Background and importance The proprotein convertase subtilisin kexin type 9 inhibitors (PCSK9i), evolocumab and alirocumab, approved by the European Medicines Agency in 2015, are a new approach in obtaining a large reduction in serum low density lipoprotein cholesterol (LDL-C), which is traditionally linked to cardiovascular events.
Aim and objectives This study was conducted to shed light on the variation in lipid profile of patients treated with PCSK9i, in a setting that differed from clinical trials.
Material and methods An observational retrospective study was conducted of all patients treated with a PCSK9i in our hospital (September 2016 to February 2019). The following data were obtained from the electronic clinical record: demographic variables, diagnosis, drug, posology, previous treatments, prescription for primary or secondary prevention and adverse events. Before (1 determination) and after (1–3 determinations) PCSK9i, total cholesterol (TC), LDL-C, high density lipoprotein cholesterol (HDL-C) and triglyceride (TG) concentrations were obtained and statistically analysed using R statistical software.
Results Fifty-three patients were included, 33 men, with a median age of 64 years (range 35–83). Diagnoses were heterozygous familial hypercholesterolaemia (64%), homozygous familial hypercholesterolaemia (2%) and dyslipidaemia (34%): 70% received evolocumab (140 mg/14 days, except for 1 patient who received 420 mg/month) and 30% received alirocumab (75 mg/14 days except for 2 patients who received 150 mg/14 days). Regarding previous treatments, 83% had been treated with ezetimibe and 73% with a statin. Eight patients suffered adverse effects of whom four discontinued treatment. Analytical data were obtained from 51 patients (table 1).
Conclusion and relevance A large decrease in TC and LDL-C, which is agreement with commercialisation trials, was observed. A slight increase in HDL-C levels can be assumed, although clinical trials referred to a higher increase. Moreover, no statistically significant reduction in TG was observed in this study in contrast with the clinical trials. These findings reveal the importance of real world data studies, in a context where all the variables are not controlled, unlike in clinical trials, to disclose the real efficacy of new drugs.
References and/or acknowledgements No conflict of interest.