Trial To Evaluate the Efficacy of Oral Salsalate in the Treatment of Older Adults With Unexplained Anemia

Exclusion Criteria

• •Red blood cell transfusions within the past 3 months
• •Estimated glomerular filtration rate (eGFR) of \< 30 ml/min (by abbreviated MDRD)
• •Use of erythropoiesis stimulating agents (ESA) in the past 3 months
• •Active infection defined as symptomatic, requiring active treatment (prophylaxis allowed) or hospitalized for \> 24 hours primarily for infection within the past month
• •Uncontrolled hypertension defined as diastolic blood pressure \> 95 mm Hg or systolic blood pressure \> 160 mm Hg on 2 separate occasions during screening period
• •Distance on 6MWT above the median for age and sex adjusted population medians (see Table 4)
• •Other primary uncorrected cause for anemia including:
• •* Known active inflammatory disease including auto-immune diseases (e.g., systemic lupus erythematosis, rheumatoid arthritis, mixed connective tissue disease, sarcoidosis, bronchiolitis obliterans, vasculitis, polymyalgia rheumatica, temporal arteritis, inflammatory bowel disease or related diseases);
• •* Chronic active infection (e.g., HIV, viral hepatitis, tuberculosis, osteomyelitis) or receiving therapy within the past 3 months for chronic infection
• •* Acute infection within past 3 months (pneumonia, sepsis, bacteremia, prostatitis, urosepsis, pyelonephritis, cholecystitis)
• •* Receipt of immunosuppressive therapy in the past 2 years including prednisone except for topical therapy
• •* Any cancer (aside from non-melanoma skin cancer) in the past 2 years or on therapy for cancer. In addition, prostate cancer will be excluded if patients have metastatic disease, have had prostatectomy within the prior 6 months, have ever received external beam radiation therapy or brachytherapy, or have received androgen deprivation therapy in the prior 24 months. Subjects with a history of any other form of cancer will likewise be excluded if they have received any radiation or chemotherapy in the prior 24 months.
• •* Fecal Occult Blood Test positivity in the past 3 years, Gastrointestinal bleeding in past 3 years and history of peptic ulcer w/ evidence of bleeding
• •Elevated AST or ALT ≥ 2x upper limit of normal
• •Use of any other experimental drug or therapy within 28 days of initial screening visit
• •History of moderate tinnitus affecting instrumental activities of daily activities in the past 3 months