Twice yearly inclisiran safe and efficacious in heterozygous familial hypercholesterolaemia


  • Heather Mason
  • Univadis Medical News
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Twice yearly inclisiran, significantly decreased levels of low-density lipoprotein (LDL) cholesterol in patients with heterozygous familial hypercholesterolaemia, according to a study in the New England Journal of Medicine.

A global, randomised, placebo-controlled study, recruited 482 patients to receive inclisiran 300mg subcutaneously (N=242) or placebo (N=240). Inclisiran was administered on days one, 90, 270 and 450. Primary endpoints were percentage change from baseline in LDL cholesterol and time-adjusted changes. Secondary endpoints were changes in levels of proprotein convertase subtilisin-kexin type 9 (PCSK9), total cholesterol, apolipoprotein B and non-high-density lipoprotein (HDL) cholesterol.

At day 510, LDL level was reduced by 39.7 per cent in the inclisiran group vs an 8.2 per cent increase in the placebo group. In the inclisiran group, a reduction of 38.1 per cent in LDL cholesterol level was seen between day 90 and day 540, compared to an increase of 6.2 per cent in the placebo group.

At day 510, the PCSK9 level was decreased by 60.7 per cent with inclisiran and increased by 17.7 per cent in the placebo group. Inclisiran was associated with lower levels of total cholesterol, non-HDL cholesterol, apolipoprotein B, and triglycerides than placebo, along with higher HDL cholesterol levels.

No differences in adverse events were seen between the two groups.