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

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.

Study Overview

• Status: Unknown
• Conditions: Polypharmacy; Drug-drug Interactions
• Intervention / Treatment: Other: No intervention is planned in our study

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.

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

Study Locations

• Turkey
  • Gaziantep, Turkey
    • Recruiting
    • Nizip State Hospital
    • Contact: IBRAHIM HALIL OZDEMIR, M.D.; Phone Number: +90 342 517 54 00; Email: dribrahimhalilozdemir@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients older than 65 years who presented to cardiology outpatient clinics will be screened.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of polypharmacy	Polypharmacy will be defined as being on five or more medications at one time.	6 months
Severity of comorbid diseases	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.	6 months
Drug-drug interactions	DDIs will be checked with Lexicomp®. Severe drug interactions will be defined with category D or X DIs.	6 months
Prevalence of inappropriate medications	Potentially inappropriate medications will be defined with 2015 update of Beers criteria.	6 months

Collaborators and Investigators

• Sponsor: Muğla Sıtkı Koçman University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2018
• Primary Completion (Anticipated): July 30, 2019
• Study Completion (Anticipated): August 30, 2019

Study Registration Dates

• First Submitted: December 1, 2017
• First Submitted That Met QC Criteria: December 11, 2017
• First Posted (Actual): December 12, 2017

Study Record Updates

• Last Update Posted (Actual): July 8, 2019
• Last Update Submitted That Met QC Criteria: July 4, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: MuglaSKUTRH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No