Amgen's Statin Intolerance Study May Not Cure What Ails PCSK9 Inhibitors

Amgen Inc.'s well-designed GAUSS-3 study shows a role of its PCSK9 inhibitor Repatha in patients who truly can't tolerate statins, but how this translates into real-world utilization in the highly cost-conscious cardiology space remains to be seen.

Amgen Inc.'s well-designed GAUSS-3 study shows a role of its PCSK9 inhibitor Repatha in patients who truly can't tolerate statins, but how this translates into real-world utilization in the highly cost-conscious cardiology space remains to be seen.

GAUSS-3 tested the cholesterol-lowering ability of Repatha (evolocumab) in about 500 patients who could not tolerate a low dose of a statin. Participants were at high risk of an event (most had cardiovascular disease) and the mean LDL-C at the start of the study was an extremely high 219 mg/dL. The reduction in LDL associated with a monthly 420 mg injection Repatha (evolocumab) after 24 weeks was 52.8%, versus 16

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