4CPS-035 Effectiveness and safety of monoclonal antibody pcsk9 inhibitors

Abstract

BackgroundMonoclonal antibody PCSK9-Inhibitors (PCSK9i), alirocumab and evolocumab, are a new class of drugs used to decrease LDL cholesterol (LDLc) and can be an option for patients with heterozygous familial hypercholesterolaemia (HeFH) and cardiovascular diseases (CVD) with high levels of LDLc despite statins’ treatment or statins’ intolerance.PurposeStudy the effectiveness and safety of PCSK9i in patients with LDLc >100 mg/dL and HeFH or CVD treated with high doses of atorvastatin or rosuvastatin or patients with statins’ intolerance.Material and methodsRetrospective and descriptive study of all prescriptions of PCSK9i in a general hospital from May 2016 until August 2017. Demographic data, indication, basal LDLc, date of treatment start, adherence, LDLc after 3 to 6 months and after 6 to 9 months of treatment and adverse effects (AE) were registered in an Excel file. Effectiveness variable was LDLc <100 mg/dL or ≥50% LDLc reduction after 3 to 6 and 6 to 9 months of treatment.ResultsForty-two prescriptions: 12 HeFH, 17 CVD (six rejected because they did not adhere to statins’ treatment) and 13 statins’ intolerants (six rejected because criteria of intolerance was not clear). Thirty patients were treated with PCSK9i (combined with statins/ezetimibe except intolerant). All patients were adherents. Treatment was intensified in four patients, because LDLc >100 mg/dL.With alirocumab, one patient had skin rash, one patient local reaction in injection site and one patient respiratory symptoms. With evolocumab, four patients had back pain and one patient gastrointestinal disorders.Abstract 4CPS-035 Table 1 HeFH (n=9) CVD (n=14) Statins’ intolerants (n=7) Drug (number of patients)Alirocumab (n=1)Evolocumab (n=8)Alirocumab (n=8)Evolocumab (n=6)Alirocumab (n=3)Evolocumab (n=4)Treatment duration (days)330 (90.146)210 (22.422)274 (22.420)Basal LDLc (mg/dL)139 (111.219)142 (105.206)202 (106.242)LDLc after 3.6 months (mg/dL)n=974 (20.109)n=1175 (11.128)n=5112 (22.126)% LDLc reduction after 3.6 months of treatment50% (39.85%)47% (4.92%)45% (35.79%)Effectiveness after 3.6 months of treatment100%55% (6/11)40% (2/5)LDLc after 6.9 months (mg/dL)n=548 (24.113)n=530 (10.275)n=487 (9.110)Effectiveness after 6.9 months of treatment100%80% (4/5)75% (3/4)ConclusionPCSK9i are effective at 3 to 6 months, especially in HeHF. In CVD and statins’ intolerants, it is necessary to achieve a good effectiveness after more than 6 months. No patient has suspected treatment for AE.No conflict of interest