Lipid-efficacy RCT · Lancet 2015
TESLA Part B trial
Inhibition of PCSK9 with evolocumab in homozygous familial hypercholesterolaemia (TESLA Part B): a randomised, double-blind, placebo-controlled trial.
The bottom line
In patients with homozygous familial hypercholesterolaemia on stable background therapy, adding evolocumab 420 mg every 4 weeks significantly lowered LDL cholesterol compared with placebo and was well tolerated over 12 weeks.
Primary lipid endpoint metUS status: US-approved
At a glance
- Medicine
- Subcutaneous evolocumab 420 mg every 4 weeks for 12 weeks
- Compared with
- Placebo
- People
- 50
- Who took part
- Patients (aged ≥12 years) with homozygous familial hypercholesterolaemia, on stable lipid-regulating therapy for at least 4 weeks, and not receiving lipoprotein apheresis
- Design
- randomised, double-blind, placebo-controlled phase 3 trial
- Follow-up
- 12 weeks
- Main question
- Percentage change in ultracentrifugation LDL cholesterol from baseline at week 12 compared with placebo
Main result
Evolocumab significantly reduced ultracentrifugation LDL cholesterol at 12 weeks by 30·9% (95% CI -43·9% to -18·0%; p<0·0001)
Effect on LDL cholesterol
30.9% reduction in ultracentrifugation LDL cholesterol vs placebo (95% CI -43.9% to -18.0%; p<0.0001)
Safety
Treatment-emergent adverse events occurred in ten (63%) of 16 patients in the placebo group and 12 (36%) of 33 in the evolocumab group. No serious clinical or laboratory adverse events occurred, and no anti-evolocumab antibody development was detected during the study.
In the trial's own words
“Compared with placebo, evolocumab significantly reduced ultracentrifugation LDL cholesterol at 12 weeks by 30·9% (95% CI -43·9% to -18·0%; p<0·0001).”
Quoted from the abstract of Lancet 2015, checked word for word against PubMed. PubMed 25282520 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Evolocumab (Repatha) and alirocumab (Praluent)
Common questions
What did the TESLA Part B trial find?
In patients with homozygous familial hypercholesterolaemia on stable background therapy, adding evolocumab 420 mg every 4 weeks significantly lowered LDL cholesterol compared with placebo and was well tolerated over 12 weeks.
Who was in TESLA Part B?
50 people. Patients (aged ≥12 years) with homozygous familial hypercholesterolaemia, on stable lipid-regulating therapy for at least 4 weeks, and not receiving lipoprotein apheresis.
What was TESLA Part B's main result?
Evolocumab significantly reduced ultracentrifugation LDL cholesterol at 12 weeks by 30·9% (95% CI -43·9% to -18·0%; p<0·0001)
How much did LDL cholesterol change in TESLA Part B?
30.9% reduction in ultracentrifugation LDL cholesterol vs placebo (95% CI -43.9% to -18.0%; p<0.0001)
Related trials
- ODYSSEY ALTERNATIVE (2015)In statin-intolerant patients, alirocumab lowered LDL-C far more than ezetimibe and caused fewer muscle-related adverse events than statin rechallenge with atorvastatin.
- ODYSSEY FH I and II (2015)In patients with heterozygous familial hypercholesterolemia inadequately controlled on maximally tolerated lipid-lowering therapy, adding alirocumab produced large, durable LDL-C reductions through 78 weeks and was generally well tolerated.
- ODYSSEY LONG TERM (2015)Adding alirocumab to maximally tolerated statin therapy markedly lowered LDL cholesterol and was associated with a post hoc reduction in cardiovascular events, though with somewhat higher rates of injection-site reactions, myalgia, neurocognitive, and ophthalmologic events.
- RUTHERFORD-2 (2015)In patients with heterozygous familial hypercholesterolaemia on stable lipid-lowering therapy, adding evolocumab produced rapid, large LDL cholesterol reductions of about 60% compared with placebo with a tolerability profile similar to placebo.
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