PHILADELPHIA — In a real-world cohort of patients on maximally tolerated lipid-lowering therapies, PCSK9 inhibitors lowered LDL by 26% to 52%, according to a poster presented at the National Lipid Association Scientific Sessions.
The researchers analyzed 47 patients (median age, 65 years; 64% women; 13% black) with heterozygous familial hypercholesterolemia or CVD.
After PCSK9 inhibitors became commercially available in the United States, 11 patients were started on alirocumab (Praluent, Sanofi/Regeneron) 75 mg biweekly, 12 on alirocumab 150 mg biweekly and 24 on evolocumab (Repatha, Amgen) 140 mg biweekly, Kenneth D’Souza, MD, a resident at Jewish Hospital, Mercy Health, Cincinnati, and colleagues reported.
"The new PCSK9 inhibitors, while controversial, are revolutionary in our ability to lower LDL,” D’Souza told Cardiology Today. “Recently published data have shown that the new drugs are able to lower LDL by 60% and reduce the risk of [CV] events."
Patients were followed for a median of 49 weeks and were assessed for change in LDL and 10-year CVD risk score by the American Heart Association and NIH risk calculators.
At baseline, 32% of patients were taking statins and the rest could not tolerate any dose of statin.
At 49 weeks, LDL decreased 26% from baseline (110 mg/dL to 86 mg/dL) in the alirocumab 75 mg group, 51% (135 mg/dL to 84 mg/dL) in the alirocumab 150 mg group and 52% (168 mg/dL to 81 mg/dL) in the evolocumab group (P < .0001 for all), according to the researchers.
Median percent reductions in 10-year CVD risk were as follows:
- Alirocumab 75 mg: AHA calculator, –4%; NIH calculator, –72% (P = .001 for NIH score).
- Alirocumab 150 mg: AHA calculator, –26%; NIH calculator, –71% (P < .03).
- Evolocumab 140 mg: AHA calculator, –22; NIH calculator, –76% (P < .03).
The most common adverse events were flu-like myositis (13%), injection-site reaction (9%) and respiratory tract infections (6%), which did not differ among the three regimens, D’Souza and colleagues found.
“Adverse events were minimal and tolerable,” D’Souza and colleagues wrote on the poster. “[Alirocumab] and [evolocumab] represent paradigm shifts in LDL lowering. Long-term, post-commercial efficacy and safety remain to be further documented.”
Researcher Vybhav Jetty, MD, also a resident at Jewish Hospital, Mercy Health, told Cardiology Today that “alirocumab and evolocumab are able to lower LDL to target levels in patients that otherwise would not be able to reduce their [CV] risk.” – by Erik Swain
D’Souza K, et al. Abstract 148. Presented at: National Lipid Association Scientific Sessions; May 18-21, 2017; Philadelphia.
Disclosure: D’Souza and Jetty report no relevant financial disclosures.