doi: 10.1093/toxsci/67.1.108
Nature 364 , 7982 (1993)
Heres what the clinical evidence shows: Study Scope: 900+ participants across 6 randomized, double-blind, placebo-controlled trials Safety Profile: Indistinguishable from placebo in tolerability assessments Serious Events: Zero serious adverse events attributed to AOD-9604 Withdrawals: No treatment-related discontinuations in any trial Common Effects: Mild headache and minor GI symptoms at rates similar to placebo IGF-1 Impact: No effect on insulin-like growth factor-1 levels Metabolic Safety: No negative impact on glucose metabolism or insulin sensitivity Immunogenicity: Zero participants developed anti-AOD9604 antibodies The following analysis provides complete details on the clinical trial evidence supporting AOD-9604s favorable safety profile
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may cause iron-deficiency anemia Nausea and vomiting particularly with stricturing disease/obstruction Urgency and tenesmus with rectal/colonic involvement Weight loss and malnutrition due to malabsorption, food avoidance, elevated metabolic demand Fever with active inflammation, abscess, or fistula Perianal disease fissures, fistulae, skin tags, abscesses Extraintestinal Manifestations Arthropathy peripheral or axial (enteropathic arthritis, M07.6x) Dermatologic: Erythema nodosum (L52), pyoderma gangrenosum, psoriasis (L40.5) Ocular: Uveitis/iritis (H20.01), episcleritis, scleritis Hepatobiliary: Primary sclerosing cholangitis (K73.2), fatty liver, cholelithiasis Metabolic: Osteopenia/osteoporosis (from steroid use and malabsorption), nephrolithiasis Hematologic: Anemia (iron deficiency, B12/folate deficiency, anemia of chronic disease) When a patient with Crohns disease is admitted with significant weight loss, malnutrition, or protein-calorie deficiency , query the provider to specify the degree of malnutrition (mild, moderate, severe protein-calorie malnutrition)
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