Abstract
PurposeThis drug utilization study of ivabradine evaluated prescriber compliance with the new risk minimization measures (RMMs), communicated starting 2014 following preliminary results from the SIGNIFY study.MethodsThis was a multinational (five European countries) chart review study with two study periods: pre‐RMM and post‐RMM. Patients initiating ivabradine for chronic stable angina pectoris in routine clinical practice were identified across general practitioners and specialists. The primary outcome analysis evaluated the compliance with the new RMMs, ie, use in patients with a heart rate greater than or equal to 70 bpm at initiation, no doses higher than those recommended in the summary of product characteristics (SmPC) at initiation and during 6 months of follow‐up, and no concomitant use of verapamil or diltiazem.ResultsOverall, 711 and 506 eligible patients were included in the pre‐RMM and post‐RMM periods, respectively. The percentage of patients prescribed ivabradine according to the new RMMs increased significantly in the post‐RMM period (70.6% and 78.4% in the pre‐ and post‐RMM periods respectively; P value = .0035). The compliance to RMMs increased for all the criteria assessed independently: the proportions of patients with (a) heart rate ≥ 70 bpm at initiation (79.4% and 85.2%, respectively; P value = .0141), (b) no dose higher than the SmPC doses at initiation and during follow‐up (92.8% and 94.1%, respectively; P value = .3957), and (c) no concomitance with verapamil or diltiazem (96.1% and 99.2%, respectively; P value = .0007).ConclusionsThe RMMs for ivabradine were well implemented across the five participating European countries confirming a favorable benefit‐risk balance of ivabradine in chronic stable angina pectoris.
Highlights
Ivabradine hydrochloride (Procoralan/Corlentor) is a selective inhibitor of the cardiac pacemaker if current, with corresponding reductions in cardiac workload and myocardial oxygen consumption.[1]
Extensions of the indication were subsequently approved in combination with beta‐blockers in patients inadequately controlled despite an optimal beta‐blocker dose and heart rate (HR) > 60 bpm (October 2009) and in chronic heart failure (HF) in patients with sinus rhythm and HR ≥ 75 bpm (February 2012)
The study results show that the heart rate at treatment initiation, ivabradine dosing at initiation and during follow‐up, and concomitant use of verapamil or diltiazem were in line with the updated summary of product characteristics (SmPC)
Summary
Ivabradine hydrochloride (Procoralan/Corlentor) is a selective inhibitor of the cardiac pacemaker if current, with corresponding reductions in cardiac workload and myocardial oxygen consumption.[1]. The recommended ivabradine starting dose for these indications was 5‐mg bid, with consideration of 2.5‐mg bid for patients aged 75 years and older. Results showed an increase of cardiovascular events, possibly because of bradycardia in a subgroup of patients with angina of Canadian Cardiovascular Society Class II or higher. These findings triggered a benefit‐risk reevaluation by the European Commission[3] in May 2014, and a direct health care professional communication (DHPC) was disseminated in Europe in June 2014 to inform prescribers and remind them of the current conditions of use of the product in patients with angina pectoris
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