Statin Monotherapy or Statins in Combination With Ezetimibe in Patients for Prevention of CVD (UNISON)

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 CVD

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).

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Lipid Metabolism Disorders
• Intervention / Treatment: Drug: statin and ezetimibe combination therapy; Drug: statin monotherapy

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Russian Federation
  • Cheboksary, Russian Federation, 428015
    • FGBOU VO "ChGU named after I.N. Ulianova"
  • Chita, Russian Federation, 672000
    • FGBOU VO "ChGMA" Ministery of Health Russia
  • Ekaterinburg, Russian Federation, 620028
    • FGBOU VO "UGMU" Ministry of Health Russia
  • Irkutsk, Russian Federation, 664049
    • Gbuz "Iokb"
  • Kazan, Russian Federation, 420103
    • Gauz "Gkb #7"
  • Kemerovo, Russian Federation, 650002
    • Nii "Kpssz"
  • Kirov, Russian Federation, 610011
    • KOGBUZ "Severnaya klinicheskaya bolnitca skoroi meditcinskoi pomotschi"
  • Krasnodar, Russian Federation, 350004
    • OOO TsEN YUG
  • Lipetsk, Russian Federation, 398004
    • GUZ "Lipetskaya Gorpolyklinika #7"
  • Magnitogorsk, Russian Federation, 455034
    • ООО "MC "Semeiny doctor"
  • Magnitogorsk, Russian Federation, 455044
    • OOO "Semeiny doctor"
  • Moscow, Russian Federation, 101000
    • Fgbu Mnic Pm Ministry of Health Russia
  • Moscow, Russian Federation, 119296
    • OOO ''Ne bolit"
  • Moscow, Russian Federation, 121552
    • FGBU NMIC of Cardiology Ministry of heath RF
  • Moscow, Russian Federation, 125993
    • FGBOU DPO RMANPO Ministry of Health
  • Moscow, Russian Federation, 129128
    • Chuz ''Ckb Rzhd Medicina"
  • Moscow, Russian Federation, 129226
    • Osp Rgnkc
  • Nizhny Novgorod, Russian Federation, 603000
    • GBUZ NO "Gorodskaya Klinicheskaya Bolnitsa #38"
  • Nizhny Novgorod, Russian Federation, 603005
    • Gbuz No "Gkb #5"
  • Nizhny Novgorod, Russian Federation, 603022
    • OOO "DaVinchi-NN"
  • Novosibirsk, Russian Federation, 630089
    • NII TPM - affiliate of SO RAN
  • Omsk, Russian Federation, 644024
    • Buzoo "Kkd"
  • Petrozavodsk, Russian Federation, 185031
    • Gbus "Bsmp"
  • Saint Petersburg, Russian Federation, 191015
    • FGBOU VO SZGMU named after I.I.Mechnikov
  • Saint Petersburg, Russian Federation, 194291
    • FGBU "SZONKC named after L.G.Sokolov FMBA of Russia"
  • Saint Petersburg, Russian Federation, 195267
    • Ooo "Veraks-Med"
  • Samara, Russian Federation, 443070
    • GBUZ "SOKKD named after V.P.Polyakov"
  • Tyumen, Russian Federation, 625023
    • Fgbou Vo Tyumensky Gmu Ministry of Health Russia
  • Ulyanovsk, Russian Federation, 432071
    • Cardiology cabinet "Serdce pod zaschitoy" IP Barov P.A.
  • Vladimir, Russian Federation, 600020
    • GBUZ VO "City hospital #4 of Vladimir"
  • Vladimir, Russian Federation, 600020
    • GBUZ VO "GB #4 c. Vladimir"

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

Inclusion Criteria:

Patient can be included in the study only once.

1. Age > 18 years.
2. Patient receiving lipid-lowering therapy with statin monotherapy or statins in combination with ezetimibe for both primary and secondary prevention of CVD.
3. Receiving statins as monotherapy or statins in combination with ezetimibe in a stable dosing regimen for 3 or more months at the time of enrolment in the study.
4. Willingness and ability to sign an informed consent to participate in the study.
5. Availability of primary medical documentation, which allows assessment of all parameters necessary for the study from the moment of initiation of statin monotherapy or statins in combination with ezetimibe.
6. Initiation of lipid-lowering therapy not earlier than 2 years before enrolment into the study.

Exclusion Criteria:

1. Age < 18 years.
2. A diagnosis of familial hypercholesterolemia made prior to study enrolment or the investigator's suspicious of the possible presence of familial hypercholesterolemia.
3. Change in lipid-lowering therapy within 3 months prior to study enrolment.
4. Concomitant administration of omega-3 PUFA with statin monotherapy or combination therapy of statins and ezetimibe, as well as the use of any methods of extracorporeal filtration and/or plasmapheresis.
5. Clinically significant impairment of liver and/or kidney function, which may impede interpretation of test results
6. Presence of hypothyroidism
7. Ezetimibe monotherapy
8. Intolerance to statins at any dose

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
combination therapy group; 750 Subjects in the statin and ezetimibe combination therapy group	Drug: statin and ezetimibe combination therapy; 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.; Other Names: no other intervention
monotherapy group; 250 Subjects in the statin monotherapy group	Drug: statin monotherapy; 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.; Other Names: no other intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Akrikhin
• Collaborators: Russian National Atherosclerosis Society
• Investigators: Principal Investigator: Igor V Sergienko, MD,PHD,Prof., Russian National Atherosclerosis Society

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Actual): November 25, 2021
• Study Completion (Actual): July 8, 2022

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Cardiovascular diseases; Lipid-lowering therapy; Statin; Ezetimibе
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Metabolic Diseases; Lipid Metabolism Disorders; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Ezetimibe; Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Other Study ID Numbers: EZE-01/21

Plan for Individual participant data (IPD)

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