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Previous Volume 332:848-854 March 30, 1995 Number 13 Next

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ABSTRACT

Background Since the inflammatory response to chronic infection contributes to lung destruction in patients with cystic fibrosis, we hypothesized that antiinflammatory therapy might slow the progression of lung disease.

Methods In a double-blind trial, 85 patients, 5 to 39 years of age, with mild lung disease (forced expiratory volume in one second [FEV₁], >60 percent of the predicted value) were randomly assigned to receive ibuprofen or placebo orally twice daily for four years. Doses were adjusted individually to achieve peak plasma concentrations of 50 to 100 µg per milliliter. Changes in pulmonary function, the percentage of ideal body weight, the chest-radiograph score, and the frequency of hospitalization were assessed.

Results Patients randomly assigned to ibuprofen had a slower annual rate of change in FEV₁ than the patients assigned to placebo (mean [±SE] slope, -2.17±0.57 percent vs. -3.60±0.55 percent in the placebo group; P = 0.02), and weight (as a percentage of ideal body weight) was better maintained in the former group (P = 0.02). Among the patients who took ibuprofen for four years and had at least a 70 percent rate of compliance, the annual rate of change in FEV₁ was even slower (-1.48±0.69 percent vs. -3.57±0.65 percent in the placebo group, P = 0.03), and this group of patients also had a significantly slower rate of decline in forced vital capacity, the percentage of ideal body weight, and the chest-radiograph score. There was no significant difference between the ibuprofen and placebo groups in the frequency of hospitalization. One patient was withdrawn from the study because of conjunctivitis, and one because of epistaxis related to ibuprofen.

Conclusions In patients with cystic fibrosis and mild lung disease, high-dose ibuprofen, taken consistently for four years, significantly slows the progression of the lung disease without serious adverse effects.

Source Information

From the Departments of Pediatrics (M.W.K., P.J.B., P.B.D.), Medicine (C.L.H., P.B.D.), and Pharmacology (C.L.H.), Case Western Reserve University School of Medicine, Rainbow Babies and Children's Hospital, and the Veterans Affairs Medical Center, Cleveland.

Address reprint requests to Dr. Konstan at the Rainbow Babies and Children's Hospital, 2101 Adelbert Rd., Cleveland, OH 44106.

Full Text of this Article

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