Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials.

ABSTRACT:

Aim

To evaluate the safety of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab according to diabetes mellitus status.

Methods

Safety data from 14 trials (8-104-week durations) were analysed by treatment (alirocumab or placebo/ezetimibe control) and diabetes status (yes/no, defined by medical history). Adverse event data were assessed using descriptive statistics and Cox models.

Results

Of the 5234 trial participants, 1554 (29.7%) had diabetes. Overall, treatment-emergent adverse events were similar in the alirocumab and control groups, except for more frequent local injection site reactions with alirocumab. Fewer people with diabetes experienced local injection site reactions [alirocumab, 3.5%, control, 2.9%; hazard ratio 1.24 (95% CI 0.6

SUBMITTER: Leiter LA 

PROVIDER: S-EPMC6585811 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature