Long-term PCSK9 inhibition plus background therapy improves LDL goal attainment in FH
Click Here to Manage Email Alerts
Long-term adherence to PCSK9 inhibition was high among a high-risk cohort with familial hypercholesterolemia, which improved LDL goal attainment when added on top of background statin therapy and ezetimibe, researchers reported.
This long-term prospective analysis of the Spanish Familial Hypercholesterolemia Cohort Study (SAFEHEART) was published in the European Journal of Preventive Cardiology.
Source: Adobe Stock
“Our findings show the difficulty in the attainment of LDL-C goals in patients with familial hypercholesterolemia as they usually have higher baseline LDL-C levels, and that the addition of PCSK9 inhibition to the combination of statins and ezetimibe could be the best option as in other high-risk populations,” Rodrigo Alonso, MD, of the Center for Advanced Metabolic Medicine and Nutrition, Santiago de Chile Fundación Hipercolesterolemia Familiar in Madrid, and colleagues wrote.
Alonso and colleagues evaluated the persistence, efficacy and impact on quality of life of PCSK9 inhibition in 696 patients with familial hypercholesterolemia (FH; 46% women).
The median LDL level in the cohort was 145 mg/dL before PCSK9 inhibitor initiation.
PCSK9 persistence and LDL goal attainment
Over a median follow-up of 3.7 years, 96.1% of participants remained adherent to PCSK9 inhibition while 3.5% discontinued treatment (0.7% temporarily; 3.2% permanently).
Median LDL level after 1 year of PSCK9 inhibitor treatment at 1 year was 63 mg/dL and 61 mg/dL at last follow-up, correlating to a median reduction of 57.6% at 1 year and 58% at last follow-up.
The 2016 European Society of Cardiology/European Atherosclerosis Society (EAS) guidelines for the management of dyslipidemias state that for very high-risk patients, a target LDL level less than 70 mg/dL and an overall LDL 50% reduction from baseline is recommended. In contrast, the 2019 ESC/EAS guideline recommends a target LDL less than 55 mg/dL and a 50% reduction from baseline, according to the study.
Researchers observed attainment of the 2016 guideline recommended LDL last follow-up visit in 77% of the cohort and attainment of the 2019 guideline target in 48% of patients (P < .001).
Individuals already on both statin therapy and ezetimibe attained lower LDL and higher percent reduction in LDL compared with those taking either alone (P < .001).
Change in quality of life
Change in quality of life was measured using the EuroQol-5D questionnaire to assess patient perceived health status at PCSK9 initiation, 1 year and the last follow-up. The five-component measure of health status used scales of mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Researchers reported that the mean EuroQol-5D index improved from baseline to 1 year (P < .001) and remained consistent to the last follow-up (P vs. 1 year = .16). Improvement was observed in measures including mobility, usual activities and pain/discomfort (P < .001), whereas self-care and anxiety/depression did not change during year 1 of PCSK9 inhibition.
No changes were observed between 1 year and last follow-up except for patient-reported anxiety/depression dimension, which increased (P < .001), according to the study.
“These results could be important in the prevention of CV events in FH patients since the sustained absolute LDL-C reduction of 84 mg/dL (2.2 mmol/L) obtained with PCSK9 inhibition in the follow-up could be translated into a significant reduction of events of at least 40%, according [to] the Cholesterol Treatment Trialists’ collaboration study,” the researchers wrote.
References:
- Catapano AL, et al. Eur Heart J. 2016;doi:10.1093/eurheartj/ehw272.
- Mach F, et al. Eur Heart J. 2020;doi:10.1093/eurheartj/ehz455.
Collapse
Read more about
Click Here to Manage Email Alerts