Phase 3
N=218
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3
Hyperlipidemia
Bottom Line
View on ClinicalTrials.gov: NCT01984424 ↗Enrolled (actual)
218
Serious AEs
8.7%
Results posted
Mar 2018
Primary outcome: Primary: Percent Change From Baseline in LDL-C at the Mean of Weeks 22 and 24 — -16.70; -54.50 percent change — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Atorvastatin (Drug); Placebo to Atorvastatin (Drug); Placebo to Ezetimibe (Other); Ezetimibe (Drug); Placebo to Evolocumab (Other); Evolocumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in LDL-C at the Mean of Weeks 22 and 24 |
-16.70; -54.50 | <0.0001 sig |
| PRIMARY Percent Change From Baseline in LDL-C at Week 24 |
-16.69; -52.76 | <0.0001 sig |
| SECONDARY Change From Baseline in LDL-C at the Mean of Weeks 22 and 24 |
-31.0; -106.8 | <0.0001 sig |
| SECONDARY Change From Baseline in LDL-C at Week 24 |
-31.2; -102.9 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Achieved a Mean LDL-C at Weeks 22 and 24 of Less Than 70 mg/dL |
1.4; 29.9 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Achieved LDL-C at Week 24 of Less Than 70 mg/dL |
0.0; 27.4 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 22 and 24 |
-11.43; -38.04 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol at Week 24 |
-11.57; -36.64 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 22 and 24 |
-14.38; -47.44 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 24 |
-14.62; -45.72 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 22 and 24 |
-11.42; -45.28 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B at Week 24 |
-11.74; -43.50 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at the Mean of Weeks 22 and 24 |
-11.48; -41.39 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 24 |
-12.84; -40.04 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 22 and 24 |
-11.86; -45.99 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 |
-12.62; -44.60 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 22 and 24 |
-1.63; -22.71 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein(a) at Week 24 |
0.17; -21.06 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Triglycerides at the Mean of Weeks 22 and 24 |
-0.95; -5.39 | 0.37 |
| SECONDARY Percent Change From Baseline in Triglycerides at Week 24 |
-1.07; -2.88 | 0.37 |
| SECONDARY Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 24 |
1.66; 7.85 | 0.0083 sig |
| SECONDARY Percent Change From Baseline in HDL-C at Week 24 |
2.90; 7.40 | 0.0083 sig |
| SECONDARY Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 22 and 24 |
-2.15; -6.81 | 0.37 |
| SECONDARY Percent Change From Baseline in VLDL-C at Week 24 |
-2.66; -3.90 | 0.37 |
Summary
The primary objective of this study was to evaluate the effect of 24 weeks of evolocumab administered subcutaneously (SC) every month, compared with ezetimibe, on low-density lipoprotein cholesterol (LDL-C) levels in adults with high cholesterol who are unable to tolerate an effective dose of a statin due to muscle-related side effects (MRSE).
Eligibility Criteria
Inclusion Criteria
- Male or female ≥ 18 to ≤ 80 years of age
- Subject not at LDL-C goal
- History of statin intolerance
- Lipid lowering therapy has been stable prior to enrolment for at least 4 weeks
- Fasting triglycerides ≤ 400 mg/dL
Exclusion Criteria
- New York Heart Association (NYHA) III or IV heart failure
- Uncontrolled cardiac arrhythmia
- Uncontrolled hypertension
- Type 1 diabetes
- Poorly controlled type 2 diabetes
- Uncontrolled hypothyroidism or hyperthyroidism
Data sourced from ClinicalTrials.gov (NCT01984424). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.