Potential Effects of Fluticasone Propionate on Bone Mineral Density in Patients With Asthma: A 2-Year Randomized, Double-Blind Placebo-Controlled Trial

Kemp, James P.; Osur, Scott; Shrewsbury, Stephen B.; Herje, Nancy E.; Duke, Susan P.; Harding, Stuart M.; Faulkner, Kennethf; Crim, Courtney C.
April 2004
Mayo Clinic Proceedings;Apr2004, Vol. 79 Issue 4, p458
Academic Journal
• Objective: To evaluate the effects of treatment with fluticasone propionate vs placebo on bone, hypothalamicpituitary-adrenal (HPA) axis function, and the eyes in patients with asthma. • Patients and Methods: This randomized, double-blind, placebo-controlled study of 160 patients with asthma who had minimal previous exposure to corticosteroids was conducted from July 1994 through June 1997. Patients received fluticasone at 88 µg twice dally, fiuticasone at 440 µg twice daily, or placebo twice daily for 2 years. Bone mineral density (BMD) was evaluated every 6 months by lumbar spine, proximal femur, and total body scans. Measurements of HPA axis function and ophthalmic evaluations were conducted at similar intervals. • Results: Among the 3 groups, no significant differences were observed in BMD at week 104 (at any anatomical site). Mean percent change from baseline in the lumbar spine was less than 1% for all 3 groups. At all time points, HPA axis function was similar in the 88-µg fluticasone group compared with the placebo group. For mean change from baseline in corticotropin-stimulated peak cortisol (P=.003 and P=.02 at weeks 24 and 52, respectively) and area under the stimulated plasma cortisol vs time curve (P=.002 and P=.02 at weeks 24 and 52, respectively), statistically significant reductions from baseline were observed in the 440-µg fluticasone group compared with the placebo group. These reductions of 10% to 13% from baseline were not accompanied by other signs of systemic effect and did not persist with continued treatment (at weeks 76 and 104). No important ocular changes were observed. • Conclusion: Long-term treatment with 88 µg of fluticasone twice dally was comparable to placebo in all skeletal, ophthalmic, and HPA axis function assessments. Treatment with fluticasone at 440 µg twice daily resulted in no significant effects on BMD and a statistically significant but not clinically important temporary reduction in cortisol production.


Related Articles

  • Step One for Asthma Treatment: β-Agonists or Inhaled Corticosteroids? Redington, A.E. // Drugs;Jul2001, Vol. 61 Issue 9, p1231 

    Inhaled corticosteroids have proven effectiveness in chronic persistent asthma and are now recommended as first-line therapy in this condition. In contrast, long term preventative therapy is not currently considered necessary for patients with disease that is only mild and episodic. Recently,...

  • COPD combination therapy questioned.  // Independent Nurse;11/2/2009, p15 

    The article discusses a Dutch study concerning the addition of long-acting beta-agonists (LABAs) to corticosteroid therapy for chronic obstructive pulmonary disease (COPD). The findings of the study negate an analysis of the Toxoplasmosis, Rubella, Cytomegalovirus and Herpes Simplex (TORCH)...

  • Using exhaled NO concentrations to adjust inhaled corticosteroid dose maintained asthma control and reduced the dose. Smith, A. D.; Cowan, J. O.; Brassett, K. P.; Taylor, R. // Evidence Based Medicine;Feb2006, Vol. 11 Issue 1, p20 

    The article reports on a study to determine whether optimizing the inhaled corticosteroid dose using the fraction of nitric oxide in exhaled air can reduce asthma exacerbations and the daily dosage compared to the use of standard criteria for patients with chronic asthma. Patients aged 12-75...

  • Commentary. Rees, P. John // Evidence Based Medicine;Feb2006, Vol. 11 Issue 1, p20 

    The article comments on a study by A. D. Smith and colleagues to determine whether optimizing the inhaled corticosteroid dose using the fraction of nitric oxide in exhaled air can reduce asthma exacerbations and the daily dosage compared to the use of standard criteria for patients with chronic...

  • The efficacy and safety of inhaled corticosteroids: are we ignoring the potential advantages of ciclesonide? van der Molen, Thys; Kocks, Janwillem W. H. // Primary Care Respiratory Society UK;5/20/2014, p1 

    The authors reflect on the safety and effectiveness of inhaled corticosteroids (ICS) as well as the possible benefits of ciclesonide. They mention that the synthetic steroids are considered the basic treatment for asthma and prescribed by physicians for handling chronic obstructive pulmonary...

  • Inhaled corticosteroids and COPD. Farquhar, Donald // CMAJ: Canadian Medical Association Journal;8/08/2000, Vol. 163 Issue 3, p326 

    Reports on a study of the effect of inhaled corticosteroid therapy as a treatment for chronic obstructive pulmonary disease (COPD). Use of the therapy on patients with asthma; Design; Results; Practice implications.

  • Beclomethasone revisited: the modern view of a classic inhaled corticosteroid. Bakakos, Petros; Loukides, Stelios; Kostikas, Konstantinos // Pneumon;Apr-Jun2014, Vol. 27 Issue 2, p120 

    Asthma is a worldwide problem affecting more than 300 million people of all ages with a relevant impact on quality of life and healthcare resources. International guidelines recommend the combination of a long acting beta-2-agonist and an inhaled corticosteroid when asthma is not fully...

  • Changes in recommended treatments for mild and moderate asthma. Redding, Gregory J.; Stoloff, Stuart W. // Journal of Family Practice;Sep2004, Vol. 53 Issue 9, p692 

    This article reviews the 2002 National Asthma Education and Prevention Program (NAEPP) recommendations for the use of controlled medications for asthma, including the relative effectiveness of inhaled corticosteroids (ICSs) versus other controller medications, safety of long-term ICS use in...

  • Stepping down inhaled corticosteroids in asthma: randomised controlled trial. Hawkins, Gillian; Wood, Stuart F; McMahon, Alex D; Ford, Ian; Twaddle, Sara; Thomson, Neil C // BMJ: British Medical Journal (International Edition);5/24/2003, Vol. 326 Issue 7399, p1115 

    Abstract Objectives To determine whether the dose of inhaled corticosteroids can be stepped down in patients with chronic stable asthma while maintaining control. Design One year, randomised controlled, double blind, parallel group trial. Setting General practices throughout western and central...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics