Not sure if this was in a PR six months back or not but I saw mention of it in the 8/23 PR. "This follows the recent issuance to BTG No. 5,872,147 (US PAT) with claims directed to the use of oxandrolone in patients suffering from chronic obstructive pulmonary disease."
United States Patent 5,872,147
February 16, 1999
Use of oxandrolone in the treatment of chronic obstructive pulmonary disease
Abstract
The subject invention provides a method of treating a symptom associated with chronic obstructive pulmonary disease in a
patient suffering from chronic obstructive pulmonary disease which comprises administering a therapeutically effective amount of an oxandrolone to the patient. The subject invention further provides a method of improving functional capacity and/or pulmonary function in a patient suffering from chronic obstructive pulmonary disease which comprises administering a therapeutically effective amount of an oxandrolone to the patient.
Inventors:Bowen; Robert E. (Martinsburg, WV)
Assignee:Bio-Technology General Corp. (Iselin, NJ)
Appl. No.: 986015
Filed:December 5, 1997
164.195.100.11
The subject invention discloses the use of an oxandrolone for the treatment of symptoms associated with chronic obstructive pulmonary disease and symptoms associated with ARDS.
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Chronic Obstructive Pulmonary Disease (COPD)
COPD is a progressively debilitating disease affecting an estimated 16 million Americans. In 1984, COPD ranked fifth as the leading cause of death in the United States. From a disability standpoint, COPD is the most frequent reason that people seek medical attention (1).
It has been found that there is a direct relationship between body weight and respiratory muscle mass (2) and that a significant percentage of patients with COPD are malnourished (1, 2). Epidemiologic surveys of COPD have suggested that undernutrition might be an important prognostic variable (2). When the COPD patient begins to lose weight, the average life expectancy is only 2.9 years (1).
Disabilities in patients with COPD due to limitations in pulmonary function are often compounded by a loss of muscle strength and lean body mass, resulting in an inability to perform many activities of daily living. These losses may be attributable to a number of factors including decreased ability to exercise, decreased appetite, hypermetabolism and protein catabolism resulting from prolonged glucocortoid therapy. Because of undue dyspnea, these patients are frequently afraid to exercise, which exacerbates their muscle wasting condition. Shortness of breath during eating also worsens this condition because it leads to inadequate calorie and protein intake. Furthermore, many of these patients are receiving intermittent or chronic treatment with anti-inflammatory steroids that may result in myopathy, especially causing weakness in the proximal lower extremities. A combination of these factors often contribute to disability in patients with COPD that exceeds what would generally be expected based on airflow limitation alone.
Because of the progressive decline due to dyspnea and cachexia in these patients, levels of morbidity and mortality exceed those expected based on pulmonary limitations alone.
The subject invention provides therapies to reverse or halt the catabolic process and restore lean body mass in COPD patients.
The subject invention also provides therapies to improve functional capacity and/or pulmonary function in these patients.
Adult Respiratory Distress Syndrome (ARDS)
ARDS consists of respiratory failure associated with various acute pulmonary injuries and is characterized by noncardiogenic pulmonary edema, respiratory distress and hypoxemia.
ARDS may be caused by a variety of pulmonary or systemic insults but is particularly frequent in patients with sepsis. Although termed "adult", ARDS occurs in children as well as adults.
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Results presented by these study facts.. Looks like a long way to FDA approval for this "off label" treatment. Maybe that is just a use BTG would like -- off label?
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Patient characteristics
Eighteen (18) patients (11 women and 7 men), ranging in age from 47-77 who had a pulmonary function (FEV.sub.1) of less than 50% of predicted normal according to their size and age, were included in this study. Patients served as their own controls. Of the 18 patients enrolled, 17 completed the study. One patient declined to continue participation after carefully reading the consent form and did not receive treatment with oxandrolone. None of the patients stopped taking the drug because of adverse effects.
Study design
17 patients received 0.2 mg/kg/day of oxandrolone in a single dose for 8 weeks. Baseline values were obtained for pulmonary function, percentage of body fat, maximum oxygen consumption (VO.sub.2 max) and leg muscle strength. Total cholesterol and HDL levels were also determined as well as SGOT levels. Assessments were repeated at 5 and 10 weeks after treatment was initiated. Thus, the last assessment was 2 weeks after the last dose of oxandrolone.
Jim |
