Medication Optimisation for Reducing Events in a Private Practice Setting (MORE)

Observational Study of the Pharmaco-Economic and Medical Effects of Optimising Medication Using Pharmacokinetic Pharmacogenomics and Medication Interaction Analysis in Private Practice.

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.

Study Overview

• Status: Unknown
• Conditions: Pharmacogenetic Analysis to Reduce Events.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Köln, NRW, Germany, 50829
      • Awenydd Gmbh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Community sample.

Description

Inclusion Criteria:

• older than 18 years
• not demented
• 1 or more documented events in the previous 6 months.
• more than one medication
• multi-morbid

Exclusion Criteria:

• demented
• life expectancy less than 1 year
• heart attack within the last 6 months
• Marcumar® Therapy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Group A; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction of reported events in the time frame.	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Reduction of total costs associated per patient in the time frame.	3 months

Collaborators and Investigators

• Sponsor: Awenydd GmbH
• Investigators: Study Director: Lee S Griffith, Ph.D., Awenydd Gmbh; Principal Investigator: André Gessner, MD Ph.D., University of Erlangen-Nürnberg

Publications and helpful links

General Publications

• Chialda L, Griffith LS, Heinig A, Pahl A. Prospective use of CYP pharmacogenetics and medication analysis to facilitate improved therapy - a pilot study. Per Med. 2008 Jan;5(1):37-45. doi: 10.2217/17410541.5.1.37.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Anticipated): June 1, 2009
• Study Completion (Anticipated): October 1, 2009

Study Registration Dates

• First Submitted: April 2, 2008
• First Submitted That Met QC Criteria: April 4, 2008
• First Posted (Estimate): April 7, 2008

Study Record Updates

• Last Update Posted (Estimate): April 8, 2009
• Last Update Submitted That Met QC Criteria: April 7, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: pharmacogenetics; adverse events; drug metabolism; pharmacoeconomics
• Other Study ID Numbers: AW_SH_08