N/A
N=5,115
Atorvastatin Effectiveness and Safety in Cardiology Patients in Real World Setting
Coronary Artery Disease, Hypercholesterolemia, Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02565615 ↗Enrolled (actual)
5,115
Serious AEs
1.9%
Results posted
Nov 2019
Primary outcome: Primary: Achievement Rate for Low Density Lipoprotein-Cholesterol (LDL-C) for Overall — 0.79; 0.67; 0.83; 0.57 Ratio
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No intervention (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Achievement Rate for Low Density Lipoprotein-Cholesterol (LDL-C) for Overall |
0.79; 0.67; 0.83; 0.57 | — |
| PRIMARY Achievement Rate for LDL-C by Dose Group Within Each Cardiovascular Disease (CVD) Risk Level |
1.00; 0.93; 1.00; 1.00; 0.89; 0.78 | — |
| SECONDARY Change From Baseline for Lipid Parameters at Week 12 for Overall |
-24.81; -45.12; -40.35; -36.98; 0.55; 0.44 | — |
| SECONDARY Percent Change From Baseline for Lipid Parameters at Week 12 for Overall |
-9.96; -13.66; -17.33; -3.07; 3.68; 4.18 | — |
| SECONDARY Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group |
-51.42; -47.99; -94.98; -26.97; -43.23; -5.28 | — |
| SECONDARY Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level |
-21.06; -15.39; -36.33; -11.66; -18.50; 73.60 | — |
| SECONDARY Study Drug Exposure for Overall - Total Dose and Week 12 Dose |
958.90; 1816.63; 2506.19; 3326.93; 178.90; 9.96 | — |
| SECONDARY Study Drug Exposure for Overall - Daily Dose |
10.43; 20.00; 29.00; 39.96; 20.09 | — |
| SECONDARY Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose |
975.00; 1760.84; 2790.00; 3456.00; 914.47; 1781.18 | — |
| SECONDARY Study Drug Exposure Within Each CVD Risk Group -Daily Dose |
10.81; 20.00; 30.00; 40.00; 10.53; 20.03 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) for Overall |
36; 241; 1; 7; 19; 17 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level |
1; 18; 0; 1; 8; 27 | — |
| SECONDARY Number of Participants With Adverse Events of Special Interest (AESI) for Overall |
18; 146; 1; 5; 7 | — |
| SECONDARY Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level |
1; 9; 0; 0; 3; 11 | — |
| SECONDARY Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline for Clinical Laboratory Overall- ALT and AST |
0.39; 1.60; 1.40; -0.25; -1.00; -0.04 | — |
| SECONDARY Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid |
0.02; 0.02; -0.01; 0.00; -0.08; -0.01 | — |
| SECONDARY Change From Baseline for Clinical Laboratory Overall- Creatine Kinase |
-12.77; -30.49; -7.60; -300.8; -139.0; 12.65 | — |
| SECONDARY Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST |
-0.28; 1.68; 4.00; -2.80; 2.21; -29.23 | — |
| SECONDARY Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid |
-0.01; -0.03; 0.07; -0.07; 0.08; 0.02 | — |
| SECONDARY Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase |
15.40; 22.89; 15.75; 3.00; 29.41; 0.45 | — |
| SECONDARY Precentage of Participants With Discontinuation From the Study for Overall |
0; 0.03; 0; 0; 0.37; 0.68 | — |
| SECONDARY Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level |
0; 0; 0; 0; 0; 0.36 | — |
Summary
The study is to verify atorvastatin effectiveness and safety in Chinese population, and explore the optimal atorvastatin regimens in high-to-moderate risk for ASCVD。
Eligibility Criteria
Inclusion Criteria
- Men and women aged ≥18 years;
- Cardiology patients who has been prescribed atorvastatin by physician's clinical judgment under normal clinical care. These patients will include those with established coronary heart disease, or having multiple risk factors and at risk for cardiovascular disease, or primary hypercholesterolemia.
- Baseline laboratory reports prior to starting atorvastatin therapy can be tracked , including lipid measurement, liver function, and Creatine Kinase (CK) value. The date of baseline reports should be within 1 month before taking atorvastatin or within 24h after starting atorvastatin therapy.
- Evidence of a personally or his/her legally acceptable representative signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study and accept follow-up visit.
Exclusion Criteria
- Patients who have regularly taken atorvastatin therapy more than 4 weeks before enrollment
- Concomitant any other lipid-lower medication at baseline, or during the study conduction on physician clinical judgement
Data sourced from ClinicalTrials.gov (NCT02565615). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.