High-Dose Versus Low-Dose Pitavastatin in Japanese Patients With Stable Coronary Artery Disease (REAL-CAD)): A Randomized Superiority Trial
An erratum to this article was published (Circulation, 2 Apr 2019 ↗)
Primary resultResult — go to the resultHazard ratio 0.81 95% CI 0.69–0.95Authors' conclusion
High-dose (4 mg/d) compared with low-dose (1 mg/d) pitavastatin therapy significantly reduced cardiovascular events in Japanese patients with stable coronary artery disease.
Study context
- Population
- Japanese patients with stable CAD who achieved low-density lipoprotein cholesterol (LDL-C) <120 mg/dL during a run-in on pitavastatin 1 mg/d
- Participants
- 13,054 patients
- Comparison
- High-dose vs low-dose statin therapy
- High-dosen = 6,526
- Low-dosen = 6,528reference
- Primary endpoint
- CV death, nonfatal MI, nonfatal ischemic stroke or unstable angina requiring emergency hospitalization
- Follow-up
- Median 3.9 years
Methodological detailsprospective, multicenter, open-label, blinded end point
- Prospective
- Multicenter
- Open-label
- Blinded end point
Primary result
As reported in the abstract
Hazard ratio
0.81
95% CI 0.69–0.95
P = 0.01
Events by treatment group
High-dosevs Low-dose
HR 0.81 (95% CI 0.69–0.95); P = 0.01
Secondary outcomes
| Outcome | High-dose | Low-dose | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Secondary composite end point (primary end point plus clinically indicated coronary revascularization excluding target-lesion revascularization at prior PCI sites) | 7.9% | 9.7% | 0.83 (0.73–0.93) | P = 0.002 | |
| 0.512Hazard ratio (log scale) |
LDL-C during follow-up · entire course of follow-up
- LDL-C lower in High-dose than Low-dose by 14.7 mg/dL
- P < 0.001
All-cause death, MI, clinically indicated coronary revascularization
- Significantly reduced with high-dose pitavastatin
Primary and secondary composite end points across prespecified subgroups, incl. low (<95 mg/dL) baseline LDL-C
- Results consistent across subgroups
Safety
- Serious adverse event rates were low in both groups
Original publication
High-Dose Versus Low-Dose Pitavastatin in Japanese Patients With Stable Coronary Artery Disease (REAL-CAD)): A Randomized Superiority Trial. Circulation. Published 8 May 2018. doi:10.
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