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Context: Given the dramatic rise in the incidence of type 2 diabetes mellitus (T2DM) in recent decades, identifying individuals at increased risk of T2DM and validating methods to reduce their risk of disease progression is important. With more than one-third of US adults having prediabetes, a more precise stratification of absolute risk of T2DM incidence would help in prioritizing prevention efforts. Objective: To develop a simple and clinically useful schema to stratify short-term (2-year) absolute risk of T2DM. Design: Observational study of more than 77,000 adult members (age 18-75 years) from 3 Regions of the Kaiser Foundation Health Plan with prediabetes (hemoglobin A1C [HbA1C] = 5.7%-6.4%). Main Outcome Measures: The 2-year probability for development of diabetes as a function of baseline HbA1C and body mass index (BMI). Results: The 2-year risk of diabetes diagnosis varied widely by HbA1C and BMI. A small subset (5.2%) had a very high risk of T2DM developing within 2 years. Another 13.3% had a moderate 2-year risk of T2DM, whereas most (81.5%) of the population was at much lower risk. Thus, most Kaiser Foundation Health Plan members with prediabetes have only modest risk of progression to T2DM within 2 years. Conclusion: Using HbA1C and BMI, we created a simple stratification scheme to more precisely estimate risk of T2DM incidence. This will enable more efficient assignment of prevention interventions and clinical and laboratory follow-up to the small subset at highest risk, while minimizing the potentially negative effects of overdiagnosis among the majority with prediabetes who are not at high short-term risk of T2DM. [ABSTRACT FROM AUTHOR]

Objectives To better understand the effectiveness of xylitol in caries prevention in adults and to attempt improved clinical trial efficiency. Methods As part of the Xylitol for Adult Caries Trial (X- ACT), non cavitated and cavitated caries lesions were assessed in subjects who were experiencing the disease. The trial was a test of the effectiveness of 5 g/day of xylitol, consumed by dissolving in the mouth five 1 g lozenges spaced across each day, compared with a sucralose placebo. For this analysis, seeking trial efficiency, 538 subjects aged 21-80, with complete data for four dental examinations, were selected from the 691 randomized into the 3-year trial, conducted at three sites. Acceptable inter- and intra-examiner reliability before and during the trial was quantified using the kappa statistic. Results The mean annualized noncavitated plus cavitated lesion transition scores in coronal and root surfaces, from sound to carious favoured xylitol over placebo, during the three cumulative periods of 12, 24, and 33 months, but these clinically and statistically nonsignificant differences declined in magnitude over time. Restricting the present assessment to those subjects with a higher baseline lifetime caries experience showed possible but inconsistent benefit. Conclusions There was no clear and clinically relevant preventive effect of xylitol on caries in adults with adequate fluoride exposure when non cavitated plus cavitated lesions were assessed. This conformed to the X- ACT trial result assessing cavitated lesions. Including non cavitated lesion assessment in this full-scale, placebo-controlled, multisite, randomized, double-blinded clinical trial in adults experiencing dental caries did not achieve added trial efficiency or demonstrate practical benefit of xylitol. Trial Registration: ClinicalTrials.Gov NCT00393055. [ABSTRACT FROM AUTHOR]

Purpose: In 2009, the US Food and Drug Administration (FDA) mandated a label change for leukotriene inhibitors (LTIs) to include neuropsychiatric adverse events (eg, depression and suicidality) as a precaution. This study investigated how this label change affected the use of LTIs and other asthma controller medications, mental health visits, and suicide attempts. Methods: We analyzed data (2005-2010) from 5 large health plans in the US Population-Based Effectiveness in Asthma and Lung Diseases (PEAL) Network. The study cohort included children and adolescents (n = 30,000), young adults (n = 20,0), and adults (n = 90,000) with asthma. We used interrupted time series to examine changes in rates of LTI dispensings, non-LTI dispensings, mental health visits, and suicide attempts (using a validated algorithm based on a combination of diagnoses of injury or poisoning and psychiatric conditions). Findings: The label change was associated with abrupt reductions in LTI use among all age groups (relative reductions of 8.3%, 15.1%, and 6.0% among adolescents, young adults, and adults, respectively, compared with expected rates at 1 year after the warnings). Although we detected immediate offset increases in non-LTI asthma medication use, these increases were not sustained among adolescents and young adults. There were small increases in mental health visits among LTI users. Implications: The FDA label change for LTIs communicated possible risk of neuropsychiatric events. Communication and enhanced awareness may have increased reporting of mental health symptoms among young adults and adults. It is important to assess intended and unintended consequences of FDA warnings and label changes. [ABSTRACT FROM AUTHOR]