Bringing LDL Levels Way Down with New Cholesterol Drug Doesn't Seem to Boost Adverse Events — Physician’s First Watch
Bringing LDL Levels Way Down with New Cholesterol Drug Doesn't Seem to Boost Adverse Events
By Amy Orciari Herman
Achievement of very low LDL cholesterol levels using the PCSK9 inhibitor alirocumab is not associated with increased risk for adverse events, according to an industry-funded study in the Journal of the American College of Cardiology.
The analysis included data from 14 trials in which over 5000 adults were randomized to alirocumab or control, usually in addition to statin therapy. During a median 18 months' treatment, 25% of alirocumab recipients achieved LDL levels below 25 mg/dL, and 9% achieved levels under 15 mg/dL. Adverse events — including peripheral neuropathy, cognitive issues, and diabetes complications — were not significantly higher in these patients than in those with higher LDL levels.
One safety signal emerged: cataracts developed significantly more often in those with LDL below 25 mg/dL than in those with higher levels (2.6% vs. 0.8%). The authors note that "cholesterol needed by the lens is synthesized in situ."
Dr. Karol Watson, an associate editor with NEJM Journal Watch Cardiology, calls for further exploration of the cataracts finding. She adds, "The biggest concern is that any post hoc analysis is still vulnerable to confounding; thus we must await data from the large, ongoing outcomes trials to understand the true adverse event profiles."