LCP-tacrolimus administered daily to target a goal trough level of 10-14 ng/mL x 7 months (with Mycophenolate mofetil and prednisone).
Additional standard immunosuppression with either mycophenolate mofetil (500-1500mg twice daily) OR Azathioprine (up to 2mg/kg daily) AND Prednisone (5-10mg daily) will be administered.

IR-tacrolimus administered twice daily to target a goal trough level of 10-14 ng/mL x 7 months (with Mycophenolate mofetil and prednisone). This is currently the standard of care at Vanderbilt University Medical Center and most other lung transplant centers (ISHLT Registry 2019).
Additional standard immunosuppression with either mycophenolate mofetil (500-1500mg twice daily) OR Azathioprine (up to 2mg/kg daily) AND Prednisone (5-10mg daily) will be administered.

Lung Transplant; Complications

Immunosuppression regimen with Tacrolimus Extended Release as the backbone.

Tacrolimus Extended Release Oral Tablet [Envarsus]

Standard Immunosuppression regimen with Intermediate-Release Tacrolimus.

Tacrolimus

Standard immunosuppression of the anti-proliferative class.

Mycophenolate Mofetil Hydrochloride

Standard immunosuppression (corticosteroid class).

Prednisone

Azathioprine

Vanderbilt University Medical Center

Early Use of Long-acting Tacrolimus in Lung Transplant Recipients

A Prospective, Randomized, Controlled Pilot Study of Early-Use Long Acting Tacrolimus (Envarsus XR) in Lung Transplant Recipients

Composite of mortality, allograft failure, potential drug induced liver injury, supra-therapeutic trough levels (>20 ng/mL), sub-therapeutic trough levels (<5 ng/mL), seizures, encephalopathy, thrombotic microangiopathy and serious hyperkalemia associated with use of LCP-tacrolimus, compared to matched historical controls administered IR-tacrolimus.

Median change in eGFR from study start to 9 months post-transplantation with patients administered LCP-tacrolimus compared to IR-tacrolimus.

Quality of life related to headache frequency and severity using the Headache Impact Tool (HIT-6).

Quality of life related to tremor as measured by the QUEST tool.

Incidence of acute cellular rejection (>= A1) or lymphocytic bronchiolitis (>= B1R)

Incidence of de novo donor-specific anti-HLA antibodies (MFI > 1500) within the first 9 months post-transplant.

Anil Trindade

Assistant Professor of Medicine

Veloxis Pharmaceuticals

Prospective, randomized, controlled pilot study.

flecainide x 6 months, then crossover to sotalol x 6 months

sotalol x 6 months, then crossover to flecainide x 6 months

Atrial Fibrillation

flecainide up to 150mg twice daily for the control of atrial fibrillation

Flecainide

sotalol up to 120mg twice daily for the control of atrial fibrillation

Sotalol

Jesse Brown VA Medical Center

Rush University Medical Center

University of Illinois at Chicago

Advocate Christ Medical Center

Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation

A Prospective, Multi-Center, Randomized, Open Label Trial to Determine if a Common Atrial Fibrillation Risk Locus Modulates Differential Response to Antiarrhythmic Drugs

Subjects will be monitored with the Medtronic Reveal LINQ Insertable Cardiac Monitor (ICM) system to assess AF burden. The device will be programmed to optimize the memory for storing AF episode..

Quality of life assessment: Patients will be asked to fill out the AFEQT quality of life questionnaire baseline (study randomization), two, four, six, eight, ten, and 12 months (completion of the study). The questionnaire at the end of the 6rd month will be administered just prior to stopping the first study drug. The validated questionnaire is comprised of 20 questions about AF symptoms with answers given on a Likert scale. The questionnaire will be provided to the patients in paper format either in person or by mail, as applicable. A follow-up phone call will be made to each patient to ensure that the questionnaire is completed and returned.

bronchiolitis obliterans/céphalée

Early Use of Long-acting Tacrolimus in Lung Transplant Recipients

Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation

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