Abstract | OBJECTIVES: STUDY DESIGN: We performed a randomized, double-blind, placebo controlled study. All patients were taking replacement enzymes to compensate for pancreatic insufficiency. Patients (n = 17) were randomly assigned to receive either megestrol acetate or placebo. RESULTS: The treatment group had a significant increase in weight-for-age z scores compared with placebo and reached 100% of their ideal body weight within 3 months of initiating therapy. Weight gain included both fat and fat-free mass. Improved pulmonary function (forced vital capacity and forced expiratory volume in 1 second) was noted in the treatment group compared with placebo (P <.04). Reversible adrenal suppression was observed in the majority of patients who received megestrol acetate. CONCLUSIONS: Short-term use of megestrol acetate results in significant weight gain and improved pulmonary function in malnourished subjects with CF. Our study provides a controlled basis for this intervention, identifies important side effects, and provides the foundation for multiyear, longitudinal trials in a larger number of patients with CF.
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Authors | Valerie Eubanks, Nicki Koppersmith, Nancy Wooldridge, J P Clancy, Raymond Lyrene, Ramin B Arani, Jeanette Lee, Lyle Moldawer, Joy Atchison, Eric J Sorscher, Christopher M Makris |
Journal | The Journal of pediatrics
(J Pediatr)
Vol. 140
Issue 4
Pg. 439-44
(Apr 2002)
ISSN: 0022-3476 [Print] United States |
PMID | 12006958
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Insulin
- Megestrol Acetate
- Hydrocortisone
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Topics |
- Adolescent
- Adult
- Age Factors
- Body Composition
(drug effects)
- Bone Density
(drug effects)
- Child
- Child Welfare
- Cystic Fibrosis
(drug therapy)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Humans
- Hydrocortisone
(blood)
- Insulin
(blood)
- Lung
(drug effects, physiology)
- Male
- Megestrol Acetate
(therapeutic use)
- Time Factors
- Treatment Outcome
- Weight Gain
(drug effects)
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