Evaluation of the Effect in Platelet Count of Atorvastatin and N-acetyl Cysteine

Evaluation of the Effect in Platelet Count of Atorvastatin and N-acetyl Cysteine in Patients With Primary Immune Thrombocytopenia Resistant to Steroid Treatment or in Relapse: An Exploratory Clinical Trial

The purpose of this study is to assess the ability of Atorvastatin and N-acetyl cysteine to elevate the blood (serum) platelet count in patients with Immune Thrombocytopenia as a mean of a new treatment.

Evaluate the efficacy in the elevation of platelet count of the combination of atorvastatin and N-acetyl cysteine in patients with immune thrombocytopenia resistant to steroid therapy or with relapse after treatment, a prospective, proof of concept clinical trial.

Inclusion Criteria:

• Patients that give their informed consent before the procedures of study
• Thrombocytopenia before intervention (<100 x10^9 /L)
• Patients of either biological sex older than 15 years old
• Patients with previous diagnosis of primary immune thrombocytopenia that not reach complete remission after treatment (steroid based) or that have a relapse
• If the patient is taking steroid based treatment, the dose need to be stable before intervention.

Exclusion Criteria:

• Patients with secondary immune thrombocytopenia
• Pregnant patients
• Patients with hypersensitivity to study treatments
• Patients that are taking anticoagulant medication or any drug that have an effect on platelet count
• Hepatic alteration consisting in serum levels of Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 3 times above superior laboratory reference limit.
• Elevation of serum levels of Creatinine or bilirubins above 1.5 mg/dl
• Any cancer diagnosis
• Coronary heart disease, congestive heart failure, uncontrolled hypertension or arrhythmias.
• Previous autoimmune disease diagnosis including: systemic lupus erythematosus, rheumatoid arthritis or systemic sclerosis.