Cardiovascular safety of liraglutide: meta-analysis of major adverse cardiovascular events (MACE) across weight management and T2D development programs — ASN Events
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Cardiovascular safety of liraglutide: meta-analysis of major adverse cardiovascular events (MACE) across weight management and T2D development programs (#310)

Ian D Caterson 1 , Neil Poulter 2 , Stephen C Bain 3 , Jorge L Gross 4 , Jason C Hatch 5 , John A House 6 , Adam C Salisbury 6 7 , Christine B Jensen 8 , Sabina Furber 9 , Steven P Marso 10
  1. Boden Institute of Obesity Nutrition Exercise and Eating Disorders, Sydney, NSW, Australia
  2. Imperial College, London, UK
  3. Swansea University, Swansea, UK
  4. Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil
  5. Cardiovascular Institute of North Colorado, Banner Health, Loveland, CO, USA
  6. Saint Luke’s Mid America Heart Institute, Kansas City, MO, USA
  7. University of Missouri-Kansas City School of Medicine, Kansas City, MO, USA
  8. Novo Nordisk A/S, Soeborg, Denmark
  9. Novo Nordisk Pharmaceuticals, Sydney, NSW, Australia
  10. University of Texas Southwestern Medical Center, Dallas, TX, USA

Cardiovascular safety of liraglutide among overweight/obese individuals and those with type 2 diabetes (T2D) is unknown. Therefore, a meta-analysis of data from five Phase II/III liraglutide weight management (WM) trials, including follow-up through a 120-Day Safety Update, was performed. A meta-analysis of data from 21 trials from T2D development programs (with liraglutide as a treatment) provided additional information. Maximum dose of liraglutide was 3.0 mg and 1.8 mg in the WM program and T2D trials, respectively.

The primary endpoint was first occurrence of MACE on liraglutide or pooled comparator, analysed using a Cox proportional hazards model stratified by trial. Individuals who did not experience an event during the treatment period or within 30 days after last dose were censored at last treatment date plus 30 days.

Across WM trials (liraglutide: n=3872; comparator: n=2036), baseline characteristics were: 71% women; history of CV disease, 9%; mean age, 47 years; mean body mass index (BMI), 38 kg/m2. Across T2D trials (liraglutide: n=5511; comparator: n=2748): 43% women; history of CV disease, 13%; mean age, 56 years; mean BMI, 30 kg/m2.

In the WM trials, the overall number of adjudicated MACE was low and numerically lower with liraglutide (any dose: 10 events, frequency 0.2%, 0.2 events/100 patient-years of exposure [PYE]; liraglutide 3.0 mg: 7 events, 0.2%, 0.2 events/100 PYE) than with comparator (total comparator: 10 events, 0.5%, 0.4 events/100 PYE; placebo: 10 events, 0.5%, 0.4 events/100 PYE). Hazard ratios (HR) and 95% confidence intervals (CI) for liraglutide (any dose) vs. total comparator: 0.40 [0.16; 1.01]; liraglutide 3.0 mg vs. placebo, 0.33 [0.12; 0.90]. Higher event rates were observed across the T2D trials: liraglutide (any dose), 26 events, 0.5%, 0.6 events/100 PYE vs. total comparator, 23 events, 0.8%, 1.3 events/100 PYE; HR [95% CI]: 0.64 [0.35, 1.15].

There was no indication of an increased risk of MACE with liraglutide up to doses of 3.0 mg once-daily in overweight/obese individuals, or in those with T2D.