Endocrine Abstracts

Introduction and objectives: The treatment with monoclonal antibodies that inhibit proprotein convertase subtilisin-kexin type 9 (PCSK9) is a new group of drugs that allows us to reach the therapeutic targets of low density cholesterol (LDL-c) in patients intolerant to statins or those who despite treatment with maximum doses of them do not obtain a proper lipid control.

Material and methods: We performed a descriptive observational study. We include all patients with hypercholesterolemia who started treatment with iPCSK9 at the Virgen de la Victoria Hospital of Malaga. We analyzed the clinical characteristics, indication for iPCSK9 treatment and changes in LDL-c levels at the first visit and after 6 months of treatment. The diagnoses included are: Heterozygous Familial Hypercholesterolemia, 23 patients (66%); Mixed Dyslipidemia, 8 patients (23%); and Polygenic Hypercholesterolemia, 4 patients (11%).

Results: We analyzed data from 35 patients with mean age 60 years (±10 years), 57% males. They had associated comorbidities: 20% were active smokers, 63% had high blood pressure, 11% had diabetes mellitus, 49% were obese and 63% have had a cardiovascular event. Regarding the treatment prior to the addition of iPCSK9: 77% were on statins plus ezetimibe at maximum doses; 3% were only statins, 11% were on ezetimibe and 9% were without treatment because of intolerance. Before starting iPCSK9 treatment: Total cholesterol was 256 mg/dl (±90), LDL-C was 161 mg/dl (±47), was HDL-C 51 mg/dl (±14) and triglycerides 165 mg/dl (±105). 48% (n=17) of patients presented intolerance to maximum doses of statins (myalgias and gastrointestinal symptoms). They received iPCSK9 as follows: Evolocumab 140 mg 13 patients (34%) and Alirocumab 22 patients (63%); 14% Alirocumab 75 mg and 48.6% Alirocumab 150 mg. The mean LDL-C levels after the first six months of treatment was 74±40 mg/dl (55% reduction compared to the initial LDL-C, P=0.000). In the analysis by subgroups: Alirocumab reduced 46% and Evolocumab 65%, this reduction was statistically significant with respect to the initial parameters but without finding differences between the two drugs (P=0.092). Two patients presented mild adverse reactions and other three were hyper responders, None had to suspend the treatment for these reasons or presented new cardiovascular event.

Conclusions: The iPCSK9 are an effective and safe treatment in patients with high cardiovascular risk and high levels of c-LDL, at least in the first 6 months after administration without differences between both options.