The Veterans Administration (VA) medical system is a health care system consisting of patients who are or who have been members of the United States armed forces. We sought to describe the characteristics of this unique population to illustrate the opportunities to study new interventions in this system.
A six-month randomized, double-blind, placebo-controlled clinical trial (n=1,829) was undertaken with tiotropium, a once-daily inhaled anticholinergic, in patients with COPD. Patients were required to have an FEV1 ≤ 60% predicted and have a smoking history ≥ 10 pack years. Exclusion criteria included a history of asthma, pulmonary resection, respiratory tract infection in the preceding six weeks, recent MI, recent hospitalization for CHF, life-threatening cardiac arrhythmia, and active treatment for malignancy. Population demographics have been extracted from blinded data.
Approximately 99% were male, 91.3% Caucasian, 8.2% Black, and 0.5% Asian. The mean age was 68 years. Patients smoked an average of 68 pack years, had a mean FEV1=1.04 L (35% predicted) and FEV1/FVC=48%. Concomitant diseases other than COPD were present in 99% of patients. The most common non-respiratory categories of diseases were as follows: vascular (including hypertension) 64%, gastrointestinal 48%, MSK/connective tissue 46%, cardiac 39%, metabolism/nutrition 47%, reproductive system including prostate 27%, psychiatric disorders 26%, drug hypersensitivity 19%, neoplasm 18%, and nervous system 22%. The most common specific diagnoses were hypertension (54% of patients) and GE reflux (26% of patients).
Patients in the VA setting appear to have frequent co-morbidities with high incidences of the more common diseases in the general population.
The numerous co-morbidities and associated polypharmacy in this population provide an opportunity to study interventions in a specific population that might be more difficult to assess in a broader clinical trial setting.
D.E. Niewoehner, None.