Goal 2: Reduce Human Disease

Testing PCSK9 Inhibitors

Several inhibitors of PCSK9 are in phase 3 development and show considerable promise for improving the lipid profile; they will be especially appropriate for patients with Familial Hypercholesterolemia and those with statin intolerance. The sponsoring pharmaceutical companies need to complete CVD endpoint trials with full safety testing. However, there may well be more than one drug approved for marketing. The sponsors will have little reason to compare their drug to others. NHLBI should therefore anticipate sponsoring a comparative effectiveness trial, hopefully in collaboration with the manufacturers.

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Idea No. 837