Amgen's new drug was found capable of shrinking artery-clogging plaques when used with cholesterol-lowering statin, results of a new clinical trial have shown.
The combination of the drug Repatha (evolocumab) and statin also reduced LDL, also known as bad cholesterol, to extremely low levels in a majority of high-risk heart patients after a treatment period of 18 months.
Statin Plus Repatha Versus Statin Alone
In the trial reported in the Journal of the American Medical Association on Tuesday, Nov. 15, Cleveland Clinic head of cardiology Dr. Steven Nissen and colleagues compared the effect of monthly injections with Repatha with statin therapy and statins alone on plaques that can cause heart attack.
The nearly 1,000 participants of the study were patients with symptomatic heart disease and had blockages of between 20 and 50 percent in tested arteries. Nissen and colleagues collected the measurements of the plaque at the start of the trial and 18 months after using an ultrasound probe placed inside the diseased artery.
In patients who received only statin, bad cholesterol remained at around 93 but the average level dropped to 36.6 in patients who used both Repatha and statin. Artery plaque likewise stayed about the same in those who received only statin but shrank 1 percent in those who received both drugs. In some participants who experienced more dramatic reduction in LDL levels, plaque shrank by 2 percent.
"Among patients with angiographic coronary artery disease treated with statins, addition of subcutaneous evolocumab, compared with placebo, resulted in a greater decrease in percent atheroma volume after 76 weeks of treatment," researchers wrote in their study.
Bigger studies are to see if the drops in cholesterol level can lead to fewer heart attacks and even deaths. Based on the plaque regression data from the study presented on Tuesday, however, investigators think that these trials will be positive.
"These findings suggest that the large clinical outcome trials currently underway are likely to show major benefits," said one of study's lead directors Dr. Stephen Nicholls from Canisius Wilhelmina Hospital in the Netherlands.
Promising Drug With Expensive Price
Although the result of the trial is promising, use of Amgen's new drug has its drawback. Statins are pills and they are sold at a cheap price. Repatha on the other hand must be given as shots twice or once a month using a pen-like device. The new drug, which belongs to a new class of drugs known as PCSK9 inhibitors, is also far more expensive, costing $14,000 a year and insurers do not often pay.