No evidence for inhaled corticosteroids efficacy in cystic fibrosis
Jun 15, 2006, 16:57, Reviewed by: Dr. Priya Saxena
|"Replacing the inhaled corticosteroids with a placebo was found to be safe as there was no significant increase in lung-related adverse effects leading to withdrawal from the study, nor an increased need for oral corticosteroids,"
In comparison to cystic fibrosis (CF) patients who regularly use inhaled corticosteroid, those who did not use these drugs for six months exhibited no positive or negative effects in terms of major disease factors. Such factors include amount of lung function decline, number of antibiotics prescribed, time to onset of acute chest exacerbation or frequency of using a bronchodilator.
Ian M. Balfour-Lynn, M.D., F.R.C.P., of the Department of Pediatric Respiratory Medicine at Royal Brompton Hospital in London, and six associates concluded that it is safe for CF patients to stop using inhaled corticosteroids in order to lower their drug burden, to reduce potential adverse side effects, and to save money.
According to the authors, 52 percent of children and 55 percent of the adults with CF in Great Britain have been prescribed inhaled corticosteroid medication for their illness.
CF, an inherited disorder, is characterized by the production of thick, sticky mucus that frequently obstructs the lungs. The problem can lead to life-threatening lung infections and difficulties with the pancreatic ducts, preventing normal digestion and causing patient malnutrition. Because of improved treatment techniques in recent years, however, patient survival has increased from 25 to 33 years.
"Oral corticosteroids slow the progression of CF lung disease, but long-term use is precluded by unacceptable side effects," said Dr. Balfour-Lynn. "A systematic review of inhaled corticosteroid use in CF revealed 10 randomized controlled trials, with six having been published. The trials studied 293 adults and children. Although there was variable methodological quality among the studies, the conclusion was that there was 'no evidence from existing trials to support the practice of prescribing inhaled steroids in cystic fibrosis.'"
The authors noted that 52 percent of the patients were on high-dose inhaled corticosteroids (1,000 micrograms or more per day). At those levels, the drug can lead to significant symptoms related to adrenal suppression and insufficiency. Also, among pediatric patients, slowing of linear growth has been a problem for individuals taking the drug for a year or more.
Over a 6-month period, the researchers studied 84 CF patients (median age 14.6 years) who were using an inhaled corticosteroid (fluticasone) and 87 CF patients (median age 15.8 years) who were not.
"Replacing the inhaled corticosteroids with a placebo was found to be safe as there was no significant increase in lung-related adverse effects leading to withdrawal from the study, nor an increased need for oral corticosteroids," said Dr. Balfour-Lynn.
The researchers stressed that they were not advocating stopping inhaled corticosteroid use in all CF patients, but urging clinicians to assess the need in each individual.
"If there is objective evidence that a patients benefited when inhaled corticosteroids were first started, then it is likely they should be continued on the drug," said Dr. Balfour-Lynn.
- The findings appear in the second issue for June 2006 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.
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