High-intensity statin treatment fails to influence LDL-lowering response to alirocumab

Background high-intensity statin treatment did not affect the LDL-lowering response to alirocumab, according to results of an analysis presented at the Annual Congress of the European Atherosclerosis Society.

In another analysis presented at the meeting, researchers reported a high rate of achievement of LDL goals for patients on statin therapy assigned alirocumab (Sanofi/Regeneron), an investigational proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor.

Intensity of statin did not matter

Researchers conducted an analysis of six trials of alirocumab, including 4,166 patients at high CV risk receiving background treatment with a high-intensity statin or a non–high-intensity statin. In addition to background statin treatment, all patients received alirocumab 75 mg or 150 mg every 2 weeks, placebo or ezetimibe (Zetia, Merck).

“In patients treated with high-intensity statins compared with non–high-intensity statins, higher plasma PCSK9 levels could be expected, and this could potentially reduce the efficacy of the same dose of PCSK9 inhibitor,” Michel Krempf, MD, PhD, head of the department of endocrinology, metabolic diseases and nutrition at the University Hospital of Nantes, France, said in a press release.

The LDL-lowering response to alirocumab was not affected by high-intensity statin treatment, according to the results. The least square mean reduction in LDL ranged from 47% to 62% on high-intensity statin treatment vs. 35% to 61% reduction on non–high-intensity statin treatment.

In the largest trial analyzed, ODYSSEY LONG TERM (n = 2,310), treatment with alirocumab was associated with a 62% reduction in LDL for patients on high-intensity statin therapy and a 61% reduction in LDL for those on non–high-intensity statin therapy.

LDL goals achieved

Michel Farnier

In another analysis presented at the meeting, Michel Farnier, MD, PhD, from Point Médical, Dijon, France, and colleagues evaluated LDL goal attainment in eight phase 3 trials of patients at high CV risk who were receiving statin treatment with or without other lipid-lowering therapies. Patients in those trials were assigned alirocumab 75 mg or 150 mg every 2 weeks, placebo or ezetimibe.

At 24 weeks, alirocumab reduced LDL by 49% from baseline among those assigned 75 mg every 2 weeks with an increase to 150 mg every 2 weeks if LDL goal was not achieved at 8 weeks, and by 60% for those assigned 150 mg every 2 weeks (P < .0001), according to the researchers.

In all the trials, 75% to 79% of patients achieved their LDL goal of less than 1.8 mmol/L or less than 2.6 mmol/L.

Alirocumab was well tolerated and the most common adverse events were injection-site reactions, influenza and pruritus, according to the release. – by Erik Swain

References:

Farnier M, et al. Abstract EAS-0563 45.

Krempf M, et al. Abstract EAS-0493 45. Both presented at: 83rd Annual Congress of the European Atherosclerosis Society; March 22-25, 2015; Glasgow, Scotland.

Disclosures: The trials were funded by Sanofi and Regeneron. Krempf reports he receives grants, consulting fees and/or honoraria from Abbott, Amgen, AstraZeneca, Bristol-Myers Squibb, Merck, Novartis, Pfizer, Roche and Sanofi-Aventis. Farnier reports he receives research support from/participated in a speakers’ bureau for Amgen, Merck and Sanofi; honoraria from Abbott, Eli Lilly and Pfizer; and serves as a consultant/advisory panel member for Amgen, AstraZeneca, Kowa, Merck, Recordati, Roche and SMB.