Immunosuppressive After Lung Transplantation
Conditions
Keywords
generic immunosuppressive
Brief summary
Extent of use of generics immunosuppressive drugs in clinical practice after lung transplantation
Detailed description
Solid organ transplant recipients are treated with immunosuppressive drugs to prevent rejection of their grafts. The most frequently important maintenance immunosuppressive drugs in Europe are calcineurin inhibitors. For a number of these compounds drug patents have expired in recent years and generic formulations have entered the market. There is considerable debate regarding the efficacy and safety of generic drug substitution in solid organ recipients.
Interventions
OTHERpatient questionnaire (tablet pc based)
Sponsors
Hannover Medical School
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients after lung transplantation (single, double or combined) * informed consent * patient with an immunosuppressive therapy with tacrolimus or ciclosporin
Exclusion criteria
* immunosuppressive therapy without calcineurin inhibitors * need for isolation (Colonization with multi. or pan resistant organisms e.g. methicillin-resistant staph. aureus\[MRSA), B. cenocepacia) * limited German language skills or other reasons which might impair patient communication or computer handling
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of use of generic immunosuppressive drugs | baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Calcineurin inhibitor through levels | baseline, retrospective 6 months | Frequency of calcineurin inhibitor through levels in target range between generic and original immunosuppressive drugs during last 6 months |
| Dose of calcineurin inhibitors | baseline | Dose of calcineurin inhibitors between generic and original immunosuppressive drugs at questionnaire |
| Therapy adherence | baseline | Therapy adherence between generic and original immunosuppressive drugs. Adherence will be measured by a 5 item Likert scale covering self-monitoring, generla health perception, contacts, nutrition/exercise compliance and adherence to immunosuppression. |
| Satisfaction with immunosuppression | baseline | Satisfaction with immunosuppression between generic and original immunosuppressive drugs will be measured by a 5-point Likert scale. |
Countries
Germany
Contacts
Primary ContactJens Gottlieb, MD
Backup ContactImke Zinowsky
Outcome results
None listed