Ignite Creation Date:
2024-05-06 @ 10:52 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03370523
Status:
UNKNOWN
Last Update Posted:
2019-07-08
First Post:
2017-12-01
Brief Title:
Epidemiology of Polipharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients
Sponsor:
Muğla Sıtkı Koçman University
Organization:
Muğla Sıtkı Koçman University
Study Overview
Official Title:
Epidemiology of Polipharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients
Status:
UNKNOWN
Status Verified Date:
2019-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPIC
Brief Summary:
As the proportion of elderly population increasing over the last years polypharmacy and drug-drug interactions DDI has been a common health care problem This study will be performed to find out to prevalence of polypharmacy inappropriate drug use and DDIs in in elderly patients presenting to a outpatient cardiology clinics
Detailed Description:
Objective
As the proportion of elderly population increasing over the last years polypharmacy and drug-drug interactions DDI has been a common health care problem However very limited epidemiologic data are available describing polypharmacy potentially DDIs and potentially inappropriate medications and their consequences in elderly Turkish patients Therefore this study will be performed to find out to prevalence of polypharmacy inappropriate drug use and DDIs in elderly patients presenting to a outpatient cardiology clinics
Methods
The EPIC Epidemiology of Polipharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients study will be the first large-scale observational real-world multicenter study to evaluate DDIs ve polypharmacy in elderly cardiac outpatients conducted in Turkey We will enroll all consecutive patients aged 65 years admitted to the outpatient cardiology clinics from January 30 2018 through June 30 2018 provided written informed consent Approximately 5000 patients will be enrolled in this non-interventional study All the data will be collected at one point in time and current clinical practice will be evaluated
Results
Patient demographics disease characteristics laboratory test results and medications used willl be collected by self reports and medical records The severity of comorbid diseases will be recorded and scored according to Charlson comorbidity index CCI and patients will be divided into three groups mild with CCI scores of 1-2 moderate with CCI scores of 3-4 and severe with CCI scores 5 Polypharmacy will be defined as being on five or more medications at one time DDIs will be checked with Lexicomp and and potentially inappropriate medications will be defined with 2015 update of Beers criteria Severe drug interactions will be defined with category D or X DIs
Conclusion
EPIC will be the first study evaluating polypharmacy potentially inappropriate medications and DDIs in elderly cardiac outpatients in a real world clinical setting
As the proportion of elderly population increasing over the last years polypharmacy and drug-drug interactions DDI has been a common health care problem However very limited epidemiologic data are available describing polypharmacy potentially DDIs and potentially inappropriate medications and their consequences in elderly Turkish patients Therefore this study will be performed to find out to prevalence of polypharmacy inappropriate drug use and DDIs in elderly patients presenting to a outpatient cardiology clinics
Methods
The EPIC Epidemiology of Polipharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients study will be the first large-scale observational real-world multicenter study to evaluate DDIs ve polypharmacy in elderly cardiac outpatients conducted in Turkey We will enroll all consecutive patients aged 65 years admitted to the outpatient cardiology clinics from January 30 2018 through June 30 2018 provided written informed consent Approximately 5000 patients will be enrolled in this non-interventional study All the data will be collected at one point in time and current clinical practice will be evaluated
Results
Patient demographics disease characteristics laboratory test results and medications used willl be collected by self reports and medical records The severity of comorbid diseases will be recorded and scored according to Charlson comorbidity index CCI and patients will be divided into three groups mild with CCI scores of 1-2 moderate with CCI scores of 3-4 and severe with CCI scores 5 Polypharmacy will be defined as being on five or more medications at one time DDIs will be checked with Lexicomp and and potentially inappropriate medications will be defined with 2015 update of Beers criteria Severe drug interactions will be defined with category D or X DIs
Conclusion
EPIC will be the first study evaluating polypharmacy potentially inappropriate medications and DDIs in elderly cardiac outpatients in a real world clinical setting
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None