Guidelines Based Undertaking for Improvement in Dyslipidemia Related Events (GUIDE )
Guidelines Based Undertaking for Improvement in Dyslipidemia Related Events (GUIDE )
This is a multi-center, open label observational study conducted over 26 weeks.

 Approximately 2,500 high-risk patients with an elevated LDL-C level (> 2.5 mmol/L) will be
 enrolled. Patients meeting all inclusion criteria and having none of the exclusion criteria
 at Visit 1 (Screening) will be included in the study. Eligible patients that agree to
 participate and sign an informed consent will be treated with either statin therapy
 (increased or started or switched) or combination of statin and ezetimibe 10 mg
 (added/started) as per Study Schematic (Table 1) in order to achieve the recommended target
 of LDL<2.5 mmol/L and providing that this treatment is in the best interest of the patient.

 After enrollment there are a total of three scheduled clinic visits. All patients will have
 vital signs measured as well as a brief physical examination performed at Visit 1
 (Screening).

 At Visit 2 (6 weeks) patients with LDL-C > 2.5mmol/L will be treated with either statin
 therapy increase or combination of statin and ezetimibe 10 mg (added/started) as per Study
 Schematic (Table 1) in order to achieve the recommended target of LDL<2.5 mmol/L and
 providing that this treatment is in the best interest of the patient.

 At Visit 3 (12 -18 weeks) patients with LDL > 2.5 mmol/L will be treated with combination of
 statin and ezetimibe 10 mg as per Study Schematic (Table 1) in order to achieve the
 recommended target of LDL<2.5 mmol/L and providing that this treatment is in the best
 interest of the patient.

 At final Visit 4 (24-26 weeks) safety and efficacy of treatment will be reviewed. Following
 Visit 4 physicians will continue to treat these patients according to their clinical
 judgment.
Overview This is a Quality Enhancement Research Initiative (QERI) whereby physicians are
 provided guidelines and easy to follow steps for their achievement..

 Approximately 2,500 high-risk patients with an elevated LDL-C level (> 2.5 mmol/L) will be
 enrolled. Patients meeting all inclusion criteria and having none of the exclusion criteria
 at Visit 1 (Screening) will be included. Eligible patients that agree to participate and sign
 an informed consent will be treated with appropriate treatment optimization including the use
 of ezetimibe on achieving Study Schematics (Table 1).

 After enrollment there are a total of three scheduled clinic visits. Physicians may assess
 the patient between visit 2 and 3 if maximization of statin therapy is required.

 At Visit 2 (6 weeks) patients with LDL > 2.5mmol/L will be treated with either statin therapy
 (increased or started or switched) or combination of statin and ezetimibe 10 mg
 (added/started) as per Study Schematic (Table 1) in order to achieve the recommended target
 of LDL<2.5 mmol/L and providing that this treatment is in the best interest of the patient.

 At Visit 3 (12-18 weeks) patients with LDL > 2.5 mmol/L will be treated with combination of
 statin and ezetimibe 10 mg (added/started) as per Study Schematic (Table 1) in order to
 achieve the recommended target of LDL<2.5 mmol/L and providing that this treatment is in the
 best interest of the patient.

 At final Visit 4 (24-26 weeks) safety and efficacy of treatment will be reviewed. Following
 Visit 4 physicians will continue to treat these patients according to their clinical
 judgment.

 1.5.1 Treatment

 During this observational study patients will be treated under standard care with either
 statin therapy and/or co-administered with ezetimibe 10 mg /day. This is an open label
 observational study, therefore patients and physicians will be aware of treatment allocation
 and the treatment chosen will be that in the best interests of the patient and according to
 the physician's preference. Treatment will begin at Visit 1- Screening/Baseline (Day 0) and
 will extend through Visit 4 (Week 24-26).

 Based on patient's LDL-C level, at visit 1 (Screening/Baseline) patient will receive
 prescription of initial or increased dose of statin 10-80 mg/day and/or ezetimibe 10 mg/day
 for the following 6 weeks. At visit 2 (6 weeks F/U) patients will receive prescription of
 statin (dose increased) and/or ezetimibe 10 mg per day for the following 6 weeks based on
 their target level of LDL-C. At visit 3 (week 12 -18 F/U) for patients who did not reach
 their LDL-C target, ezetimibe 10 mg per day will be considered if appropriate for the patient
 for the following 14 weeks to complete the observational study.
Inclusion Criteria:

 1. Patient is male or female older 18 years of age.

 2. Patients with a diagnosis of primary hypercholesterolemia and who are defined as being
 "high risk" (10-year risk of coronary artery disease greater than 20 % based on the
 Framingham model and history of cardiovascular disease or)

 3. Patients who have not reached their recommended LDL-C target levels of 2.5 mmol/L
 while on a statin alone.

 4. According to the judgment of the treating physician patient enrollment is in the best
 interest of the patient.

 5. Patient agrees to participate and signs an informed consent allowing follow up and
 sharing of patient related data.

 Exclusion Criteria:

 1. Individuals with poor mental function, drug or substance abuse, or individuals with
 unstable psychiatric illnesses, which, in the opinion of the investigator, may
 interfere with optimal participation in the observational study. Alcoholic substance
 abuse would be defined as a patient with alcohol consumption > 14 drink per week. (A
 drink is: a can of beer, glass of wine, or single measure of spirits.)

 2. Patients who have been treated with any investigational drug within 30 days prior to
 Visit 1. (If <30 days, contact the clinical monitor for a case-by-case evaluation.)

 3. Patients with clinically significant concomitant illnesses of liver, muscle or kidney
 abnormalities.