Medication Optimisation for Reducing Events in a Private Practice Setting (MORE)
Using a prospective study design of two three month periods (before and after genotyping) in which the patients will self-monitor their health status and possible medical events it is hypothesized that it will be shown that patients having their medication altered to fit their genetic status and/or having their medication altered because of inherent interaction potential will have less recordable events after genotyping and medical analysis than before.
It is well known that ADRs (recordable adverse events to medication) are responsible for a large number of deaths and hospitalizations. Furthermore it is well recorded that genotyping of individual cytochrome P450 enzymes (2D6, 2C9, 2C19, among others) is directly related to a metabolic phenotype - fast metabolisers, slow metabolisers, intermediate and normal metabolisers. These differing phenotypes have altered metabolism of many medications and in a number of retrospective clinical trails it has been shown that ADRs and effect can be reduced/bettered through genotyping and alteration of medication.
Pharmacogenetic Analysis to Reduce Events.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Observational Study of the Pharmaco-Economic and Medical Effects of Optimising Medication Using Pharmacokinetic Pharmacogenomics and Medication Interaction Analysis in Private Practice.|
- Reduction of reported events in the time frame. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Reduction of total costs associated per patient in the time frame. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2008|
|Estimated Study Completion Date:||October 2009|
|Estimated Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Recruited patients will be prospectively observed as one cohort with genotyping/medication interaction analysis after 3 months, followed up by a further 3 month observational period.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653653
|Köln, NRW, Germany, 50829|
|Study Director:||Lee S Griffith, Ph.D.||Awenydd GmbH|
|Principal Investigator:||André Gessner, MD Ph.D.||University of Erlangen-Nürnberg|