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1.
Alzheimers Dement ; 20(3): 1839-1850, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38145469

ABSTRACT

INTRODUCTION: Alzheimer's Prevention Initiative Generation Study 1 evaluated amyloid beta (Aß) active immunotherapy (vaccine) CAD106 and BACE-1 inhibitor umibecestat in cognitively unimpaired 60- to 75-year-old participants at genetic risk for Alzheimer's disease (AD). The study was reduced in size and terminated early. Results from the CAD106 cohort are presented. METHODS: Sixty-five apolipoprotein E ε4 homozygotes with/without amyloid deposition received intramuscular CAD106 450 µg (n = 42) or placebo (n = 23) at baseline; Weeks 1, 7, 13; and quarterly; 51 of them had follow-up Aß positron emission tomography (PET) scans at 18 to 24 months. RESULTS: CAD106 induced measurable serum Aß immunoglobulin G titers in 41/42 participants, slower rates of Aß plaque accumulation (mean [standard deviation] annualized change from baseline in amyloid PET Centiloid: -0.91[5.65] for CAD106 versus 8.36 [6.68] for placebo; P < 0.001), and three amyloid-related imaging abnormality cases (one symptomatic). DISCUSSION: Despite early termination, these findings support the potential value of conducting larger prevention trials of Aß active immunotherapies in individuals at risk for AD. HIGHLIGHTS: This was the first amyloid-lowering prevention trial in persons at genetic risk of late-onset Alzheimer's disease (AD). Active immunotherapy targeting amyloid (CAD106) was tested in this prevention trial. CAD106 significantly slowed down amyloid plaque deposition in apolipoprotein E homozygotes. CAD106 was generally safe and well tolerated, with only three amyloid-related imaging abnormality cases (one symptomatic). Such an approach deserves further evaluation in larger AD prevention trials.


Subject(s)
Alzheimer Disease , Amyloid beta-Peptides , Humans , Middle Aged , Aged , Amyloid beta-Peptides/metabolism , Alzheimer Disease/therapy , Alzheimer Disease/drug therapy , Homozygote , Apolipoprotein E4/genetics , Plaque, Amyloid , Amyloid/metabolism , Positron-Emission Tomography , Immunotherapy , Brain/metabolism
2.
Surgery ; 167(2): 432-435, 2020 02.
Article in English | MEDLINE | ID: mdl-31492434

ABSTRACT

BACKGROUND: As robotic surgery becomes more ubiquitous, determining clinical benefit is necessary to justify the cost and time investment required to become proficient. We hypothesized that robotic cholecystectomy would be associated with improved clinical outcomes but also increased cost as compared with standard laparoscopic cholecystectomy. MATERIALS AND METHODS: All patients undergoing robotic or laparoscopic cholecystectomy at a single academic hospital between 2007 and 2017 were identified using an institutional clinical data repository. Patients were stratified by operative approach (robotic versus laparoscopic) for comparison and propensity score matched 1:10 based on relevant comorbidities and demographics. Categorical variables were analyzed by the χ2 test and continuous variables using the Mann-Whitney U test. RESULTS: A total of 3,255 patients underwent cholecystectomy during the study period. We observed no differences in demographics or body mass index, but greater rates of diabetes mellitus, hypertension, and gastroesophageal reflux disease were present in the laparoscopic group. After matching (n = 106 robotic, n = 1,060 laparoscopic), there were no differences in preoperative comorbidities. Patients who underwent robotic cholecystectomy had lesser durations of stay (robotic: 0.1 ± 0.7 versus laparoscopic: 0.8 ± 1.9, P < .0001) and lesser 90-day readmission rates (robotic: 0% [0], laparoscopic: 4.1% [43], P = 0.035); however, both operative and hospital costs were greater compared with laparoscopic cholecystectomy. CONCLUSION: Robotic cholecystectomy is associated with lesser duration of stay and lesser readmission rate within 90 days of the index operation, but also greater operative duration and hospital cost compared with laparoscopic cholecystectomy. Hospitals and surgeons need to consider the improved clinical outcomes but also the monetary and time investment required before pursuing robotic cholecystectomy.


Subject(s)
Cholecystectomy, Laparoscopic/statistics & numerical data , Robotic Surgical Procedures/statistics & numerical data , Adult , Cholecystectomy, Laparoscopic/economics , Female , Humans , Male , Middle Aged , Operative Time , Patient Readmission/statistics & numerical data , Propensity Score , Robotic Surgical Procedures/economics , Treatment Outcome
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