Use of Low‐Density Lipoprotein–Lowering Therapies Before and After PCSK9 Inhibitor Initiation

Abstract

Background Proprotein convertase subtilisin/kexin type 9 inhibitors ( PCSK 9i) are used to reduce low‐density lipoprotein ( LDL ) cholesterol. PCSK 9i use after initiation, as well as persistence with or alterations to other LDL ‐lowering therapy after PCSK 9i initiation, is not well understood. Methods and Results We conducted a retrospective study of alirocumab or evolocumab ( PCSK 9i) new users from July 2015 to December 2017 in the MarketScan Early View database of US commercial insurance beneficiaries. We determined the prevalence of PCSK 9i interruption (≥30‐day gap in supply) and LDL ‐lowering therapy use in the year after PCSK 9i initiation. The average age of 6151 patients initiating PCSK 9i therapy was 63 years, 44.4% were women, and 76.8% had atherosclerotic cardiovascular disease. Overall, 52.2% (95% CI , 50.8%–53.7%) of patients had an interruption in PCSK 9i therapy in the first year after treatment initiation and 62.5% remained on PCSK 9i therapy at 1‐year postinitiation. Also, 27.7% of patients were taking a statin at the time of PCSK 9i initiation, with only 22.4% on statin therapy at 1 year after PCSK 9i initiation. Ezetimibe use decreased from 20.9% at the time of PCSK 9i initiation to 12.0% a year later. By 1 year after PCSK 9i initiation, 44.0% of patients had experienced an interruption in all LDL ‐lowering therapies, and 26.6% were no longer on any LDL ‐lowering therapies. Conclusions After PCSK 9i initiation, statins were often discontinued, whereas more than half of patients experienced an interruption in PCSK 9i therapy. These results suggest that many new PCSK 9i users may remain at high risk for cardiovascular events because of interruptions in LDL ‐lowering therapy.

Low‐density lipoprotein cholesterol lowering in real‐world patients treated with evolocumab

“…Of note, the 60.6% of patients treated with statins prior to evolocumab initiation in the current study is considerably higher than that reported in a recently published study where only 29.3% of patients filled a statin in the period 31-365 days prior to PCSK9 inhibitor initiation. 35 The relatively higher proportion of patients treated with statins in the current study may be accounted for by lower levels of statin intolerance versus earlier patient cohorts who initiated PCSK9 inhibitors following their Food and Drug Administration (FDA) approval in 2015 35 ; however, statin intolerance was not assessed in the current study and therefore firm conclusions should be avoided.…”

Patient perceptions and use of non‐statin lipid lowering therapy among patients with or at risk for atherosclerotic cardiovascular disease: Insights from the PALM registry

“…This discussion remains relevant in the PCSK9 inhibitor era. PCSK9 inhibitors remain much more cost prohibitive than statin therapy, and over half of patients started on a PCSK9 inhibitor discontinue statin therapy or have an interruption in their PCSK9 inhibitor treatment within a year of initiation 16 . Thus, statin persistence and dose optimization remain a top priority for patients with or at risk of ASCVD.…”

Belgian data of ODYSSEY APPRISE: stringent LDL‐c targets are in reach when using all available tools

“…The importance of adherence to oral lipid‐lowering therapies, especially statin therapy, in patients initiated on PCSK9 inhibitors is crucial for adequate lipid control. Since the mechanism of action of statins, ezetimibe and PCSK9 inhibitors is different, all these drugs have a cumulative effect on lowering LDL‐c and one cannot replace the other 17,18 . Therefore, we should keep in mind that after initiating PCSK9 inhibitors or ezetimibe, monitoring and stressing the importance of adherence to the other LLT’s remains important.…”