IMPORTANCE Nausea and vomiting, unrelated to chemotherapy, can be substantial symptoms in patients with advanced cancer.OBJECTIVE To evaluate the utility of olanzapine for treating chronic nausea/vomiting, unrelated to chemotherapy, in patients with advanced cancer. DESIGN, SETTING, AND PARTICIPANTSThis study is a double-line, placebo-controlled, randomized clinical trial conducted from July 2017 through April 2019, with analysis conducted in 2019. Eligible participants were outpatients with advanced cancer who had persistent nausea/vomiting without having had chemotherapy or radiotherapy in the prior 14 days. Chronic nausea was present for at least 1 week (worst daily nausea numeric rating scores needed to be greater than 3 on a 0-10 scale).INTERVENTIONS Patients received olanzapine (5 mg) or a placebo, orally, daily for 7 days.MAIN OUTCOMES AND MEASURES Patient-reported outcomes were used for study end points. Data were collected at baseline and daily for 7 more days. The primary study end point (the change in nausea numeric rating scores from baseline to the last treatment day) and the study hypothesis were both identified prior to data collection.RESULTS A total of 30 patients (15 per arm) were enrolled; these included 16 women and 14 men who had a mean (range) age of 63 (39-79) years. Baseline median nausea scores, in all patients, were 9 out of 10 (range, 8-10). After 1 day and 1 week, the median nausea scores in the placebo arm were 9 out of 10 (range, 8-10) on both days, compared with the olanzapine arm scores of 2 out of 10 (range, 2-3) after day 1 and 1 out of 10 (range, 0-3) after 1 week. After 1 week of treatment, the reduction in nausea scores in the olanzapine arm was 8 points (95% CI, 7-8) higher than that of the placebo arm. The primary 2-sided end point P value was <.001. Correspondingly, patients in the olanzapine arm reported less emesis, less use of other antiemetic drugs, better appetite, less sedation, less fatigue, and better well-being. One patient, on the placebo, stopped treatment early owing to lack of perceived benefit. No patients receiving olanzapine reported excess sedation or any other adverse event.CONCLUSIONS AND RELEVANCE Olanzapine, at 5 mg/d, appeared to be effective in controlling nausea and emesis and in improving other symptoms and quality-of-life parameters in the study population.
OBJECTIVE We characterized annual trends of severe hypoglycemic and hyperglycemic crises (diabetic ketoacidosis/hyperglycemic hyperosmolar state) in patients with diabetes and end-stage kidney disease (ESKD). RESEARCH DESIGN AND METHODS This was a nationwide, retrospective study of adults (≥18 years old) with diabetes/ESKD, from the United States Renal Data System registry, between 2013 and 2017. Primary outcome was annual rates of emergency department visits or hospitalizations for hypoglycemic and hyperglycemic crises, reported as number of events/1,000 person-years. Event rates and risk factors were adjusted for patient age, sex, race/ethnicity, dialysis modality, comorbidities, treatment regimen, and U.S. region. RESULTS Among 521,789 adults with diabetes/ESKD (median age 65 years [interquartile range 57–73], 56.1% male, and 46% White), overall adjusted rates of hypoglycemic and hyperglycemic crises were 53.64 and 18.24 per 1,000 person-years, respectively. For both hypoglycemia and hyperglycemia crises, respectively, the risks decreased with age and were lowest in older patients (≥75 vs. 18–44 years old: incidence rate ratio 0.35, 95% CI 0.33–0.37, and 0.03, 0.02–0.03), women (1.09, 1.06–1.12, and 1.44, 1.35–1.54), and those with smoking (1.36, 1.28–1.43, and 1.71, 1.53–1.91), substance abuse (1.27, 1.15–1.42, and 1.53, 1.23–1.9), retinopathy (1.10, 1.06–1.15, and 1.36, 1.26–1.47), and insulin therapy (vs. no therapy; 0.60, 0.59–0.63, and 0.44, 0.39–0.48). For hypoglycemia, specifically, additional risk was conferred by Black race (1.11, 1.08–1.15) and amputation history (1.20, 1.13–1.27). CONCLUSIONS In this nationwide study of patients with diabetes/ESKD, hypoglycemic crises were threefold more common than hyperglycemic crises, greatly exceeding national reports in nondialysis patients with chronic kidney disease. Young, Black, and female patients were disproportionately affected.
<b>Objective</b>: We characterized annual trends of severe hypoglycemic and hyperglycemic crises (diabetic ketoacidosis/hyperglycemic hyperosmolar state) in patients with diabetes and end-stage kidney disease (DM/ESKD). <p> </p> <p><b>Design</b>: Nationwide, retrospective study of adults (≥18 years) with DM/ESKD, from the United States Renal Data System registry, 2013 to 2017. Primary outcome was annual rates of emergency department visits or hospitalizations for hypoglycemic and hyperglycemic crises, reported as number of events/1000 person-years. Adjusted event rates and risk factors were adjusted for patient age, sex, race/ethnicity, dialysis modality, comorbidities, treatment regimen and U.S. region.</p> <p> </p> <p><b>Results</b>: Among 521,789 adults with DM/ESKD (median age 65 years [IQR 57-73], 56.1% male, and 46% White), overall adjusted rates of hypoglycemic and hyperglycemic crises were 53.64 and 18.24 per 1000 person-years, respectively. For both hypoglycemia and hyperglycemia crises, the risks decreased with age and were lowest in older patients (≥75 vs 18-44 years: IRR 0.35 [95% CI 0.33-0.37] and 0.03 [0.02-0.03], women (IRR 1.09 [1.06-1.12] and 1.44 [1.35-1.54]), and with smoking (IRR 1.36 [1.28-1.43] and 1.71 [1.53-1.91]), substance abuse (IRR 1.27 [1.15-1.42] and 1.53 [1.23-1.9]), retinopathy (IRR 1.10 [1.06-1.15] and 1.36 [1.26-1.47]), and insulin therapy (vs. no therapy; IRR 0.60 [0.59-0.63] and 0.44 [0.39-0.48]), respectively. For hypoglycemia, specifically, additional risk was conferred by Black race (IRR 1.11 [1.08-1.15]) and amputation history (IRR 1.20 [1.13-1.27]).</p> <p> </p> <p><b>Conclusions</b>: In this nationwide study of patients with DM/ESKD, hypoglycemic crises were three-fold more common than hyperglycemic crises, greatly exceeding national reports in non-dialysis patients with chronic kidney disease. Young, Black, and female patients were disproportionately affected. </p>
BACKGROUND:The objective of this study was to evaluate the association between self-identified race and overall survival (OS), progression-free survival (PFS), and response to therapy among patients enrolled in the randomized Cancer and Leukemia Group B (CALGB)/SWOG 80405 trial. METHODS: Patients with advanced or metastatic colorectal cancer who were enrolled in the CALGB/ SWOG 80405 trial were identified by race. On the basis of covariates (treatment arm, KRAS status, sex, age, and body mass index), each Black patient was exact matched with a White patient. The association between race and OS and PFS was examined using a marginal Cox proportional hazard model for matched pairs. The interaction between KRAS status and race was tested in the model. The association between race and response to therapy and adverse events were examined using a marginal logistic regression model. RESULTS: In total, 392 patients were matched and included in the final data set. No difference in OS (hazard ratio [HR], 0.92; 95% confidence interval [CI], 0.73-1.16), PFS (HR, 0.97; 95% CI, 0.78-1.20), or response to therapy (odds ratio [OR], 1.00; 95% CI, 0.65-1.52) was observed between Black and White patients.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.