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1.
JAMA ; 331(1): 38-48, 2024 01 02.
Article in English | MEDLINE | ID: mdl-38078870

ABSTRACT

Importance: The effect of continued treatment with tirzepatide on maintaining initial weight reduction is unknown. Objective: To assess the effect of tirzepatide, with diet and physical activity, on the maintenance of weight reduction. Design, Setting, and Participants: This phase 3, randomized withdrawal clinical trial conducted at 70 sites in 4 countries with a 36-week, open-label tirzepatide lead-in period followed by a 52-week, double-blind, placebo-controlled period included adults with a body mass index greater than or equal to 30 or greater than or equal to 27 and a weight-related complication, excluding diabetes. Interventions: Participants (n = 783) enrolled in an open-label lead-in period received once-weekly subcutaneous maximum tolerated dose (10 or 15 mg) of tirzepatide for 36 weeks. At week 36, a total of 670 participants were randomized (1:1) to continue receiving tirzepatide (n = 335) or switch to placebo (n = 335) for 52 weeks. Main Outcomes and Measures: The primary end point was the mean percent change in weight from week 36 (randomization) to week 88. Key secondary end points included the proportion of participants at week 88 who maintained at least 80% of the weight loss during the lead-in period. Results: Participants (n = 670; mean age, 48 years; 473 [71%] women; mean weight, 107.3 kg) who completed the 36-week lead-in period experienced a mean weight reduction of 20.9%. The mean percent weight change from week 36 to week 88 was -5.5% with tirzepatide vs 14.0% with placebo (difference, -19.4% [95% CI, -21.2% to -17.7%]; P < .001). Overall, 300 participants (89.5%) receiving tirzepatide at 88 weeks maintained at least 80% of the weight loss during the lead-in period compared with 16.6% receiving placebo (P < .001). The overall mean weight reduction from week 0 to 88 was 25.3% for tirzepatide and 9.9% for placebo. The most common adverse events were mostly mild to moderate gastrointestinal events, which occurred more commonly with tirzepatide vs placebo. Conclusions and Relevance: In participants with obesity or overweight, withdrawing tirzepatide led to substantial regain of lost weight, whereas continued treatment maintained and augmented initial weight reduction. Trial Registration: ClinicalTrials.gov Identifier: NCT04660643.


Subject(s)
Anti-Obesity Agents , Obesity , Weight Loss , Adult , Female , Humans , Male , Middle Aged , Double-Blind Method , Gastric Inhibitory Polypeptide/administration & dosage , Gastric Inhibitory Polypeptide/adverse effects , Gastric Inhibitory Polypeptide/pharmacology , Gastric Inhibitory Polypeptide/therapeutic use , Obesity/drug therapy , Obesity/complications , Overweight/complications , Overweight/drug therapy , Treatment Outcome , Weight Loss/drug effects , Glucagon-Like Peptide-2 Receptor/administration & dosage , Glucagon-Like Peptide-2 Receptor/agonists , Glucagon-Like Peptide-2 Receptor/therapeutic use , Incretins/administration & dosage , Incretins/adverse effects , Incretins/pharmacology , Incretins/therapeutic use , Anti-Obesity Agents/administration & dosage , Anti-Obesity Agents/adverse effects , Anti-Obesity Agents/pharmacology , Anti-Obesity Agents/therapeutic use , Maintenance Chemotherapy , Injections, Subcutaneous , Withholding Treatment
2.
Ann Thorac Surg ; 112(3): e169-e171, 2021 09.
Article in English | MEDLINE | ID: mdl-33497668

ABSTRACT

We report the case of an 18-year-old male patient with a history of bicuspid aortic valve with severe aortic insufficiency who had undergone a Ross procedure 1 year prior but subsequently developed stenosis of the pulmonary homograft necessitating conduit replacement. His postoperative course was complicated by acute respiratory distress syndrome. Bronchoscopy revealed significant mucus plugging without identification of contributing pathogen. Further evaluation revealed a history of electronic cigarette use not identified preoperatively and thought to be largely contributory to his postoperative complications. This case highlights the importance of screening preoperatively for electronic cigarette use and counseling on cessation before surgical procedures.


Subject(s)
Postoperative Complications/etiology , Respiratory Distress Syndrome/etiology , Vaping/adverse effects , Adolescent , Humans , Male
3.
Fam Syst Health ; 37(3): 212-223, 2019 09.
Article in English | MEDLINE | ID: mdl-31328928

ABSTRACT

INTRODUCTION: Improving family centered care in the PICU requires understanding the milestones that families need assistance preparing for as well as factors that facilitate or obstruct preparedness. We present a model of family preparedness for transitions in the PICU based on semistructured interviews with clinicians and families that is designed to improve family centered care through the reduction of failed or traumatic transitions. METHOD: We conducted semistructured interviews with 20 clinicians and 25 families in an academic PICU. Transcript analysis focused on identifying factors facilitating or obstructing family preparedness for care transitions. We analyzed interview transcripts for emergent themes and metathemes using grounded theory methodology. RESULTS: Family preparedness for care transitions is dependent upon both cognitive and emotional preparedness. Six metathemes form a novel model for understanding the factors influencing both components of preparedness and their interrelationship. Specifically, family preparedness is influenced by (a) individualized backgrounds, coping skills, and support systems as well as the (b) emotional context, (c) care environment, (d) course of care, (e) content of preparatory information, and (f) manner in which care is coordinated to effectively deliver information. We also describe 10 transitional categories that provide context for application of the model. DISCUSSION: Cognitive and emotional preparedness for care transitions in the PICU develops through attentiveness to six features. The conceptual model presented here will allow clinicians to support family centered care through interventions to facilitate a shared development of expectations for the future and reduce the risk of failed or traumatic transitions. (PsycINFO Database Record (c) 2019 APA, all rights reserved).


Subject(s)
Critical Illness/rehabilitation , Disabled Children/rehabilitation , Family , Transition to Adult Care/trends , Child , Cohort Studies , Female , Humans , Male , Transition to Adult Care/standards
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