NEW ORLEANS — A leading authority on PCSK9 inhibitors told the audience at the National Lipid Association Scientific Sessions that while the drugs can lower LDL by large amounts, use of PCSK9 inhibitors should be restricted to those with excessive LDL burden.
“Keeping CVD therapy affordable necessitates restricted use of PCSK9 antibodies to select patient groups: familial hypercholesterolemia, statin intolerance and very high CVD risk with residual LDL burden,” Erik S.G. Stroes, MD, from Academic Medical Center, Amsterdam, who has led clinical trials of PCSK9 inhibitors, said.
Erik S.G. Stroes
There is a need for lipid-lowering therapies beyond statins for patients who cannot achieve LDL targets on maximally tolerated statin therapy, for those intolerant to statins and for those with familial hypercholesterolemia, he said.
PCSK9 inhibitors such as alirocumab (Praluent, Sanofi/Regeneron) and evolocumab (Repatha, Amgen) are potentially good choices in these populations because the drugs’ effect on LDL reduction is potent and prolonged, there are few associated adverse and post hoc analyses have shown signals of reduced CV events, according to Stroes.
This makes them a better option for many patients over other nonstatin therapies that have more adverse effects and are less potent, but cost must be considered, Stroes said. In the United States, the wholesale price of 1 year of alirocumab or evolocumab treatment for one patient is more than $14,000.
Before starting PCSK9 inhibitors, clinicians should ensure that patients are in fact receiving maximally tolerated statin therapy, Stroes said. He noted that, in many cases, patients who appear to be intolerant of statins do tolerate them on rechallenge.
He also said it is up to clinicians to emphasize to their patients that the muscle pain that is the most common adverse event from statins is not going to cause serious harm, while failure to take lipid-lowering therapy may well cause serious harm.
“Survival is reduced in patients who discontinue statins, even compared to those on non-daily statin doses,” he said.
However, he said, clinicians should be aware that statin intolerance is a major issue for some patients.
“GAUSS-3 demonstrates that muscle-related intolerance is reproducible during blinded statin challenge in more than 40% of patients with a history of symptoms,” Stroes said. “Development of alternative approaches to LDL reduction for these patients is an important medical priority.”
He concluded, “LDL lowering is currently the best target in CV therapy, and statin/ezetimibe (Zetia, Merck) is always the No. 1 option, but PSCK9 antibodies offer potent and safe LDL lowering in patient groups currently facing residual LDL burden.” – by Erik Swain
Stroes ESG. PCSK9 Antibodies: Lipids and Beyond? Presented at: National Lipid Association Scientific Sessions; May 19-22, 2016; New Orleans.
Disclosure: Stroes reports receiving lecturing fees from Amgen, Cerenis, Chiesi, Merck, Novartis and Sanofi.