New fat-lowering drugs! Sanofi/Regenerative Progenior Praluent Cardiovascular Prognosmation Milestone Study Significantly Reduces All-Cause Death Wind:

French pharmaceutical giant Sanofi and partner Regeneron recently presented new analysis data for ODYSSEY OUTCOMES at the American Heart Association (AHA) scientific conference in Chicago, USA, for the PCSK9 inhibitor-type lipid-lowering drug Praluent(alirocumab) Cardiovascular Outcomes Milestone Study.
The study included 18,924 patients, and the analysis showed that Praluent was associated with fewer all-cause deaths in patients who had previously experienced heart attack or unstable angina (known as acute coronary artery syndrome, ACS), and that the benefits of the treatment were higher in patients who followed for at least three years and in patients with baseline LDL-C≥100mg/dL. In addition, the new analysis showed that Praluent was associated with reduced non-lethal cardiovascular (CV) events and reduced non-CV deaths during the study period.
specific data are: a pre-designated analysis of 8,242 patients followed for at least 3 years showed that Praluent reduced the risk of all-cause death by 22% (HR=0.78,95% CI:0.65-0.94, nominal p=0.01). A separate post-mortem analysis showed that Praluent reduced the risk of all-cause death by 29% in patients with baseline LDL-C≥100mg/dL (HR=0.71, 95% CI: 0.56-0.90).
In another post-mortem analysis, the researchers found that patients treated with Praluent experienced fewer non-lethal CV events and were less likely to die from non-CV events, and that the two findings may be related (correlation between non-fatal and fatal events: 2.35, 95% CI: 1.98-2.73, p<0001).
the analysis, no new safety signals were found, and the rates of adverse reactions were similar in two groups in the study, with the exception of local injection site reactions (3.8 percent in the Praluent treatment group and 2.1 percent in the placebo group).
, Praluent's positive data on CV morbidity and mortality are currently under review by regulators. Data from the ODYSSEY OUTCOMES study have been submitted to the FDA and the European Union EMA, which will make a review decision on April 28, 2019.
Praluent is a monoantial drug that targets a protein called pre-protein-converting enzyme oxalolytic 9 (PCSK9), which reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C) from the blood, and LDL-C is recognized as a major risk factor for cardiovascular disease (CVD). PCSK9 inhibitors offer a new treatment model against LDL-C and are seen as the biggest advance in fat reduction since statins such as Lipitor and Zocor. (Bio Valley)