364 Use of Blinded Hypnotic Tapering for Hypnotic Discontinuation: Final Report

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A145-A145
Author(s):  
Jack Edinger ◽  
Frederick Wamboldt ◽  
Kristen Holm ◽  
Rachel Johnson ◽  
Bryan Simmons ◽  
...  
Keyword(s):  
Benzodiazepine Receptor ◽  
Final Report ◽  
Weekly Dose ◽  
Open Label ◽  
Ctrl Group ◽  
Medication Dosage ◽  
Promising Treatment ◽  
Double Blinded ◽  
Hypnotic Dose

Abstract Introduction Many patients have difficulties achieving hypnotic discontinuation due to anxiety that arises when they knowingly reduce their hypnotic dose or withhold it entirely. This study tested a blinded tapering approach to reduce patients’ anxiety and help them discontinue their hypnotics. Methods The study sample included 78 (M age = 55.2 ± 12.8 yrs.; 65.4% women) users of benzodiazepine and benzodiazepine receptor agonists. Following baseline assessments, enrollees first completed 4 sessions of cognitive behavioral insomnia therapy (CBTI). Subsequently they were randomized to one of three 20-week, double-blinded tapering protocols wherein their medication dosage either remained unchanged (CTRL) or was reduced by 25% or 10% every two weeks. At the end of the 20-week period the study blind was eliminated and those who completed one of the two blinded tapering protocols entered a 3-month follow-up period, whereas CTRL participants were offered an open label taper before completing the follow-up. Results Among those who completed one of the blinded tapering protocols, 92.9% totally discontinued their medication use by the end of the 20-week tapering phase, whereas 77.3% in the CTRL group discontinued hypnotic use by the end of their open label tapering. At follow-up 72.1% of those who completed blinded tapering remained medication free whereas only 52% of those who underwent open-label tapering remained medication free. Comparisons at follow-up showed those who received the open-label taper continued to use hypnotics on average 2.06 nights/week compared to .051 times per week for the blinded taper group (p = .042). The average weekly diazepam equivalent dose of medication used by the open label tapering group was 11.29 mg whereas the weekly dose for the blinded tapering group was 3.22 (p = .069). Conclusion CBTI combined with blinded hypnotic tapering is a promising treatment approach for helping hypnotic users overcome their medication dependence. Support (if any) National Institute of Drug Abuse, Grant # R34 DA042329-01

scholarly journals 0509 Use of Blinded Hypnotic Tapering for Hypnotic Discontinuation

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A195-A195
Author(s):  
J D Edinger ◽  
F Walmboldt ◽  
K Holm ◽  
R L Johnson ◽  
B Simmons ◽  
...  
Keyword(s):  
Treatment Approach ◽  
Benzodiazepine Receptor ◽  
Weekly Dose ◽  
Open Label ◽  
Ctrl Group ◽  
Medication Dosage ◽  
Promising Treatment ◽  
Double Blinded ◽  
Hypnotic Dose

Abstract Introduction Many patients have difficulties achieving hypnotic discontinuation due to anxiety that arises when they knowingly reduce their hypnotic dose or withhold it entirely. This study tested a blinded tapering approach to reduce patients’ anxiety and help them discontinue their hypnotics. Methods The study sample included 78 (M age = 55.2 ± 12.8 yrs.; 65.4% women) users of benzodiazepine and benzodiazepine receptor agonists. Following baseline assessments, enrollees first completed 4 sessions of cognitive behavioral insomnia therapy (CBTI). Subsequently they were randomized to one of three 20-week, double-blinded tapering protocols wherein their medication dosage either remained unchanged (CTRL) or was reduced by 25% or 10% every two weeks. At the end of the 20-week period the study blind was eliminated and those who completed one of the two blinded tapering protocols entered a 3-month follow-up period, whereas CTRL participants were offered an open label taper before completing the follow-up. Results Among those who completed one of the blinded tapering protocols, 92.9% totally discontinued their medication use by the end of the 20-week tapering phase, whereas 77.3% in the CTRL group discontinued hypnotic use by the end of their open label tapering. At follow-up 72.1% of those who completed blinded tapering remained medication free whereas only 52% of those who underwent open-label tapering remained medication free. Comparisons at follow-up showed those who received the open-label taper continued to use hypnotics on average 2-3 nights/week compared to about 1 time every other week for the blinded taper group (p = .05). The average weekly diazepam equivalent dose of medication used by the open label tapering group was about 5 times higher than the average weekly dose used by the blind tapering group (p = .025). Conclusion CBTI combined with blinded hypnotic tapering is a promising treatment approach for helping hypnotic users overcome their medication dependence. Support National Institute of Drug Abuse, Grant # R34 DA042329-01

scholarly journals CTNI-14. A 3-ARM, PHASE IIA TRIAL OF SAFETY & EFFICACY OF OLINVACIMAB, A MONOCLONAL ANTIBODY TO VEGFR2 IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME WITH IMAGING AND PK/PD ASSESSMENTS: FINAL REPORT

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii44-ii45
Author(s):  
Lawrence Cher ◽  
Anna Nowak ◽  
George Iatropoulos ◽  
Samantha Bowyer ◽  
Hui Gan ◽  
...  
Keyword(s):  
Recurrent Glioblastoma ◽  
Final Report ◽  
Recurrent Glioblastoma Multiforme ◽  
Open Label ◽  
Impaired Wound Healing ◽  
Significant Difference ◽  
Angiogenic Effect ◽  
Vegf Pathway ◽  
Recurrent Gbm

Abstract The VEGF pathway remains an important target in GBM given its vascularity and autocrine VEGF signalling. Olinvacimab (TTAC-0001) is a fully humanised VEGFR2 Mab that binds and inhibits the receptor. This report assesses the safety, dosing schedules and efficacy of Olinvacimab in recurrent GBM. We conducted a two-site, 3 arm, open-label study of Olinvacimab in recurrent GBM. Eligible patients were ≥18 years with RANO-measurable lesion, KPS ≥ 80, and had completed chemoradiotherapy without prior bevacizumab therapy. We assessed three arms, 8 mg/kg and 12mg/kg weekly for 3 of every 4 weeks, and 12 mg/kg weekly. Three patients were treated in arms 1 and 2 and 6 in arm 3. Safety assessments were performed prior to dose escalation. The main toxicity was development of grade 1 (67%) and 2 (8%%) cutaneous haemangiomas. Common toxicities seen with other VEGF directed therapies, including hypertension, impaired wound healing, and proteinuria were not seen in this cohort. Efficacy was assessed by MRI using RANO criteria. 6 month PFS was 17%, with disease control in 25%, with steroid dose reduction. The longest response was 15 months. On DCE MRI, there was no significant difference in perfusion parameters between baseline and 1st follow-up MRI comparing those with SD and PD. However, 6 of 12 patients showed decreased Ktrans > 20 % of baseline, consistent with an anti-angiogenic effect of Olinvacimab. Pharmacokinetics showed a decreased clearance rate and increased half-life of Olinvacimab compared to the prior Phase I study. Pharmacodynamic studies showed significantly higher levels of angiogenic markers, particularly VEGF-A in those treated at 12mg/kg vs arm 1. VEGF-A, C and D levels were elevated in patients with SD compared to those with PD. Conclusion: Olinvacimab was well tolerated with a different toxicity profile to other VEGFR directed therapies. There were promising responses in 25% of patients.

scholarly journals Chinese Herbal Medicine Dingji Fumai Decoction for Ventricular Premature Contraction: A Real-World Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Bo Liang ◽  
Fei-Hu Zou ◽  
Ling Fu ◽  
Hui-Ling Liao
Keyword(s):  
Herbal Medicine ◽  
Chinese Herbal Medicine ◽  
Clinical Symptoms ◽  
Medication Compliance ◽  
Controlled Trial ◽  
Ventricular Premature Contraction ◽  
Traditional Chinese Medicine Syndrome ◽  
Chinese Herbal ◽  
Double Blinded

Background. Chinese herbal medicine Dingji Fumai Decoction (DFD) is widely clinically used for ventricular premature contraction (VPC). This real-word trial was designed to assess the safety and effectiveness of DFD for VPC. Methods. This was a double-blinded, randomized placebo-controlled trial. Patients with VPC were randomized (1 : 1) to treatment with DFD combined with metoprolol (DFD arm) or metoprolol combined with placebo (MET arm). A primary end point was a composite of clinical symptoms and signs determined by the traditionalChinese medicine syndrome score and the number of VPC determined by the Holter examination. Second outcomes were adverse events, medication compliance, and laboratory examination. Results. 144 patients were randomized to DFD arm (76 patients) or MET arm (68 patients), and 136 cases (71 in DFD arm and 65 in MET arm) finally completed this trial. After a 12-week follow-up, DFD arm significantly decreased traditional Chinese medicine syndrome score and the number of VPC compared with MET arm (P=0.003 and 0.034, respectively). There was no adverse drug effect and patient medication compliance was good. Conclusions. Superiority with DFD arm for VPC was demonstrated over MET arm for both the safety and effectiveness end points.

scholarly journals Low dose oral ketamine treatment in chronic suicidality: An open-label pilot study

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Adem T. Can ◽  
Daniel F. Hermens ◽  
Megan Dutton ◽  
Cyrana C. Gallay ◽  
Emma Jensen ◽  
...  
Keyword(s):  
Suicidal Ideation ◽  
Low Dose ◽  
Suicide Ideation ◽  
Well Being ◽  
Primary Outcome Measure ◽  
Open Label ◽  
Oral Ketamine ◽  
High Level ◽  
Chronic Suicidality

AbstractRecently, low-dose ketamine has been proposed as a rapid-acting treatment option for suicidality. The majority of studies to date have utilised intravenous (IV) ketamine, however, this route of administration has limitations. On the other hand, oral ketamine can be administered in a range of settings, which is important in treating suicidality, although studies as to safety and feasibility are lacking. n = 32 adults (aged 22–72 years; 53% female) with chronic suicidal thoughts participated in the Oral Ketamine Trial on Suicidality (OKTOS), an open-label trial of sub-anaesthetic doses of oral ketamine over 6 weeks. Participants commenced with 0.5 mg/kg of ketamine, which was titrated to a maximum 3.0 mg/kg. Follow-up assessments occurred at 4 weeks after the final dose. The primary outcome measure was the Beck Scale for Suicide Ideation (BSS) and secondary measures included scales for suicidality and depressive symptoms, and measures of functioning and well-being. Mean BSS scores significantly reduced from a high level of suicidal ideation at the pre-ketamine (week 0) timepoint to below the clinical threshold at the post-ketamine (week 6) timepoint. The proportion of participants that achieved clinical improvement within the first 6 weeks was 69%, whereas 50% achieved a significant improvement by the follow-up (week 10) timepoint. Six weeks of oral ketamine treatment in participants with chronic suicidality led to significant reduction in suicidal ideation. The response observed in this study is consistent with IV ketamine trials, suggesting that oral administration is a feasible and tolerable alternative treatment for chronic suicidality.

scholarly journals Echocardiographic screening for the anomalous aortic origin of coronary arteries

Open Heart ◽  
2021 ◽  
Vol 8 (1) ◽  
pp. e001495
Author(s):  
Francesco Bianco ◽  
Massimo Colaneri ◽  
Valentina Bucciarelli ◽  
Francesca Chiara Surace ◽  
Federica Valentina Iezzi ◽  
...  
Keyword(s):  
Young Adults ◽  
Coronary Arteries ◽  
Sports Activity ◽  
Coronary Ct ◽  
Registration Number ◽  
Echocardiographic Assessment ◽  
Echocardiographic Images ◽  
Double Blinded ◽  
Significant Increment

AimsWe sought to determine the diagnostic performance, clinical profiles and outcomes of anomalous aortic origin of coronary arteries (AAOCA) using a standardised echocardiographic approach in young adults and athletes.MethodsIn 2015–2019, we screened 5998 outpatients (age 16 years (Q1–Q3: 11, 36)), referred for routine echocardiography, using four specific echocardiographic windows: parasternal short/long axis and apical 4/5-chambers view. Coronary CT confirmed AAOCA. For the performance analysis, 300 coronary-CT scans were available; two independent and double-blinded physicians retrospectively reviewed echocardiographic images.ResultsA total of 47 AAOCA was diagnosed; the overall prevalence was 0.0078%. Over 5 years, we found a significant increment of AAOCA diagnostic rate (P for trend=0.002). Syncope (n=17/47) and palpitations (n=6/47) were prevalent symptoms. All patients suspended sports activity at the diagnosis. Twenty-seven patients underwent surgery, while 20 underwent a conservative medical treatment. All patients are alive at a median follow-up of 3±1.6 years; only surgical repairs restarted their activity. Our method showed better sensitivity than traditional short-axis evaluation: 93% vs 83%, p=0.0030 (AUC 0.96 (95% CI 0.92, 0.99) and AUC 0.89 (95% CI 0.83, 0.95), respectively), with a good interobserver agreement (95%, k=0.83, p<0.001).ConclusionsThe application of a standardised echocardiographic approach for AAOCA detection led to a significantly increased rate of identified anomalies. This approach demonstrated higher sensitivity than the traditional echocardiographic assessment. Implementing this protocol in clinical practice may help improve the AAOCA diagnosis in young adults and athletes.Trial registration numberNCT04224090.

scholarly journals Angiographic control versus ischaemia-driven management of patients undergoing percutaneous revascularisation of the unprotected left main coronary artery with second-generation drug-eluting stents: rationale and design of the PULSE trial

Open Heart ◽  
2020 ◽  
Vol 7 (2) ◽  
pp. e001253
Author(s):  
Ovidio De Filippo ◽  
Matteo Bianco ◽  
Matteo Tebaldi ◽  
Mario Iannaccone ◽  
Luca Gaido ◽  
...  
Keyword(s):  
Second Generation ◽  
Controlled Trial ◽  
Drug Eluting Stents ◽  
Major Adverse Cardiovascular Events ◽  
Relative Reduction ◽  
Left Main ◽  
Bleeding Events ◽  
Open Label ◽  
Drug Eluting

BackgroundThe role of planned angiographic control (PAC) over a conservative management driven by symptoms and ischaemia following percutaneous coronary intervention (PCI) of the unprotected left main (ULM) with second-generation drug-eluting stents remains controversial. PAC may timely detect intrastent restenosis, but it is still unclear if this translated into improved prognosis.Methods and analysisPULSE is a prospective, multicentre, open-label, randomised controlled trial. Consecutive patients treated with PCI on ULM will be included, and after the index revascularisation patients will be randomised to PAC strategy performed with CT coronary after 6 months versus a conservative symptoms and ischaemia-driven follow-up management. Follow-up will be for at least 18 months from randomisation. Major adverse cardiovascular events at 18 months (a composite endpoint including death, cardiovascular death, myocardial infarction (MI) (excluding periprocedural MI), unstable angina, stent thrombosis) will be the primary efficacy outcome. Secondary outcomes will include any unplanned target lesion revascularisation (TLR) and TLR driven by PAC. Safety endpoints embrace worsening of renal failure and bleeding events. A sample size of 550 patients (275 per group) is required to have a 80% chance of detecting, as significant at the 5% level, a 7.5% relative reduction in the primary outcome.Trial registration numberNCT04144881

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