Amgen's cholesterol drug shows positive effect in cardiovascular outcomes study
PCSK9 inhibitors and statins start lowering LDL cholesterol nearly right away, but the beneficial effects on harder outcomes like heart attack and stroke take longer to emerge in clinical studies.
The drug reduces cholesterol-specifically, low-density lipoprotein (LDL) cholesterol that can build up in artery walls-by blocking an enzyme known as PCSK9, which would otherwise inhibit liver receptors that clear LDL cholesterol from the body. It is too soon to know if the drug is saving lives.
Excitement about the drug has been building over the last three years, with scientists predicting it had the power to "switch off" heart disease. Bad cholesterol is the villain in heart world - it leads to blood vessels furring up, becoming easy to block which fatally starves the heart or brain of oxygen.
Overall, this equated to a 15 per cent reduction in the risk of serious cardiovascular events for patients taking the drug with statins.
The larger reductions in heart attacks and strokes drove the drug's performance on the MACE measure, and on the primary endpoint, which comprised the MACE numbers as well as hospitalization for unstable angina and coronary revascularization procedures, Levy said. Results for each of these showed a similar change from baseline for evolocumab and placebo.
"Our results suggest this new, extremely potent class of drug can cut cholesterol dramatically, which could provide great benefit for a lot of people at risk of heart disease and stroke", said Professor Peter Sever from Imperial College London, and the United Kingdom branch lead of the study, according to The New Daily. In an editorial in The New England Journal of Medicine, Dr. Robin Dullaart, a researcher at the University of Groningen in the Netherlands, called it a landmark study.
After an initial injection of 300 milligrams of inclisiran and another three months later, the drug is created to be taken just twice a year. Dr. Hlatky says the biggest issue is whether the cut heart attacks and strokes enough to be worth the higher price.
Benefits continued to accrue through the median 2.2 years of the study and the risk reduction grew over time, from 16% in the first year to 25% beyond the first year.
The benefit of Repatha was seen on those tested within six months.
Prof Sever said: "The end result was cholesterol levels came down and down and down and we've seen cholesterol levels lower than we have ever seen before in the practice of medicine".
How Effective Is Repatha In Lowering Cholesterol Levels? Repatha was approved for people with an inherited condition that causes high LDL levels or who have underlying heart disease but haven't been able to adequately lower their LDL with statins alone.
Amgen said it is taking steps to remove barriers to patient access, including a plan under which it would offer to refund Repatha costs for eligible patients who have a heart attack or stroke. They cost more than $80,000 for a course of treatment, but the drugs essentially cure a debilitating disease and they had no competition.
At an absolute risk reduction of 1.5 percent to 2 percent over 2.2 years, the number needed to treat to prevent an even is in the range of 65 to 75 patients.
The standard treatment for cholesterol, other than diet and exercise, is a generic statin, which costs $250 a year. He noted that access to Repatha and other similar drugs has mostly been hard, which he believes is a "critically important" issue, as there may be millions of people considering taking these drugs for their heart problems.
'These results, I think, will mean the guidelines are adjusted slightly, but unless the price comes down it won't mean we give it to anyone by any means'.
While doctors said they were relieved that Repatha is safe, doctors such as David Rind said they had hoped the study would show that the injectable medication reduces heart attacks and other serious complications by 30 percent or more, given its success in early studies.