Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Russian National Atherosclerosis Society | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Retrospective observational study of the efficacy and safety of statin monotherapy or statins in combination with ezetimibe in patients receiving lipid-lowering therapy in both primary and secondary prevention of cardiovascular diseases (CVD). The study will include patients receiving lipid-lowering therapy in both primary and secondary prevention of CVD who have received therapy of interest for ≥ 3 months in the 2 years preceding the signing of informed consent, i.e. statins as monotherapy or in combination with ezetimibe in a stable mode (without dose adjustment and/or statin replacement). Effectiveness of therapy will be evaluated based on the data on changes in baseline levels of total cholesterol (CS), low density lipoproteins (LDL), high density lipoproteins (HDL), triglycerides (TG), data on which will be obtained from primary medical records. Demographic and anthropometric data on patients, information on the history of hyperlipidemia and concomitant diseases will also be obtained. Also, the study will collect data on the development of adverse reactions of particular interest during therapy (liver/muscle damage, major cardiovascular events (MACE).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combination therapy group | 750 Subjects in the statin and ezetimibe combination therapy group |
| |
| monotherapy group | 250 Subjects in the statin monotherapy group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| statin and ezetimibe combination therapy | Drug | Receiving statins (atorvastatin/rosuvastatin or others) in combination with ezetimibe 10mg/day in a stable dosing regimen (without changing the dose of the therapy and/or replacing the statin) for 3 or more months at the time of enrolment in the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of achieving target LDL (%) | Frequency of achieving target LDL cholesterol levels at the time of enrolment (%) | at the time of enrolment in the study |
| Average change in LDL (absolute difference) | Average change in LDL cholesterol level from the moment of the index event to inclusion (absolute difference) | from the moment of initiation of lipid-lowering drug therapy (not earlier than 2 years before enrolment into the study) to inclusion in the study |
| Average change in LDL (% from the baseline) | Average change in LDL cholesterol level from the moment of the index event to inclusion (% from the baseline) | from the moment of initiation of lipid-lowering drug therapy (not earlier than 2 years before enrolment into the study) to inclusion in the study |
| Average change in total cholesterol (% and absolute difference) | Average change in total cholesterol level from the moment of the index event to inclusion (% and absolute difference) | from the moment of initiation of lipid-lowering drug therapy (not earlier than 2 years before enrolment into the study) to inclusion in the study |
| Average change in LDL (% and absolute difference) | Average change in LDL cholesterol level from the moment of the index event to inclusion (% and absolute difference) | from the moment of initiation of lipid-lowering drug therapy (not earlier than 2 years before enrolment into the study) to inclusion in the study |
| Average change in TG (% and absolute difference) | Average change in TG level from the moment of the index event to inclusion (% and absolute difference) |
Not provided
Not provided
Inclusion Criteria:
Patient can be included in the study only once.
Exclusion Criteria:
Not provided
Not provided
Not provided
The study will include patients receiving lipid-lowering therapy in both primary and secondary prevention of CVD who have received therapy of interest for ≥ 3 months in the 2 years preceding the signing of informed consent, i.e. statins as monotherapy or in combination with ezetimibe in a stable mode (without dose adjustment and/or statin replacement).
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Igor V Sergienko, MD,PHD,Prof. | Russian National Atherosclerosis Society | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FGBOU VO "ChGU named after I.N. Ulianova" | Cheboksary | 428015 | Russia | |||
| FGBOU VO "ChGMA" Ministery of Health Russia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| statin monotherapy | Drug | Receiving statins (atorvastatin/rosuvastatin or others) as monotherapy in a stable dosing regimen (without changing the dose of the therapy and/or replacing the statin) for 3 or more months at the time of enrolment in the study. |
|
|
| from the moment of initiation of lipid-lowering drug therapy (not earlier than 2 years before enrolment into the study) to inclusion in the study |
| The incidence of liver damage | an increase in ALT/AST levels over 1.5 of the upper limit normal [ULN] | from the moment of initiation of lipid-lowering drug therapy (not earlier than 2 years before enrolment into the study) to inclusion in the study |
| The frequency of development of muscle damage | an increase in CPK level while excluding other possible factors of the development of the disorder | from the moment of initiation of lipid-lowering drug therapy (not earlier than 2 years before enrolment into the study) to inclusion in the study |
| Major adverse cardiovascular events (MACE) incidence | Within the framework of this study, major adverse cardiovascular events (MACE) are considered as follows: myocardial infarction (MI), unstable angina pectoris, ischaemic stroke, aortocoronary bypass, mammary coronary bypass, coronary artery bypass, peripheral artery surgery, atherosclerotic stenosis of any artery more than 50%. | from the moment of initiation of lipid-lowering drug therapy (not earlier than 2 years before enrolment into the study) to inclusion in the study |
| Chita |
| 672000 |
| Russia |
| Gbuz "Iokb" | Irkutsk | 664049 | Russia |
| Gauz "Gkb #7" | Kazan' | 420103 | Russia |
| Nii "Kpssz" | Kemerovo | 650002 | Russia |
| KOGBUZ "Severnaya klinicheskaya bolnitca skoroi meditcinskoi pomotschi" | Kirov | 610011 | Russia |
| OOO TsEN YUG | Krasnodar | 350004 | Russia |
| GUZ "Lipetskaya Gorpolyklinika #7" | Lipetsk | 398004 | Russia |
| ООО "MC "Semeiny doctor" | Magnitogorsk | 455034 | Russia |
| OOO "Semeiny doctor" | Magnitogorsk | 455044 | Russia |
| Fgbu Mnic Pm Ministry of Health Russia | Moscow | 101000 | Russia |
| OOO ''Ne bolit" | Moscow | 119296 | Russia |
| FGBU NMIC of Cardiology Ministry of heath RF | Moscow | 121552 | Russia |
| FGBOU DPO RMANPO Ministry of Health | Moscow | 125993 | Russia |
| Chuz ''Ckb Rzhd Medicina" | Moscow | 129128 | Russia |
| Osp Rgnkc | Moscow | 129226 | Russia |
| GBUZ NO "Gorodskaya Klinicheskaya Bolnitsa #38" | Nizhny Novgorod | 603000 | Russia |
| Gbuz No "Gkb #5" | Nizhny Novgorod | 603005 | Russia |
| OOO "DaVinchi-NN" | Nizhny Novgorod | 603022 | Russia |
| NII TPM - affiliate of SO RAN | Novosibirsk | 630089 | Russia |
| Buzoo "Kkd" | Omsk | 644024 | Russia |
| Gbus "Bsmp" | Petrozavodsk | 185031 | Russia |
| FGBOU VO SZGMU named after I.I.Mechnikov | Saint Petersburg | 191015 | Russia |
| FGBU "SZONKC named after L.G.Sokolov FMBA of Russia" | Saint Petersburg | 194291 | Russia |
| Ooo "Veraks-Med" | Saint Petersburg | 195267 | Russia |
| GBUZ "SOKKD named after V.P.Polyakov" | Samara | 443070 | Russia |
| Fgbou Vo Tyumensky Gmu Ministry of Health Russia | Tyumen | 625023 | Russia |
| Cardiology cabinet "Serdce pod zaschitoy" IP Barov P.A. | Ulyanovsk | 432071 | Russia |
| GBUZ VO "City hospital #4 of Vladimir" | Vladimir | 600020 | Russia |
| GBUZ VO "GB #4 c. Vladimir" | Vladimir | 600020 | Russia |
| FGBOU VO "UGMU" Ministry of Health Russia | Yekaterinburg | 620028 | Russia |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| ID | Term |
|---|---|
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |
Not provided
Not provided