In a pre-specified analysis, the patients with baseline LDL cholesterol (LDL-C) levels at or above 100 mg/dL experienced a more pronounced effect from alirocumab, reducing their risk of MACE by 24% (HR=0.76, CI: 0.65-0.87), and in a post-hoc analysis of the same group, the drug was associated with a lower risk of death from any cause by 29% (HR=0.71, CI: 0.56-0.90).
Last year, researchers reported similar results for a different PCSK9 inhibitor called Repatha (evolocumab), made by Amgen Pharmaceuticals, which also cut the risk of heart attack, stroke, and hospitalization for blocked arteries by 15 percent. The new drugs clearly help people at high risk and are not aimed at people at low risk, such as those who have high cholesterol but have never had a heart attack, he said.
Praluent was shown to have cut down the overall risk of major adverse cardiovascular events (MACE) by 15%, which is the primary endpoint of the trial.
Efforts will be focused on patients who are most vulnerable for future cardiovascular events, such as those who have suffered a previous coronary event and are unable to reduce their cholesterol below a healthy level despite maximally-tolerated statin therapy.
Regeneron and Sanofi said on Saturday they would lower the net price of Praluent if onerous barriers to its access are removed for the highest-risk patients. "It has shown that these drugs can reduce the risk of death in such patients, when used alongside statins".
Now, Sanofi and Regeneron have laid down the gauntlet to their rival, saying they will "offer United States payers that agree to reduce burdensome access barriers for high-risk patients a further reduced net price for Praluent ... in alignment with a new value assessment for high-risk patients".
"I think that will impress the field and people who have to make (reimbursement) decisions", said Dr. Phillippe Steg, the study's co-chairman who presented the data at the American College of Cardiology meeting in Orlando, Florida.
Alirocumab inhibits the binding of proprotein convertase subtilisin/kexin type 9 (PCSK9) to the LDL receptor and thus heightens the number of available LDL receptors on the surface of liver cells. "Really, it's not just a shame, it's nearly a crime to deny this drug to these patients who are at such high risk and will derive such a big benefit".
"We need to reset our expectations" and realize that benefits for any new drug are going to be fairly small when added to already good treatments such as statins, said Dr Jeffrey Kuvin, conference leader and cardiology chief at Dartmouth-Hitchcock Medical Centre.
"We will begin working with payers to ensure that high-risk patients have appropriate access".
The drug, Praluent, also led to fewer deaths among high-risk patients, which could be the strongest argument for insurers to finally remove barriers that have severely constrained sales and frustrated physicians trying to get the medicine to patients. "This is the right thing to do for patients".