Abstract
IntroductionAnalyses of efficacy and tolerability of pharmacologic interventions are based on clinical trials that often include predominately white populations, in part because of challenges associated with recruitment and retention of racial/ethnically diverse study populations. Using real-world electronic health record (EHR) data, we sought to evaluate the tolerability and effectiveness of exenatide once weekly (EQW), overall and relative to basal insulin (BI), according to race.MethodsPatients with type 2 diabetes initiating EQW or BI between 2012 and 2015 were selected from the Optum EHR Research Database, a system pooling data from dozens of hospitals throughout the US. Measures of HbA1c, weight, and body mass index (BMI) were summarized at initiation and quarterly in the first year afterwards. Occurrences of gastrointestinal (GI) symptoms and hypoglycemia were identified by diagnostic codes and clinical notes, and incidence rates (IR) and relative rates (RR) were calculated.ResultsOverall, 4907 white patients (mean age = 57 years) and 454 African American patients (mean age = 53 years) were included. The percent change in HbA1c from initiation through 9–12 months was similar for white and African American patients [EQW-White: −6.89 (95% CI: −8.29, −5.50), EQW-African American: −5.99 (95% CI: −10.33, −1.65), BI-White: −4.68 (95% CI: −5.51, −3.86), BI-African American: −3.11 (95% CI: −5.37, −0.85)]. For EQW, percent change in weight was −1.73 (95% CI: −2.45, −1.02) for white patients and −1.11 (95% CI: −3.02, −0.81) for African American patients. No weight loss was observed among BI initiators. Relative to BI initiators, EQW initiators had lower rates of hypoglycemia [White RR: 0.82 (95% CI: 0.66, 1.01), African American RR: 0.59 (95% CI: 0.26, 1.34)]. GI symptoms were increased in white EQW initiators.ConclusionsTreatment with EQW, relative to BI, was associated with larger reductions in HbA1c and weight and reduced risk of hypoglycemia, effects that were not different for white and African American patients.FundingAstraZeneca, Gothenburg, Sweden
Highlights
IntroductionAnalyses of efficacy and tolerability of pharmacologic interventions are based on clinical trials that often include predominately white populations, in part because of challenges associated with recruitment and retention of racial/ethnically diverse study populations
Analyses of efficacy and tolerability of pharmacologic interventions, including those used to treat type 2 diabetes mellitus, are based on clinical trials that often include predominately white populations, in part because of challenges associated with recruitment and retention of racial/ethnically diverse study populations [7, 8]
We evaluate the tolerability and effectiveness of EQW among type 2 diabetes patients of different races in routine patient care in the US, with additional results for basal insulin (BI) provided for context
Summary
Analyses of efficacy and tolerability of pharmacologic interventions are based on clinical trials that often include predominately white populations, in part because of challenges associated with recruitment and retention of racial/ethnically diverse study populations. Despite the underrepresentation of non-white patients, there is some evidence of different treatment efficacy and tolerability according to race for some antihyperglycemic medications [9, 10] Indicators of tolerability, such as hypoglycemia incidence, have been reported to be elevated in African American patients relative to non-Hispanic white patients [10]. This observation has been attributed to self-administered type 2 diabetes mellitus treatments and may be due to differences in adherence, lower use of or access to HbA1c testing, as well as environmental and lifestyle factors
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