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135132

Evaluation of Clinical outcomes of Generic versus Reference Ivabradine in Heart Failure Patients

Article

Last updated: 22 Jan 2023

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Abstract

Economic benefits associated with usage of generic drugs have been suggested to increase patients' adherence to their medications and to improve patients' health outcomes. However, the therapeutic equivalence of certain generic products to their branded counterparts has been questioned. Our study aims to compare the efficacy and safety of generic and branded ivabradine in adult patients with chronic heart failure with reduced ejection fraction (≤40%) (HFrEF). This was a randomized, open label, crossover, two period comparative study. A total of 32 patients with HFrEF were randomized into two groups. Group A received brand ivabradine® for 12 weeks followed by generic ivabradine for the next 12 weeks. Group B received generic ivabradine for 12 weeks followed by brand ivabradine for the next 12 weeks with no washout period. The efficacy outcomes included resting heart rate (HR), New York Heart Association Functional Classification (NYHA FC), Quality of life (QoL) using Minnesota Living with Heart Failure (MLWHF) and ejection fraction (EF). After taking the drugs for the first 12 weeks, no statistically significant difference was detected in all efficacy outcomes between Group A and Group B. After crossover and taking drugs for further 12 weeks, similar results were obtained. Only minor side effects, mainly phosphenes were observed in both products. No mortality was demonstrated in both groups. This study showed no statistically significant difference between the generic and brand ivabradine in terms of efficacy and safety. The results suggest that generic ivabradine can be a safe substitute for branded ivabradine for economic reasons.

DOI

10.21608/aps.2020.43341.1041

Keywords

Heart failure, Ivabradine, generic, Brand, Therapeutic Equivalence

Authors

First Name

Hadeer

Last Name

Eid

MiddleName

-

Affiliation

Pharmacy Practice and Clinical pharmacy Department, Faculty of Pharmacy, Future University in Egypt, Cairo, Egypt

Email

hadeir.eid@fue.edu.eg

City

-

Orcid

0000-0001-6095-2511

First Name

Hazem

Last Name

Khorshid

MiddleName

-

Affiliation

Cardiology Department, Ain Shams University, Cairo, Egypt.

Email

hazemkhorshid@yahoo.com

City

-

Orcid

-

First Name

Ahmed

Last Name

Elsherif

MiddleName

-

Affiliation

Critical Care Medicine Department, Cairo University Hospitals, Cairo-Egypt.

Email

ahalsherif@yahoo.com

City

-

Orcid

-

First Name

Ebtissam

Last Name

Darweesh

MiddleName

-

Affiliation

Pharmacy Practice and Clinical pharmacy Department, Faculty of Pharmacy, Future University in Egypt, Cairo, Egypt

Email

edrweesh@fue.edu.eg

City

-

Orcid

-

First Name

Nagwa

Last Name

Sabri

MiddleName

-

Affiliation

Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University

Email

nagwa.sabri@yahoo.com

City

-

Orcid

-

First Name

Naglaa

Last Name

Bazan

MiddleName

-

Affiliation

Fellow and Head of Clinical Pharmacy, Critical Care Medicine Department, Cairo University Hospitals, Egypt.

Email

naglaabazan@cu.edu.eg

City

cairo

Orcid

0000-0002-8930-4697

Volume

4

Article Issue

2

Related Issue

20170

Issue Date

2020-12-01

Receive Date

2020-09-22

Publish Date

2020-12-01

Page Start

194

Page End

206

Print ISSN

2356-8380

Online ISSN

2356-8399

Link

https://aps.journals.ekb.eg/article_135132.html

Detail API

https://aps.journals.ekb.eg/service?article_code=135132

Order

2

Type

Original Article

Type Code

657

Publication Type

Journal

Publication Title

Archives of Pharmaceutical Sciences Ain Shams University

Publication Link

https://aps.journals.ekb.eg/

MainTitle

-

Details

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Article

Created At

22 Jan 2023