Abstract
Background:
Whether statins benefit patients with type 2 diabetes mellitus (T2DM) with low predicted 10-year cardiovascular risk is uncertain.
Objective:
To evaluate the effectiveness and safety of statin initiation for primary prevention among adults with T2DM stratified by predicted 10-year risk for cardiovascular disease (CVD).
Design:
Cohort study using target trial emulation.
Setting:
U.K. primary care using the IQVIA Medical Research Data database.
Participants:
Persons aged 25 to 84 years with a diagnosis of T2DM between 2005 and 2016 and no history of coronary artery disease, myocardial infarction, stroke, heart failure, myopathy, liver disease, rheumatic heart disease, schizophrenia, or cancer.
Intervention:
Statin initiation versus noninitiation, with estimation of the observational analogues of the intention-to-treat effect. Statin initiators were propensity score–matched to noninitiators in a 1:4 ratio within 4 QRISK3 strata of 10-year predicted cardiovascular risk: low (<10%), intermediate (10% to 19%), high (20% to 29%), and very high (≥30%).
Measurements:
Absolute risk differences (RDs) and risk ratios (RRs) at 10 years of follow-up for all-cause mortality and major CVD, as well as myopathy and liver dysfunction.
Results:
Statin initiation was associated with reductions in all-cause mortality and major CVD across QRISK3 strata. In the low-risk stratum, RDs and RRs were −0.53% (95% CI, −0.90% to −0.08%) and 0.80 (95% CI, 0.67 to 0.97), respectively, for all-cause mortality and −0.83% (95% CI, −1.28% to −0.34%) and 0.78 (95% CI, 0.66 to 0.91), respectively, for major CVD. A small increased risk for myopathy was observed in the moderate-risk stratum only, and there was no associated increased risk for liver dysfunction in any stratum.
Limitations:
Unmeasured confounding and underascertainment of some hospitalization outcomes.
Conclusion:
Statin use in T2DM for primary prevention was associated with reductions in all-cause mortality and major CVD across the full spectrum of predicted cardiovascular risk.
Primary Funding Source:
National Natural Science Foundation of China.
Whether statins benefit patients with type 2 diabetes mellitus (T2DM) with low predicted 10-year cardiovascular risk is uncertain.
Objective:
To evaluate the effectiveness and safety of statin initiation for primary prevention among adults with T2DM stratified by predicted 10-year risk for cardiovascular disease (CVD).
Design:
Cohort study using target trial emulation.
Setting:
U.K. primary care using the IQVIA Medical Research Data database.
Participants:
Persons aged 25 to 84 years with a diagnosis of T2DM between 2005 and 2016 and no history of coronary artery disease, myocardial infarction, stroke, heart failure, myopathy, liver disease, rheumatic heart disease, schizophrenia, or cancer.
Intervention:
Statin initiation versus noninitiation, with estimation of the observational analogues of the intention-to-treat effect. Statin initiators were propensity score–matched to noninitiators in a 1:4 ratio within 4 QRISK3 strata of 10-year predicted cardiovascular risk: low (<10%), intermediate (10% to 19%), high (20% to 29%), and very high (≥30%).
Measurements:
Absolute risk differences (RDs) and risk ratios (RRs) at 10 years of follow-up for all-cause mortality and major CVD, as well as myopathy and liver dysfunction.
Results:
Statin initiation was associated with reductions in all-cause mortality and major CVD across QRISK3 strata. In the low-risk stratum, RDs and RRs were −0.53% (95% CI, −0.90% to −0.08%) and 0.80 (95% CI, 0.67 to 0.97), respectively, for all-cause mortality and −0.83% (95% CI, −1.28% to −0.34%) and 0.78 (95% CI, 0.66 to 0.91), respectively, for major CVD. A small increased risk for myopathy was observed in the moderate-risk stratum only, and there was no associated increased risk for liver dysfunction in any stratum.
Limitations:
Unmeasured confounding and underascertainment of some hospitalization outcomes.
Conclusion:
Statin use in T2DM for primary prevention was associated with reductions in all-cause mortality and major CVD across the full spectrum of predicted cardiovascular risk.
Primary Funding Source:
National Natural Science Foundation of China.
| Original language | English |
|---|---|
| Journal | Annals of Internal Medicine |
| DOIs | |
| Publication status | E-pub ahead of print - 30 Dec 2025 |
Bibliographical note
Copyright © 2025, ACP. This article is protected by copyright. This is an accepted manuscript of an article published in Annals of Internal Medicine. The published version is available at: https://doi.org/10.7326/ANNALS-25-00662Funding
Primary Funding Source: National Natural Science Foundation of China.
Keywords
- Cardiovascular disease risk
- Cardiovascular diseases
- Intent to treat analysis
- Low density lipoprotein cholesterol
- Medical risk factors
- Mortality
- Risk assessments
- Risk management
- Statins
- Type 2 diabetes