Background The reduction of LDL cholesterol lowers the risk of coronary and cerebrovascular events in individuals without manifest cardiovascular diseases. In Germany, statins may only be prescribed at the expense of statutory health insurance for patients with atherosclerosis-related diseases or those at high cardiovascular risk (over 20 percent event probability within the next 10 years, calculated using one of the "available risk calculators"). However, international guidelines recommend lower risk thresholds for the use of statins. Methods The health and economic impacts of different risk thresholds for statin use in primary prevention within the German population are estimated for thresholds of 7.5, 10, and 15 percent over 10 years, based on the US Pooled Cohort Equation (PCE) which has been validated for Germany, using Markov models. Findings Cost-effectiveness increases with a rising risk threshold, while individual benefit decreases with age at the start of treatment. The use of statins at a risk of 7.5 percent or more is cost-effective at any age (cost per QALY between 410 and 2,100 euros). In none of the examined scenarios does the proportion of the population qualifying for statin therapy exceed 25 percent. Interpretation Lowering the threshold for statin therapy based on age to a risk of 7.5 percent, estimated with the US PCE, aligns statin prescription with international standards. There is no urgent rationale for applying age-stratified risk thresholds using the SCORE2 proposed for Europe, which tends to underestimate actual risks.

Dr Dressel has nothing to disclose. Mr Fath receives personal fees from SYNLAB Holding Deutschland GmbH and personal fees from mgo fachverlage GmbH Co. KG outside the submitted work. Prof. Kraemer has nothing to disclose. Prof Klose has nothing to disclose. Prof Maerz reports grants and personal fees from AMGEN, grants and personal fees from Sanofi, grants and personal fees from Amryt Pharmaceuticals, grants and personal fees from Abbott Diagnostics, grants and personal fees from Akzea Therapeutics, grants from Novartis Pharma GmbH, other from SYNLAB Holding

This study did not receive any funding

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