Ivabradine Improves Quality of Life in Subjects with Chronic Heart Failure Compared to Treatment with β-Blockers: Results of a Multicentric Observational APULIA Study

Riccioni, Graziano; Masciocco, L; Benvenuto, Arianna; Saracino, Patrick G.; Viti, Daniele De; Massari, Ferdinando; Meliota, Giovanni; Buta, F; Saglio, Giuseppe

doi:10.1159/000355169

Cited by 17 publications

(15 citation statements)

References 19 publications

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“…These results are supported by a study by Riccioni et al [25] and also a head-to-head comparison trial of ivabradine, carvedilol, or combination treatment [15], demonstrating greater improvement in QOL with ivabradine alone or with combination therapy with carvedilol compared with carvedilol alone. In this head-to-head study, Volterrani et al [15] found no significant effect of carvedilol monotherapy on QOL after 3 months of treatment versus baseline.…”

Section: Discussionsupporting

confidence: 69%

Ivabradine Treatment in a Chronic Heart Failure Patient Cohort: Symptom Reduction and Improvement in Quality of Life in Clinical Practice

Zugck¹,

Martinka

Stöckl

2014

Adv Ther

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IntroductionIn the prospective, open-label multicenter INTENSIFY study, the effectiveness and tolerability of ivabradine as well as its impact on quality of life (QOL) in chronic systolic heart failure (CHF) patients were evaluated over a 4-month period.MethodsIn CHF patients with an indication for treatment with ivabradine, resting heart rate (HR), heart failure symptoms [New York Heart Association (NYHA) class, signs of decompensation], left ventricular ejection fraction, brain natriuretic peptide (BNP) values, QOL, and concomitant medication with focus on beta-blocker therapy were documented at baseline, after 4 weeks, and after 4 months. The results were analyzed using descriptive statistical methods.ResultsThousand nine hundred and fifty-six patients with CHF were included. Their mean age was 67 ± 11.7 years and 56.9% were male. 77.8% were receiving beta-blockers. Other concomitant medications included angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (83%), diuretics (61%), aldosterone antagonists (18%), and cardiac glycosides (8%). At baseline, the mean HR of patients was 85 ± 11.8 bpm, 51.1% and 37.2% of patients were classified as NYHA II and III, respectively, and 22.7% showed signs of decompensation. BNP concentrations were tracked in a subgroup, and values exceeding 400 pg/mL were noted in 53.9% of patients. The mean value of the European quality of life-5 dimensions (EQ-5D) QOL index was 0.64 ± 0.28. After 4 months of treatment with ivabradine, HR was reduced to 67 ± 8.9 bpm. Furthermore, the proportion of patients presenting with signs of decompensation decreased to 5.4% and the proportion of patients with BNP levels >400 pg/mL dropped to 26.7%, accompanied by a shift in NYHA classification towards lower grading (24.0% and 60.5% in NYHA I and II, respectively). EQ-5D index improved to 0.79 ± 0.21.ConclusionOver 4 months of treatment, ivabradine effectively reduced HR and symptoms in CHF patients in this study reflecting daily clinical practice. These benefits were accompanied by improved QOL and good general tolerability.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-014-0147-3) contains supplementary material, which is available to authorized users.

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Section: Discussionsupporting

confidence: 69%

Ivabradine Treatment in a Chronic Heart Failure Patient Cohort: Symptom Reduction and Improvement in Quality of Life in Clinical Practice

Zugck¹,

Martinka

Stöckl

2014

Adv Ther

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“…Guideline-recommended HF medication is clearly focused on prolongation of life, but much less on improving QoL:119,120 ACE inhibitors and ARBs,120 beta-blockers114,119–121 and also the aldosterone antagonist eplerenone122 are neutral, or only modestly improve or at best delay the progressive worsening of QoL.…”

Section: Patient Focus Perspectives: Quality Of Life (Qol)mentioning

confidence: 99%

“…in ivabradine group and 72 ± 4 b.p.m. in beta-blocker group) 119. According to the new HF classification of the ESC,3 these patients would now be classified as patients with HFmrEF.…”

Section: Patient Focus Perspectives: Quality Of Life (Qol)mentioning

confidence: 99%

Advances in the management of heart failure: the role of ivabradine

Müller‐Werdan

Stöckl

Werdan

2016

VHRM

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A high resting heart rate (≥70–75 b.p.m.) is a risk factor for patients with heart failure (HF) with reduced ejection fraction (EF), probably in the sense of accelerated atherosclerosis, with an increased morbidity and mortality. Beta-blockers not only reduce heart rate but also have negative inotropic and blood pressure-lowering effects, and therefore, in many patients, they cannot be given in the recommended dose. Ivabradine specifically inhibits the pacemaker current (funny current, If) of the sinoatrial node cells, resulting in therapeutic heart rate lowering without any negative inotropic and blood pressure-lowering effect. According to the European Society of Cardiology guidelines, ivabradine should be considered to reduce the risk of HF hospitalization and cardiovascular death in symptomatic patients with a reduced left ventricular EF ≤35% and sinus rhythm ≥70 b.p.m. despite treatment with an evidence-based dose of beta-blocker or a dose below the recommended dose (recommendation class “IIa” = weight of evidence/opinion is in favor of usefulness/efficacy: “should be considered”; level of evidence “B” = data derived from a single randomized clinical trial or large nonrandomized studies). Using a heart rate cutoff of ≥ 75 b.p.m., as licensed by the European Medicines Agency, treatment with ivabradine 5–7.5 mg b.i.d. reduces cardiovascular mortality by 17%, HF mortality by 39% and HF hospitalization rate by 30%. A high resting heart rate is not only a risk factor in HF with reduced EF but also at least a risk marker in HF with preserved EF, in acute HF and also in special forms of HF. In this review, we discuss the proven role of ivabradine in the validated indication “HF with reduced EF” together with interesting preliminary findings, and the potential role of ivabradine in further, specific forms of HF.

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“…There is now much evidence for the use of ivabradine to improve quality of life in symptomatic HF patients, who may have dyspnea at rest or on effort, altered exercise capacity, and fatigue [ 21 , 23 , 26 , 27 ], all of which may improve in the first weeks of therapy. In a sub-analysis of SHIFT (Systolic Heart failure treatment with the I f inhibitor ivabradine Trial) [ 28 ] in 1944 patients, health-related quality of life, as recorded by the disease-specific Kansas City Cardiomyopathy Questionnaire, was found to be inversely associated with clinical events [ 26 ].…”

Section: Effect Of Ivabradine On Quality Of Lifementioning

confidence: 99%

Addressing Major Unmet Needs in Patients with Systolic Heart Failure: The Role of Ivabradine

Pereira-Barretto

2016

Am J Cardiovasc Drugs

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We reviewed clinical evidence for the use of ivabradine in systolic heart failure (HF), in which it appears to improve symptoms, improve quality of life, prevent hospitalization, and prolong survival, thereby addressing unmet needs in the management of HF. Ivabradine provides symptomatic benefits in HF on top of standard therapies, in terms of functional parameters and exercise capacity, and there is some evidence that this leads to improvements in quality of life in symptomatic HF patients, who may have dyspnea, altered exercise capacity, and fatigue. The SHIFT trial demonstrated that ivabradine has significant beneficial effects on major outcomes in HF. Ivabradine had a significant effect on pump failure death, which was reduced by 26 % (p = 0.014), with no effect on sudden cardiac death. This is an important result since pump failure death is currently the main cause of death in HF, and also because the reductions in mortality obtained with beta-blockers and spironolactone in the last 20 years appear to be mainly due to reduction in sudden death rather than reduction in pump failure death. Ivabradine also has a beneficial effect on hospital admissions (−26 %, p < 0.0001), which is clinically relevant since a quarter of HF patients can expect to be readmitted to hospital for HF within 1 month of discharge. Ivabradine-treated patients are also at significantly lower risk of experiencing a second or third hospitalization for worsening HF. Ivabradine clearly has a key role to play in the management of HF by covering the main therapeutic objectives of symptoms, quality of life, and outcomes.

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Ivabradine Improves Quality of Life in Subjects with Chronic Heart Failure Compared to Treatment with β-Blockers: Results of a Multicentric Observational APULIA Study

Cited by 17 publications

References 19 publications

Ivabradine Treatment in a Chronic Heart Failure Patient Cohort: Symptom Reduction and Improvement in Quality of Life in Clinical Practice

Ivabradine Treatment in a Chronic Heart Failure Patient Cohort: Symptom Reduction and Improvement in Quality of Life in Clinical Practice

Advances in the management of heart failure: the role of ivabradine

Addressing Major Unmet Needs in Patients with Systolic Heart Failure: The Role of Ivabradine

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