Pharmacokinetics (PK)/Safety Study of Atorvastatin in Children With Kawasaki Disease and Coronary Artery Abnormalities

Inclusion criteria

• Age ≥ 2 years to 17 years old
• Meets clinical criteria for KD according to American Heart Association guidelines (Table 2): Fever (T≥38oC or 100.4oC) ≥ 3 days and ≥ 2 clinical criteria with left anterior descending coronary artery/right coronary artery z-score ≥ 2.5 or an aneurysm (≥ 1.5 x the adjacent segment) of one of the coronary arteries
• Patient presents within the first 20 days after fever onset
• Parent or legal guardian able and willing to provide informed consent and subject willing and able to provide assent when appropriate.
• Post-menarchal females: Negative pregnancy test at screening and willing to use two forms of contraception during the study
• Males engaging in sexual activity that could lead to pregnancy must use a condom.

Exclusion criteria

• Use of a statin, fibrate, or niacin within the 3 months prior to enrollment
• Have any chronic disease, except asthma, atopic dermatitis, autism or controlled seizure disorder
• Screening creatine phosphokinase (CK) ≥ 3x upper limit of normal for age
• Patient taking a CYP3A4 inhibitor (ie. cyclosporine or clarithromycin) in the last 7 days
• Patient has a history of allergy to atorvastatin or its derivatives