Primary Hypercholesterolemia
Conditions
Brief summary
The main objective of this study is to determine the percentage of patients who met the low-density lipoprotein cholesterol (LDL-C) objective with INEGY, that were not under statin monotherapy treatment.
Detailed description
The type of patient sampling used was consecutive patient sampling
Interventions
DRUGINEGY
Ezetimibe 10mg - Simvastatine 20 mg or 40 mg; Tablet - OD; Patient currently treated for INEGY for at least 4 weeks
Sponsors
Organon and Co
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* man or woman aged over 18; * patient suffering from primary hypercholesterolemia; * patient justifying treatment with INEGY® (2nd intention); * patient currently treated with INEGY® for at least 4 weeks; * patient with a lipid profile before treatment with INEGY®, documenting a level of LDL-C exceeding the therapeutic objective under treatment with a statin as monotherapy; * patient with an evaluation of lipid disorder (EAL) treated with INEGY®, performed within 1 to 3 months of starting treatment.
Exclusion criteria
* patient not previously treated with a statin; * patient previously treated with a combination of hypolipemics; * patient treated with INEGY® as first intention; * patient treated with INEGY® for less than 4 weeks; * patient already included in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reaching the Targeted LDL-C Levels | 1 to 3 months after starting treatment | A subject was considered to have met targeted LDL-C levels (been controlled) if: * subject had no cardiovascular (CV) risk factors and level of LDL-C after initiating INEGY was lower than 2.2 g/L, * subject had only 1 CV risk factor and level of LDL-C after initiating INEGY was lower than 1.9 g/L, * subject had 2 CV risk factors and level of LDL-C after initiating INEGY was lower than 1.6 g/L, * subject had 3 or more CV risk factors and level of LDL-C after initiating INEGY was lower than 1.3 g/L, * subject had a high CV risk and level of LDL-C after initiating INEGY was lower than 1 g/L. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects Treated With INEGY Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg). | 1,663 |
| Total | 1,663 |
Baseline characteristics
| Characteristic | Subjects Treated With INEGY |
|---|---|
| Age, Continuous | 61.6 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment France | 1663 participants |
| Sex: Female, Male Female | 585 Participants |
| Sex: Female, Male Male | 1078 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,663 |
| serious Total, serious adverse events | 2 / 1,663 |
Outcome results
Primary
Number of Participants Reaching the Targeted LDL-C Levels
A subject was considered to have met targeted LDL-C levels (been controlled) if: * subject had no cardiovascular (CV) risk factors and level of LDL-C after initiating INEGY was lower than 2.2 g/L, * subject had only 1 CV risk factor and level of LDL-C after initiating INEGY was lower than 1.9 g/L, * subject had 2 CV risk factors and level of LDL-C after initiating INEGY was lower than 1.6 g/L, * subject had 3 or more CV risk factors and level of LDL-C after initiating INEGY was lower than 1.3 g/L, * subject had a high CV risk and level of LDL-C after initiating INEGY was lower than 1 g/L.
Time frame: 1 to 3 months after starting treatment
Population: This was the efficacy population per protocol (PP) targeted for study treatment, and consisted of patients having taken INEGY at least once, with a primary efficacy criterion available (presence of risk factors or not plus lipid assessment after introduction of INEGY), and showing no major deviations from the protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Treated With INEGY | Number of Participants Reaching the Targeted LDL-C Levels | 740 Participants |