Abstract
AimsThere is an unmet need among healthcare providers to identify subgroups of patients with type 2 diabetes who are most likely to respond to treatment.MethodsData were taken from electronic medical records of participants of an observational, retrospective study in Italy. We used logistic regression models to assess the odds of achieving glycated haemoglobin (HbA1c) reduction ≥ 1.0% point after 12-month treatment with liraglutide (primary endpoint), according to various patient-related factors. RECursive Partitioning and AMalgamation (RECPAM) analysis was used to identify distinct homogeneous patient subgroups with different odds of achieving the primary endpoint.ResultsData from 1325 patients were included, of which 577 (43.5%) achieved HbA1c reduction ≥ 1.0% point (10.9 mmol/mol) after 12 months. Logistic regression showed that for each additional 1% HbA1c at baseline, the odds of reaching this endpoint were increased 3.5 times (95% CI: 2.90–4.32). By use of RECPAM analysis, five distinct responder subgroups were identified, with baseline HbA1c and diabetes duration as the two splitting variables. Patients in the most poorly controlled subgroup (RECPAM Class 1, mean baseline HbA1c > 9.1% [76 mmol/mol]) had a 28-fold higher odds of reaching the endpoint versus patients in the best-controlled group (mean baseline HbA1c ≤ 7.5% [58 mmol/mol]). Mean HbA1c reduction from baseline was as large as − 2.2% (24 mol/mol) in the former versus − 0.1% (1.1 mmol/mol) in the latter. Mean weight reduction ranged from 2.5 to 4.3 kg across RECPAM subgroups.ConclusionsGlycaemic response to liraglutide is largely driven by baseline HbA1c levels and, to a lesser extent, by diabetes duration.
Highlights
Liraglutide is a once-daily human glucagon-like peptide-1 (GLP-1) analogue available for the treatment of type 2 diabetes (T2D), and its efficacy and safety have been demonstrated in the Liraglutide Effect and Action in Diabetes (LEAD) study programme [1,2,3,4,5,6,7]
Liraglutide was approved in the EU in 2009, and data from real-world observational studies have further demonstrated that the benefits of liraglutide on glycated haemoglobin (HbA1c) and body weight loss were consistent with those obtained in the randomised LEAD trials [9]
Most patients received liraglutide as an add-on to previous therapies (63.2%), with 33.4% replacing another prior drug with liraglutide, and 3.4% reducing the number of prior therapies
Summary
Liraglutide is a once-daily human glucagon-like peptide-1 (GLP-1) analogue available for the treatment of type 2 diabetes (T2D), and its efficacy and safety have been demonstrated in the Liraglutide Effect and Action in Diabetes (LEAD) study programme [1,2,3,4,5,6,7]. Liraglutide has been demonstrated to have benefits across a diverse spectrum of patients with T2D, but the extent of H bA1c improvement differs within patient groups having different demographics and clinical characteristics [12]. There is an unmet need to identify subgroups of patients with T2D receiving liraglutide who are most likely to have the greatest response to treatment. This information would help healthcare providers individualise treatment options and assess cost benefits. Patients and healthcare professionals could benefit from a more detailed understanding of factors associated with improved response to liraglutide
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