What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: Free of cardiovascular disease with near-optimal to borderline high LDL-C (n=58504). Intervention: Statin therapy vs. Placebo, standard therapy, or no treatment. Primary outcome: Composite cardiovascular outcome (RR 0.71, 95% CI 0.62 to 0.82).

October 5, 2020Open Access

Role of Statins in the Primary Prevention of Atherosclerotic Cardiovascular Disease and Mortality in the Population with Mean Cholesterol in the Near-Optimal to Borderline High Range: A Systematic Review and Meta-Analysis

Key Result

Statin therapy reduced the risk of composite cardiovascular outcomes by 29% (RR 0.71) compared to control in populations without prior cardiovascular disease and near-optimal to borderline high LDL-C.

Study Design

Type

Meta-Analysis (n=58,504)

Structured PICO

Does statin therapy reduce cardiovascular events and mortality in a primary prevention population with mean LDL-C in the near-optimal to borderline high range?

Population

58,504 participants from 11 RCTs, >90% free of cardiovascular disease (primary prevention), with average LDL-C between 100 to 159 mg/dl (near-optimal to borderline high range).

Intervention

Statin therapy

Comparator

Placebo, standard therapy, or no treatment

Outcome

Myocardial infarction (MI), major cerebrovascular and coronary events, all-cause mortality, composite cardiovascular outcomes, CHD mortality, cardiovascular mortality, muscle-related adverse events, the incidence of any cancer, and incidence of diabetescomposite

Statin therapy safely reduces the risk of cardiovascular events and revascularization procedures in primary prevention patients with near-optimal to borderline high LDL-C, though it does not reduce overall or cardiovascular mortality.

Main Result

Effect estimate: RR 0.71 (95% CI 0.62 to 0.82)

Absolute Event Rate: 3.27% vs 4.55%

Limitations

Significant heterogeneity was present in the composite cardiovascular outcome (I2 = 55%) and withdrawal due to adverse events (I2 = 90%).
Inconsistency and lack of reporting of certain outcomes in some included trials.
Imprecise estimate of effect size for some outcomes leading to moderate or low GRADE scores.
Some included trials lacked blinding of participants and personnel, or had unclear randomization sequence and allocation concealment.

Abstract

Abstract Objective The objective of this meta-analysis was to analyze the benefits and harms of treating the population with statins in those having mean low-density lipoprotein cholesterol (LDL-C) in the near-optimal (100 to 129 mg/dl) to borderline high (130 to 159 mg/dl) range and free of cardiovascular disease (CVD). Methods: We searched PubMed, PubMed Central, Cochrane Library, and Google Scholar databases for randomized controlled trials (RCTs) published between 1994 and July 2020. We included RCTs with greater than 90% of participants free of CVD. Two reviewers independently screened the articles using the Covidence software, assessed the methodological quality using the risk of bias 2 tool, and analyzed the data using the RevMan 5.4 software. Results: Eleven trials were included. Statin therapy was associated with a decreased risk of myocardial infarction (RR=0.56, 95% CI: 0.47 to 0.67), major cerebrovascular events (RR=0.78, 95% CI: 0.63 to 0.96), major coronary events (RR=0.67, 95% CI: 0.57 to 0.80), composite cardiovascular outcome (RR=0.71, 95% CI: 0.62 to 0.82), revascularizations (RR=0.65, 95% CI: 0.57 to 0.74), angina (RR=0.76, 95% CI: 0.63 to 0.92) and hospitalization for cardiovascular causes (RR=0.74, 95% CI: 0.64 to 0.86). There was no benefit associated with statin therapy for cardiovascular mortality and coronary heart disease mortality. All-cause mortality benefit with statin therapy was seen in the population with diabetes and increased risk of CVD. Statin therapy was associated with no significant increased risk of myalgia, creatine kinase elevation, rhabdomyolysis, myopathy, incidence of any cancer, incidence of diabetes, withdrawal of the drug due to adverse events, serious adverse events, fatal cancer, and liver enzyme abnormalities. Conclusion: Statin therapy was associated with a reduced risk of cardiovascular disease and procedures without increased risk of harm in populations with mean LDL-C near-optimal to the borderline high range without prior atherosclerotic cardiovascular disease.

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