Mixed Dyslipidemia, Primary Hypercholesterolemia
Conditions
Keywords
LDL-C, triglycerides, high cholesterol
Brief summary
The primary objective of this study was to assess users' ability to administer a full dose of evolocumab in home-use using either a pre-filled syringe or autoinjector/pen.
Interventions
BIOLOGICALEvolocumab Pre-filled Syringe
Evolocumab subcutaneous injection via a single use, disposable pre-filled syringe.
BIOLOGICALEvolocumab AI/pen
Evolocumab subcutaneous injection via a handheld mechanical (spring-based) autoinjector/pen.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Fasting LDL-C at screening \> 85 mg/dL * Fasting triglycerides less than or equal to 400 mg/dL (4.5 mmol/L)
Exclusion criteria
* New York Heart Association (NYHA) III or IV heart failure * Uncontrolled cardiac arrhythmia * Uncontrolled hypertension * Type 1 diabetes or poorly controlled type 2 diabetes * Uncontrolled hypothyroidism or hyperthyroidism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4 | Week 2 and Week 4 | Self-administration of evolocumab was assessed by a telephone interview at Weeks 2 and 4. Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all. |
Secondary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in LDL-C at Week 6 | Baseline and Week 6 |
Countries
Canada, United States
Participant flow
Recruitment details
Eligible patients were men and women ≥ 18 and ≤ 80 years of age with fasting low-density lipoprotein cholesterol (LDL-C) ≥ 85 mg/dL, fasting triglycerides ≤ 400 mg/dL and on a stable dose of a statin with or without ezetimibe for at least 4 weeks. The first patient enrolled on 18 April 2013 and last patient enrolled on 05 August 2013.
Pre-assignment details
Randomization was stratified on the basis of screening LDL-C concentration (\< 130 mg/dL \[3.4 mmol/L\] or ≥ 130 mg/dL). Participants were trained by study site staff to prepare and self-administer the study drug.
Participants by arm
| Arm | Count |
|---|---|
| Evolocumab PFS Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS). | 75 |
| Evolocumab AI/Pen Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen). | 74 |
| Total | 149 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Sponsor Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Evolocumab PFS | Evolocumab AI/Pen | Total |
|---|---|---|---|
| Age, Continuous | 61.2 years STANDARD_DEVIATION 11.1 | 60.6 years STANDARD_DEVIATION 9.6 | 60.9 years STANDARD_DEVIATION 10.3 |
| LDL-C Concentration | 116.9 mg/dL STANDARD_DEVIATION 25 | 118.1 mg/dL STANDARD_DEVIATION 28.7 | 117.5 mg/dL STANDARD_DEVIATION 26.8 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 2 participants | 7 participants | 9 participants |
| Race/Ethnicity, Customized Black or African American | 11 participants | 7 participants | 18 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 9 participants | 6 participants | 15 participants |
| Race/Ethnicity, Customized Missing | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 66 participants | 68 participants | 134 participants |
| Race/Ethnicity, Customized White | 62 participants | 58 participants | 120 participants |
| Sex: Female, Male Female | 36 Participants | 26 Participants | 62 Participants |
| Sex: Female, Male Male | 39 Participants | 48 Participants | 87 Participants |
| Stratification Factor: LDL-C Level < 130 mg/dL | 56 participants | 56 participants | 112 participants |
| Stratification Factor: LDL-C Level ≥ 130 mg/dL | 19 participants | 18 participants | 37 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 75 | 2 / 74 |
| serious Total, serious adverse events | 3 / 75 | 2 / 74 |
Outcome results
Primary
Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4
Self-administration of evolocumab was assessed by a telephone interview at Weeks 2 and 4. Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all.
Time frame: Week 2 and Week 4
Population: Full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Evolocumab PFS | Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4 | 96.0 percentage of participants |
| Evolocumab AI/Pen | Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4 | 89.2 percentage of participants |
95% CI: [-16.3, 2]
Secondary
Percent Change From Baseline in LDL-C at Week 6
Time frame: Baseline and Week 6
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Evolocumab PFS | Percent Change From Baseline in LDL-C at Week 6 | -59.74 percent change | Standard Error 2.57 |
| Evolocumab AI/Pen | Percent Change From Baseline in LDL-C at Week 6 | -63.43 percent change | Standard Error 2.67 |
95% CI: [-10.38, 2.99]