This article is more than 5 years old. Information may no longer be current.
Evolocumab response rate high in FOURIER population
Click Here to Manage Email Alerts
Most patients assigned the PCSK9 inhibitor evolocumab in the FOURIER CV outcomes trial responded to it, researchers reported in JAMA Cardiology.
“We pursued this study because there is a concern among physicians that individuals vary in their response to LDL cholesterol reduction with PCSK9 inhibitors — some think that there may be responders and nonresponders — and insurance companies require that prescribers prove that their patients are responders to PCSK9 inhibitors for reauthorization,” Arman Qamar, MD, clinical fellow in the TIMI Study Group at Brigham and Women’s Hospital and Harvard Medical School, told Cardiology Today.
Qamar and colleagues analyzed 21,768 patients from the FOURIER study, of whom 10,902 were assigned evolocumab (Repatha, Amgen). The outcome of interest was variation in percent reduction in LDL with evolocumab.
The median percent reduction in LDL associated with evolocumab was 66% at 4 weeks (interquartile range [IQR], 54-76), according to the researchers.
At 1 year, 99.5% of those assigned evolocumab had any reduction in LDL, 97.9% had a reduction of at least 30% and 94.7% had a reduction of at least 50%, Qamar and colleagues wrote.
“Almost all patients derive the robust LDL cholesterol reduction with evolocumab, an approved PCSK9 inhibitor, meaning all the patients get the desired benefit in lowering LDL cholesterol,” Qamar said in an interview. “Our findings put to rest or settle the concern about variability in LDL cholesterol reduction with evolocumab.”
Among patients assigned placebo, the median LDL reduction was 4% at 4 weeks (IQR, 6% increase to 13% reduction), whereas at 1 year, 4.9% of patients had an LDL increase of at least 25% and 9.1% had an LDL decrease of at least 25%.
In a placebo-adjusted analysis, median reduction in LDL with evolocumab was 61% (IQR, 58-63) at 4 weeks, and at 1 year, evolocumab reduced LDL by at least 30% in 99.8% of patients and by at least 50% in 90.5% of patients.
The findings could reassure clinicians that the drug will work in appropriate patients, Qamar told Cardiology Today.
“Based on our findings, we expect that the physicians will feel more reassured to prescribe LDL cholesterol lowering with evolocumab, a proven and approved therapy that reduces cardiovascular death, myocardial infarction or stroke,” he said. “Insurance companies may stop asking prescribers to prove that their patients are responders to evolocumab prior to reauthorization.” – by Erik Swain
For more information:
Arman Qamar, MD, can be reached at mqamar@bwh.harvard.edu; Twitter: @aqamarmd.
Disclosures: FOURIER was funded by Amgen. Qamar reports no relevant financial disclosures. Please see the study for the other authors’ relevant financial disclosures.
Click Here to Manage Email Alerts