Amgen's new cholesterol drug Repatha has been shown to lower risks for stroke and heart attacks in a new clinical trial. The trial involved more than 27,000 patients with heart disease who already take statins but still have a high cholesterol level.
The results of the two-year trial showed that patients who were given Amgen's drug had a 15 percent reduced risk for combined measures of heart attack, stroke, chest pain that requires hospitalization, placement of stent, and death.
Results Disappointed Doctors, Patients, And Investors
The findings, however, disappointed doctors, patients, and even investors. The results were below what was hoped for the drug given its high list price of $14,523 per year.
Analysts and cardiologists were hoping as much as a 30 percent reduction in risks but the result was just 15 percent, albeit the drug performed well at reducing risk for stroke and heart attack.
In participants of the trial, Repatha reduced prevalence of heart attack by 27 percent, stroke by 21 percent, and stents and heart bypass procedures by 22 percent.
Unfortunately, it did not have remarkable results in terms of hospitalizations for chest pain since the rate remained the same for participants given placebo and Repatha.
More importantly, the drug did not appear to have impact on a very important measure, the length of the patient's survival. Of the 100 patients who received Repatha, 1.8 died of cardiovascular causes while the figure was 1.7 in those who belonged to the placebo group.
The cardiovascular causes for these deaths though were not strokes and heart attacks. These were sudden cardiac deaths that happen when a person suddenly died for unknown reasons.
Mark Hlatky, a Stanford University cardiologist said that people were looking forward to a far better result.
"People were hoping for a breakthrough, a lot bigger result than 20 percent," he told the Associated Press.
The results also disappointed investors, causing Amgen's stock to go down on the morning of Friday, March 17.
Is It Worth The Money?
Repatha clearly prevents heart attacks but it isn't the issue here. The concern essentially boils down to whether or not it is worth the money. Hlatky said that the biggest issue is whether the cost of the drug is worth it. Drugs that cost 50 times more than statins should ideally be 50 times better but the cardiologist, who is also a cost effectiveness researcher, said he does not think so.
Cleveland Clinic chief of cardiology Steven Nissen, who was not part of the study but has led other trials of Repatha, however, has a different view on the drug not preventing deaths in the study participants.
Nissen noted that expectations for more dramatic results were unrealistic. He said that he did not expect a death benefit after a period of just 26 months.
"The magnitude of benefit on heart attacks and strokes are about what thoughtful people would have expected," Nissen said.
Repatha
Repatha is a PCSK9 inhibitor. It works by suppressing the genes that slow down the production of cholesterol receptors found in the liver. This results in more receptors available to deal with the bad cholesterol, reducing its levels.
