Background and importance In recent years innovative therapies have been developed for the treatment of hypercholesterolaemia that allow an effective decrease in low density lipoprotein (LDL)-cholesterol (LDL-c). These are alirocumab and evolocumab, anti-proprotein convertase subtilisin-kexin type 9 (PCSK9) monoclonal antibodies. The Pharmacy and Therapeutics Commission of our hospital has accepted the following indications: familial hypercholesterolaemia (HF) with LDL-c >100 mg/dL with maximum tolerated dose of statins, cardiovascular disease (CVD) established with LDL-c >100 mg/dL with maximum tolerated dose of statins and statin intolerant with LDL-c >100 mg/dL.
Aim and objectives To study the correct use of PCSK9 inhibitors in real clinical practice in a third level hospital. To evaluate efficacy and adherence to treatment.
Material and methods This was an observational, analytical and retrospective study of patients treated with anti-PCSK9 who attended the pharmacy service for a consultation. On 30 September 2019, a cross section was performed and the data collected were: sex, prescribed anti-PCKS9, dosage, theoretical and real dispensed units, indication and analytical data at 0 and 12 weeks (total cholesterol, LDL-c, high density lipoprotein cholesterol and triglycerides).
Results A total of 82 patients (53 men, 29 women) were studied: 57(69.5%) patients received evolocumab and 25 (30.5%) alirocumab. The distribution by diagnoses were: 17.1% HF, 46.3% CVD, 13.3% statin intolerance and 15.8% other.
After 12 weeks, the mean reduction in LDL-c was 54.3%, reaching the LDL-c target <100 mg/dL in 89.0% of cases. However, 4.9% of patients experienced an increase in LDL-c levels. Adherence to treatment was calculated by an indirect method from the record of dispensations (medication possession rate (MPR)=real/theoretical dispensed units×100). A patient with MPR >80% was considered adherent. Only 8.5% of patients were below the established limit, and were non-adherent.
Conclusion and relevance PCSK9 inhibitors are effective in decreasing LDL-c levels (<100 mg/dL). The reduction obtained in our study was similar to that obtained in pivotal studies. The prevalent diagnosis was uncontrolled CVD with maximum doses of statins. Only in 15.8% of cases was the PCSK9 inhibitor not indicated (initial LDL-c <100 mg/dL). Adherence to treatment was high bur it could have been overestimated because it was assumed that the patient administered the dispensed medication. More long term studies are needed to corroborate the data. In real clinical practice, it would be interesting to assess if this reduction in LDL-c is associated with a decrease in cardiovascular events.
References and/or acknowledgements No conflict of interest.
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