Cardiovascular outcome trial · BMJ 2023
LODESTAR trial
Rosuvastatin versus atorvastatin treatment in adults with coronary artery disease: secondary analysis of the randomised LODESTAR trial.
The bottom line
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.
No significant benefitUS status: US-approved
At a glance
- Medicine
- Rosuvastatin (n=2204; mean daily dose 17.1 mg (SD 5.2 mg) at three years)
- Compared with
- Atorvastatin (n=2196; mean daily dose 36.0 (12.8) mg at three years)
- People
- 4,400
- Who took part
- 4400 adults (age ≥19 years) with coronary artery disease, enrolled at 12 hospitals in South Korea, September 2016 to November 2019
- Design
- Randomised, open label, multicentre trial (2x2 factorial randomisation)
- Follow-up
- Three years
- Main question
- Three year composite of all cause death, myocardial infarction, stroke, or any coronary revascularisation
Main result
The primary outcome occurred in 189 participants (8.7%) in the rosuvastatin group and 178 (8.2%) in the atorvastatin group (hazard ratio 1.06, 95% confidence interval 0.86 to 1.30; P=0.58)
Effect on LDL cholesterol
The mean low density lipoprotein (LDL) cholesterol level during treatment was 1.8 mmol/L (SD 0.5 mmol/L) in the rosuvastatin group and 1.9 (0.5) mmol/L in the atorvastatin group (P<0.001)
Other results
Composite primary outcome (including all-cause death) did not differ significantly between groups; no separate all-cause mortality figure reported
Safety
Rosuvastatin group had higher incidence of new onset diabetes mellitus requiring antidiabetics (7.2% v 5.3%; hazard ratio 1.39, 95% CI 1.03 to 1.87; P=0.03) and cataract surgery (2.5% v 1.5%; 1.66, 1.07 to 2.58; P=0.02). Other safety endpoints did not differ between groups.
In the trial's own words
“The primary outcome occurred in 189 participants (8.7%) in the rosuvastatin group and 178 (8.2%) in the atorvastatin group (hazard ratio 1.06, 95% confidence interval 0.86 to 1.30; P=0.58).”
Quoted from the abstract of BMJ 2023, checked word for word against PubMed. PubMed 37852649 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Statins
Common questions
What did the LODESTAR trial find?
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.
Who was in LODESTAR?
4,400 people. 4400 adults (age ≥19 years) with coronary artery disease, enrolled at 12 hospitals in South Korea, September 2016 to November 2019.
What was LODESTAR's main result?
The primary outcome occurred in 189 participants (8.7%) in the rosuvastatin group and 178 (8.2%) in the atorvastatin group (hazard ratio 1.06, 95% confidence interval 0.86 to 1.30; P=0.58)
How much did LDL cholesterol change in LODESTAR?
The mean low density lipoprotein (LDL) cholesterol level during treatment was 1.8 mmol/L (SD 0.5 mmol/L) in the rosuvastatin group and 1.9 (0.5) mmol/L in the atorvastatin group (P<0.001)
Related trials
- REPRIEVE (2023)In people with HIV at low-to-moderate cardiovascular risk, daily pitavastatin significantly reduced major adverse cardiovascular events compared with placebo, though with modestly more muscle symptoms and diabetes.
- SPORT (2023)In people with elevated ASCVD risk but no prior ASCVD, low-dose rosuvastatin (5 mg) lowered LDL-C far more than placebo or any of six common dietary supplements, which showed no significant LDL-C benefit over placebo.
- 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.
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