High levels of bad cholesterol in the blood has been linked to potentially fatal health conditions but clinical trials of a new experimental cholesterol-lowering drug have shown it could significantly reduce LDL cholesterol, which largely contributes to the occurrence of heart attacks and strokes.
The drug alirocumab, an injectable PCSK9 inhibitor from Paris-based pharmaceutical giant Sanofi and New York-based biotechnology company Regeneron Pharmaceuticals, is targeted for patients with heterozygous familial hypercholesterolemia, or HeFH, a hereditary condition marked by high levels of bad cholesterol and early cardiovascular disease. It is also intended for statin-intolerant patients and those with high risks for heart attack who have difficulty controlling their LDL levels using current medications.
When administered once every two weeks, the experimental drug was shown to reduce the levels of bad cholesterol in four ongoing studies. There are also early signs that indicate the drug may also help prevent death and heart attack.
In the Odyssey Long Term Trial, the largest of the four trials which involved 2,341 patients and aims to assess the long-term safety and efficacy of the drug when given in 150 mg dose every two weeks, investigators have found that in patients with hypercholesterolemia who have increased risks for cardiovascular problems and those who received alirocumab saw a 62 percent reduction in their bad cholesterol levels after receiving the drug for six months compared with the patients who received placebo. Similar promising results were also observed in the three other trials, the ODYSSEY COMBO II, FH I and FH II trials.
"Across these four trials, alirocumab showed significant and sustained reductions in LDL-C over one year on top of standard-of-care statin therapy across different patient types," said Jennifer Robinson, from the College of Public Health at the University of Iowa, who presented the Odyssey Long Term results. "We are also encouraged by the consistent safety profile across the trials, including in ODYSSEY LONG TERM, the largest Phase 3 trial of a PCSK9 inhibitor, with the longest follow-up period reported to date."
An analysis has likewise showed that the patients who received the experimental drug had lesser risks for early death, stroke, heart attack and hospitalization when compared with those in the placebo group albeit a larger study is required to confirm this result.
The results of the four studies, which all have already achieved their primary efficacy endpoint, were presented at the European Society of Cardiology (ESC) Congress in Barcelona, Spain on Aug. 31.
