Send to

Choose Destination
Diabetes Metab. 2019 Sep 15:101120. doi: 10.1016/j.diabet.2019.101120. [Epub ahead of print]

Alirocumab efficacy and safety by body mass index: A pooled analysis from 10 Phase 3 ODYSSEY trials.

Author information

Hospital Universitario Virgen de la Victoria (IBIMA), Málaga University and CIBER Fisiopatología Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Malaga, Spain. Electronic address:
Department of Cardiology, Leipzig University Hospital, Leipzig, Germany.
L'institut du Thorax, Department of Endocrinology, CIC INSERM 1413, CHU Nantes, Nantes, France.
Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Sanofi, Bridgewater, NJ, USA.
Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.



Increased body mass index (BMI) contributes to cardiovascular risk and may influence efficacy of therapeutic antibodies. We investigated the effect of baseline BMI on efficacy and safety of alirocumab, a PCSK9 monoclonal antibody.


In a post-hoc analysis, data were pooled from 10 Phase 3 trials (n=4975) of alirocumab vs. placebo/ezetimibe controls. Alirocumab dose was 150mg every 2 weeks in two trials, and 75mg every 2 weeks with possible increase to 150mg at 12 weeks (based on Week 8 low-density lipoprotein cholesterol [LDL-C]) in eight trials. Efficacy/safety data were assessed in baseline BMI subgroups of≤25,>25 to 30,>30 to 35, and>35kg/m2.


Baseline LDL-C levels were lower among patients in the higher BMI subgroups. Significant LDL-C reductions from baseline were observed at Weeks 12 and 24 for alirocumab vs. controls, of similar magnitude regardless of baseline BMI (interaction P-value=0.7119). LDL-C<1.81mmol/L (<70mg/dL) was achieved at Week 24 by 69.8-76.4% of alirocumab-treated patients and 9.7-18.4% of control-treated patients, with no pattern by BMI. A greater proportion of patients in higher vs. lower BMI subgroups required alirocumab dose increase (P=0.0343); proportions were 22.5%, 24.9%, 31.7%, and 27.2% of patients across BMI subgroups of≤25,>25 to 30,>30 to 35, and>35kg/m2, respectively. Adverse event frequencies were similar regardless of BMI; injection-site reaction frequency was higher with alirocumab (5.1-8.2% across BMI categories) vs. controls (3.6-4.8%).


Alirocumab provided consistent LDL-C reductions, with similar safety findings across BMI subgroups.


Alirocumab; Body mass index; LDL-C; Obesity; PCSK9 inhibitor

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center