Portal de Periódicos da CAPES

Effect of ciclesonide and fluticasone on hypothalamicpituitary-adrenal axis function in adults with mild-to-moderate persistent asthma

2005; Elsevier BV; Volume: 94; Issue: 4 Linguagem: Inglês

10.1016/s1081-1206(10)61117-9

1534-4436

Brian J. Lipworth, Michael Kaliner, Craig LaForce, James Baker, Harold B. Kaiser, Dilip Amin, Sudeep Kundu, James E. Williams, Renate Engelstaetter, Donald Banerji,

Herbal Medicine Research Studies

Background Despite their proven efficacy in the treatment and prevention of asthma exacerbations, current inhaled corticosteroids carry safety concerns, especially adrenal suppression. Ciclesonide (hydrofluoroalkane propellant) is a novel inhaled corticosteroid with few, if any, clinical adverse events. Objective To evaluate the potential effects of ciclesonide therapy on the dynamic cortisol response to sequential low- and high-dose cosyntropin stimulation in adults with mild-to-moderate persistent asthma. Methods This was a double-blind, randomized, placebo-controlled, 12-week study in adults with mild-to-moderate asthma. One hundred sixty-four patients were randomized and treated; 148 patients completed the study. Fluticasone propionate (chlorofluorocarbon propellant) was used as an active comparator. The doses administered were 320 μg of ciclesonide once daily, 320 μg of ciclesonide twice daily, and 440 μg of fluticasone propionate twice daily, all doses ex-actuator. Results For both ciclesonide groups, changes in mean low- and high-dose peak serum cortisol levels and in 24-hour urinary free cortisol levels corrected for creatinine were small vs baseline and comparable with placebo. For the fluticasone propionate group, significant reductions vs placebo in serum cortisol levels in response to high-dose cosyntropin stimulation and in 24-hour urinary free cortisol levels were observed. Oral candidiasis rates were 2.5% for 320-μg/d ciclesonide, 2.4% for 640-μg/d ciclesonide, and 22.0% for 880-μg/d fluticasone propionate. Conclusions These findings confirm the safety of ciclesonide therapy, demonstrating that at doses up to 640 μg/d, the drug does not affect sensitive markers of adrenal function. Despite their proven efficacy in the treatment and prevention of asthma exacerbations, current inhaled corticosteroids carry safety concerns, especially adrenal suppression. Ciclesonide (hydrofluoroalkane propellant) is a novel inhaled corticosteroid with few, if any, clinical adverse events. To evaluate the potential effects of ciclesonide therapy on the dynamic cortisol response to sequential low- and high-dose cosyntropin stimulation in adults with mild-to-moderate persistent asthma. This was a double-blind, randomized, placebo-controlled, 12-week study in adults with mild-to-moderate asthma. One hundred sixty-four patients were randomized and treated; 148 patients completed the study. Fluticasone propionate (chlorofluorocarbon propellant) was used as an active comparator. The doses administered were 320 μg of ciclesonide once daily, 320 μg of ciclesonide twice daily, and 440 μg of fluticasone propionate twice daily, all doses ex-actuator. For both ciclesonide groups, changes in mean low- and high-dose peak serum cortisol levels and in 24-hour urinary free cortisol levels corrected for creatinine were small vs baseline and comparable with placebo. For the fluticasone propionate group, significant reductions vs placebo in serum cortisol levels in response to high-dose cosyntropin stimulation and in 24-hour urinary free cortisol levels were observed. Oral candidiasis rates were 2.5% for 320-μg/d ciclesonide, 2.4% for 640-μg/d ciclesonide, and 22.0% for 880-μg/d fluticasone propionate. These findings confirm the safety of ciclesonide therapy, demonstrating that at doses up to 640 μg/d, the drug does not affect sensitive markers of adrenal function.