April 30, 2021
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Jones reports that he has received research grants from the Agency for Research and Quality in Health Care, AstraZeneca, the American Heart Association, Bristol Myers Squibb, the Doris Duke Charitable Foundation and the Research Institute for Patient-Centered Outcomes, and honoraria from the American College of Radiology and Daiichi Sankyo receive . In the study you will find all relevant financial information from all other authors.
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A risk score may identify adults with type 2 diabetes who are at high risk of serious adverse events in the limb, even in patients with no history of peripheral artery disease, according to a study published in Diabetic Medicine.
“This post-hoc analysis of the EXSCEL study found a predictive score for serious adverse events in the limbs in participants with diabetes with a C statistic of 0.822, which is generally considered a very good discrimination.” W. Schuyler Jones, MD, an associate professor of medicine at Duke University School of Medicine, and colleagues wrote. “Factors associated with Serious Limb Adverse Events in this model include age, race, gender, and smoking. coronary artery disease and ischemic cerebrovascular disease; and characteristics related to type 2 diabetes such as increased HbA1c, insulin use, neuropathy, previous injury, and previous amputation. “
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The researchers analyzed post-hoc data from the EXSCEL study, a randomized, placebo-controlled study that looked at the effects of exenatide (Byetta, AstraZeneca) on type 2 diabetes. Adults with type 2 diabetes and an HbA1c of 6.5% to 10% were included in the study. Participants were monitored for adverse events for the duration of the study and a follow-up period of 90 days after the study. Major adverse events in the limb included nontraumatic amputation, gangrene, and lower extremity revascularization. Results were assessed at clinical care visits at 1 week, 2 months, 6 months, and then every 6 months thereafter for the duration of the study.
Of 14,752 participants in the study, 3.55% had one or more serious adverse events in the limb. There were 736 events among 523 participants, including 247 amputations, 166 episodes of gangrene, and 323 revascularizations.
In the study’s predictive model, the risk of a serious adverse event in the limb was found in patients with peripheral artery disease (adjusted HR = 4.83; 95% CI, 3.94-5.92) and previous foot ulcer (aHR = 2.16; 95% CI, 1.63) increased -2.87), previous amputation (aHR = 2; 95% CI, 1.53-2.64), CAD (aHR = 1.67; 95% CI, 1.38 -2.03) and cerebrovascular disease (aHR = 1.41; 95% CI, 1.14-1.73). Participants who were currently smokers (aHR = 2; 95% CI, 1.54-2.61), participants who were using insulin (aHR = 1.86; 95% CI, 1.52-2.27), men (aHR = 1.64; 95% CI, 1.31-2.06)) and former smokers (aHR = 1.41; 95% CI, 1.15-1.72) also had a higher risk of serious undesirable effects Events in the limbs. Other factors significantly associated with serious adverse events in the limb were HbA1c (aHR = 1.24; 95% CI, 1.13-1.36) and neuropathy (aHR = 1.26; 95% CI, 1st , 03-1.53). Older age was only significantly associated with serious adverse events in the limb in participants aged 65 years or younger.
The study’s predictive model had a C-index score of 0.822. Using the predictive model, the researchers created a risk score with a maximum of 96 possible points. Individuals with 40 points or less had a 0.8% or less chance of having a serious limb adverse event after 3 years. The likelihood of a Serious Adverse Event for Limbs increased to 11.8% with a score of 65 to 69 and 64.5% for those with a score of 85 to 89.
“Although the majority of serious limb adverse events occurred in participants with peripheral artery disease, a significant minority occurred in participants with no documented history of peripheral artery disease,” the researchers wrote. “This suggests that individuals at high risk for serious limb adverse events without a documented diagnosis of peripheral artery disease could be usefully identified by a risk score as they may need additional assessment to rule out asymptomatic peripheral artery disease . “
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