High doses of a common over-the-counter pain reliever slowed lung deterioration by 90% over four years in children with cystic fibrosis, a study has found.
The benefits of ibuprofen--sold under such brand names as Advil, Nuprin and Motrin--were most dramatic in children ages 5 to 13 who consistently took it in addition to conventional treatment with other drugs, the study's authors said. Ibuprofen might also have some reduced benefit in older patients, the researchers said.
"I think this study suggests it's a valid therapy to introduce into the clinic," said one of the authors, Dr. Pamela Davis of Rainbow Babies and Children's Hospital in Cleveland. The study appears today in the New England Journal of Medicine.
Doctors agreed that the addition of the treatment is likely to increase the life expectancy of cystic fibrosis patients, although it will be years before that is proved. With current treatments, half of the 1,000 people found to have cystic fibrosis each year die before the age of 30.
Davis cautioned patients not to begin treating themselves with the drug because it can have harmful side effects if not used correctly. It can harm the stomach and kidneys and interfere with other drugs used to treat cystic fibrosis, she said.
On Tuesday, a Food and Drug Administration advisory panel recommended that Children's Motrin be approved for sale without a prescription. Adult versions are already available without prescription.
Part of the lung damage that occurs in cystic fibrosis is caused by inflammation of the lungs. Ibuprofen, an anti-inflammatory, helps control that.
The Cystic Fibrosis Foundation, which partly funded the study, has sent information to doctors across the country telling them this was an important development that they should consider adding to conventional treatments.
Cystic fibrosis is the most common fatal inherited disease of Americans. About 30,000 Americans, mostly whites, are afflicted with the disease, and one in 25 white Americans is a carrier of the cystic fibrosis gene. The disease occurs only in those who get two copies of the gene, one from each parent.
Davis and her colleagues studied 85 patients ages 5 to 39. Some were given ibuprofen and some were given placebos for four years. Doses were adjusted individually, with some patients taking the equivalent of 16 over-the-counter tablets a day. The recommended dose is normally one or two tablets every four to six hours with a maximum of six tablets in 24 hours.
In a standard measure of lung function in which patients are asked to exhale as quickly as they can, the researchers saw a 16% decline in the placebo group over the four years, compared with a 2% decline in the members of the ibuprofen group ages 5 to 13 who took their medication consistently.
That represents a slowing of 90% in lung deterioration, she said.