Browsing by Subject "Titration"

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    Aducanumab: Appropriate Use Recommendations
    (Springer, 2021) Cummings, J.; Aisen, P.; Apostolova, L.G.; Atri, A.; Salloway, S.; Weiner, M.; Neurology, School of Medicine
    Aducanumab has been approved by the US Food and Drug Administration for treatment of Alzheimer's disease (AD). Clinicians require guidance on the appropriate use of this new therapy. An Expert Panel was assembled to construct Appropriate Use Recommendations based on the participant populations, conduct of the pivotal trials of aducanumab, updated Prescribing Information, and expert consensus. Aducanumab is an amyloid-targeting monoclonal antibody delivered by monthly intravenous infusions. The pivotal trials included patients with early AD (mild cognitive impairment due to AD and mild AD dementia) who had confirmed brain amyloid using amyloid positron tomography. The Expert Panel recommends that use of aducanumab be restricted to this population in which efficacy and safety have been studied. Aducanumab is titrated to a dose of 10 mg/kg over a 6-month period. The Expert Panel recommends that the aducanumab be titrated to the highest dose to maximize the opportunity for efficacy. Aducanumab can substantially increase the incidence of amyloid-related imaging abnormalities (ARIA) with brain effusion or hemorrhage. Dose interruption or treatment discontinuation is recommended for symptomatic ARIA and for moderate-severe ARIA. The Expert Panel recommends MRIs prior to initiating therapy, during the titration of the drug, and at any time the patient has symptoms suggestive of ARIA. Recommendations are made for measures less cumbersome than those used in trials for the assessment of effectiveness in the practice setting. The Expert Panel emphasized the critical importance of engaging in a process of patient-centered informed decision-making that includes comprehensive discussions and clear communication with the patient and care partner regarding the requirements for therapy, the expected outcome of therapy, potential risks and side effects, and the required safety monitoring, as well as uncertainties regarding individual responses and benefits.
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    Comparison of clinical pathways for hypoglossal nerve stimulation management: in-laboratory titration polysomnography vs home-based efficacy sleep testing
    (American Academy of Sleep Medicine, 2023) Kent, David; Huyett, Phillip; Yu, Phoebe; Ro, Asim; Mehra, Reena; Vensel Rundo, Jessica; Stahl, Stephanie; Manchanda, Shalini; Medicine, School of Medicine
    Study objectives: We conducted this study to evaluate whether laboratory or home-based hypoglossal nerve stimulation (HNS) management would have equivalent objective and subjective obstructive sleep apnea outcomes 6 months after activation. Methods: Patients undergoing standard-of-care HNS implantation were randomly assigned in a prospective, multicenter clinical trial to either a 3-month postactivation in-laboratory titration polysomnography (tPSG) or an efficacy home sleep study (eHST) with tPSG by exception for eHST nonresponders at 5 months. Both groups underwent an eHST 6 months postactivation. Results: Sixty patients were randomly assigned. Patients experienced equivalent decreases in the apnea-hypopnea index (mean difference: -0.01 events/h [-8.75, 8.74]) across both groups with HNS; the selection of tPSG or eHST did not associate with therapy response rates (tPSG vs eHST: 63.2% vs 59.1%). The Epworth Sleepiness Scale (median of differences: 1 [-1, 3]) and device usage (median of differences: 0.0 hours [-1.3, 1.3]) outcomes were similar but did not meet a priori statistical equivalence criteria. Conclusions: This prospective, multicenter, randomized clinical trial demonstrated that patients undergoing HNS implantation experienced statistically equivalent improvements in objective obstructive sleep apnea outcomes and similar improvements in daytime sleepiness regardless of whether they underwent tPSG. HNS titration with tPSG may not be required for all postoperative patients. Clinical trial registration: Registry: ClinicalTrials.gov; Name: Inspire Home Study: Utilization of Home Monitoring During Therapy Optimization in Patients With an Inspire Upper Airway Stimulation System (Comparison of Home Sleep Testing vs. In-lab Polysomnography Testing) (HOME); URL: https://clinicaltrials.gov/ct2/show/NCT04416542; Identifier: NCT04416542. Citation: Kent D, Huyett P, Yu P, et al. Comparison of clinical pathways for hypoglossal nerve stimulation management: in-laboratory titration polysomnography vs home-based efficacy sleep testing.