Safety and Tolerability of Phenylbutyrate in Inclusion Body Myositis

Exclusion Criteria

• •Presence of any one of the following medical conditions: chronic infection; chronic renal insufficiency; cancer other than skin cancer less than five years prior; multiple sclerosis or prior episode of central nervous system demyelination; or other chronic serious medical illnesses
• •Presence of any of the following on routine blood screening: WBC\<3000; Platelets \< 100,000; hematocrit \< 30%; BUN \> 30 mg %; creatine \> 1.5 mg%; liver disease with serum albumin \< 3 G/DL
• •Women who are pregnant or lactating
• •History of non-compliance with other therapies
• •Coexistence of other muscular disease
• •Drug or alcohol abuse within past three months
• •Known bleeding disorder
• •Known liver disease
• •Known congestive heart failure
• •Known hypernatremia
• •Inability to give informed consent