scholarly journals Propranolol in Use for Treatment of Complex Infant Hemangiomas: Literature Review Regarding Current Guidelines for Preassessment and Standards of Care before Initiation of Therapy

2013 ◽  
Vol 2013 ◽  
pp. 1-9 ◽  
Author(s):  
Andreas Fette
Keyword(s):  
Clinical Practice ◽  
Literature Review ◽  
Paradigm Shift ◽  
Standards Of Care ◽  
Current Evidence ◽  
Off Label Use ◽  
Off Label ◽  
Positive Effects ◽  
Initiation Of Therapy ◽  
Current Guidelines

In 2008, the positive effects of propranolol on infantile hemangiomas (IH) have been discovered serendipitously by Léauté-Labrèze and her coworkers. Since then, propranolol has been in use in allday clinical practice worldwide for treatment of IH. It even caused some kind of paradigm shift in the overall management of these lesions, though propranolol is still not FDA approved, respectively, in “off-label” use for this indication in the majority of institutions. Thus, the aim of this communication is to evaluate the literature for current evidence regarding guidelines for preassessment and standards of care before initiation of therapy.

scholarly journals Apixaban for Stroke Prevention in Atrial Fibrillation: Why are Event Rates Higher in Clinical Practice than in Randomized Trials?—A Systematic Review

2020 ◽  
Vol 120 (09) ◽  
pp. 1323-1329 ◽  
Author(s):  
Tim A. C. de Vries ◽  
Jack Hirsh ◽  
Ke Xu ◽  
Imaad Mallick ◽  
Vinai C. Bhagirath ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Practice ◽  
Thromboembolic Event ◽  
Meta Analysis ◽  
Patient Characteristics ◽  
Thromboembolic Events ◽  
Off Label Use ◽  
Off Label ◽  
Event Rates ◽  
Label Use

Abstract Background Recent reports suggest an important contribution from frequent off-label use of apixaban 2.5 mg twice daily to the higher rates of thromboembolic events observed in observational studies (OSs) relative to in randomized controlled trials (RCTs), and consequently, advocate against such use in all patients. Objectives To examine factors contributing to the higher thromboembolic event rates, we estimated the prevalence of off-label use in contemporary practice, and compared patient characteristics and rates of stroke/systemic embolism, major bleeding, and mortality by apixaban dose and by study design in a systematic review and meta-analysis. Results and Discussion We identified 18 OSs and 2 RCTs that included 155,228 and 11,928 patients, respectively. Patients in OSs more often received apixaban 2.5 mg twice daily (31.3% vs. 5.1%), were older (mean age 73.8 vs. 69.8 years), and had higher CHA2DS2-VASc scores (mean 3.6 vs. 2.9) versus those in RCTs. We observed a consistent pattern of higher rates of thromboembolic events, bleeding, and mortality in patients treated with 2.5 versus 5 mg twice daily apixaban in both OSs and RCTs. Conclusion The higher risk profiles of patients in OSs versus RCTs, and higher rates of both bleeding and mortality not attributable to thromboembolism in patients treated with apixaban 2.5 versus 5 mg twice daily suggest that differences in patient characteristics are additional important contributors to the higher than expected thromboembolic event rates in clinical practice.

Efficacy and Safety of SGLT2 Inhibitors in Type 1 Diabetes After the Introduction of an Off-Label Use Protocol for Clinical Practice

2020 ◽  
Vol 22 (3) ◽  
pp. 208-215 ◽  
Author(s):  
Ane Bayona Cebada ◽  
Lía Nattero-Chávez ◽  
Sara Alonso Díaz ◽  
Héctor F. Escobar-Morreale ◽  
Manuel Luque-Ramírez
Keyword(s):  
Type 1 Diabetes ◽  
Clinical Practice ◽  
Sglt2 Inhibitors ◽  
Efficacy And Safety ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

scholarly journals Trastuzumab and Metastatic Breast Cancer: Trastuzumab Use in Australia—Monitoring the Effect of an Expensive Medicine Access Program

2007 ◽  
Vol 25 (24) ◽  
pp. 3688-3693 ◽  
Author(s):  
Sallie-Anne Pearson ◽  
Clare L. Ringland ◽  
Robyn L. Ward
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Metastatic Breast Cancer ◽  
Clinical Practice ◽  
Metastatic Breast ◽  
Cardiac Monitoring ◽  
Off Label Use ◽  
Off Label ◽  
Trastuzumab Therapy ◽  
Drug Wastage

Purpose Data from clinical trials are used for drug registration; however, many cancer medicines are ultimately used off-label. This study examines the extent to which the clinical practice use of trastuzumab for the treatment of metastatic breast cancer differs from its use under trial conditions. Methods This study involved all women (N = 1,469) with metastatic breast cancer who received trastuzumab in Australia between December 2001 and March 2005. Given that Australia operates a universal health care system, administrative databases could be examined to determine the duration of therapy, rate of off-label use, compliance with cardiac monitoring, and the extent of drug wastage (volume and cost). Results A total of 433 enrollees (29.5%) received trastuzumab as monotherapy and 1,036 enrollees (70.5%) received the drug in combination with chemotherapy. A total of 321 women (22%) received off-label trastuzumab. The median duration of trastuzumab therapy was longer than that on trial: 5.6 v 3.1 months for enrollees receiving monotherapy and 12.5 v 6.9 months for concomitant chemotherapy. Only 47 (3%) of enrollees received cardiac monitoring before and during trastuzumab therapy. We estimated 24% of trastuzumab dispensed was discarded, at a cost of $21.1 million Australian. Alternative administration schedules and the addition of another vial size potentially reduce wastage to 6% of volume dispensed. Conclusion Debates about the use of expensive cancer medicines should consider postmarketing assessments as well as trial experience. The longer duration of trastuzumab use in clinical practice and the high rates of off-label use provide incentive for new clinical trials. Strategies to improve cardiac monitoring and to minimize drug wastage are issues that require immediate attention.

scholarly journals «Off-label» use of botulinic toxin type A preparations in neurological practice

2018 ◽  
Vol 20 (2) ◽  
pp. 195-201
Author(s):  
L R Akhmadeeva ◽  
Kh P Derevyanko
Keyword(s):  
Botulinum Toxin ◽  
Therapeutic Option ◽  
Botulinum Toxin Type A ◽  
Case Series ◽  
Type A ◽  
Botulinum Toxin Type ◽  
Off Label Use ◽  
Off Label ◽  
Positive Effects ◽  
Label Use

The modern view on the application of botulinum toxin type A for the off-label use in neurology and foreign experience analysis are presented. The «off-label» category referred to any prescription of a medication in case of using it for unregistered indications, with product instruction violation or in the presence of contraindications including age restrictions. The sources of information about medicines were the leaflets of manufacturers of medicines and the State Register of Medicines. It is well known that Botulinum toxin type A is a good therapeutic option for treating children with cerebral palsy. Increased efficacy of regularly repeated cycles with Onabotulinumtoxin A in medication-overuse headache patients beyond the first year of treatment. Botulinum toxin type A is effective in the management of sialorrhea. Botulinum toxin type A is a safe and effective treatment for primary axillary hyperhidrosis and produces high levels of patient satisfaction. Facing depression with botulinum toxin: positive effects on mood have been observed in subjects who underwent treatment of glabellar frown lines with botulinum toxin and, in an open case series, depression remitted or improved after such a treatment. Botox injection significantly improved foot dystonia, pain and lower limb functional outcomes in patients with Parkinson’s disease with deep brain stimulation. The paper describes the problems associated with the lack of clinical data about the possibility of using botulinum toxin type A in different conditions, emphasizes the need to organize clinical trials and educational programs for neurologists as well as more active implementation of protocols for the treatment of patients.

Off-Label Use of Clozapine in Children and Adolescents—A Literature Review

2019 ◽  
Vol 26 (3) ◽  
pp. e406-e416 ◽  
Author(s):  
Vivekananda Rachamallu ◽  
Benjamin W. Elberson ◽  
Emily Vutam ◽  
Manish Aligeti
Keyword(s):  
Literature Review ◽  
Children And Adolescents ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

scholarly journals Available evidence and outcome of off-label use of rituximab in clinical practice

2013 ◽  
Vol 69 (9) ◽  
pp. 1689-1699 ◽  
Author(s):  
I. Danés ◽  
A. Agustí ◽  
A. Vallano ◽  
J. Martínez ◽  
C. Alerany ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

Off-label use of maraviroc in HIV-1-infected paediatric patients in clinical practice

AIDS ◽  
2015 ◽  
Vol 29 (16) ◽  
pp. 2155-2159 ◽  
Author(s):  
Claudia Palladino ◽  
María Luisa Navarro Gómez ◽  
Pere Soler-Palacín ◽  
María Isabel González-Tomé ◽  
Santiago J. De Ory ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Off Label Use ◽  
Off Label ◽  
Paediatric Patients ◽  
Hiv 1 ◽  
Label Use

scholarly journals Expert Opinion on COVID-19 Vaccination and the Use of Cladribine Tablets in Clinical Practice

2021 ◽  
Author(s):  
Peter Rieckmann ◽  
Diego Centonze ◽  
Gavin Giovannoni ◽  
Le H Hua ◽  
Celia Oreja-Guevara ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Expert Opinion ◽  
Steering Committee ◽  
Current Evidence ◽  
Clinical Recommendations ◽  
Before And After ◽  
Agreement Score ◽  
Clinical Questions ◽  
Practice Methods ◽  
Current Guidelines

Background: Gaps in current evidence and guidance leave clinicians with unanswered questions on the use of cladribine tablets for the treatment of multiple sclerosis (MS) in the era of the COVID 19 pandemic, in particular relating to COVID 19 vaccination. Objective: We describe a consensus-based programme led by international MS experts with the aim of supplementing current guidelines and treatment labels by providing timely recommendations relating to COVID 19 vaccination and the use of cladribine tablets in clinical practice. Methods: A steering committee (SC) of 10 international MS experts identified 7 clinical questions to answer concerning the use of cladribine tablets and COVID 19 vaccination, which addressed issues relating to patient selection, timing and efficacy, and safety. Clinical recommendations to address each question were drafted using available evidence combined with expert opinion from the SC. An extended faculty of 28 MS experts, representing 19 countries, in addition to the SC members, voted on the recommendations. Consensus on recommendations was achieved when more than or equal to 75% of respondents expressed an agreement score of 7 to 9, on a 9 point scale. Results: Consensus was achieved on all 13 recommendations. Clinical recommendations are provided on whether all patients with MS receiving cladribine tablets should be vaccinated against COVID 19, and whether they should be prioritized; the timing of vaccination around dosing of cladribine tablets (i.e., before and after a treatment course); and the safety of COVID 19 vaccination for these patients. Conclusions: These expert recommendations provide timely guidance on COVID 19 vaccination in patients receiving cladribine tablets, which is relevant to everyday clinical practice.

scholarly journals First experience of off-label use GLE/PIB+SOF in treating a patient with relapse of RNA HCV 1b viremia and RAS R117H in the NS3 region after NS3/4A PI + NS5AI + NS5BI failure of 3D-therapy PTV/R/OBV+DSV in Russia (case report)

2021 ◽  
Vol 13 (1) ◽  
pp. 59-69
Author(s):  
D. L. Sulima ◽  
A. A. Yakovlev ◽  
V. N. Koryagin ◽  
V. A. Larionov ◽  
O. V. Gorchakova ◽  
...  
Keyword(s):  
Case Report ◽  
Clinical Practice ◽  
Virological Response ◽  
Immunological Response ◽  
Off Label Use ◽  
Off Label ◽  
Free Mode ◽  
First Time ◽  
Label Use

For the first time in Russia, a description of a case of full application in clinical practice of a completely interferon-free mode of the 3D-mode GLE/PIB + SOF for the treatment of recurrence of HCV 1b RNA viremia after a primary course of interferonfree therapy in the PTV/r/OBV + DSV mode, which included inhibitors of NS3/4A PI, NS5Ai and NS5Bi, in a patient with combined HCV syndrome is presented. The target result of the repeated course of interferon-free therapy — SVR12 — was achieved despite the presence of significant RAS R117H in the NS3 region of the HCV genome and multiple RASs in the NS3 and NS5A regions, the nature of resistance of which to the corresponding inhibitors of GLE and PIB was unknown. Along with a complete virological response, the treatment also achieved a complete immunological response, which lasted for 12 weeks after the end of the repeated course of interferon-free therapy.

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