Background:
The 3-year SCALE Obesity and Prediabetes trial (NCT01272219) randomized 2254 adults with prediabetes (female 76%; mean: age 48 years; BMI 39kg/m²) 2:1 to liraglutide 3.0mg or placebo (PBO) as adjunct to diet+exercise for 160 weeks (W).
Methods:
This post-hoc analysis compared liraglutide efficacy and safety for adults with prediabetes and BMI < vs ≥35kg/m² at baseline (BL). Liraglutide treatment effect across BMI subgroups was evaluated by statistical testing of interaction between treatment and BMI subgroup.
Results:
BL characteristics were similar between liraglutide and PBO BMI subgroups (< vs ≥35) except weight-related characteristics (weight, BMI, waist circumference) and dyslipidaemia history (commoner for liraglutide BMI <35).
At 160W, significantly greater mean and categorical weight losses (WLs) were seen with liraglutide vs PBO for BMI < and ≥35 (mean WL [%]: −6.4, −6.0 vs −1.7, −2.0; percentage achieved ≥5% WL: 51.1, 48.9 vs 19.7, 25.0; >10% WL: 25.7, 23.7 vs 8.9, 9.8; >15% WL: 8.1, 8.0 vs 2.5, 2.2) and greater improvements in glycaemic parameters and QoL endpoints; these treatment effects appeared to be independent of BL BMI (interaction p>0.05). While on treatment at 160W, more people with liraglutide vs PBO regressed to normoglycaemia, irrespective of BL BMI: 66.1, 65.8% vs 34.9, 36.9%.
AE rates, and serious/severe AEs were generally comparable across BMI subgroups. Gallbladder-related AE rates were similar for liraglutide < and ≥35 (24 events [2.4 events/100 years-observation], 69 [3.1]) but higher than PBO (6 [1.3], 12 [1.2]). Rates of pancreatitis were low, similar between BMI < and ≥35 but higher with liraglutide vs PBO (2 [0.2], 8 [0.3] vs 1 [0.2], 1 [0.1]), as were breast neoplasms (2 [0.3], 8 [0.4] vs 0 for PBO).
Conclusions:
3 years’ treatment with liraglutide 3.0mg had similar effects on body weight, glycaemic control and safety in subjects with baseline BMI < and ≥35kg/m².