Evaluating different low‐density lipoprotein cholesterol thresholds to initiate statin for prevention of cardiovascular diseases in patients with type 2 diabetes mellitus: A target trial emulation study
Authors' conclusion
Compared with the threshold of 2.6 mmol/L, initiating statin in patients with a lower baseline LDL-C level at 1.8-2.5 mmol/L can further reduce the risks of CVD and all-cause mortality without significantly increasing the risk of major adverse events in patients with T2DM, including patients aged >75 years.
Study context
- Population
- Patients with T2DM with elevated low-density lipoprotein cholesterol (LDL-C), primary prevention of CVD, Hong Kong public electronic medical records, January 2008 to December 2014
- Comparison
- Statin initiation vs no initiation at baseline LDL-C 1.8-2.5 or ≥2.6 mmol/L
- Outcome
- CVD incidence (stroke, MI, HF)
Methodological detailssequence of emulated trials, territory-wide electronic medical records, pooled logistic regression
- Sequence of emulated trials
- Territory-wide electronic medical records
- Pooled logistic regression
Main finding
As reported in the abstract
CVD incidence, by baseline LDL-C
Statin initiation vs No statin initiationHazard ratio (95% CI)
Baseline LDL-C 1.8-2.5 mmol/L; intention-to-treat
0.78(0.72–0.84)
Baseline LDL-C ≥2.6 mmol/L; intention-to-treat
0.90(0.88–0.92)
Baseline LDL-C 1.8-2.5 mmol/L; per-protocol
0.59(0.51–0.68)
Baseline LDL-C ≥2.6 mmol/L; per-protocol
0.77(0.74–0.81)
Further findings
CVD incidence, per-protocol analysis, by baseline LDL-C
- HR (95% CI) for statin initiation, baseline LDL-C 1.8-2.5 mmol/L
- 0.59 (0.51, 0.68)
- HR (95% CI) for statin initiation, baseline LDL-C ≥2.6 mmol/L
- 0.77 (0.74, 0.81)
- Per-protocol analysis
Absolute 10-year risk difference of overall CVD, per-protocol analysis, by baseline LDL-C
- Risk difference (95% CI), baseline LDL-C 1.8-2.5 mmol/L
- −7.1% (−10.7%, −3.6%)
- Risk difference (95% CI), baseline LDL-C ≥2.6 mmol/L
- −3.9% (−5.1%, −2.7%)
- Per-protocol analysis
Patients aged >75 years
- Effectiveness and safety consistently observed in patients aged >75 years initiating statin at both LDL-C thresholds
Safety
Major adverse events (myopathies and liver dysfunction)
- No significant increased risks for the major adverse events
Original publication
Evaluating different low‐density lipoprotein cholesterol thresholds to initiate statin for prevention of cardiovascular diseases in patients with type 2 diabetes mellitus: A target trial emulation study. Diabetes Obes Metab. Published 21 February 2024. doi:10.
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