ABSTRACT
BACKGROUND AND PURPOSE: The landmark National Institute of Neurological Disorders and Stroke (NINDS) tissue plasminogen activator (tPA) trial established the effectiveness and dosing of intravenous tPA for acute ischemic stroke (AIS) at .9 mg/kg with a maximum dose of 90 mg. Since the publication of the NINDS trial in 1995, there has been a drastic increase in the amount of obesity and the average weight of adults in the United States, which has caused an increase in the number of patients receiving 90 mg of alteplase for AIS. This retrospective trial was an attempt to see if reduced-dose tPA is as effective as full .9 mg/kg dosing. METHODS: We performed a single-center retrospective analysis to assess the dosing rate and 90-day outcomes comparing maximum dosage (90 mg) and standard dosage (.9 mg/kg) of tPA. RESULTS: A total of 301 patients were included in the analysis with 64 (21%) receiving less than .9 mg/kg dosing. The adjusted binary logistic regression model showed a statistically significant association toward a good outcome for increases in tPA dose rate (odds ratio = 1.7, P = .027) when compared against a poor outcome. Our analysis showed that patients receiving doses of alteplase closer to .9 mg/kg had a higher likelihood of a modified Rankin Scale score of 0-1 at 90 days. CONCLUSIONS: With the growth of obesity in the United States and the lack of data supporting dose capping of alteplase, it remains unclear if this dosing practice should continue to be accepted without question. Further studies are needed to assess optimum dosing practices particularly given the obesity epidemic.
Subject(s)
Body Weight , Brain Ischemia/drug therapy , Drug Dosage Calculations , Fibrinolytic Agents/administration & dosage , Obesity/physiopathology , Stroke/drug therapy , Thrombolytic Therapy/methods , Tissue Plasminogen Activator/administration & dosage , Adult , Aged , Aged, 80 and over , Brain Ischemia/diagnosis , Brain Ischemia/epidemiology , Brain Ischemia/physiopathology , Disability Evaluation , Female , Fibrinolytic Agents/adverse effects , Humans , Logistic Models , Male , Middle Aged , Obesity/diagnosis , Obesity/epidemiology , Odds Ratio , Recovery of Function , Retrospective Studies , Stroke/diagnosis , Stroke/epidemiology , Stroke/physiopathology , Thrombolytic Therapy/adverse effects , Time Factors , Tissue Plasminogen Activator/adverse effects , Treatment Outcome , West Virginia/epidemiology , Young AdultABSTRACT
BACKGROUND: The purpose of this study was to evaluate the effectiveness of directly integrating self-monitoring blood glucose (BG) information with insulin pump therapy on overall glycemic control. METHODS: In this randomized trial, 34 youth with type 1 diabetes using insulin pump therapy were trained on the use of the Deltec Cozmo Insulin Pump. Seventeen were randomized to use the CoZmonitor Blood Glucose Module, a device that attaches to the back of the pump using FreeStyle technology to perform BG tests which read directly on the pump screen. The remaining 17 (control group) used a FreeStyle Flash meter, a stand-alone BG meter, for their BG testing. At baseline, 3 and 6 months, the subjects filled out a questionnaire, had a hemoglobin A1c (HbA1c) test, and had pumps and meters downloaded. RESULTS: After 3 months of study, there were no changes in mean HbA1c (+/- SD) values for the experimental (8.7 +/- 1.1 to 8.6 +/- 1.1) or the control groups (9.1 +/- 1.4 to 9.2 +/- 1.5). There were also no significant differences in HbA1c values after 6 months. The average number of BG tests per day did not change significantly in either group during the study. After 3 and 6 months, the experimental group rated satisfaction with the use of the CoZmonitor at 4.4 and 3.8 (respectively) on a five-point Likert scale, with 5 being the most satisfied. CONCLUSIONS: Although significant changes in HbA1c values or the number of BG tests were not found, use of the BG module had a positive level of satisfaction.
Subject(s)
Blood Glucose/analysis , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 1/drug therapy , Monitoring, Ambulatory/instrumentation , Adolescent , Adult , Blood Glucose/metabolism , Child , Glycated Hemoglobin/metabolism , Humans , Insulin Infusion Systems , Patient SelectionABSTRACT
OBJECTIVE: The aim of this study was to determine whether the use of meal bolus alarms would result in fewer missed meal boluses per week in youth with type 1 diabetes using continuous subcutaneous insulin infusion (CSII) therapy. RESEARCH DESIGN AND METHODS: This was a randomized trial of 48 youth using CSII, who were in suboptimal glycemic control with HbA(1c) (A1C) values > or =8.0%. Twenty-four subjects were randomized to use a Deltec Cozmo insulin pump with meal bolus alarms (experimental group), while the other 24 subjects continued use of their current insulin pumps (control group) without meal bolus alarms. RESULTS: After 3 months of study, the number of missed meal boluses per week was significantly lower in the experimental group (from 4.9 +/- 3.7 to 2.5 +/- 2.5; P = 0.0005) but not significantly lower in the control group (from 4.3 +/- 2.7 to 4.2 +/- 3.9; P = 0.7610). Also after 3 months, the mean A1C value of the experimental group declined significantly (from 9.32 +/- 1.12 to 8.86 +/- 1.10; P = 0.0430). No significant decline in A1C was present for the control group (from 8.93 +/- 1.04 to 8.67 +/- 1.17; P = 0.1940). After 6 months of study, the significant decline in A1C from baseline in the experimental group was no longer present. Pooling of all available data from the control and experimental groups showed that at baseline and 3 and 6 months, the number of missed meal boluses per week was significantly correlated with A1C values. CONCLUSIONS: While meal bolus alarms may have the potential to improve suboptimal glycemic control in youth using CSII, our results demonstrated that these alarms had only a transient, modest effect in doing so.
