Statin Therapy: Diabetes Risk and Cardiovascular Benefit per Euro-SCORE risk

Purpose: To retrospectively assess the risk-benefit of statin therapy in a large, unselected population.

Method: We assessed the effect of statin therapy on the incidence of diabetes mellitus (DM) and coronary heart disease (CHD) among 351,917 subjects aged 40-70 years old without DM or CHD at baseline.

From 2010 to 2014, 6,359 (1.9%) new cases of CHD and 14,221 (4.0%) of DM were recorded. Observed outcomes were evaluated according to dose-intensity regimen, level of adherence to statin therapy and retrospectively determined baseline 10-years cardiovascular (CV) mortality risk (European SCORE).

Results: Statin therapy was used by 15.8% of the study population. 89.6% of statins users were prescribed low-intensity dose regimens. Statin therapy of low-intensity above 50% adherence increased DM incidence in patients at low or intermediate baseline CV risk, but not in patients at high CV risk. Patients with normal weight were at highest risk of statins-induced DM.

Statin therapy at all intensity and adherence levels reduced CHD incidence in patients at intermediate or high baseline CV risk, but not in low-risk patients where only high intensity statins reduced CV risk.

Expressed as numbers needed to treat (NNT) or harm (NNH): in patients at low CV risk practically no CV protective benefit was obtained and the NNH (incident DM) for low-intensity dose regimens and above 50% adherence was 40; in patients at intermediate CV risk the NNT was 125 with an NNH of 50; in high CV risk patients the NNT was 29 with an NNH of 200.

Conclusion: Primary prevention of CV disease using statins should take in consideration statin-induced DM risk. Prescribing low-dose statins is beneficial in patients at high and detrimental in patients at low global CV risk. In patients with intermediate CV risk our data support current recommendations of individualizing the statin treatment decisions.