Clinical trial: Efficacy and Safety Study of Pitavastatin and Atorvastatin in High Risk Hypercholesterolemic Patients (NCT01386853)

Eligibility criteria:
Inclusion Criteria:

          -  Patient aged ≥ 20 years old and < 75 years old.

          -  Patient who was eligible and able to participate in the study and accepts to enter the
             study by signing written informed consent.

          -  Patient with fasting LDL-C > 100 mg/dL. The concentration of LDL-C is obtained from
             laboratory examination.

          -  Patient with at least one of the following description (NCEP ATP III guideline).

          -  Female patient with child-bearing potential must take reliable contraception method(s)
             during the participation of the study.

        Exclusion Criteria:

          -  Patient who has participated in other investigational studies within 3 months.

          -  Patient took medication and natural health foods known to alter blood lipid profiles
             within 4 weeks.

          -  Patient is taking any medication or food that is prohibited by the study.

          -  Patient taking Amiodarone will be excluded from this study (due to long half life of
             this medication).

          -  Patient is diagnosed with type 1 DM or has been using insulin/insulin analog
             medication.

          -  Patient with a history of multiple drug allergies or with a known allergy to HMG-CoA
             reductase inhibitors.

          -  Patient with TG > 400 mg/dL.

          -  Excessive obesity defined as BMI above 35 kg/m2.

          -  Cerebral vascular disease (including cerebrovascular hemorrhage or ischemia, transient
             ischemic attack) diagnosed within 3 months.

          -  Myocardial infarction, heart failure (NYHA class III or IV), gross cardiac enlargement
             (cardiothoracic ratio > 0.5), significant heart block or cardiac arrhythmias within 3
             months; history of uncontrolled complex ventricular arrhythmias, uncontrolled atrial
             fibrillation/flutter or uncontrolled supraventricular tachycardia, pacemaker or
             implantable cardiac device were not eligible for this study.

          -  Patient with advanced renal disorder (Serum creatinine levels ≥ 2 mg/dL and BUN ≥ 25
             mg/dL).

          -  Patient with advanced hepatic disorder (AST or ALT level ≥ 100 IU/L)

          -  Patient with CK level > 5 × ULRR at any time point between Visit 1 and Visit 2.

          -  Patient with poorly controlled diabetes mellitus (HbA1c > 9.0%) or patient with severe
             hypertension (> 180 mmHg for systolic or > 120 mmHg in diastolic blood pressure).

          -  Patient with hypothyroidism, hereditary muscular disorders, family history of the
             above or history of drug-induced myopathy.

          -  Patient has significant alcohol consumption (> 65 mL pure alcohol) within 48 hours
             before Visit 2.

          -  Any major surgery within 3 months prior to Visit 2.

          -  Female patient who is lactating, being pregnant or plans to become pregnant.

          -  Patient with conditions judged by the investigator as unsuitable for the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? Contradiction