Epidemiology of Polipharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients
NCT ID: NCT03370523
Last Updated: 2019-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
5000 participants
OBSERVATIONAL
2018-07-30
2019-08-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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No intervention is planned in our study
No intervention is planned in our study
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients who do not want to participate in our study
65 Years
ALL
No
Sponsors
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Muğla Sıtkı Koçman University
OTHER
Responsible Party
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EDA ÖZLEK
Faculty of Medicine, Department of Cardiology, M.D., Principal Investigator
Locations
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Nizip State Hospital
Gaziantep, , Turkey (Türkiye)
Countries
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Facility Contacts
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References
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Ozlek E, Cekic EG, Ozlek B, Cil C, Celik O, Dogan V, Basaran O, Tanik VO, Ozdemir HI, Celik Y, Kacmaz C, Simsek Z, Gunes HM, Safak O, Ozkan B, Tasar O, Onal C, Bekar L, Biteker M. Rationale, design, and methodology of the EPIC (Epidemiology of Polypharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients) study. Turk Kardiyol Dern Ars. 2019 Jul;47(5):391-398. doi: 10.5543/tkda.2019.27724.
Other Identifiers
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MuglaSKUTRH
Identifier Type: -
Identifier Source: org_study_id
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