Background The introduction of PCSK9 inhibitors in the treatment of hypercholesterolaemia marks a breakthrough for patients unresponsive to traditional treatment. However, in our country, 44.9% of adults have high LDL-C levels (≥ 130 mg/dL or under treatment), so inadequate use of these innovative drugs might have a strong impact on efficiency and safety. The national atherosclerosis association published a document regarding the restricted indications for use of the PCSK9 inhibitors, and we adapted it to our centre.
Purpose We evaluated compliance with the protocol for prescription of PCSK9 inhibitors in our centre.
Material and methods In March 2016, the pharmacy and therapeutics committee created their own protocol together with internal medicine, cardiology and endocrinology services. It turned out to be more restrictive than the national guidelines, with higher LDL-C levels required. Based on the available evidence and taking into account criteria of efficacy and safety, four indications were included: (1) HoFH: homozygous familial hypercholesterolaemia with LDL-C >120 mg/dL with the maximum tolerated dose of statin and ezetimibe; (2) HeFH: heterozygous familial hypercholesterolaemia with LDL-C >120 mg/dL with the maximum tolerated dose of statin and ezetimibe; (3) previous cardiovascular event (pCVE) with LDL-C >100 mg/dL with the maximum tolerated dose of statin and ezetimibe; and (4) any of the above with LDL-C >120 mg/dL in patients who are statin intolerant, or for whom a statin is contraindicated. We evaluated the compliance with our protocol for prescribing PCSK9 inhibitors from March to September 2016, based on computerised medical records.
Results We received 26 prescriptions, 20 from the internal medicine service, 3 from the endocrinology service and 3 from the cardiology service. All complied with the protocol, except for 1 that was approved by the committee for the treatment of hyperlipoproteinaemia. The following patients were treated: 18 HeFH, 6 pCVE and 1 pCVE who was statin intolerant.
Conclusion In our centre, there was high compliance with the protocol for the prescription of PCSK9 inhibitors. Due to the major economic impact of these new drugs, continuous follow-up would be required to ensure that every prescription meets the requirements of the protocol in the treatment of hypercholesterolaemia with PCSK9 inhibitors.
No conflict of interest
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