Background Monoclonal antibody PCSK9-inhibitor, evolocumab, is a new drug for the treatment of patients with uncontrolled familial hypercholesterolaemia (FH), uncontrolled stable atherosclerotic cardiovascular disease (ASCVD), mixed dyslipidaemia, or in patients who cannot tolerate or cannot be given statins. Evolocumab is used in monotherapy or in combination with statins or another hypolipemiant.
Clinical trials (CT) showed that evolocumab obtained LDL-C reductions of 64% when combined with statins and of 58% in monotherapy, at week 12. No significant adverse events were detected.
In our hospital, pharmacists validate every prescription of evolocumab according to the regional autonomous authorisation criteria.
Purpose To compare the efficacy and safety of evolocumab in the clinical practice with the CT.
Material and methods Retrospective observational study (May 2017 to September 2018) of all evolocumab prescriptions. Demographic, clinical, analytical and treatment variables were collected at baseline and after the first follow-up visit. Efficacy was measured, by the percentage of LDL-C reduction at week 12, using laboratory analysis and medical records. Safety was obtained from medical and pharmaceutical records.
Results Thirty patients (63% male) with a mean age of 62.2 (52–78) were considered for treatment. One of them was not treated because he did not comply with the authorisation criteria (LDL >100 mg/dl). Diagnosis was ASCVD (15/29), statins intolerance (10/29) and FH (4/29). Evolocumab was prescribed in combination with statins in 13 patients, in five with another hypolipemiant and in 11 in monotherapy. The percentage change in LDL-C from baseline in the combination with statins group, was a reduction of 67% ((+7.2%) to (−79.1%)) at week 12 (7–20). In the monotherapy group, it was of 68% ((+24.5%) to (−92.2%)) at week 9 (7–12). Treatment adherence was >96% in all patients. Regarding safety, 20% of patients had an adverse event: itching (2/29), fatigue (1/29), myalgia (1/29), abdominal pain (1/29), diarrhoea (1/29) and glucose alterations (1/29).
Conclusion In clinical practice, the reduction in LDL-C in the monotherapy group was slightly higher than in CT. The adding of statins did not affect the efficacy in our patients, they were similar in both groups. Safety was comparable to CT. It would be interesting to evaluate if these reductions are maintained in the future.
References and/or acknowledgements No conflict of interest.