Off-label use of maraviroc in clinical practice

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.

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

Diabetes Technology & Therapeutics ◽

10.1089/dia.2019.0316 ◽

2020 ◽

Vol 22 (3) ◽

pp. 208-215 ◽

Cited By ~ 2

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

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

European Journal of Clinical Pharmacology ◽

10.1007/s00228-013-1518-4 ◽

2013 ◽

Vol 69 (9) ◽

pp. 1689-1699 ◽

Cited By ~ 9

Author(s):

I. Danés ◽

A. Agustí ◽

A. Vallano ◽

J. Martínez ◽

C. Alerany ◽

...

Keyword(s):

Clinical Practice ◽

Off Label Use ◽

Off Label ◽

Label Use

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

AIDS ◽

10.1097/qad.0000000000000819 ◽

2015 ◽

Vol 29 (16) ◽

pp. 2155-2159 ◽

Cited By ~ 3

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

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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)

HIV Infection and Immunosuppressive Disorders ◽

10.22328/2077-9828-2021-13-1-59-69 ◽

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

Palliative Medicine ◽

10.1177/0269216319840602 ◽

2019 ◽

Vol 33 (6) ◽

pp. 650-662 ◽

Cited By ~ 5

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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6ER-007 Off-label use of dalbavancin in gram-positive infections: effectiveness, safety and cost in clinical practice

10.1136/ejhpharm-2019-eahpconf.604 ◽

2019 ◽

Author(s):

E Chamorro-De Vega ◽

CG Rodriguez-Gonzalez ◽

ME Rochet ◽

M Valerio ◽

M Olmedo ◽

...

Keyword(s):

Clinical Practice ◽

Off Label Use ◽

Gram Positive ◽

Off Label ◽

Label Use

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Off-label use of ketamine for treatment-resistant depression in clinical practice: European perspective

The British Journal of Psychiatry ◽

10.1192/bjp.2019.102 ◽

2019 ◽

Vol 215 (2) ◽

pp. 447-448 ◽

Cited By ~ 2

Author(s):

Álvaro López-Díaz ◽

Manuel Murillo-Izquierdo ◽

Elisa Moreno-Mellado

Keyword(s):

Clinical Practice ◽

Public Healthcare ◽

Evidence Based ◽

European Perspective ◽

Treatment Resistant Depression ◽

Off Label Use ◽

Treatment Resistant ◽

Off Label ◽

Resistant Depression ◽

Label Use

SummaryKetamine therapy for treatment-resistant depression in European national health systems may only be considered after attempting all evidence-based antidepressant strategies outlined in clinical guidelines. This paper seeks to explain the ethical, regulatory and procedural framework for the off-label use of ketamine for treatment-resistant depression within a public healthcare system.Declaration of interestNone.

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