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The PCSK9 inhibitor phenomenon

The work of Professor Jennifer Robinson (University of Iowa, USA) and her colleagues as part of the ODYSSEY trial has been pivotal in demonstrating the effectiveness of the PCSK9 inhibitor, alirocumab. Her lecture was timely given the recent National Institute of Health and Care Excellence (NICE) recommendations (TA393) regarding the use of alirocumab in primary hypercholesterolaemia and mixed dyslipidaemia.1

The efficacy of this new drug is without question. The ODYSSEY trial2 showed that when used in conjunction with statin therapy, alirocumab demonstrated a 62% drop in calculated serum low-density lipoprotein (LDL) within the first few weeks when compared to placebo (see table 1).

At 78 weeks, the reduction in calculated serum LDL was still 52% lower than placebo plus statin. Alongside this, the team also demonstrated a significant reduction in cardiovascular risk, with the total number of adverse events related to cardiovascular causes just over half those seen in the placebo group (1.7% vs. 3.3%).

Table 1. NICE guidance for alirocumab* for primary hypercholesterolaemia or mixed dyslipidaemia

Table 1. NICE guidance for alirocumab* for primary hypercholesterolaemia or mixed dyslipidaemia

Although the benefits of alirocumab with concomitant statin use are there for all to see, the side effects profile remains a point of contention. The degree of myalgia was double that of the placebo plus statin group, and there have been question marks raised regarding the neurological safety of the drug – several episodes of amnesia and ophthalmological events were seen in the alirocumab treatment arm during the ODYSSEY trial. Although these were not deemed significant in the study, long-term safety remains an ongoing concern. Results from further trials are due to follow in 2017/18, with closer attention to the adverse effects and safety profile of what could be a very exciting drug for dyslipidaemia.

References

1. National Institute for Health and Care Excellence. Technology Appraisal Guidance (TA393): alirocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia. NICE: June 2016. https://www.nice.org.uk/search?q=TA393

2. Robinson J, Farnier M, Krempf M et al. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med 2015;372:1489–99. http://dx.doi.org/10.1056/NEJMoa1501031

Published on: February 21, 2017

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