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« on: May 10, 2007, 07:43:01 pm » |
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March 2, 2007 (San Diego) — People who take intranasal ciclesonide (Alvesco) along with fluticasone 500 µg/salmeterol 50 µg per inhalation (Advair) do not have increased hypothalamic-pituitary-adrenal (HPA) suppression beyond what is typically seen with fluticasone at that dose, according to investigators who presented their findings here at the 63rd annual meeting of the American Academy of Allergy, Asthma, and Immunology (AAAAI).
"Ciclesonide had no additive inhibitory effect when used concomitantly with combined fluticasone-salmeterol," said principal investigator Kenneth Kim, MD, during his presentation. "Therefore, ciclesonide may provide a safe treatment option for patients with allergic rhinitis and comorbid asthma who need both an intranasal and an inhaled corticosteroid." Dr. Kim is president and chief executive officer of West Coast Clinical Trials in Long Beach, California.
The investigators conducted the study because so many patients have both asthma and allergic rhinitis and because of the concern that taking both intranasal and inhaled corticosteroids could increase the risk of cortisol suppression beyond that of taking an inhaled corticosteroid alone. Therefore, they wanted to assess the safety of patients with perennial allergic rhinitis taking an intranasal and an inhaled corticosteroid concomitantly. The inhaled corticosteroid fluticasone propionate, at a dose of 500 mcg, combined with salmeterol at a dose of 50 mcg, was taken in the conventional manner of twice daily.
After the 150 patients underwent a 10-day run-in period with the fluticasone-salmeterol combination and a placebo nasal spray taken once daily, the investigators randomized them to receive, in addition, once-daily administration of intranasal ciclesonide at a dose of 200 µg or placebo for 43 days. They also received a single oral dose of 2 mg of dexamethasone as an active control on the last treatment day. The investigators obtained patients' 24-hour plasma cortisol levels on the first and last days of the run-in and at the end of treatment.
The plasma cortisol area-under-curve in a 24-hour period (AUC0-24h) was lower by an average of 53.7 µg/dL for the corresponding hour during the fluticasone-salmeterol run-in period (P < .001 compared with baseline). Not surprisingly, this reduction showed that this dose of fluticasone was associated with a measurable suppression. When ciclesonide was added to the treatment regimen, the average decrease in plasma cortisol AUC0-24h was 2.9 µg/dL greater for matched hours in the group receiving the intranasal placebo compared with those receiving the intranasal corticosteroid, a difference that was not statistically significant, according to the investigators. When the patients received the dexamethasone dose, the average plasma cortisol AUC0-24h decreased by 73.3 µg/dL for corresponding hours (P < .001). This finding showed that further cortisol suppression was possible, the investigators reported.
"It is generally recognized that 800 µg or more daily of fluticasone can suppress the HPA axis," Hannelore Brucker, MD, told Medscape in a phone interview. "The fact is that ciclesonide doesn't further suppress HPA in patients on high-dose inhaled fluticasone is welcome. We know that many people with asthma have allergic rhinitis also and get both [drugs]." Dr. Brucker is an allergist in private practice at Southdale Allergy and Asthma Clinic in Minneapolis, Minnesota, and a member of AAAAI's Public Education Committee.
However, Dr. Brucker added, "It would be interesting to compare [ciclesonide] to other intranasal steroids to see if they give the same result, not causing any further suppression of the HPA axis beyond the suppression caused by the high-dose inhaled fluticasone."
The study was supported by Altana, which manufactures Alvesco. Neither Dr. Kim nor Dr. Brucker has any financial ties to the company.
AAAAI 63rd Annual Meeting: Abstract 562. Presented February 25, 2007.
Source: http://www.medscape.com/viewarticle/553091?src=mp
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