Atorvastatin Effectiveness and Safety in Cardiology Patients in Real World Setting

Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level

Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG) according to the CVD risk stratification. Low-risk: 10 years CVD risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes. The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Percent change from baseline was reported.

Time frame: Baseline to Week 12

Study Drug Exposure for Overall - Total Dose and Week 12 Dose

Atorvastatin total dose: calculated from Day 1 to Week 12 or last dose day; Week 12 dose: dose taken at Week 12

Time frame: Day 1 to Week 12

Study Drug Exposure for Overall - Daily Dose

Daily dose was calculated by total dose divided by the total days of receiving atorvastatin.

Time frame: Day 1 to Week 12

Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose

Atorvastatin total dose: calculated from Day 1 to Week 12 or last dose; Week 12 dose: dose taken at Week 12 according to the CVD risk stratification. Low-risk: 10 years CVD risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

Time frame: Day 1 to Week 12

Study Drug Exposure Within Each CVD Risk Group -Daily Dose

Daily dose was calculated by total dose divided by the total days of receiving atorvastatin according to the CVD risk stratification. Low-risk: 10 years CVD risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

Time frame: Day 1 to Week 12

Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) for Overall

All causalities adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage; Treatment-related AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; The event has a causal relationship with the treatment or usage.

Time frame: Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 )

Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level

All causalities adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage; Treatment-related AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; The event has a causal relationship with the treatment or usage. The AEs were categorized by the CVD risk stratification. Low-risk: 10 years CVD risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

Time frame: Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 )

Number of Participants With Adverse Events of Special Interest (AESI) for Overall

AESI were categorized as muscle symptoms: myalgia, fatigue, weakness, creatine kinase (CK) values 10 times the upper limit of normal, or rhabdomyolysis, and muscle damage based on significant elevated CK; major cardiovascular events: myocardial infarction, stroke, unstable angina requiring re-hospitalization, revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting; Death.

Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16)

Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level

AESI were categorized as muscle symptoms: myalgia, fatigue, weakness, creatine kinase (CK) values 10 times the upper limit of normal, or rhabdomyolysis, and muscle damage based on significant elevated CK; major cardiovascular events: myocardial infarction, stroke, unstable angina requiring re-hospitalization, revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting; Death according to the CVD risk stratification. Low-risk: 10 years CV risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CV risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

Time frame: Baseline (Day 1) to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)

Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall

The elevated abnormal laboratory data was summarized: significant elevated CK: CK values 10 times the upper limit of normal; Persistent elevation in alanine aminotransferase, aspartate aminotransferase, or both: 2 consecutive measurements obtained 4 to 10 days apart that was more than 3 times the upper limit of the normal range.

Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)

Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk

The elevated abnormal laboratory data was summarized: significant elevated CK: CK values 10 times the upper limit of normal; Persistent elevation in alanine aminotransferase, aspartate aminotransferase, or both: 2 consecutive measurements obtained 4 to 10 days apart that was more than 3 times the upper limit of the normal range according to the CVD risk stratification. Low-risk: 10 years CV risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CV risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

Time frame: Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)

Change From Baseline for Clinical Laboratory Overall- ALT and AST

The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for ALT and AST date were reported.

Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)

Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid

The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from baseline for bilirubin, blood urea nitrogen, cholesterol (total), creatinine, triglycerides, uric acid data were reported.

Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)

Change From Baseline for Clinical Laboratory Overall- Creatine Kinase

The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for creatine kinase was reported.

Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)

Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST

The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for ALT and AST date were reported according to the CVD risk stratification. Low-risk: 10 years CVD risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16)

Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid

The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from baseline for bilirubin, blood urea nitrogen, cholesterol (total), creatinine, triglycerides, uric acid data were reported according to the CVD risk stratification. Low-risk: 10 years CVD risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)

Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase

The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for creatine kinase was reported according to the CVD risk stratification. Low-risk: 10 years CV risk \<5%; Moderate-risk: 10 years CVD risk 5%\~10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CV risk 10%\~15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)

Precentage of Participants With Discontinuation From the Study for Overall

Percentage of participants who dropped out of the study and reasons for discontinuation were summarized overall.

Time frame: 12 weeks of follow-up

Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level

Percentage of participants who dropped out of the study and reasons for discontinuation were summarized by the CVD risk stratification. Low-risk: 10 years CVD risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

Time frame: 12 weeks of follow-up