Megestrol (Megestrol Acetate) - Summary

MEGESTROL SUMMARY

MEGESTROL ACETATE Oral Suspension USP

Megestrol Acetate Oral Suspension USP contains megestrol acetate, a synthetic derivative of the naturally occurring steroid hormone, progesterone.

Megestrol Acetate Oral Suspension USP is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).

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NEWS HIGHLIGHTS

Published Studies Related to Megestrol

Report of a Pilot, Double-Blind, Placebo-Controlled Study of Megestrol Acetate in Elderly Dialysis Patients With Cachexia. [2009.10.09]
OBJECTIVE: We examined the effects of megestrol acetate versus placebo and progressive resistance physical exercise on weight, lean muscle mass, quality of life, ability to exercise, proinflammatory cytokines, and anti-inflammatory cytokines, and their correlations with one another... CONCLUSION: In a pilot trial in dialysis patients, MA showed significant benefits in improving weight and ability to exercise. Cytokine changes were correlated with weight gains and increases in fat-free mass.

Usage of megestrol acetate in the treatment of anorexia-cachexia syndrome in the elderly. [2009.05]
The aim of this review is to assess the efficacy and safety of megestrol acetate (MA) in geriatric cachexia. The paper presented here reviews a previously published study of MA use in 69 patients in a randomized double blind placebo-controlled trial... Considering possible confounders, higher initial IL-6, initial TNFR-p75 levels, and final neutrophil percentage were associated with elevated mortality, whereas higher initial pre-albumin, initial albumin, final pre-albumin, final albumin and final weight gain were associated with decreased death.

Effect of megestrol acetate on serum albumin level in malnourished dialysis patients. [2009.03]
OBJECTIVE: Malnutrition is a common problem in dialysis patients, and may affect up to one third of patients. It is associated with high mortality and morbidity. Although a number of studies were performed to determine effective treatment, there is no proven medication for this condition. This study aimed to evaluate the effect of megestrol acetate (MA) on serum albumin levels in malnourished dialysis patients... CONCLUSION: At a dose of 40 mg twice a day, MA safely increased serum albumin in malnourished dialysis patients.

Is megestrol acetate a suitable option for treatment of hot flashes in women with breast cancer? [2008.12]
Chemotherapy for breast cancer is associated with the development of hot flashes, which can cause the patient considerable discomfort... and place them into clinical context, highlighting the need for additional studies of hormonal therapies in women with breast cancer.

Effects of megestrol acetate in patients with cancer anorexia-cachexia syndrome--a systematic review and meta-analysis. [2008.11]
INTRODUCTION: Anorexia-cachexia syndrome (ACS) often occurs in patients with advanced cancer. OBJECTIVES: To review the effect of megestrol acetate (MA) in patients with ACS... CONCLUSIONS: Compared to placebo, MA reduces the symptoms of ACS, with no effect on survival. The beneficial effect of MA on the overall quality of life has not been confirmed. In identified studies the effect of MA and glucocorticosteroids on anorexia and cachexia is similar. The estimation of the treatment utility in ACS depends on the weight attributed to discomfort caused by symptoms, adverse effects of the drugs and the treatment cost. Because of the low quality of the included studies a new randomized controlled trial is needed for valid assessment of the effects of MA.

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Clinical Trials Related to Megestrol

Evaluate Weight Gain Using 2 Different Formulations of Megestrol Acetate Oral Suspension for AIDS-Related Weight Loss [Completed]
Explore weight gain in HIV-positive patients who have weight loss associated with AIDS-related wasting (anorexia/cachexia). Patients are treated for 12 weeks with either megestrol acetate oral suspension nanocrystal dispersion formulation, or megestrol acetate oral suspension original formulation

Effect of Renal Impairment on the Pharmacokinetics, and Safety of Megestrol Acetate Concentrated Suspension [Terminated]
To determine the pharmacokinetics and safety of megestrol acetate after a single oral 300 mg dose of megestrol acetate concentrated suspension in healthy subjects, and subjects with varying degrees of renal impairment

Evaluating the Effect of Food on Absorption of Megace ES [Completed]

Treatment of Cancer-Associated Anorexia Using Megestrol Acetate Concentrated Suspension [Terminated]
To compare the effect of megestrol acetate concentrated suspension and placebo on caloric intake in patients with cancer-associated anorexia.

Treatment of Cancer-Anorexia Using Megestrol Acetate Concentrated Suspension in Lung or Pancreatic Cancer Patients [Terminated]
Purpose of the study is to compare the effects of megestrol acetate concentrated suspension and placebo for the treatment of cancer-associated anorexia in patients with lung or pancreatic cancer

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