ODYSSEY OUTCOMES: LDL reduction with alirocumab sustained at 3 years
Patients who adhered to alirocumab and background statin therapy did not experience any significant diminution in the treatment’s lipid-lowering efficacy after 3 years, according to a research letter published in the Journal of the American College of Cardiology.
From a sample of patients from the ODYSSEY OUTCOMES trial who had all LDL measurements, adhered to alirocumab (Praluent, Sanofi/Regeneron) or placebo and did not change background statin therapy (18.8% of the original cohort), researchers observed sustained LDL lowering associated with alirocumab at 3 years.
Researchers stated that, due to the relative size of this subgroup, generalizability to the broader cohort may be limited.
“In ODYSSEY OUTCOMES, ‘neutralizing’ antidrug antibodies were detected infrequently (0.5% alirocumab, < 0.1% in the placebo group) (Schwartz GG, et al. N Engl J Med 2018;doi:10.1056/NEJMoa1801174.); the current sustained treatment analysis included LDL measurements in patients who had positive titers for anti-alirocumab antibodies,” Shaun G. Goodman, MD, MSc, of the division of cardiology at St Michael’s Hospital, Toronto, and colleagues wrote. “Previous data indicate that the presence of these antibodies rarely accounts for attenuation of LDL lowering (Bays HE, et al. Cardiovasc Drugs Ther. 2018;doi:10.1007/s10557-018-6784-z.); therefore, neutralizing antibodies would be expected to have minimal impact on the LDL levels, as observed in ODYSSEY OUTCOMES.”
Among all patients treated with alirocumab, including those not in the present analysis, a rise in LDL levels was attributed to study treatment discontinuation (14.2%), protocol-specified blinded substitution of placebo to avoid sustained LDL of more than 15 mg/dL (7.7%) or a reduction in treatment adherence.
“These findings are consistent with previous, shorter-duration trials with alirocumab and indicate no clinically meaningful diminution of its lipid-lowering efficacy over several years,” the researchers wrote. – by Scott Buzby
Disclosures: Goodman reports he has financial ties with multiple pharmaceutical companies, including Regeneron and Sanofi. Please see the study for all other authors’ relevant financial disclosures.