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Late Breaking Abstracts from ADA 2014 Late Breaking Abstracts June 2014 | Volume 63 | Suppl. 1A | www.diabetes.org/diabetes Late Breaking Abstracts LB1 Subject Index LB78 Abstract Author Index LB82 Abstract Author Disclosure Information LB91 scientificsessions.diabetes.org COMPLIcatIONS—HyPOGLYCEMIA COMplIcatIONS—HYpoGLYceMIA 3-LB Warfarin Use and Hospitalization Events for Hypoglycemia among Elderly Patients on Glipizide 1-LB JOHN ROMLEY, DANA GOLDMAN, CYNTHIA GONG, ANNE L. PETERS, Los A Phase 2 Comparative Safety PK/PD Study of Stable Nonaqueous Angeles, CA Glucagon (G-Pen) vs. Lilly Glucagon for Treatment of Severe Hypo- Oral hypoglycemic agents and warfarin account for nearly half of adverse drug glycemia events resulting in emergency hospitalization among elderly Americans. Clinical EUGENIO CERSOSIMO, MARTIN J. CUMMINS, JOHN H. KINZELL, JOEL drug references note that warfarin may interact with glipizide, potentiating its MICHALEK, BRETT J. NEWSWANGER, STEVEN J. PRESTRELSKI, CURTIS TRIPLITT, POSTERS hypoglycemic effects. These warnings, however, are based on pharmacokinetic Complications RALPH A. DEFRONZO, San Antonio, TX, Austin, TX data and case reports for older sulfonylureas which are rarely used. In this Acute and Chronic Severe hypoglycemia remains a significant unmet medical need in study, we investigated hospitalization events for hypoglycemia among elderly patients with diabetes. Currently approved rescue products (Lilly Glucagon Americans with diabetes with concomitant glipizide and warfarin use. A 20% for Injection [rDNA origin]; Novo Nordisk GlucaGen® (glucagon [rDNA origin]) sample of Medicare claims (2006-2011) was used to identify individuals with HypoKit®) are based on lyophilized formulations, which require reconstitution diabetes who used glipizide (defined as at least one prescription fill in a Part at time of use, complicating administration in emergency situations. Xeris is D plan), and were continuously enrolled in Medicare Parts A and B (or died), developing a ready-to-use, soluble liquid glucagon formulation in a pre-filled during a calendar quarter. Concomitant warfarin use was determined, and syringe, based on biocompatible, non-aqueous solvents that suppress the whether individuals had a hospital admission or emergency department (ED) fibrillation of glucagon typically observed in aqueous solutions. The G-Pen™ visit with a primary diagnosis of hypoglycemia, during the same quarter. Our (glucagon injection) formulation has demonstrated excellent chemical analysis sample included 293,322 individuals and 2,639,392 person-quarters. stability after storage as a liquid at room temperature. A Phase 2, double- Warfarin was filled in 9.4% of quarters, and a hypoglycemia admission or blind, cross-over, comparative pharmacology study in fasted, healthy, ED visit occurred in 569 quarters. Using logistic random effects analysis, the non-diabetic volunteers (n = 30) demonstrated that subcutaneously (SC) unadjusted odds ratio (OR) for hypoglycemia admission / ED visit was 1.54 injected G-Pen™ glucagon (1 mg) resulted in bioequivalent mean glucose (p<0.001) in quarters with warfarin use. When adjusted for age, sex, non-white AUC, Cmax, and Tmax as compared to 1 mg SC doses of Lilly Glucagon race/ethnicity and comorbidities, the OR for warfarin use was 1.24 (p=0.040). reference drug. The TOST procedure indicated significance (p<0.05) for all Risk was elevated for hospitalization alone (OR of 1.53, p=0.047), and with pairwise contrasts and all 95% pairwise confidence intervals for the ratio initial warfarin use (OR of 3.61, p<0.001). Confounding was addressed with a of means were contained in the interval 0.80 to 1.2, the FDA standard for fixed effects logistic analysis which accounted for unmeasured time-invariant bioequivalence. Injection of both 1 mg G-Pen™ [Cmax 148.0 (24.9) mg/dL] and person-level factors, and found an adjusted OR for hospitalization / ED visit with Lilly Glucagon [Cmax 154.9.0 (28.0) mg/dL] showed rapid, marked elevation warfarin use of 1.57 (p=0.023). Hospitalization events for hypoglycemia are rare of blood glucose levels from baseline. Despite therapeutic equivalence, but serious, and clinicians should exercise caution when prescribing warfarin to pharmacokinetic serum glucagon parameters (AUC, Cmax, Tmax) were elderly glipizide users, especially when initiating treatment. significantly different between Xeris and Lilly preparations. There were no Supported By: National Institute on Aging (5P01AG033559-03) apparent safety or tolerability issues with any of the glucagon treatments; all AEs observed were those expected with rescue injections of glucagon. No serious adverse reactions were reported. Overall these data support 4-LB the development of G-Pen™ as a commercial rescue treatment for severe Hypoglycemic Episodes among Race/Ethnicity Groups in the VA hypoglycemia in a single-use auto-injector pen format. Diabetes Trial (VADT) Supported By: NIDDK (5R44DK085809-03) ARAMESH SAREMI, DERRICK KAUFMAN, DAWN C. SCHWENKE, PETER D. REAVEN, FOR THE VADT, Phoenix, AZ, Hines, IL We have previously shown that the effect of intensive glycemic control on 2-LB CVD outcomes differed across major race/ethnic groups in VADT. We now Different Clinical Predictors of Nonsevere and Severe Hypoglycemia determined whether the frequency of hypoglycemic episodes in response to this during Treatment with Glargine or Standard Care in the ORIGIN therapy differed across major race/ethnic groups. The total numbers of interim Trial hypoglycemia episodes with symptoms were reported at each visit. The current MATTHEW C. RIDDLE, HERTZEL GERSTEIN, HYEJUNG JUNG, LARS E. RYDÉN, analysis included 1096 non-Hispanic Whites (NHW), 303 non-Hispanic Blacks LINDA MELLBIN, JULIO ROSENSTOCK, JEFFREY PROBSTFIELD, Portland, OR, (NHB) and 303 Hispanics (His). Total number of hypoglycemic episodes per year Hamilton, ON, Canada, Stockholm, Sweden, Dallas, TX, Seattle, WA were more frequent in NHW compared with NHB and His [mean (95% CI): NHW, Hypoglycemia limits treatment of diabetes and is associated with increased 10 (9-11); NHB, 6 (5-7) His, 7 (6-8), P < 0.0]. After adjustment for other predictors risks. This large, long-term, randomized trial (NCT00069784) compared use of hypoglycemia, including treatment assignment (Figure), NHW continued to of insulin glargine with standard care in people with dysglycemia (IGT, have 32% and 31% (P <0.01) more frequent hypoglycemic episodes compared IFG, or T2DM) and high cardiovascular risk. We analyzed data from 12,537 with NHB and His, respectively. Very similar patterns were seen for severe participants to identify baseline and on-treatment factors associated with and nocturnal hypoglycemia. Although intensive treatment was a significant symptomatic hypoglycemia confirmed by glucose 3 mmol/L or (separately) ≤ predictor of hypoglycemic events, there was no interaction between treatment severe hypoglycemia. Over median 6.2 yrs with median A1C ~ 6.5%, 28% effect and ethnicity. Together with our previous report, these data suggest that of participants had 1 non-severe and 3.8% severe events. Independent ≥ the risk/benefit ratio for intensive glycemic control differs between major race/ predictors of events as time-varying covariates were assessed by Cox ethnic groups in the VADT. proportional hazard models including baseline characteristics, treatment allocation, and mean on-treatment A1C. Sulfonylurea use (Hazard Ratio [HR] 2.07 for non-severe, 1.35 for severe) and glargine treatment (HR 4.53 for non-severe, 3.57 for severe) were independently associated with higher risk in both categories. Risk of non-severe events was lower with older age (HR [95%CI] 0.98 [0.98-0.99]) and higher BMI (HR 0.97 [0.96-0.98]), and higher with presence of diabetes (HR 1.52 [1.21-1.92] and higher baseline A1C (HR 1.24 [1.14-1.35]). Risk of severe events was higher with older age (HR 1.04 [1.03-1.06]), hypertension (HR 1.51 [1.14-2.00]), higher serum creatinine (HR 1.01 [1.01-1.02]); lower with higher MMSE score (HR 0.96 [0.93-0.99]); and unrelated to baseline glycemic status. With glargine treatment, risk of both non-severe and severe events was higher at lower on-treatment A1C; with standard care risk of severe events increased at higher A1C. Conclusions: Overall incidences of hypoglycemia were low. Sulfonylurea and glargine are associated with both non-severe and severe events, but other independent predictors differ between categories. Non-severe and severe events affect Supported By: ADA (1-06-CR-32); NIH (R01067690, R01HL094775) different people and occur in different settings. Awareness of predictors may guide individualized therapy. Supported By: Sanofi ADA-Funded Research For author disclosure information, see page LB91. LB1 COMPLIcatIONS—Macrovascular—ATHEROSCLEROTIC CARDIovascular DISEASE AND HUMAN DIABETES 5-LB 7-LB Natural Language Processing of Clinical Notes in Electronic Health Records to Improve Capture of Hypoglycemia ANTHONY P. NUNES, SHENGSHENG YU, KAREN M. KURTYKA, CYNTHIA SENER- WIthdrawN CHIA, JEFFREY M. HILL, KIMBERLY G. BRODOVICZ, LARRY RADICAN, SAMUEL S. ENGEL, SEAN R. CALVO, DAVID D. DORE, Waltham, MA, Whitehouse Station, NJ, Boston, MA, North Wales, PA, Providence, RI POSTERS Hypoglycemia is under ascertained in healthcare billing data, especially Complications for mild or moderate events. Clinical notes in electronic health records (EHR) Acute and Chronic 8-LB include details of medical encounters that may not be represented in structured Effect of Baseline Atherosclerosis on Long-term Consequences of data fields. We assessed
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