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Clinical Trials/NCT03370523
NCT03370523
Unknown
N/A

Epidemiology of Polipharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients

Muğla Sıtkı Koçman University1 site in 1 country5,000 target enrollmentJuly 30, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Polypharmacy
Sponsor
Muğla Sıtkı Koçman University
Enrollment
5000
Locations
1
Primary Endpoint
Prevalence of polypharmacy
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 30, 2018
End Date
August 30, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Muğla Sıtkı Koçman University
Responsible Party
Principal Investigator
Principal Investigator

EDA ÖZLEK

Faculty of Medicine, Department of Cardiology, M.D., Principal Investigator

Muğla Sıtkı Koçman University

Eligibility Criteria

Inclusion Criteria

  • All consecutive patients with aged ≥ 65 years

Exclusion Criteria

  • Patients under 65 years of age
  • Patients who do not want to participate in our study

Outcomes

Primary Outcomes

Prevalence of polypharmacy

Time Frame: 6 months

Polypharmacy will be defined as being on five or more medications at one time.

Severity of comorbid diseases

Time Frame: 6 months

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.

Drug-drug interactions

Time Frame: 6 months

DDIs will be checked with Lexicomp®. Severe drug interactions will be defined with category D or X DIs.

Prevalence of inappropriate medications

Time Frame: 6 months

Potentially inappropriate medications will be defined with 2015 update of Beers criteria.

Study Sites (1)

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