Imaging RCT · JAMA 2016
GLAGOV trial
Effect of Evolocumab on Progression of Coronary Disease in Statin-Treated Patients: The GLAGOV Randomized Clinical Trial.
The bottom line
Adding evolocumab to statin therapy in patients with coronary artery disease caused regression of coronary atherosclerosis on IVUS imaging compared with placebo, though its effect on clinical cardiovascular outcomes was not assessed in this trial.
Plaque regression / favourable changeUS status: US-approved
At a glance
- Medicine
- Monthly evolocumab 420 mg subcutaneous injection plus statin (n=484)
- Compared with
- Placebo subcutaneous injection plus statin (n=484)
- People
- 968
- Who took part
- Patients with angiographic coronary disease presenting for coronary angiography, on background statin therapy (mean age 59.8 years [SD 9.2]; 27.8% women; mean LDL-C 92.5 mg/dL [SD 27.2])
- Design
- double-blind, placebo-controlled, randomized clinical trial
- Follow-up
- 76 weeks of treatment (imaging at week 78)
- Main question
- Nominal change in percent atheroma volume (PAV) from baseline to week 78 by serial IVUS imaging
Main result
PAV increased 0.05% with placebo and decreased 0.95% with evolocumab (difference, -1.0% [95% CI, -1.8% to -0.64%]; P < .001)
Effect on LDL cholesterol
Evolocumab group achieved lower mean, time-weighted LDL-C levels (93.0 vs 36.6 mg/dL; difference, -56.5 mg/dL [95% CI, -59.7 to -53.4]; P < .001)
Other results
Normalized TAV decreased 0.9 mm3 with placebo and 5.8 mm3 with evolocumab (difference, -4.9 mm3 [95% CI, -7.3 to -2.5]; P < .001). Evolocumab induced plaque regression in a greater percentage of patients than placebo (64.3% vs 47.3%; difference, 17.0% [95% CI, 10.4% to 23.6%]; P < .001 for PAV and 61.5% vs 48.9%; difference, 12.5% [95% CI, 5.9% to 19.2%]; P < .001 for TAV)
Safety
Safety and tolerability were also evaluated (no specific safety data reported in abstract)
In the trial's own words
“The primary efficacy parameter, PAV, increased 0.05% with placebo and decreased 0.95% with evolocumab (difference, -1.0% [95% CI, -1.8% to -0.64%]; P < .001).”
Quoted from the abstract of JAMA 2016, checked word for word against PubMed. PubMed 27846344 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Evolocumab (Repatha) and alirocumab (Praluent)
Common questions
What did the GLAGOV trial find?
Adding evolocumab to statin therapy in patients with coronary artery disease caused regression of coronary atherosclerosis on IVUS imaging compared with placebo, though its effect on clinical cardiovascular outcomes was not assessed in this trial.
Who was in GLAGOV?
968 people. Patients with angiographic coronary disease presenting for coronary angiography, on background statin therapy (mean age 59.8 years [SD 9.2]; 27.8% women; mean LDL-C 92.5 mg/dL [SD 27.2]).
What was GLAGOV's main result?
PAV increased 0.05% with placebo and decreased 0.95% with evolocumab (difference, -1.0% [95% CI, -1.8% to -0.64%]; P < .001)
How much did LDL cholesterol change in GLAGOV?
Evolocumab group achieved lower mean, time-weighted LDL-C levels (93.0 vs 36.6 mg/dL; difference, -56.5 mg/dL [95% CI, -59.7 to -53.4]; P < .001)
Related trials
- GAUSS-3 (2016)In statin-intolerant patients, evolocumab produced substantially greater LDL-C lowering than ezetimibe over 24 weeks, with fewer treatment discontinuations for muscle symptoms.
- 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.
Get your LDL treated to a goal
Preval Health's protocols follow trials like this one. Licensed clinicians set your goal, prescribe and recheck until you reach it.
Get startedEducation only, not medical advice. Results describe the people in this trial and can differ for you. Talk with your clinician before starting or stopping any medicine. Back to all 106 trials.