Many physicians would agree that proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors were a game-changer when the first one, alirocumab (Praluent/Sanofi, Regeneron), was approved by the US Food and Drug Administration (FDA) in July 2015.
Clinical trials continue to gather more data on different PCSK9 drugs and some highly anticipated ones were presented at the 66th Scientific Session of the American College of Cardiology (ACC 2017) in Washington, District of Columbia.
In an interview with MD Magazine, Richard A. Chazal, MD, who was the ACC president at the time of the conference, revealed which studies he believes could change medical practice in the near future.
“I believe there’s been a continuing evolution to look at the lipid lowering effects of the PCSK9 inhibitors,” Chazal said, “and particularly two presentations at the opening late-breaking trial sessions, the FOURIER trial and SPIRE trials are a particular interest.”
“The FOURIER trial showed important outcomes in patients that already on statins had modest control, not tight control, but modest control on modern type of statins and showed a substantial risk reduction,” Chazal continued, “and it appears as though that risk reduction was getting greater year by year, so it may have even greater effects long-term.”
The SPIRE (Studies of PCSK9 Inhibition and the Reduction of vascular Events) 1 and 2 trials evaluated bococizumab (Pfizer), which was pulled from the market in November 2016 for not showing significant benefit. In the SPIRE trials, outcomes showed that the drug was safe, but had mixed results on efficacy.
“Along with the SPIRE trials, which also looked at lipid-lowering by a different PCSK9 inhibitor, they both showed dramatic improvements,” Chazal said.
But how low should LDL cholesterol guidelines go? Chazal explained that the ACC guideline task forces are working on the lipid section of it. “I believe it will likely in the future at some point to be driving LDL levels much lower than we have in the past,” he said, “and we certainly need to look very carefully at how we approach this with regard to targets.”