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 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.

FRI0386 Efficacy and Safety of Off-Label Use of Rituximab in Refractory Lupus: Data from the Italian Multicenter Registry: Table 1.

2014 ◽  
Vol 73 (Suppl 2) ◽  
pp. 527.2-527 ◽  
Author(s):  
L. Iaccarino ◽  
S. De Vita ◽  
G. Ferraccioli ◽  
M. Galeazzi ◽  
R. Gerli ◽  
...  
Keyword(s):  
Efficacy And Safety ◽  
Off Label Use ◽  
Off Label ◽  
Multicenter Registry ◽  
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 Patient Controlled, Off-label Use of Continuous Glucose Monitoring: Real-World Medical Costs and Effects of Patient Controlled Sensor Augmented Pump Therapy in Adult Patients Type 1 Diabetes

2020 ◽  
pp. 193229682092090
Author(s):  
Patrik Hidefjäll ◽  
Lars Berg
Keyword(s):  
Type 1 Diabetes ◽  
Data Analysis ◽  
Cost Effectiveness ◽  
Continuous Glucose Monitoring ◽  
Real World ◽  
Glucose Monitoring ◽  
Off Label Use ◽  
Pump Therapy ◽  
Off Label

Background: Continuous glucose monitoring (CGM) has shown promise to reduce glycated hemoglobin (HbA1c) levels, but its cost-effectiveness is seen as uncertain by reimbursement agencies. The aim of this study was to explore the impact of real-world, off-label, patient controlled CGM use in combination with continuous subcutaneous insulin infusion (CSII) on costs and effects in patients with type 1 diabetes in a Swedish clinic. Methods: A real-world, retrospective study with questionnaire on CGM use by adult patients with type 1 diabetes on CSII (Animas Vibe) were offered sensor augmented pump therapy (SAPT) (Dexcom G4) as part of hospital innovation funding program. Direct medical costs, HbA1c, and complications following switch from CSII with self-monitoring of blood glucose (SMBG) to SAPT were calculated. Results: Questionnaire data showed that CGM sensors were on average used 92% of the time for 22 days. One hundred and thirty-nine (95%) of 146 respondents used each sensor for longer than one week. Data analysis showed a statistically significant HbA1c decrease of 0.56% (6.1 mmol/mol) after change to SAPT. In patients using the sensor 100%, the decrease was 0.89% (9.8 mmol/mol). The analysis showed that SAPT led to higher costs (5500 USD/year) than CSII + SMBG (3680 USD/year), with incremental costs being 1815 USD per year to achieve an HbA1c decrease of 0.56% (6.1 mmol/mol). The incidence of all complications declined after switch to SAPT. Conclusion: The primary data analysis showed a decrease in HbA1c values following switch to SAPT, corresponding to previous cost-effectiveness studies, but at substantially lower costs due to longer sensor off-label use.

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.

scholarly journals Off-label use of maraviroc in clinical practice

2015 ◽  
Vol 14 (1) ◽  
pp. 5-8 ◽  
Author(s):  
José-Ramón Blanco ◽  
Laura Ochoa-Callejero
Keyword(s):  
Clinical Practice ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

Drug use beyond the licence in palliative care: A systematic review and narrative synthesis

2019 ◽  
Vol 33 (6) ◽  
pp. 650-662 ◽  
Author(s):  
Vera Hagemann ◽  
Claudia Bausewein ◽  
Constanze Remi
Keyword(s):  
Palliative Care ◽  
Clinical Practice ◽  
Drug Use ◽  
Meta Analysis ◽  
Management Strategies ◽  
Narrative Synthesis ◽  
Off Label Use ◽  
Off Label ◽  
Study Designs ◽  
Label Use

Background: Drug use beyond the licence (off-label use, off-label drug use) is a common practice in palliative care and respective recommendations can often be identified in the literature. It is both risky and offers opportunities at the same time and, therefore, requires special attention in clinical practice. Aim: To determine the prevalence of off-label drug use in palliative care and to identify, evaluate and critically appraise studies describing the clinical practice, healthcare professionals’ awareness, knowledge and attitudes towards off-label-use and management strategies. Design: Systematic literature review following the guidance of the Centre for Reviews and Dissemination. Data sources: Medline, Embase, Web of Science and Current Contents Connect were searched in July 2018 as well as hand searches. The reference lists of pertinent studies were screened for further relevant publications, and citation tracking was performed. Results: Eight studies met the inclusion criteria. Due to the variety in study designs and settings, no meta-analysis or meaningful statistical analysis was possible and a narrative synthesis of the data was performed. Frequency of off-label drug use ranged from 14.5% to 35%. Up to 97% of palliative care units did not have any policy or guidance on handling off-label drug use. About 20% of prescribers never obtain consent in the context of off-label use. Conclusion: Off-label use is common in palliative care with up to one-third of prescriptions affected. Challenges are often related to obtaining informed consent. Little is known about the decision-making process. More information and guidance for the prescribers are needed to enable safe handling of drugs outside their licence in palliative care.

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