Amgen announced that the addition of Repatha (evolocumab) to optimized statin therapy led to statistically significant atherosclerosis regression in patients with coronary artery disease (CAD). Study findings are published in the Journal of the American Medical Association.
The Phase 3 GLAGOV (GLobal Assessment of Plaque ReGression with a PCSK9 AntibOdy as Measured by IntraVascular Ultrasound) trial investigated whether Repatha would alter atherosclerotic plaque build-up in the coronary arteries of patients already treated with optimized statin therapy at baseline and Week 78. At baseline, 98% of patients in both study arms were receiving high to moderate intensity statin therapy.
The study achieved its primary objective demonstrating that Repatha use resulted in a statistically significant regression from baseline in percent atheroma volume (PAV). The Repatha cohort showed a 0.95% decrease vs. baseline in PAV (P<0.0001) compared with a 0.05% increase vs. baseline in patients receiving optimized statin therapy + placebo (P=0.78). The authors noted a statistically significant difference between the 2 comparators (P<0.0001).
Also, the addition of Repatha led to plaque regression in PAV for a greater percentage of patients than those receiving placebo (64.3% vs. 47.3%, respectively, P<0.0001).
In regards to normalized total atheroma volume (TAV), patients in the Repatha arm had a mean decrease of 5.8mm^3 vs. 0.9mm^3 in the placebo arm; this difference was statistically significant (P<0.0001). Moreover, adding Repatha led to plaque regression in TAV for a higher percentage of patients than placebo (61.5% vs. 48.9%; P=0.0002).
During 78 weeks of treatment, patients in the Repatha arm had a time-weighted mean LDL-C level of 36.6mg/dL-—a 59.8% reduction—compared to 93.0mg/dL in the placebo group. At Week 78, the mean LDL-C in the Repatha arm was 29mg/dL, showing a 68% decrease from baseline vs. 90mg/dL in the placebo arm.
No new safety issues were found in the GLAGOV trial, the authors noted. Treatment-emergent adverse events occurred at a comparable rate between both groups.
For more information call (800) 772-6436 or visit Repatha.com.