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Efficacy and safety of alirocumab in statin-intolerant patients over 3 years: open-label treatment period of the ODYSSEY ALTERNATIVE trial.

Publication ,  Journal Article
Moriarty, PM; Thompson, PD; Cannon, CP; Guyton, JR; Bergeron, J; Zieve, FJ; Bruckert, E; Jacobson, TA; Baccara-Dinet, MT; Zhao, J; Donahue, S ...
Published in: J Clin Lipidol
2020

BACKGROUND: The 24-week randomized, double-blind ODYSSEY ALTERNATIVE trial (NCT01709513) demonstrated significant low-density lipoprotein cholesterol (LDL-C) reductions with the PCSK9 inhibitor alirocumab vs ezetimibe in statin-intolerant patients, with significantly fewer skeletal muscle events (SMEs; 32.5%) vs atorvastatin (46.0%; hazard ratio: 0.61, 95% confidence interval: 0.38 to 0.99, P = .042). OBJECTIVE: ALTERNATIVE participants could enter an open-label treatment period (OLTP) for assessment of long-term safety. METHODS: Two hundred and eighty one patients entered the OLTP; 93.7%, 84.0%, and 92.9% of patients who received atorvastatin, ezetimibe, and alirocumab, respectively, during double-blind treatment, including 216 patients (76.9%) who completed double-blind treatment, as well as patients who either prematurely discontinued treatment due to SME (n = 51 [18.1%]) or other reasons (n = 14 [5.0%]) but completed week 24 assessments. All patients in the OLTP received alirocumab (75 or 150 mg every 2 weeks based on investigator decision) for ∼3 years or until commercial availability, whichever came first. RESULTS: SMEs were reported by 38.4% of patients in the OLTP. Safety results from the OLTP were similar to those of the alirocumab group in the double-blind period, except for a lower rate of discontinuations due to SMEs observed with alirocumab in the OLTP (3.2% vs 15.9% in the double-blind period). At OLTP week 8, mean LDL-C reduction from baseline (=week 0 of double-blind period) was 52.0%, with reductions sustained through to the end-of-treatment visits (55.4% and 53.7% reduction at weeks 100 and 148, respectively). CONCLUSIONS: In this population of statin-intolerant patients, alirocumab was well tolerated and produced durable LDL-C reductions over 3 years.

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Published In

J Clin Lipidol

DOI

ISSN

1933-2874

Publication Date

2020

Volume

14

Issue

1

Start / End Page

88 / 97.e2

Location

United States

Related Subject Headings

  • Proprotein Convertase 9
  • PCSK9 Inhibitors
  • Muscle, Skeletal
  • Middle Aged
  • Male
  • Hypercholesterolemia
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Humans
  • Female
  • Ezetimibe
 

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Moriarty, P. M., Thompson, P. D., Cannon, C. P., Guyton, J. R., Bergeron, J., Zieve, F. J., … Pordy, R. (2020). Efficacy and safety of alirocumab in statin-intolerant patients over 3 years: open-label treatment period of the ODYSSEY ALTERNATIVE trial. J Clin Lipidol, 14(1), 88-97.e2. https://doi.org/10.1016/j.jacl.2020.01.001
Moriarty, Patrick M., Paul D. Thompson, Christopher P. Cannon, John R. Guyton, Jean Bergeron, Franklin J. Zieve, Eric Bruckert, et al. “Efficacy and safety of alirocumab in statin-intolerant patients over 3 years: open-label treatment period of the ODYSSEY ALTERNATIVE trial.J Clin Lipidol 14, no. 1 (2020): 88-97.e2. https://doi.org/10.1016/j.jacl.2020.01.001.
Moriarty PM, Thompson PD, Cannon CP, Guyton JR, Bergeron J, Zieve FJ, et al. Efficacy and safety of alirocumab in statin-intolerant patients over 3 years: open-label treatment period of the ODYSSEY ALTERNATIVE trial. J Clin Lipidol. 2020;14(1):88-97.e2.
Moriarty, Patrick M., et al. “Efficacy and safety of alirocumab in statin-intolerant patients over 3 years: open-label treatment period of the ODYSSEY ALTERNATIVE trial.J Clin Lipidol, vol. 14, no. 1, 2020, pp. 88-97.e2. Pubmed, doi:10.1016/j.jacl.2020.01.001.
Moriarty PM, Thompson PD, Cannon CP, Guyton JR, Bergeron J, Zieve FJ, Bruckert E, Jacobson TA, Baccara-Dinet MT, Zhao J, Donahue S, Ali S, Manvelian G, Pordy R. Efficacy and safety of alirocumab in statin-intolerant patients over 3 years: open-label treatment period of the ODYSSEY ALTERNATIVE trial. J Clin Lipidol. 2020;14(1):88-97.e2.
Journal cover image

Published In

J Clin Lipidol

DOI

ISSN

1933-2874

Publication Date

2020

Volume

14

Issue

1

Start / End Page

88 / 97.e2

Location

United States

Related Subject Headings

  • Proprotein Convertase 9
  • PCSK9 Inhibitors
  • Muscle, Skeletal
  • Middle Aged
  • Male
  • Hypercholesterolemia
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Humans
  • Female
  • Ezetimibe