Amgen on Tuesday unveiled data indicating that the PCSK9 inhibitor Repatha (evolocumab) met its primary endpoint in the GLAGOV Phase III study. Results from the trial, which were presented at the American Heart Association Scientific Sessions and simultaneously published in JAMA, illustrated that the addition of the drug to optimised statin therapy showed a statistically significant regression of atherosclerosis in patients with coronary artery disease. Amgen vice president of R&D Sean Harper remarked "this study shows that maximal LDL-C reduction with Repatha can actually regress coronary atherosclerotic disease compared to statins alone."
In the study, 968 patients with coronary artery disease undergoing clinically indicated coronary angiogram and receiving optimised statin therapy, consisting of Pfizer's Lipitor (atorvastatin) or an equivalent), were randomised to monthly treatment with Repatha or placebo. The primary endpoint of the study was the change in percent atheroma volume (PAV) from baseline to week 78 as measured by intravascular ultrasound.
According to Amgen, the study findings showed that the PAV declined by 0.95 percent versus baseline over the treatment period for patients in the Repatha arm, compared to an increase of 0.05 percent in the placebo group. The addition of Repatha to optimised statin therapy also resulted in plaque regression as assessed by PAV for 64.3 percent of patients, versus 47.3 percent of people in the placebo group.
Additionally, the drugmaker noted that the mean decrease in the normalised total atheroma volume (TAV) was 5.8mm³ in the Repatha group, compared to 0.9mm³ in the placebo arm. Meanwhile, plaque regression as determined by normalised TAV was achieved in 61.5 percent of Repatha-treated patients, versus 48.9 percent of subjects in the placebo group.
In an exploratory analysis of 144 patients with baseline LDL-C levels of less than 70 mg/dL, findings revealed that the change in PAV declined by 1.97 percent in the Repatha arm, versus 0.35 percent in the placebo group. Moreover, 81.2 percent of patients in the Repatha group experienced plaque regression, compared to 48 percent of placebo-treated subjects.
Study author Steven Nissen of the Cleveland Clinic remarked "this is the first time anyone has shown these drugs do anything other than lower cholesterol." Nissen also noted "there doesn't appear to be any level at which there is harm" from too little LDL-C, as plaque shrinkage increased with greater reductions in LDL-C levels.
Repatha became the first PCSK9 inhibitor available anywhere globally following its approval for the treatment of high cholesterol by European regulators in July 2015. The therapy was later cleared by authorities in the US and Japan.
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