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A total of 100 patients aged 18-85 years old with a definite diagnosis of ACS were admitted to the Department of Cardiovascular, The First Affiliated Hospital of Nanjing Medical University. These patients had fasting serum low-density lipoprotein (LDL-C) >1.8mmol/L (70mg/dL) and were divided into three groups according to the lipid-lowering regimen used: a total of 50 people in the statin-only group received a daily oral medium-dose statin (atorvastatin 20mg qn or rosuvastatin 10mg qn); a total of 30 people in the statin + one injection group per month received oral atorvastatin 20mg qn or rosuvastatin 10mg qn + once a month, subcutaneous injection of 1 injection of PCSK9 inhibitor each time; the remaining 20 people were divided into statin + two injections per month group, oral atorvastatin 20mg qn or rosuvastatin 10mg qn + twice a month, subcutaneous injection of 1 injection of PCSK9 inhibitor each time. We followed up the blood lipid levels of these patients at different time points (one month,three month, six month), including TC, TG, HDL-C, LDL-C,taking the LDL-C reduction ≥50% from the baseline, LDL-C<1.8mmol/L (70mg/dL), and LDL-C<1.4mmol/L (55mg/dL) as the the compliance standard, the blood lipid compliance rates of the three groups at the 6th month of treatment were calculated respectively. The adverse drug reactions of the patients during follow-up were recorded.
Purpose:The purpose of this study was to explore the short-term effect of a modified, lower-than-guideline-recommended doses of PCSK9 inhibitors combined with a statin in the treatment of dyslipidemia in Chinese with the acute coronary syndrome (ACS), to provide evidence for the use of this drug in real-world Chinese populations. This study will provide more economical, convenient, and acceptable treatment options.
A total of 100 patients aged 18-85 years old with a definite diagnosis of ACS were admitted to the Department of Cardiovascular, The First Affiliated Hospital of Nanjing Medical University. These patients had fasting serum low-density lipoprotein (LDL-C) >1.8mmol/L (70mg/dL) and were divided into three groups according to the lipid-lowering regimen used: a total of 50 people in the statin-only group received a daily oral medium-dose statin (atorvastatin 20mg qn or rosuvastatin 10mg qn); a total of 30 people in the statin + one injection group per month received oral atorvastatin 20mg qn or rosuvastatin 10mg qn + once a month, subcutaneous injection of 1 injection of PCSK9 inhibitor each time; the remaining 20 people were divided into statin + two injections per month group, oral atorvastatin 20mg qn or rosuvastatin 10mg qn + twice a month, subcutaneous injection of 1 injection of PCSK9 inhibitor each time. We followed up the blood lipid levels of these patients at different time points (one month,three month, six month), including TC, TG, HDL-C, LDL-C, taking the LDL-C reduction ≥50% from the baseline, LDL-C<1.8mmol/L (70mg/dL), and LDL-C<1.4mmol/L (55mg/dL) as the the compliance standard, the blood lipid compliance rates of the three groups at the 6th month of treatment were calculated respectively. The adverse drug reactions of the patients during follow-up were recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Statin-only group | Experimental | The patients in this group are treated with medium-dose statin daily(atorvastatin 20mg qn or rosuvastatin 10mg qn). |
|
| Low-dose PCSK9 inhibitor group | Experimental | The patients in this group are treated with medium-dose statin daily(atorvastatin 20mg qn or rosuvastatin 10mg qn) and 1 injection of PCSK9 inhibitor once a month SC. |
|
| Normal-dose PCSK9 inhibitor group | Experimental | The patients in this group are treated with medium-dose statin daily(atorvastatin 20mg qn or rosuvastatin 10mg qn) and 1 injection of PCSK9 inhibitor twice a month SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Statin | Drug | Medium-dose statin daily(atorvastatin 20mg qn or rosuvastatin 10mg qn) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The level of total cholesterol(TC) | The level of total cholesterol(TC) at 6 month | 6 month |
| The level of triglyceride(TG) | The level of triglyceride(TG) at 6 month | 6 month |
| The level of high-density lipoprotein cholesterol(HDL-C) | The level of high-density lipoprotein cholesterol(HDL-C) at 6 month | 6 month |
| The level of low-density lipoprotein cholesterol(LDL-C) | The level of low-density lipoprotein cholesterol(LDL-C) at 6 month | 6 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liansheng Wang | Contact | +86 13390787111 | jsyzcxw@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210029 | China |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| ID | Term |
|---|---|
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
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| PCSK9 inhibitor | Drug | 1 injection of PCSK9 inhibitor once a month SC |
|
| PCSK9 inhibitor | Drug | 1 injection of PCSK9 inhibitor twice a month SC |
|
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |