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Item Three-year measured weight change in the African American health study(Sage Publications, 2009-03) Wolinsky, Fredric D.; Andresen, Elena M.; Malmstrom, Theodore K.; Schootman, Mario; Miller, J. Philip; Miller, Douglas K.; Department of Medicine, IU School of MedicineOBJECTIVE: This study examines 3-year weight change in African Americans. METHOD: Nine hundred and ninety-eight participants 49 to 65 years old were assessed at baseline and 3 years later. Weight was measured, and weight change was defined as clinically meaningful increases or decreases (+/- 5 kg). Potential risk factors were investigated using multinomial logistic regression. RESULTS: In-home measured weights were available for 752 participants (75%): 504 (67%) had stable weights, 131 (17%) gained more than 5 kg, and 117 (16%) lost more than 5 kg. Among all participants, the risks for weight gains were cancer, chronic obstructive pulmonary disease, lower income, and Medicaid status; the risks for weight losses were angina, cancer, high measured systolic blood pressure, asthma, and physical inactivity. Sex-stratified analyses reveal differences involving age, socioeconomic status, cancer, blood pressure, and lower body function. DISCUSSION: Three-year weight changes in middle-aged African Americans were frequent and significantly associated with several risk factors.Item Tolerability, Safety, and Benefits of Risperidone in Children and Adolescents with Autism: 21-Month Follow-up After 8-Week Placebo-Controlled Trial(Mary Ann Liebert, Inc., 2015-08-01) Aman, Michael; Rettiganti, Mallikarjuna; Nagaraja, Haikady N.; Hollway, Jill A.; McCracken, James; McDougle, Christopher J.; Tierney, Elaine; Scahill, Lawrence; Arnold, L. Eugene; Hellings, Jessica; Posey, David J.; Swiezy, Naomi B.; Guhman, Jaswinder; Grados, Marco; Shah, Bhavik; Vitiello, Benedetto; Department of Psychiatry, IU School of MedicineOBJECTIVE: Risperidone has demonstrated efficacy for acute (8 week) and intermediate length (6 month) management of severe irritability and aggression in children and adolescents with autism. Less is known about the long-term effects of risperidone exposure in this population. We examined the tolerability, safety, and therapeutic benefit of risperidone exposure over a 1-2 year follow-up period. METHODS: In a naturalistic study, 84 children and adolescents 5-17 years of age (from an original sample of 101) were assessed an average of 21.4 months after initial entry into a placebo-controlled 8 week trial of risperidone for children and adolescents with autism and severe irritability. They were assessed at baseline and at follow-up on safety and tolerability measures (blood, urinalysis, electrocardiogram [ECG], medical history, vital signs, neurological symptoms, other adverse events), developmental measures (adaptive behavior, intelligence quotient [IQ]), and standardized rating instruments. Treatment over the follow-up period, after completion of protocol participation, was uncontrolled. Statistical analyses assessed outcome over time with or without prolonged risperidone therapy. RESULTS: Two-thirds of the 84 subjects continued to receive risperidone (mean 2.47 mg/day, S.D. 1.29 mg). At follow-up, risperidone was associated with more enuresis, more excessive appetite, and more weight gain, but not more adverse neurological effects. No clinically significant events were noted on blood counts, chemistries, urinalysis, ECG, or interim medical history. Regardless of drug condition at follow-up, there was considerable improvement in maladaptive behavior compared with baseline, including core symptoms associated with autism. Height and weight gains were elevated with risperidone. Social skills on Vineland Adaptive Behavior Scale (VABS) improved with risperidone. Parent-rated Aberrant Behavior Checklist (ABC) Irritability subscale scores were reduced in those taking risperidone at follow-up. Several other measures of maladaptive behavior (some related to socialization) also showed improved functioning in association with risperidone on the ABC or on the Modified Real Life Rating Scale. CONCLUSIONS: Increased appetite, weight gain, and enuresis are risks associated with long-term risperidone. Our data suggest that these risks were balanced by longer-term behavioral and social benefits for many children over 1.8 years of ongoing treatment.Item What are the causes of the ill effects of chronic hemodialysis? The fallacy of low interdialytic weight gain and low ultrafiltration rate: lower is not always better(Wiley, 2014-01) Sinha, Arjun D.; Agarwal, Rajiv; Department of Medicine, IU School of Medicine