Cardiovascular outcome trial · N Engl J Med 2016
HOPE-3 trial
Cholesterol Lowering in Intermediate-Risk Persons without Cardiovascular Disease.
The bottom line
In an intermediate-risk, ethnically diverse population without cardiovascular disease, rosuvastatin 10 mg daily significantly lowered the risk of major cardiovascular events compared with placebo, though with a modest increase in cataract surgery and muscle symptoms.
BenefitUS status: US-approved
At a glance
- Medicine
- Rosuvastatin 10 mg per day
- Compared with
- Placebo
- People
- 12,705
- Who took part
- 12,705 participants in 21 countries without cardiovascular disease, at intermediate risk, ethnically diverse
- Design
- randomized, 2-by-2 factorial trial (this comparison placebo-controlled)
- Follow-up
- median follow-up of 5.6 years
- Main question
- First coprimary outcome: composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke; Second coprimary outcome: additionally included revascularization, heart failure, and resuscitated cardiac arrest
Main result
The first coprimary outcome occurred in 235 participants (3.7%) in the rosuvastatin group and in 304 participants (4.8%) in the placebo group (hazard ratio, 0.76; 95% confidence interval [CI], 0.64 to 0.91; P=0.002). The results for the second coprimary outcome were consistent with the results for the first (occurring in 277 participants [4.4%] in the rosuvastatin group and in 363 participants [5.7%] in the placebo group; hazard ratio, 0.75; 95% CI, 0.64 to 0.88; P<0.001).
Effect on LDL cholesterol
The overall mean low-density lipoprotein cholesterol level was 26.5% lower in the rosuvastatin group than in the placebo group.
Other results
The results were also consistent in subgroups defined according to cardiovascular risk at baseline, lipid level, C-reactive protein level, blood pressure, and race or ethnic group.
Safety
In the rosuvastatin group, there was no excess of diabetes or cancers, but there was an excess of cataract surgery (in 3.8% of the participants, vs. 3.1% in the placebo group; P=0.02) and muscle symptoms (in 5.8% of the participants, vs. 4.7% in the placebo group; P=0.005).
In the trial's own words
“The first coprimary outcome occurred in 235 participants (3.7%) in the rosuvastatin group and in 304 participants (4.8%) in the placebo group (hazard ratio, 0.76; 95% confidence interval [CI], 0.64 to 0.91; P=0.002).”
Quoted from the abstract of N Engl J Med 2016, checked word for word against PubMed. PubMed 27040132 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Statins
Common questions
What did the HOPE-3 trial find?
In an intermediate-risk, ethnically diverse population without cardiovascular disease, rosuvastatin 10 mg daily significantly lowered the risk of major cardiovascular events compared with placebo, though with a modest increase in cataract surgery and muscle symptoms.
Who was in HOPE-3?
12,705 people. 12,705 participants in 21 countries without cardiovascular disease, at intermediate risk, ethnically diverse.
What was HOPE-3's main result?
The first coprimary outcome occurred in 235 participants (3.7%) in the rosuvastatin group and in 304 participants (4.8%) in the placebo group (hazard ratio, 0.76; 95% confidence interval [CI], 0.64 to 0.91; P=0.002). The results for the second coprimary outcome were consistent with the results for the first (occurring in 277 participants [4.4%] in the rosuvastatin group and in 363 participants [5.7%] in the placebo group; hazard ratio, 0.75; 95% CI, 0.64 to 0.88; P<0.001).
How much did LDL cholesterol change in HOPE-3?
The overall mean low-density lipoprotein cholesterol level was 26.5% lower in the rosuvastatin group than in the placebo group.
Related trials
- SAMSON (2021)In patients who had previously stopped statins due to side effects, symptom scores were equally elevated on statin and placebo compared with no treatment, indicating most statin-associated symptoms are a nocebo effect rather than a pharmacological effect of the drug.
- StatinWISE (2021)In patients with prior statin-associated muscle symptoms, atorvastatin 20 mg did not cause more muscle symptoms than placebo when tested in a blinded n-of-1 design, and most participants intended to resume statin therapy.
- AURORA (2009)In patients on hemodialysis, rosuvastatin lowered LDL cholesterol but did not reduce cardiovascular events or all-cause mortality compared with placebo.
- LODESTAR (2023)In patients with coronary artery disease, rosuvastatin and atorvastatin provide similar long-term cardiovascular protection, but rosuvastatin carries a higher risk of new-onset diabetes requiring medication and cataract surgery.
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.