Data on comparative effectiveness among weight-loss medications (WLMs) in real-world studies (RWS) are limited. The aim of the XENSOR study was to assess in a real-world setting the effectiveness of two WLMs, orlistat and liraglutide, in patients with obesity and insufficient weight loss (WL) after a lifestyle modification program.
A retrospective RWS was conducted comparing clinical outcomes of orlistat 120 mg tid and liraglutide (up to 3 mg daily) in adult patients with BMI ≥ 30 kg/m² (or ≥ 27 kg/m² with at least a weight-related comorbidity) who had failed to lose at least 5% of their baseline weight (BW) after 6 months (mo) of lifestyle modification. The co-primary end points, assessed at 3-6 mo (visit 2) and at the end of the follow-up (visit 3), were weight change from baseline, proportion of patients who lost at least 5% of their BW and adjusted differences in WL between both drugs.
Five hundred patients, 400 in the group of orlistat (women 75%, mean age 47.0 y, mean BW 107.8 kg), and 100 in the group of liraglutide (women 73%, mean age 51.9 y, mean BW 105.1 kg), were included. Treatment with both drugs significantly reduced weight, FPG, systolic BP, LDL-C and ALT over a median follow-up period of 7 mo. WL with liraglutide at visit 3 (-7.7 kg) was significantly greater than that observed with orlistat (-3.3 kg), adjusted mean difference -4.7 kg (95% CI -6.4 to -2.9 kg). More individuals lost at least 5% of their BW with liraglutide (64.7%) than with orlistat (27.4%) at visit 3, p<0.0001. In the subset of patients with prediabetes at baseline, persistence of prediabetes or progression to T2DM was significantly lower with liraglutide (34.6%) than with orlistat (82.8%), p<0.0001. At 12 mo of follow-up, 61% of patients remained on liraglutide, compared to 46.8% on orlistat (p 0.011).
In summary, in this RWS, liraglutide showed a greater effectiveness in WL compared to orlistat and improved several obesity-associated metabolic and cardiovascular risk factors.
J.J. Gorgojo-Martinez: Advisory Panel; Self; Abbott, AstraZeneca, Lilly Diabetes, Mundipharma, Novo Nordisk Inc., Pfizer Inc. Research Support; Self; Novo Nordisk Inc. Other Relationship; Self; Abbott, Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Lilly Diabetes, Merck Sharp & Dohme Corp., Mundipharma, Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Pfizer Inc. B. Basagoiti-Carreño: None. A. Sanz-Velasco: Other Relationship; Self; Boehringer Ingelheim Pharmaceuticals, Inc. C. Serrano-Moreno: Other Relationship; Self; Novo Nordisk A/S. F. Almodóvar-Ruiz: Other Relationship; Self; Novo Nordisk Inc.