Safety and Efficacy of Statins for Chinese Patients With Dyslipidemia

Safety and Efficacy of Statins for Chinese Patients With Dyslipidemia: A Network Register-based Follow-up Study

This study is designed to verify the clinical efficacy and safety of different statins in dyslipidemia patients, and explore the effects on glycometabolic in patients with impaired glucose regulation.

Study Overview

• Status: Unknown
• Conditions: Dyslipidemias
• Intervention / Treatment: Drug: Pitavastatin; Drug: Atorvastatin; Drug: Rosuvastatin

Detailed Description

Study Objective:

1. The main Objective: To explore the effects of different statins lipid-lowering treatment on glucose metabolism in patients with impaired glucose regulation in a large sample of Chinese population;
2. The secondary Objective: To obtain real-world evidence of the clinical efficacy and safety of statins lipid-lowering therapy in Chinese patients.

Study Design: The study was an open-label, multi-center network register-based follow-up study.

The total sample size: 10000 participants.

• Study Type: Interventional
• Enrollment (Actual): 10000
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Heart Center of Peking University People's Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • School of Public Health, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with a clinical diagnosis of ASCVD (Acute coronary syndrome, Stable coronary heart disease, Postoperative revascularization, Ischemic cardiomyopathy, Ischemic stroke, Transient ischemic attack, Peripheral atherosclerotic disease).
2. ASCVD overall risk assessment for high-risk groups: Diabetic patients with LDL-C≥1.8mmol/L（70mg/dl）and age was equal or greater than 40 years old;
3. Patients with hypertension, LDL-C > 2.6mmol/L (100mg/dL) and combined with at least two risk factors. Risk factors include smoking, low HDL-C (HDL-C<1mmol/L, 40mg/dL), male aged over 45 years old or female aged over 55 years old; *** The above (1)-(3) are juxtapositions, patients can be included into the group if only they are satisfied with at least one of the inclusion criteria.

Exclusion Criteria:

1. Patients with any allergy to statins;
2. ACS patients in acute stage；
3. Patients with severe liver disease or biliary obstruction；
4. Patients taking cyclosporine；
5. Patients who have being treated with statins currently or in the past;
6. Pregnant or lactating women and those women who planning to be pregnant;
7. Immunodeficiency or Immunocompromised patients;
8. Patients with hypothyroidism (expect those patients whose thyroid function returned to normal level after drug therapy);
9. Patients using systemic hormone drug;
10. Researchers decided that the patients who was not suitable to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pitavastatin treatment; The drug pitavastatin is given to the patient according to the doctor's order and restricted to BangZhi produced by Jiangsu Wanbang Medicine Marketing Co., Ltd..	Drug: Pitavastatin; Capsule/Tablet, oral, follow the doctor's advice Participants will receive pitavastatin treatment for 3 or 12 weeks.
Experimental: Atorvastatin treatment; The drug atorvastatin is given to the patient according to the doctor's order and the drug band is unspecified.	Drug: Atorvastatin; Capsule/Tablet, oral, follow the doctor's advice Participants will receive atorvastatin treatment for 3 or 12 weeks.
Experimental: Rosuvastatin treatment; The drug atorvastatin is given to the patient according to the doctor's order and the drug band is unspecified.	Drug: Rosuvastatin; Capsule/Tablet, oral, follow the doctor's advice Participants will receive rosuvastatin treatment for 3 or 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL-C target achieving rate	To measure the levels of LDL-C in mmol/L and calculate the LDL-C target achieving rate.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood lipid parameters	The levels of total cholesterol (TC) in mmol/L	3 months
Blood lipid parameters	The levels of triglyceride (TG) in mmol/L	3 months
Blood lipid parameters	The levels of low density lipoprotein cholesterol (LDL-C) in mmol/L	3 months
Blood glucose levels	To measure the level of glycosylated hemoglobin (HbA1) in percent (%)	1 year
Fasting blood glucose	The levels of fasting blood glucose (FBG) in mmol/L	1 year
Blood lipid parameters	The levels of total cholesterol (TC) in mmol/L	1 year
Blood lipid parameters	The levels of triglyceride (TG) in mmol/L	1 year
Blood lipid parameters	The levels of low density lipoprotein cholesterol (LDL-C) in mmol/L	1 year
Blood lipid parameters	The levels of High density lipoprotein cholesterol (HDL-C) in mmol/L	1 year
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	To evaluate the safety and tolerability of the three statins, the incidence of treatment-emergent adverse events should be recorded though the study.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Fudan University
• Collaborators: Peking University People's Hospital; Jiangsu Wanbang Medicine Marketing Co., Ltd.
• Investigators: Principal Investigator: Yuming Jin, Professor, School of Public Health，Fudan University; Principal Investigator: Dayi Hu, Professor, Director of Department of Cardiology, Peking University People's Hospital; Director of Institute of Cardiovascular Disease, Peking University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: January 14, 2018
• First Submitted That Met QC Criteria: January 31, 2018
• First Posted (Actual): February 1, 2018

Study Record Updates

• Last Update Posted (Actual): February 1, 2018
• Last Update Submitted That Met QC Criteria: January 31, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Dyslipidemia; Cardiovascular Diseases; Hypertension; LDL-C
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Rosuvastatin Calcium; Pitavastatin
• Other Study ID Numbers: BZ1701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No