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

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 ai...

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Main Authors: Hadeer Eid, Hazem Khorshid, Ahmed Elsherif, Ebtissam Darweesh, Nagwa Ali Sabri, Naglaa Bazan
Format: Article
Language:English
Published: Ain Shams University 2020-12-01
Series: Archives of Pharmaceutical Sciences Ain Shams University
Subjects:
Online Access:https://aps.journals.ekb.eg/article_135132.html
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spelling doaj-ab068f735a7147d792a76829e08e2bbb2021-02-01T06:46:09ZengAin Shams University Archives of Pharmaceutical Sciences Ain Shams University2356-83802356-83992020-12-0142194206Evaluation of Clinical outcomes of Generic versus Reference Ivabradine in Heart Failure PatientsHadeer Eid0Hazem Khorshid1Ahmed Elsherif2Ebtissam Darweesh3Nagwa Ali Sabri4Naglaa Bazan5Pharmacy practice and clinical pharmacy department, faculty of pharmacy, Future university in Egypt, Cairo, EgyptCardiology Department, Ain Shams University, Cairo, Egypt.Critical Care Medicine Department, Cairo University Hospitals, Cairo-Egypt.Pharmacy practice and clinical pharmacy department, faculty of pharmacy, Future university in Egypt, Cairo, EgyptDepartment of Clinical Pharmacy, Faculty of pharmacy, Ain Shams UniversityFellow and Head of Clinical Pharmacy, Critical Care Medicine Department, Cairo University Hospitals, EgyptEconomic 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.https://aps.journals.ekb.eg/article_135132.htmlheart failureivabradinegenericbrandtherapeutic equivalence
collection DOAJ
language English
format Article
sources DOAJ
author Hadeer Eid
Hazem Khorshid
Ahmed Elsherif
Ebtissam Darweesh
Nagwa Ali Sabri
Naglaa Bazan
spellingShingle Hadeer Eid
Hazem Khorshid
Ahmed Elsherif
Ebtissam Darweesh
Nagwa Ali Sabri
Naglaa Bazan
Evaluation of Clinical outcomes of Generic versus Reference Ivabradine in Heart Failure Patients
Archives of Pharmaceutical Sciences Ain Shams University
heart failure
ivabradine
generic
brand
therapeutic equivalence
author_facet Hadeer Eid
Hazem Khorshid
Ahmed Elsherif
Ebtissam Darweesh
Nagwa Ali Sabri
Naglaa Bazan
author_sort Hadeer Eid
title Evaluation of Clinical outcomes of Generic versus Reference Ivabradine in Heart Failure Patients
title_short Evaluation of Clinical outcomes of Generic versus Reference Ivabradine in Heart Failure Patients
title_full Evaluation of Clinical outcomes of Generic versus Reference Ivabradine in Heart Failure Patients
title_fullStr Evaluation of Clinical outcomes of Generic versus Reference Ivabradine in Heart Failure Patients
title_full_unstemmed Evaluation of Clinical outcomes of Generic versus Reference Ivabradine in Heart Failure Patients
title_sort evaluation of clinical outcomes of generic versus reference ivabradine in heart failure patients
publisher Ain Shams University
series Archives of Pharmaceutical Sciences Ain Shams University
issn 2356-8380
2356-8399
publishDate 2020-12-01
description 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.
topic heart failure
ivabradine
generic
brand
therapeutic equivalence
url https://aps.journals.ekb.eg/article_135132.html
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