Hadeer Eid Eliwa Ibrahim Fadel

Hazem Khorshid, Ahmed Elsherif, Ebtissam Darweesh, Nagwa Ali Sabri, Naglaa Samir Bazan

01/12/2020

Economic benefits associated with the 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, and 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 a 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. Keywords: Heart Failure; ivabradine, generic; brand; Therapeutic Equivalence.

Hadeer Eid Eliwa Ibrahim Fadel

Ebtissam Darweesh, Nagwa Sabri, Naglaa Bazan

01/07/2020

Heart failure (HF) is an epidemic of cardiovascular disease resulting in impaired function and worsened quality of life (QOL) of HF patients. Increased heart rate correlates with poor outcomes in these patients; therefore, its reduction may be beneficial in reducing hospitalization for worsening HF. Guideline therapy recommendation for β-blocking agents is a standard cornerstone for the treatment of HF. Despite, the dose adjustment of β-blockers for patients who cannot withstand the target dose, desired goal heart rate reduction is unfortunately not always reached. Additionally, β-blockers are contraindicated for certain patients. Ivabradine decreases the heart rate through inhibiting the cardiac pacemaker current (If) without having any influence on the sympathetic nervous system. The drug has been approved by the United States Food and Drug Administration in 2015. In 2012, ivabradine use was included in the European Society of Cardiology (ESC) guidelines for the management of HF, to be used alongside β-blockers or as a safer substitute. This short review aimed to discuss the ivabradine use in both reduced and preserved ejection fraction HF patients. Ivabradine was found to be generally tolerable and safe. Efficacy for HF patients with systolic dysfunction has been confirmed, however, in HF patients with diastolic dysfunction, it is yet to be extensively evaluated. Moreover, the role of ivabradine in HF patients with Atrial Fibrillation (AF) is currently under investigation. Keywords: Ivabradine; Heart Failure; Heart Rate; Quality of Lif. *Correspondence | Hadeer E Eliwa; Clinical Pharmacy Department, Faculty of pharmaceutical

Hadeer Eid Eliwa Ibrahim Fadel

Ebtissam Darweesh

23/10/2018

https://www.accp.com/docs/meetings/abstracts/2018_global.pdf

Hadeer Eid Eliwa Ibrahim Fadel

11/09/2018

https://www.walshmedicalmedia.com/conference-abstracts-files/2155-9627-C1-006-006.pdf

Hadeer Eid Eliwa Ibrahim Fadel

03/08/2018

https://www.longdom.org/conference-abstracts-files/2167-0501-C1-010-024.pdf