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

Bergenstal, Richard M.; Garrison, Louis P.; Miller, Lindsay; Hou, Lili; Blickensderfer, Amy; Zagar, Anthony; Stanley, Shelley; Bhargava, Anuj; Wade, Rolin L.; Herman, William H.

doi:10.1185/03007995.2011.628305

Cited by 14 publications

(16 citation statements)

References 25 publications

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“…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].…”

Section: Discussionsupporting

confidence: 83%

“…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].…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2013

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IntroductionCHOICE (CHanges to treatment and Outcomes in patients with type 2 diabetes initiating InjeCtablE therapy; NCT00635492) assessed, as its primary objective, the time to a ‘significant treatment change’ (defined within this paper) after patients with type 2 diabetes mellitus initiated their first injectable, glucose-lowering therapy [exenatide twice daily (BID) or insulin] in clinical practice in six European countries and evaluated outcomes during the study.MethodsCHOICE was a 24-month, prospective, noninterventional observational study. Patients were invited to participate in CHOICE only after their treating physician had made the clinical decision to initiate first injectable therapy with either exenatide BID or insulin. Clinical data were collected at initiation of first injectable therapy and after approximately 3, 6, 12, 18, and 24 months.ResultsA total of 2,515 patients were recruited; 1,114 patients in the exenatide BID cohort and 1,274 patients in the insulin cohort were eligible for the 24-month analysis. During the study, 42.2% and 36.0% of patients from each cohort, respectively, had a significant treatment change. By 24 months, improved mean glycated hemoglobin (p < 0.001 for both cohorts) and reduced severity of several cardiovascular risk factors were observed in both cohorts; additionally, mean weight was reduced in the exenatide BID cohort (p < 0.001) and increased in the insulin cohort (p < 0.001). Hypoglycemia was reported by 18.4% of the exenatide BID cohort and 36.8% of the insulin cohort; 25.9% of the exenatide BID cohort and 10.0% of the insulin cohort had met the secondary endpoint of glycated hemoglobin <7.0%, no weight gain, and no hypoglycemia.ConclusionCHOICE provided data on exenatide BID and insulin usage patterns and 24-month outcomes in clinical practice. On average, improved glycemic control and reduced severity of cardiovascular risk factors were observed in both cohorts, and those in the exenatide BID cohort also had mean weight loss.

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Section: Discussionsupporting

confidence: 83%

Section: Discussionmentioning

confidence: 99%

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

et al. 2013

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“…For example, from a psychosocial perspective, obese women are more likely to experience weight-related stigma, discrimination, body image disturbances, and depression than obese men (Cox et al 2011;Hammoud et al 2011). Moreover, women are more likely to view their own overweight or obese body negatively and ascribe a negative social meaning to it than men (Bergenstal et al 2011;Davies and Speight 2012;Mohamed et al 2010). Therefore, identifying factors associated with obesity-specific HRQOL may be crucial for improving HRQOL in overweight and obese individuals, especially in women.…”

Section: Introductionmentioning

confidence: 92%

“…Self-efficacy, a primary construct of social cognitive theory by Albert Bandura, involves people's beliefs in their capabilities to perform a specific action required to attain a desired outcome and to successfully cope with challenging conditions to achieve that outcome (Bandura 1997). Self-efficacy is increasingly recognized as an essential component of well-being and quality of life.…”

Section: Introductionmentioning

confidence: 99%

Factors Associated with Health-Related Quality of Life Among Overweight and Obese Korean Women

et al. 2015

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Health-related quality of life (HRQOL) tends to be lower among individuals who are overweight and obese than those of normal weight, and women may be more vulnerable to lower HRQOL associated with obesity than men. Identifying factors associated with HRQOL may be crucial for improving HRQOL for overweight/obese women. We aimed to determine the factors associated with obesity-specific HRQOL among overweight/obese Korean women. A cross-sectional study was conducted with 125 women aged 20-64 years, who comprised a baseline sample in the Community-based Heart and Weight Management Trial. The data were collected from September 2010 to November 2011. The Weight Efficacy Lifestyle, Beck Depression Inventory-II, Interpersonal Social Evaluation List, and Impact of Weight on Quality of Life (IWQOL)-Lite scales were used to measure self-efficacy for weight control, depressive symptoms, social support, and HRQOL, respectively. Increased body mass index, lower self-efficacy for weight control, and higher levels of depressive symptoms were significantly associated with greater impairment in total IWQOL in the regression models. However, social support was not significantly associated with IWQOL. Along with weight loss strategies, other strategies for improving self-efficacy and alleviating depressive symptoms may be essential for improving HRQOL among overweight and obese women.

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“…The associated anorexia contributes to weight loss, another beneficial effect in persons with metabolic syndrome. Dose-limiting symptoms reminiscent of gastroparesis are seen initially in more than 25% but decrease over time and lead to discontinuation in about 2–5% [23, 24]; however, the potential of pancreatitis has limited the more widespread use of these agents in the management of obesity [25]. Despite this caveat, the data suggest that intentional and reversible delay in gastric emptying could provide an alternative management option in obese patients(see Box 1).…”

Section: Definition Of Gastroparesismentioning

confidence: 99%

Gastroparesis: Concepts, Controversies, and Challenges

Bielefeldt

2012

Scientifica

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Patients with gastroparesis often present a challenge to the treating physician. Postprandial symptoms with nausea and vomiting may not only lead to nutritional and metabolic consequences, but also cause significant disruptions to social activities that often center around food. While the definition of gastroparesis focuses on impaired gastric emptying, treatment options that affect gastric function are limited and often disappointing. The female predominance, the mostly idiopathic nature of the illness with a common history of abuse, and coexisting anxiety or depression show parallels with other functional disorders of the gastrointestinal tract. These parallels provided the rationale for some initial studies investigating alternative therapies that target the brain rather than the stomach. This emerging shift in medical therapy comes at a time when clinical studies suggest that gastric electrical stimulation may exert its effects by modulating visceral sensory processing rather than altering gastric motility. Physiologic and detailed anatomic investigations also support a more complex picture with different disease mechanisms, ranging from impaired accommodation to apparent visceral hypersensitivity or decreased interstitial cells of Cajal to inflammatory infiltration of myenteric ganglia. Delayed gastric emptying remains the endophenotype defining gastroparesis. However, our treatment options go beyond prokinetics and may allow us to improve the quality of life of affected individuals.

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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

Abstract: The Exenatide BID Observational Study supports the clinical effectiveness of exenatide BID observed in previous clinical trials and retrospective database studies.

Cited by 14 publications

References 25 publications

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

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

Factors Associated with Health-Related Quality of Life Among Overweight and Obese Korean Women

Gastroparesis: Concepts, Controversies, and Challenges

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