Selected Late-breaking Abstracts - Complications

13-LB: The Potential of Rimonabant in Prediabetes: Pooled 1-Year Results from the RIO-Lipids, RIO-Europe and RIO-North America Studies

Rosenstock J.

The RIO trials are Phase 3 clinical trials to assess the safety of the CB1 cannabinoid receptor blocker, rimonabant, and its effects on cardiometabolic risk factors in obese/overweight individuals. A 1-year pooled analysis was performed using data from a subset of RIO study participants with impaired fasting glucose (IFG; FG ≥100 mg/dL and <126 mg/dL). Patient distribution across treatments was as follows: placebo (N=290), 5 mg/day rimonabant (N=492), 20 mg/day rimonabant (N=508). Baseline characteristics of the IFG subgroup were similar across treatment groups. Results were reported relative to placebo. Rimonabant at either dose significantly improved weight, waist circumference, and HDL-cholesterol levels. Rimonabant at 20 mg/day significantly improved fasting insulin levels, insulin resistance, triglyceride levels, supine diastolic blood pressure and reduced metabolic syndrome prevalence. FG was decreased at each dose, but not significantly. Safety in this patient subgroup was similar to the overall RIO study. Conclusion: More long-term studies are warranted to assess the ability of rimonabant to prevent type 2 diabetes and CVD among prediabetic individuals.

22-LB: Mismatch between Patients’ Perspectives and Professional Expectations in Relation to Management of Prediabetes

Heald AH, Speake N, Wakefield J, Chew-Graham C.

This study was designed to determine the psychological impact of the label, “at risk for diabetes”. Study participants were drawn from a general practice that serves an affluent inner city neighborhood in Greater Manchester, UK. Patients who had been assigned to the practice list of individuals at risk for diabetes were questioned regarding their understanding of the list, information they had sought regarding prediabetes, and professional stereotypes. Twenty-one interview transcripts were reviewed. Patient responses indicated that patients were unaware they were on a list, did not understand the implication of being on the “at risk” list, did not understand test results, felt guilty about not implementing lifestyle changes, avoided seeking information on prediabetes, and were more open to receiving information on prediabetes-associated risks from a physician than a nurse. Conclusion: This study demonstrates the need for improved communication regarding test results, their implications, and expectations for patient behaviors on diagnosis of prediabetes.

27-LB: Trends in Diabetic Ketoacidosis Death Rates among Adults with Diabetes, United States, 1984-2002.

Wang J, Williams DE, Geiss LS.

Diabetic ketoacidosis (DKA) is a serious complication of diabetes associated with insulin omission, newly diagnosed diabetes, stress, acute illness (infection), and unknown causes. DKA is preventable and treatable, with patient education reducing the rate by 70%. DKA death rates from 1984 to 2002 were considered by age group: 0-17, 18-44, 45-64, ≥65. DKA rates declined most in the ≥65 age group. The highest rates were in the 18-44 age group and among black males. While the DKA death rate declined in other age groups, there was no change in the DKA death rate among black males. The number of DKA deaths occurring at residence increased in contrast to the declining rates in healthcare facilities. Conclusion: Effective strategies are needed to prevent DKA deaths at residence and among black males.

32-LB: Recombinant Human Lactoferrin (rhLF) May Promote Healing of Diabetic Neuropathic Ulcers

Yankee E, Miller M, Serena T, Sheehan P, Lavery L, Kirsner R, Reese A, Veves A.

Talactoferrin alfa (formerly rhLF) has demonstrated ulcer healing properties in animal models. A pilot Phase1/2 trial was designed to determine safety and potential efficacy in healing diabetic neuropathic ulcers. Talactoferrin alfa gel was applied twice daily to the wound, at the time of dressing change. Gel strengths of 1%, 2.5% and 8.5% talactoferrin alfa demonstrated no adverse effects in the 30 day safety study. In the efficacy study, 15 patients were included in each of 3 arms (placebo, 2.5%, and 8.5% talactoferrin alfa), and dosing continued for 12 weeks. The study demonstrated its primary efficacy endpoint, with 75% wound healing in 50% of participants in the combined treatment groups compared to 25% of those in the placebo group (p=0.09). Superiority to placebo was also suggested by 100% healing at 20 weeks (19% placebo vs 30% treatment), 8 weeks after treatment was halted. Conclusion: Further studies are warranted.