Background and importance PCSK9 inhibitors (PCSK9i) are drugs that reduce low-density lipoprotein (LDL) levels. Due to their high cost and restrictive indications, a drug use evaluation (DUE) was performed.
Aim and objectives Evaluate a protocol for PCSK9i use and patients’ follow-up developed in our centre.
Material and methods Our PCSK9i protocol establishes criteria for new prescriptions and clinical monitoring according to European guidelines. After doctor prescription and hospital pharmacist (HP) validation, patients have an appointment with the HP to review whole treatment, dietary and exercise habits. LDL-levels are reviewed by the HP after 1 month of treatment, and annually.
Patients not reaching the desired outcome are cited with the HP, to check causes of treatment failure (lack of adherence, ineffective dosing, change of habits, etc.) and referred to the doctor to evaluate treatment optimisation if needed.
All patients with PCSK9i were included. We recorded sex, age, last appointment with the doctor, LDL-levels before treatment (LDL-1), LDL-levels after 1 month (LDL-2) and, in patients with more than 1 year of treatment, date and results of the last LDL analytic (LDL-3). A descriptive analysis was performed using measures of central tendency, dispersion and position for quantitative variables, and frequency distribution for qualitative variables.
Results 161 patients were included, 67.7% male. Medium age was 60±8,7 years. Follow-up ranged from 2 months to 5 years. Treatment regimens were: evolocumab 140 mg biweekly: 30 patients (18.6%); alirocumab 75 mg biweekly: 96 (59.6%) and 150 mg biweekly: 35 (21.7%).
Medium LDL levels improvement after 1 month was 71.7±41.2 mg/dL (Table 1).
17 patients (10.55%) did not have an analytic in the last year, and 10 patients (6.21%) had not had an appointment with their doctor in more than a year. 38 patients (23.6%) had LDL levels over the objective. According to guidelines and protocol, these patients were referred to the physician for revision.
Conclusion and relevance Although some patients do not reach the desired outcome and/or their monitoring may be improved, our data show that PCSK9i causes a great reduction of LDL levels that is maintained over time.
Conflict of interest No conflict of interest
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