DI-016 Use of arilocumab and evolocumab: lipid lowering therapies

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Abstract

Background

Monoclonal antibodies (mAb) arilocumab and evolocumab are protein convertase subtilisin/kexin type 9 inhibitors (PCSK9) for the primary treatment of hypercholesterolaemia or mixed dyslipidaemia:

Purpose

To evaluate the effectiveness, safety and cost of alirocumab and evolocumab.

Material and methods

This was a retrospective observational study from April to September 2016. Data collected: sex, age, diagnosis, previous/concomitant treatment and duration of treatment. The study evaluated: (1) effectiveness: total cholesterol (total-c) and LDL-c (electronic clinical review: MambrinoXXI); (2) safety: established adverse events (AE) reported for patients in the pharmacy outpatient unit; (3) cost: cost/patient/year.

Results

12 patients were included (92% men), median age 58 years (range 25–78). Diagnosis: 41% dyslipidaemia, 25% hypercholesterolaemia, 17% hyperlipidaemia and 17% heart disease. 50% patients received arilocumab and 50% evolocumab. All patients had been treated with statins before mAb therapy. In 42% of cases statins had to be removed, mainly because of myositis (80%). The remainder of the patients were not statin-intolerant but LDL-c goals were not achieved. During mAb therapy, 17% of patients were treated with evolocumab as monotherapy; 50% with arilocumab or evolocumab plus two lipid lowering therapies (statin and fenofibrate or ezetimibe); 17% with mAb plus fenofibrate and ezetimibe; 8% with mAb and statin; and 8% with mAb and fenofibrate. At the end of the study, median duration of treatment was 15 weeks (range 11–19) and all patients continued mAb treatment. Effectiveness: before treatment with mAb, mean total-c and LDL-c values were 208.60 mg/dL and 140.7 mg/dL, respectively. At the end of the study, these values were 125.3 mg/dL and 68.9 mg/dL, with a mean reduction of 39% and 35%, respectively. No AE were reported. Estimated cost in our hospital (first year): €5000/patient.

Conclusion

New lipid lowering drugs seem to be a new therapeutic alternative for hypercholesterolaemia or mixed dyslipidaemia when statins and/or other lipid lowering therapies are not effective or contraindicated. However, effectiveness is only valuable with LDL-c data, regardless of cardiovascular morbidity and mortality effects. Hence it is necessary to conduct long term studies to check any other effects of these drugs beyond reduction of LDL-c values.

Conclusion

No conflict of interest

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