Fluticasone propionate powder and lack of clinically significant effects on hypothalamic-pituitary-adrenal axis and bone mineral density over 2 years in adults with mild asthma
| Autor: | Stuart M. Harding, Nancy Herje, James T.C. Li, Tushar Shah, Paul Chervinsky, Abbas G. Hamedani, Donald J Kellerman, Kenneth G. Faulkner, Stephen C. Weisberg, Linda B. Ford |
|---|---|
| Rok vydání: | 1999 |
| Předmět: |
Adult
Male Hypothalamo-Hypophyseal System medicine.medical_specialty Adolescent Bone density medicine.drug_class Immunology Pituitary-Adrenal System Placebo Gastroenterology Fluticasone propionate Pulmonary function testing Double-Blind Method Bone Density Osteogenesis Internal medicine medicine Humans Immunology and Allergy Anti-Asthmatic Agents Bone Resorption Asthma Fluticasone business.industry Area under the curve Middle Aged medicine.disease Androstadienes Endocrinology Patient Compliance Corticosteroid Female Powders business medicine.drug |
| Zdroj: | Journal of Allergy and Clinical Immunology. 103:1062-1068 |
| ISSN: | 0091-6749 |
| DOI: | 10.1016/s0091-6749(99)70180-6 |
| Popis: | Background: Although inhaled corticosteroids are widely used for the treatment of inflammation in asthma, prospective, long-term, placebo-controlled trials characterizing their systemic safety with chronic use are lacking. Objective: This study was designed to prospectively evaluate the long-term safety of inhaled fluticasone propionate therapy. Methods: Fluticasone propionate powder, 500 μg, or placebo was administered twice daily by means of the Diskhaler for 104 weeks to 64 adults with mild persistent asthma in a randomized, double-blind, parallel-group study. Primary safety variables were measured at baseline and every 6 months thereafter. Although evaluation of efficacy was not an objective of this study, pulmonary function testing was performed at monthly intervals. Results: Two years of treatment with fluticasone propionate had no significant effects on the skeletal system. No clinically significant changes were observed in ophthalmic parameters (glaucoma and posterior subcapsular cataracts). Mean change from baseline in lumbar spine (L 1 to L 4 ) bone density at week 104 was not significantly different between fluticasone propionate (–0.006 ± 0.008 g/cm 2 ) and placebo (–0.007 ± 0.010 g/cm 2 ). Markers of bone formation (serum osteocalcin) and resorption (urinary N-telopeptide) did not differ significantly between treatment groups. The effects of fluticasone propionate treatment on the hypothalamic-pituitary-adrenal axis were minimal, with no alterations in morning plasma cortisol concentrations and minor but statistically significant decreases in poststimulation mean peak plasma cortisol concentrations ( P = .021) and 8-hour plasma cortisol area under the curve values ( P = .020) at week 104. Drug-related adverse events were primarily topical effects of inhaled corticosteroids. Pulmonary function improved significantly during 2 years of fluticasone propionate treatment. Conclusion: Fluticasone propionate powder, 500 μg twice daily for up to 2 years, was efficacious and well tolerated, with no clinically relevant effects on the hypothalamic-pituitary-adrenal axis, bone density, or ophthalmic parameters in adults with mild asthma. (J Allergy Clin Immunol 1999;103:1062-8.) |
| Databáze: | OpenAIRE |
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