FrancophonIA/ELRC3.0 huggingface dataset:
English: In dogs given ivabradine (doses of 2, 7 or 24 mg/kg/day) for one year, reversible changes in retinal function were observed but were not associated with any damage to ocular structures.
Danish: Hos hunde førte ivabradindoser på 2, 7 eller 24 mg/kg/dag i et år til observation af reversible forandringer i retinafunktionen, men var ikke forbundet med skader i okulære strukturer.
English: Erythema Pruritus Urticaria
Danish: Erythem Pruritus Urticaria
English: Pharmacotherapeutic group: Cardiac therapy, other cardiac preparations; ATC code: C01EB17.
Danish: Farmakoterapeutisk klassifikation: Hjerteterapi, andre hjertemidler; ATC-kode: C01EB17.
English: - Acute myocardial infarction.
Danish: - Akut myokardieinfarkt.
English: However, in the absence of extensive data, non-urgent DC-cardioversion should be considered 24 hours after the last dose of ivabradine.
Danish: Da datamængden imidlertid ikke er omfattende, bør ikke-akut DC-kardiovertering overvejes inden for et døgn efter sidste dosis af ivabradin.
English: Lack of benefit on clinical outcomes in patients with symptomatic chronic stable angina pectoris
Danish: Manglende gavnlig virkning på kliniske udfald hos patienter med symptomatisk kronisk stabil angina pectoris
English: • Anti-malarial medicines (such as mefloquine or halofantrine).
Danish: • Malariamidler (f.eks. mefloquin eller halofantrin).
English: Core:
Danish: Kerne:
English: When pregnant animals were treated during organogenesis at exposures close to therapeutic doses, there was a higher incidence of foetuses with cardiac defects in the rat and a small number of foetuses with ectrodactylia in the rabbit.
Danish: Når drægtige dyr blev behandlet under organogenesen ved eksponeringer tæt på de terapeutiske doser, var der en højere incidens af fostre med kardiale defekter hos rotter og et mindre antal fostre med ektrodaktyli hos kaniner.
English: Crospovidone Magnesium stearate
Danish: Mannitol Crospovidon Magnesiumstearat
English: - Cardiogenic shock.
Danish: - Kardiogent shock.
English: Ivabradine is approximately 70% plasma protein bound and the volume of distribution at steady-state is close to 100 L in patients.
Danish: Ivabradin er ca. 70 % bundet til plasmaproteiner, og fordelingsvolumenet i steady state er næsten 100 l hos patienter.
English: Ivabradine is eliminated with a main half-life of 2 hours (70 - 75% of the AUC) in plasma and an effective half-life of 11 hours.
Danish: Ivabradin udskilles med en hovedhalveringstid på 2 timer (70 - 75 % af AUC) i plasma og en effektiv eliminationshalveringstid på 11 timer.
English: The concomitant use of cardiovascular and non-cardiovascular QT prolonging medicinal products with ivabradine should be avoided since QT prolongation may be exacerbated by heart rate reduction.
Danish: Samtidig anvendelse af kardiovaskulære og non-kardiovaskulære QT-forlængende lægemidler med ivabradin bør dog undgås, da QT-forlængelsen kan forstærkes ved reduktion af hjertefrekvensen.
English: - Sick sinus syndrome.
Danish: - Syg sinus-syndrom.
English: 0.5% of patients experienced a severe bradycardia below or equal to 40 bpm.
Danish: 0,5 % af patienterne fik svær bradykardi under eller svarende til 40 slag/min.
English: Bradycardia was reported by 17.9 % of patients in the ivabradine group (2.1% in the placebo group).
Danish: Bradykardi blev rapporteret hos 17,9 % af patienterne i ivabradin-gruppen (2,1 % i placebogruppen).
English: The maximum plasma concentration following chronic administration at the recommended dose of 5 mg twice daily is 22 ng/mL (CV = 29%).
Danish: Den maksimale plasmakoncentration efter kronisk administration ved den anbefalede dosis på 5 mg to gange dagligt er ca. 22 ng/ml (CV = 29 %).
English: - AV-block of 3
Danish: - 3. grads AV-blok.
English: - If you are having a heart attack.
Danish: - Hvis du får et hjerteanfald.
English: The results on the primary endpoint are mainly driven by the heart failure endpoints, hospitalisation for worsening heart failure (absolute risk reduced by 4.7%) and deaths from heart failure (absolute risk reduced by 1.1%).
Danish: Hvad angår det primære endepunkt, skyldes resultatet især komponenterne hjerteinsufficiens i form af indlæggelse på grund af tiltagende hjerteinsufficiens (absolut risikoreduktion 4,7 %) og død på grund af hjerteinsufficiens (absolut risikoreduktion 1,1 %).
English: Data are insufficient to draw conclusions in patients with moderate hepatic impairment.
Danish: Der er ikke tilstrækkelige data til at drage konklusioner hos patienter med moderat leverinsufficiens.
English: Tablets are available in packs of 14, 28, 56, 84, 98, 100, 112 film-coated tablets.
Danish: Tabletterne fås i pakninger med 14, 28, 56, 84, 98, 100, 112 filmovertrukne tabletter.
English: - Pacemaker dependent (heart rate imposed exclusively by the pacemaker).
Danish: - Afhængighed af pacemaker (hjertefrekvensen styres udelukkende af pacemaker).
English: Analysis of heart rate reduction with doses up to 20 mg twice daily indicates a trend towards a plateau effect which is consistent with a reduced risk of severe bradycardia below 40 bpm (see section
Danish: Analyser af hjertefrekvensreduktionen efter doser op til 20 mg to gange dagligt tyder på en tendens til en plateaueffekt, som er konsistent med en nedsat risiko for svær bradykardi under 40 slag/min (se pkt.
English: If you are being treated for chronic heart failure
Danish: Hvis du bliver behandlet for kronisk hjertesvigt
English: In this way Ivabradine Zentiva helps to control and reduce the number of angina attacks.
Danish: På den måde hjælper Ivabradine Zentiva med at kontrollere og nedsætte antallet af anfald af hjertekrampe.
English: As ivabradine may cause bradycardia, the resulting combination of hypokalaemia and bradycardia is a predisposing factor to the onset of severe arrhythmias, especially in patients with long QT syndrome, whether congenital or substance-induced.
Danish: Da ivabradin kan medføre bradykardi, er den resulterende kombination af hypokaliæmi og bradykardi en prædisponerende faktor til svære arytmier, især hos patienter med langt QT-syndrom, hvad enten det er kongenitalt eller lægemiddel-induceret.
English: • Pentamidine (an antiparasitic medicine).
Danish: • Pentamidin (et lægemiddel mod parasitter).
English: • Quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders).
Danish: • Quinidin, disopyramid, ibutilid, sotalol, amiodaron (til behandling af forstyrrelser af hjertets rytme).
English: - If you suffer from uncontrolled blood pressure, especially after a change in your antihypertensive treatment.
Danish: - Hvis du lider af lavt blodtryk i let til moderat grad. - Hvis dit blodtryk ikke er under kontrol - især efter en ændring i din blodtryksbehandling.
English: Mean LVEF increased from 31.8% to 45.3% at M012 in ivabradine group versus 35.4% to 42.3% in the placebo group.
Danish: Den gennemsnitlige LVEF steg fra 31,8 % til 45,3 % ved M012 i ivabradin-gruppen versus 35,4 % til 42,3 % i placebogruppen.
English: - Resting heart rate below 70 beats per minute prior to treatment.
Danish: - Hjertefrekvens i hvile under 70 slag i minuttet før behandlingen.
English: • Certain types of medicines to treat anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindole).
Danish: • Visse lægemidler til behandling af angst, skizofreni eller andre alvorlige sindslidelser (f.eks. pimozid, ziprasidon og sertindol).
English: Patients received standard care including beta-blockers (89%), ACE inhibitors and/or angiotensin II antagonists (91%), diuretics (83%), and anti-aldosterone agents (60%).
Danish: Patienterne fik standardbehandling, der omfattede betablokkere (89 %), ACE-hæmmere og/eller angiotensin II-antagonister (91 %), diuretika (83 %) og aldosteronantagonister (60 %).
English: - If you have had a recent stroke (cerebral attack).
Danish: - Hvis du for nylig har haft et slagtilfælde (blodprop i hjernen/hjerneblødning).
English: These data are consistent with the pharmacological effect of ivabradine related to its interaction with hyperpolarisationactivated Ih currents in the retina, which share extensive homology with the cardiac pacemaker If current.
Danish: Disse data er konsistente med den farmakologiske effekt af ivabradin, relateret til dets interaktion med hyperpolarisations-aktiverede Ih jonkanalstrømme i retina, som har omfattende fælles homologi med den kardiale pacemaker If jonkanalstrøm.
English: In particular, the additional benefit over 5 mg twice daily was established in a reference-controlled study versus atenolol: total exercise duration at trough was increased by about 1 minute after one month of treatment with 5 mg twice daily and further improved by almost 25 seconds after an additional 3-month period with forced titration to 7.5 mg twice daily.
Danish: Specielt blev den yderligere nytte i forhold til 5 mg to gange dagligt dokumenteret i et reference-kontrolleret studie versus atenolol: den samlede arbejdsvarighed ved trough-koncentrationer var øget med ca. 1 minut efter en måneds behandling med 5 mg to gange dagligt og yderligere forbedret med næsten 25 sekunder efter yderligere 3 måneder med tvungen stigning til 7,5 mg to gange dagligt.
English: Pharmacokinetic/pharmacodynamic (PK/PD) relationship PK/PD relationship analysis has shown that heart rate decreases almost linearly with increasing ivabradine and S 18982 plasma concentrations for doses of up to 15 - 20 mg twice daily.
Danish: Farmakokinetiske/farmakodynamiske (PK/PD) forhold Analyse af PK/PD-forholdet har vist, at hjertefrekvensen falder næsten lineært med stigende plasmakoncentrationer af ivabradin og S 18982 i doser op til 15 - 20 mg to gange dagligt.
English: Symptomatic treatment of chronic stable angina pectoris It is recommended that the decision to initiate or titrate treatment takes place with the availability of serial heart rate measurements, ECG or ambulatory 24-hour monitoring.
Danish: Symptomatisk behandling af kronisk stabil angina pectoris Det anbefales, at beslutningen om at initiere eller titrere behandlingen foregår med mulighed for seriemåling af hjertefrekvens, ekg- eller ambulant 24-timers monitorering.
English: - If you suffer from a heart rhythm disorder.
Danish: - Hvis du lider af forstyrrelser i hjertets rytme.
English: A randomised, double blind, placebo controlled study was performed in 116 paediatric patients (17 aged [6 - 12] months, 36 aged [1 - 3] years and 63 aged [3 - 18] years) with CHF and dilated cardiomyopathy (DCM) on top of optimal background treatment.
Danish: Et randomiseret, dobbeltblindet, placebokontrolleret studie blev udført med 116 pædiatriske patienter (17 i alderen [6 - 12] måneder, 36 i alderen [1 - 3] år og 63 i alderen [3 - 18] år med kronisk hjerteinsufficiens og dilateret kardiomyopati (DCM) sammen med optimal igangværende behandling.
English: Efficacy was confirmed with 7.5 mg twice daily.
Danish: Effekten blev bekræftet med 7,5 mg to gange dagligt.
English: 14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 84 film-coated tablets 98 film-coated tablets 100 film-coated tablets 112 film-coated tablets
Danish: 14 filmovertrukne tabletter 28 filmovertrukne tabletter 56 filmovertrukne tabletter 84 filmovertrukne tabletter 98 filmovertrukne tabletter 100 filmovertrukne tabletter 112 filmovertrukne tabletter
English: Use in patients with congenital QT syndrome or treated with QT prolonging medicinal products
Danish: Anvendelse hos patienter med kongenit QT-syndrom eller hos patienter, som behandles med lægemidler, der forlænger QT-intervallet
English: - If you suffer from severe heart failure or heart failure with abnormality of ECG called “bundle branch block”.
Danish: - Hvis du lider af alvorligt hjertesvigt eller hjertesvigt med en abnormitet i ekg kaldet ”grenblok”.
English: Atrial fibrillation has been more common in patients using concomitantly amiodarone or potent class I anti-arrhythmics.
Danish: Atrieflimren har været hyppigere hos patienter, der samtidigt tager amiodaron eller potente klasse I- antiarytmika.
English: In patients aged 75 years or more, a lower starting dose should be considered (2.5 mg twice daily i.e. one half 5 mg tablet twice daily) before up-titration if necessary.
Danish: Hos patienter på 75 år og derover, bør det overvejes at starte med en lavere dosis hos disse patienter (2,5 mg to gange dagligt, dvs. en halv 5 mg tablet to gange dagligt), før dosis om nødvendigt øges.
English: Ivabradine Zentiva should be taken during meals.
Danish: Ivabradine Zentiva skal helst tages under et måltid.
English: In the event of bradycardia with poor haemodynamic tolerance, symptomatic treatment including intravenous betastimulating medicinal products such as isoprenaline may be considered.
Danish: Hvis der optræder bradykardi med dårlig hæmodynamisk tolerans, kan symptomatisk behandling, inklusive intravenøs behandling med betastimulerende lægemidler som fx isoprenalin, overvejes.
English: - Pregnancy, lactation and women of child-bearing potential not using appropriate contraceptive measures (see section 4.6).
Danish: - Graviditet, amning samt kvinder i den fertile alder, der ikke anvender sikker kontraception (se - pkt.
English: Angina is more likely to happen when the heart beats faster in situations such as exercise, emotion, exposure to the cold or after eating.
Danish: Hjertekrampe optræder hyppigere i situationer, hvor hjertet slår hurtigere f.eks. under arbejde, ved sindsbevægelser, udsættelse for kulde eller efter spisning.
English: A 20% heart rate reduction, without bradycardia, was achieved by 69.9% of patients in the ivabradine group versus 12.2% in the placebo group during the titration period of 2 to 8 weeks (Odds Ratio: E = 17.24, 95% CI [5.91 ; 50.30]).
Danish: Der blev opnået en reduktion i hjertefrekvens på 20 % uden bradykardi hos 69,9 % af patienterne i ivabradin-gruppen versus 12,2 % i placebogruppen i titreringsperioden på 2 til 8 uger (Odds ratio: E = 17,24; 95 % KI [5,91; 50,30]).
English: In patients with mild hepatic impairment (Child Pugh score up to 7) unbound AUC of ivabradine and the main active metabolite were about 20% higher than in subjects with normal hepatic function.
Danish: Hos patienter med let leverinsufficiens (Child-Pugh Score op til 7) var AUC for ubundet ivabradin og dets aktive hovedmetabolit ca. 20 % større end hos patienter med normal leverfunktion.
English: Ivabradine Zentiva 5 mg film-coated tablets: 14, 28, 56, 84, 98, 100, 112 film-coated tablets Ivabradine Zentiva 7.5 mg: 14, 28, 56, 84, 98, 100, 112 film-coated tablets
Danish: Ivabradine Zentiva 5 mg filmovertrukne tabletter: 14, 28, 56, 84, 98, 100, 112 filmovertrukne tabletter Ivabradine Zentiva 7,5 mg: 14, 28, 56, 84, 98, 100, 112 filmovertrukne tabletter
English: A large dose of Ivabradine Zentiva could make you feel breathless or tired because your heart slows down too much.
Danish: Hvis du har taget for mange Ivabradine Zentiva En stor dosis Ivabradine Zentiva kan få dig til at føle dig kortåndet eller træt, fordi dit hjerte slår for langsomt.
English: The potent CYP3A4 inhibitors ketoconazole (200 mg once daily) and josamycin (1 g twice daily) increased ivabradine mean plasma exposure by 7 to 8-fold.
Danish: De stærke CYP3A4-hæmmere ketoconazol (200 mg en gang dagligt) og josamycin (1 g to gange dagligt) øgede den gennemsnitlige plasmaeksponering for ivabradin 7-8 gange.
English: The impact of renal impairment (creatinine clearance from 15 to 60 mL/min) on ivabradine pharmacokinetic is minimal, in relation with the low contribution of renal clearance (about 20%) to total elimination for both ivabradine and its main metabolite S 18982 (see section 4.2).
Danish: Påvirkningen af nedsat nyrefunktion (kreatinin-clearance fra 15 til 60 ml/min) på ivabradins farmakokinetik er minimal, sammenholdt med det lille bidrag af renal clearance (ca. 20 %) til den samlede elimination af både ivabradin og dets hovedmetabolit S 18982 (se pkt.
English: - If you suffer from moderate liver problems.
Danish: - Hvis du lider af moderate leverproblemer.
English: The efficacy of 5 and 7.5 mg twice daily was consistent across studies on exercise test parameters (total exercise duration, time to limiting angina, time to angina onset and time to 1 mm ST segment depression) and was associated with a decrease of about 70% in the rate of angina attacks.
Danish: Effekten af 5 og 7,5 mg to gange dagligt var konsistent i alle studier på arbejdstestparametre (samlet arbejdsvarighed, tid indtil limiterende angina, tid indtil start af angina og tid indtil 1 mm STsegmentdepression) og var ledsaget af et fald på ca. 70 % i antallet af anginaanfald.
English: The average plasma concentration is 10 ng/mL (CV = 38%) at steady-state.
Danish: Den gennemsnitlige plasmakoncentration i steady state er 10 ng/ml (CV = 38 %).
English: Ivabradine Zentiva 5 mg film-coated tablets: EU/1/16/1144/001
Danish: Ivabradine Zentiva 5 mg filmovertrukne tabletter: EU/1/16/1144/001
English: No dose adjustment is required in patients with renal insufficiency and creatinine clearance above 15 mL/min (see section 5.2).
Danish: Dosisjustering er ikke nødvendig til patienter med nyreinsufficiens og kreatinin-clearance over 15 ml/min (se pkt.
English: Ivabradine is extensively metabolised by the liver and the gut by oxidation through cytochrome P4503A4 (CYP3A4) only.
Danish: Ivabradin undergår en omfattende metabolisering i leveren og tarmen ved oxidation, udelukkende ved hjælp af cytokrom P4503A4 (CYP3A4).
English: The difference in heart rate between ivabradine and placebo arms was 10.8 bpm at 28 days, 9.1 bpm at 12 months and 8.3 bpm at 24 months.
Danish: Forskellen i hjertefrekvens mellem ivabradin- og placeboarmen var 10,8 slag/min efter 28 dage, 9,1 slag/min efter 12 måneder og 8,3 slag/min efter 24 måneder.
English: About stable angina pectoris (usually referred to as “angina”) Stable angina is a heart disease which happens when the heart does not receive enough oxygen.
Danish: Stabil angina pectoris (også kaldet ”hjertekrampe”) Stabil hjertekrampe er en hjertesygdom, som opstår, når hjertet ikke får tilstrækkeligt med ilt.
English: Potassium-depleting diuretics (thiazide diuretics and loop diuretics) Hypokalaemia can increase the risk of arrhythmia.
Danish: Ikke-kaliumbesparende diuretika (thiazid-diuretika og loop-diuretika): Hypokaliæmi kan øge risikoen for arytmi.
English: If you forget to take Ivabradine Zentiva
Danish: Hvis du har glemt at tage Ivabradine Zentiva
English: In some cases (e.g. if you are elderly), your doctor may prescribe half the dose i.e., one half 5 mg tablet of Ivabradine Zentiva 5 mg (corresponding to 2.5 mg ivabradine) in the morning and one half 5 mg tablet in the evening.
Danish: I nogle tilfælde (f.eks. hvis du er ældre) kan din læge halvere dosis, dvs. en halv Ivabradine Zentiva-tablet på 5 mg (svarende til 2,5 mg ivabradin) om morgenen og en halv tablet på 5 mg om aftenen.
English: Ivabradine has low affinity for CYP3A4, shows no clinically relevant CYP3A4 induction or inhibition and is therefore unlikely to modify CYP3A4 substrate metabolism or plasma concentrations.
Danish: Ivabradin har lav affinitet til CYP3A4, viser ingen klinisk relevant induktion eller hæmning af CYP3A4 og vil derfor sandsynligvis ikke modificere metabolismen af CYP3A4-substrater eller deres plasmakoncentrationer.
English: There was an improvement in NYHA class in 37.7% of ivabradine patients versus 25.0% in the placebo group.
Danish: Der var en forbedring i NYHA-klasse hos 37,7 % af patienterne i ivabradingruppen versus 25,0 % i placebogruppen.
English: The pharmacokinetic profile of ivabradine in paediatric chronic heart failure patients aged 6 months to less than 18 years is similar to the pharmacokinetics described in adults when a titration scheme based on age and weight is applied.
Danish: Ivabradins farmakokinetiske profil hos pædiatriske patienter i alderen 6 måneder til under 18 år med kronisk hjerteinsufficiens svarer til farmakokinetikken, der er beskrevet hos voksne, når et titreringsskema baseret på alder og vægt anvendes.
English: Uncommon Hyperuricaemia
Danish: Ikke almindelig Hyperurikæmi
English: Moderate CYP3A4 inhibitors: specific interaction studies in healthy volunteers and patients have shown that the combination of ivabradine with the heart rate reducing agents diltiazem or verapamil resulted in an increase in ivabradine exposure (2 to 3-fold increase in AUC) and an additional heart rate reduction of 5 bpm.
Danish: Moderate CYP3A4-hæmmere: specifikke interaktionsstudier hos raske frivillige og patienter har vist, at kombinationen af ivabradin med de hjertefrekvenssænkende stoffer diltiazem eller verapamil medførte en øgning af eksponeringen over for ivabradin (2 til 3 gange øgning af AUC) samt en yderligere reduktion af hjertefrekvensen på 5 slag/min.
English: The use of ivabradine in patients with congenital QT syndrome or treated with QT prolonging medicinal products should be avoided (see section 4.5).
Danish: Anvendelse af ivabradin hos patienter med kongenit QT-syndrom eller hos patienter, som behandles med QT-forlængende lægemidler, skal undgås (se pkt.
English: Ivabradine did not show additional efficacy on secondary endpoints of ETT parameters at the trough of drug activity while an additional efficacy was shown at peak (3 - 4 hours after oral ivabradine intake).
Danish: Ivabradin viste ingen yderligere effekt på sekundære endepunkter på parametre i en arbejdstolerancetest ved trough-niveauet for lægemidlets virkning, hvorimod der observeredes yderligere effekt på tidspunktet med maksimal aktivitet (3-4 timer efter oral indtagelse af ivabradin).
English: Talk to your doctor or pharmacist before taking Ivabradine Zentiva - If you suffer from heart rhythm disorders (such as irregular heartbeat, palpitation, increase in chest pain) or sustained atrial fibrillation (a type of irregular heartbeat), or an abnormality of electrocardiogram (ECG) called “long QT syndrome”.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Ivabradine Zentiva: - Hvis du lider af forstyrrelser i hjertets rytme (uregelmæssig puls, hjertebanken, smerter i brystkassen) eller vedvarende hjerteflimmer (hurtig, meget uregelmæssig puls) eller en abnormitet i elektrokardiogrammet (ekg) kaldet ”lang QT-syndrom”.
English: The reduction in the primary endpoint was observed consistently irrespective of gender, NYHA class, ischaemic or non-ischaemic heart failure aetiology and of background history of diabetes or hypertension.
Danish: Risikoreduktionen for det primære endepunkt forekom konsekvent uanset køn, NYHAklasse, hjerteinsufficiens med/uden iskæmisk ætiologi og anamnese med diabetes eller hypertension.
English: The study showed no difference in the rate of the primary composite outcome in the ivabradine group by comparison to the placebo group (relative risk ivabradine:placebo: 1.00, p = 0.945).
Danish: Studiet viste ingen forskel i det primære sammensatte effektmål ved sammenligning af ivabradin-gruppen og placebogruppen (relativ risiko for ivabradin; placebo: 1,00, p = 0,945).
English: Hypromellose Titanium dioxide Macrogol 400
Danish: Filmovertræk: Hypromellose Titandioxid Macrogol 400 Glycerol
English: Talk to your doctor if you are breast-feeding or intending to breast-feed as breastfeeding should be discontinued if you take Ivabradine Zentiva.
Danish: Tal med lægen, hvis du ammer eller ønsker at amme, da amning skal ophøre, hvis du tager Ivabradine Zentiva.
English: A small statistically significant increase in the PCE was observed in a pre-specified subgroup of patients with angina patients in CCS class II or higher at baseline (n = 12,049) (annual rates 3.4% versus 2.9%, relative risk ivabradine/placebo 1.18, p = 0.018), but not in the subgroup of the overall angina population in CCS class ≥ I (n = 14,286) (relative risk ivabradine/placebo 1.11, p = 0.110).
Danish: En lille statistisk signifikant stigning i PCE blev observeret i en præ-specificeret subgruppe af patienter med angina pectoris i CCS-klasse II eller højere ved baseline (n = 12.049) (årsrate 3,4 % versus 2,9 %, relativ risiko ivabradin/placebo 1,18, p = 0,018), men ikke i subgruppen af den totale anginapopulation i CCS-klasse ≥ I (n = 14.286) (relativ risiko ivabradin/placebo 1,11, p = 0,110).