Research BriefReport of a Pilot, Double-Blind, Placebo-Controlled Study of Megestrol Acetate in Elderly Dialysis Patients With Cachexia
Section snippets
Setting
The MA or placebo was administered at the Northport VAMC Outpatient Research Unit to 11 out of 40 consecutively seen outpatient dialysis subjects between 1999 and 2002, who fulfilled the study criteria and signed a consent form. Two subjects failed the initial screening.
Patients aged 40 years and older, diagnosed with cachexia and receiving dialysis, were included in the study. Inclusion criteria required at least two of the following: albumin <4.0 g/dL, total cholesterol <150 mg/dL, protein
Patient Characteristics
Of nine study patients, there were minimal differences in baseline characteristics of those six who completed the trial and the three who withdrew. However, the MA patients tended to be younger. The average age for the MA group was 67.5 years, and 75.4 years for the placebo group. However, this difference in age did not seem to correlate with a difference in baseline functions, comorbid conditions, or laboratory values. Nevertheless, it may have biased the study results. For all patients
Discussion
With such a small study group, it is difficult to draw definitive conclusions. However, we were able to show significant improvements in weight (11.1 pounds; Fig. 1), fat mass (6.2 pounds; Fig. 2), and ability to exercise in cachectic dialysis patients who were given MA compared with the placebo group. This result is consistent with the results of other investigations.18, 19
We also found improved quality of life and appetite and a decrease in CRP with MA treatment, similar to what Rammohan
Acknowledgments
This study was supported by an unrestricted research grant from the Bristol-Myers Squibb Co., the manufacturer of megestrol acetate (Megace) oral solution. We thank Dr. Merrill J. Egorin and Dr. William Evans for study suggestions and guidance. We also thank Dr. Enrique Pastoriza, Dr. Gaylord Hoffert, Dr. Shawn Amann, Dr. Asrat Tesfa, Dr. Sherri Lovitt, and Dr. Jeffery S. Olson for technical assistance and support. Thanks are also extended to the Dialysis Unit, Northport Veteran Affairs Medical
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2016, Journal of Renal NutritionCitation Excerpt :Tables 3 and 4 summarize the primary efficacy outcomes of change in serum albumin, body weight, and appetite for the randomized controlled trials and observational studies, respectively. Two of the three randomized controlled trials demonstrated a statistically significant increase in body weight for the MA group.8,9 The increase in average body weight varied from 1.7 kg to 5 kg in these 2 studies.
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