Exenatide bid observational study (ExOS): baseline population characteristics of a prospective research study to evaluate the clinical effectiveness of exenatide bid use in patients with type 2 diabetes in a real-world setting

Abstract

Patients treated with exenatide tended to be obese, middle-aged women on various combinations of OADs and/or insulin who often had hypertension and/or dyslipidemia. Further planned analyses will provide the largest sample of prospective data on outcomes of exenatide therapy for up to 24 months in this usual-care population.

Using Exenatide Twice Daily or Insulin in Clinical Practice: Results from CHOICE

“…They are also in line with findings from RCTs [18–20] and other observational studies [21–24], although comparability of the primary analyses (the ‘initiators’ analyses) with findings from other studies is limited by the fact that patients could be started on an alternative treatment while remaining in CHOICE. The demographics and characteristics of the patients from CHOICE who were initiated on exenatide BID were consistent with those of patients from the Exenatide BID Observational Study (ExOS) conducted in the United States [21, 22]. The Association of British Clinical Diabetologists’ nationwide exenatide audit, which was performed in the United Kingdom, included patients who were broadly similar to our population, except that their mean baseline HbA 1c was higher (9.47%) than in our study, and 33.9% of patients in their study were also receiving insulin at the time exenatide was initiated [24].…”

“…The Association of British Clinical Diabetologists’ nationwide exenatide audit, which was performed in the United Kingdom, included patients who were broadly similar to our population, except that their mean baseline HbA 1c was higher (9.47%) than in our study, and 33.9% of patients in their study were also receiving insulin at the time exenatide was initiated [24]. In the US study, which was single-arm and included patients initiated on exenatide BID, irrespective of previous insulin use, significant improvements were observed after 12 months in HbA 1c (−0.80%), weight (−2.4 kg), and BMI (−0.83 kg/m 2 ; p  ≤ 0.0001 for all) [21, 22]. The UK audit of patients recently started on exenatide also revealed clinical improvements after a median of 6 months of exenatide therapy (the regimen was not described), with reported decreases of 0.73% for HbA 1c , 5.9 kg for weight, and 2.2 kg/m 2 for BMI ( p  < 0.001 for all) [24].…”

Exenatide BID Observational Study (ExOS): results for primary and secondary endpoints of a prospective research study to evaluate the clinical effectiveness of exenatide BID use in patients with type 2 diabetes in a real-world setting

“…These data provide insight into how exenatide BID is being used in real-world clinical practice, characteristics of patients prescribed exenatide BID, and patient risk factors and comorbidities. Baseline patient characteristics and demographics (including level of education, lifestyle practices, medical history, and comorbid conditions), clinical laboratory values, and baseline values for patient-reported outcomes (PROs) measures regarding weight, eating habits, and depression, as well as the research design and analytic plan were previously published 19 . Results for primary and secondary endpoints at 12 months are reported here.…”

Treatment outcomes after initiation of exenatide twice daily or insulin in clinical practice: 12-month results from CHOICE in six European countries

“…As such, the National Institute for Health and Clinical Excellence (NICE) in the UK suggests that the patients with T2DM likely to benefit most from GLP-1 receptor agonists are those for whom excess weight is an issue 9. Epidemiological data from the USA10,11 and UK12 suggest that the mean body mass index (BMI) of people prescribed GLP-1 receptor agonists is 38–40 kg/m 2 – somewhat higher than estimates for the general T2DM populations in both these countries 13,14. Conversely, non-obese patients are more likely than obese patients to be prescribed insulin therapy in the UK, as are patients aged ≤ 60 years, those with more severe T2DM (diabetes complications and higher glycated hemoglobin [HbA 1c ]), and patients who have received OAD therapy, compared with those aged > 60 years, without severe illness, and who have previously received lifestyle interventions only ( P ≤0.01 for all).…”

“…This paper reports interim treatment change data and clinical outcomes during the first 12 months after the initiation of injectable therapy with exenatide BID or insulin, providing a report of the use of exenatide BID for a period beyond that investigated in most clinical trials (up to 6 months), and allowing comparison with a 12-month study of exenatide BID use in clinical practice in the USA 10,28…”