Recent publications on Residual Risk

Although statins significantly reduce vascular event rates, lipid-related residual cardiovascular risk remains high in many patient groups. The SPIRE outcomes studies will offer the opportunity to test whether the level of low-density lipoprotein cholesterol (LDL-C) at study entry is a determinant of clinical benefit with the PCSK9 inhibitor bococizumab. There are two outcomes studies with bococizumab: SPIRE-1 (NCT01975376) and SPIRE-2 (NCT01975389). These event-driven studies will assess the efficacy and safety of bococizumab in reducing the residual risk of cardiovascular events in high-risk patients on statin, with and without clinical cardiovascular disease, and with LDL-C levels ?70 mg/dL or 1.8 mmol/L (SPIRE-1, n = 17,000) or ?100 mg/dL or 2.6 mmol/L (SPIRE-2, n = 11,000). SPIRE-2 has now completed recruitment. These trials, together with the outcomes studies with alirocumab and evolocumab, will test whether lowering LDL-C levels by PCSK9 inhibition beyond current targets will provide significant reduction in the residual risk of cardiovascular events in patients receiving best evidence-based treatment including statins.