efficacy, safety, and effect on quality of life of triamcinolone acetonide and fluticasone propionate aqueous nasal sprays in patients with fall seasonal allergic rhinitis

60, P < .0001), outpatient (

Effects of fluticasone propionate, triamcinolone acetonide, prednisone, and placebo on the hypothalamic-pituitary-adrenal axis☆☆☆★

735 vs

Efficacy and safety of fluticasone propionate 44 μg/salmeterol 21 μg administeredin a hydrofluoroalkane metered-dose inhaleras an initial asthma maintenance treatment

270, P < .0001), and inpatient (

A comparison of effects of triamcinolone acetonide aqueous nasal spray, oral prednisone, and placebo on adrenocortical function in male patients with allergic rhinitis☆☆☆★★★

2441 vs

Diskus and diskhaler: efficacy and safety of fluticasone propionate via two dry powder inhalers in subjects with mild-to-moderate persistent asthma

1, P < .0001) costs (including costs for IT care) were significantly reduced after IT.nnnCONCLUSIONnDespite suboptimal treatment persistence (only 16% of patients completed 3 years of IT), resource use and costs after treatment were significantly reduced from pre-IT levels.

Treating the ocular symptoms of seasonal allergic rhinitis with triamcinolone acetonide aqueous nasal spray.

BACKGROUNDnSuppression of adrenocortical function, a risk associated with oral corticosteroids, is minimized with intranasal corticosteroids. Triamcinolone acetonide (TAA) aqueous nasal spray, at therapeutic doses, has no measurable effect on adrenocortical function in adults with allergic rhinitis.nnnOBJECTIVEnThis double-blind, placebo-controlled study compared the effect of once-daily TAA aqueous nasal spray (220 or 440 microg) with placebo on adrenocortical function after 6 weeks of treatment in pediatric (children 6 to 12 years of age) patients with allergic rhinitis. The pharmacokinetic profile of TAA was examined after once-daily intranasal administration of TAA aqueous nasal spray 440 microg for 6 weeks.nnnMETHODSnEighty children received TAA aqueous nasal spray 220 microg or 440 microg or placebo for 6 weeks. Adrenocortical function was assessed by analyzing plasma cortisol levels before stimulation (0 hour) and at 30 and 60 minutes after a rapid 1-hour intravenous cosyntropin stimulation test performed before treatment and after 6 weeks of treatment. Samples for pharmacokinetic evaluation were collected from 19 patients at baseline (0 hour) and at 0.5, 1, 1.5, and 6 hours after the final dose of study medication.nnnRESULTSnAfter 6 weeks, no significant effects on adrenocortical function were observed at 30 or 60 minutes after cosyntropin stimulation with either dose of TAA aqueous nasal spray. TAA concentrations in plasma showed rapid elimination of the drug, with little or no accumulation.nnnCONCLUSIONSnTAA aqueous nasal spray (220 or 440 microg/day) has no measurable effect on adrenocortical function in pediatric patients with allergic rhinitis. Pharmacokinetic parameters after 440 microg/day of TAA aqueous nasal spray indicate a rapid decline of plasma drug levels, with little or no systemic accumulation of study drug.

Impact of newly revised sterile medication compounding guidelines USP 〈797〉 on allergy vial preparation

BACKGROUNDnThe topical potency of fluticasone propionate (FP) is known to be four times greater than that of triamcinolone acetonide (TAA). However, the significance of this difference has not been proven in the clinical treatment of seasonal allergic rhinitis (SAR).nnnOBJECTIVEnTo compare the efficacy, safety, and effect on health-related quality of life (HRQL) of FP and TAA aqueous nasal sprays in patients with SAR.nnnMETHODSnSingle-blind, parallel-group, active-controlled design. Patients were randomized to 3-week treatment with TAA 220 microg (n = 172) or FP 200 microg (n = 180) as two sprays/nostril once daily AM. Twelve-hour reflective symptom evaluations (nasal discharge, stuffiness, itching; sneezing; ocular itching/tearing/redness) were performed AM/PM, beginning at pretreatment baseline period. Incidences of specific treatment-related side effects were collected in daily questionnaires. HRQL was evaluated at baseline and end-of-treatment with a validated disease-specific, quality-of-life instrument.nnnRESULTSnTAA and FP produced similar improvement in daily total nasal symptom scores overall (49.4% and 52.7%, respectively; P = 0.332) and at every weekly time point (P > 0.05). There were no significant differences between TAA and FP in any individual symptom score at any time point except week 2 (FP provided greater reduction in sneezing, P = 0.046). No significant difference was found between groups in overall occurrence of specific treatment-related side effects. Overall Rhinoconjunctivitis Quality of Life Questionnaire scores were similar for TAA and FP at end-of-treatment.nnnCONCLUSIONSnDespite differing molecular potencies, FP and TAA demonstrated comparable efficacy in the treatment of SAR, and produced similar occurrences of specific treatment-related side effects and similar improvements in overall patient HRQL.