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 Table of Contents  
ORIGINAL ARTICLE
Year : 2017  |  Volume : 3  |  Issue : 2  |  Page : 100-102

Epidemiologic surveillance on quality of life in patients with systolic heart failure after treatment with the selective heart rate inhibitor ivabradine


1 Department of Cardiology, Care Hospital, Hyderabad, Telangana, India
2 Department of Cardiology, ICVS, IPGMER and SSKM Hospital, Kolkata, West Bengal, India

Date of Web Publication20-Nov-2017

Correspondence Address:
M Srinivasa Rao
Care Hospital, Road No. 1, Banjara Hills, Hyderabad - 500 034, Telangana
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jpcs.jpcs_8_17

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  Abstract 


Background: Patients with systolic heart failure (HF) frequently have symptoms despite receiving standard treatment. The addition of the selective heart rate inhibitor ivabradine has been shown to improve their quality of life (QOL) in randomized trials but not under day-to-day practice conditions. Objective: The objective of the study was to assess changes in QOL after the addition of ivabradine to the standard treatment of patients with systolic HF, in daily clinical practice. Patients and Methods: In a multicenter surveillance protocol, patients with a diagnosis of systolic HF who were prospectively prescribed ivabradine 5–7.5 mg twice a day for 60 days were selected for surveillance on their QOL. Primary data on demographic and clinical characteristics, together with a change in QOL assessed by a visual analog scale, during a 60-day follow-up, were extracted for analysis from the case records of patients kept with the investigators. Results: In 594 patients with systolic HF who received ivabradine in addition to standard treatment for 60 days, intention to treat analysts showed that 465 (78.3%, 95% confidence interval (CI), 74.7–81.4) had improvement in QOL. The mean (95% CI) QOL score increased by 37.0% (35.1–39.1). Conclusion: These results confirm the observations of previous randomized trials that in day-to-day clinical practice, patients with systolic HF benefit from an improvement in QOL when ivabradine is added to their standard treatment.

Keywords: Ivabradine, quality of life, systolic heart failure


How to cite this article:
Rao M S, Mandal SC. Epidemiologic surveillance on quality of life in patients with systolic heart failure after treatment with the selective heart rate inhibitor ivabradine. J Pract Cardiovasc Sci 2017;3:100-2

How to cite this URL:
Rao M S, Mandal SC. Epidemiologic surveillance on quality of life in patients with systolic heart failure after treatment with the selective heart rate inhibitor ivabradine. J Pract Cardiovasc Sci [serial online] 2017 [cited 2019 May 20];3:100-2. Available from: http://www.j-pcs.org/text.asp?2017/3/2/100/218817




  Introduction Top


The incidence of heart failure (HF) with reduced ejection fraction due to coronary artery disease is about 36% over a 7.6-year period.[1] Despite guideline-recommended treatment that includes angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) and beta-blockers (BBs) for all patients, with the addition of diuretics, nitrates, and aldosterone antagonists when required,[2] mortality is high, with as many as 40% succumbing within a year.[3] Further, almost all patients have shortness of breath, nearly half orthopnea, and about one-third suffer from paroxysmal nocturnal dyspnea,[4] which together suggests a very poor quality of life (QOL). This may in part be related to the adverse effects of BB, which in turn prevents their use at recommended doses in many patients. Newer approaches to meet the challenge of improving QOL of these patients are, therefore, required.

The specific sinoatrial node If current inhibitor ivabradine has been shown to significantly reduce cardiovascular death, hospital admission for worsening HF, and improve QOL when added to standard treatment versus placebo.[5],[6]

The aim of this prospective epidemiological surveillance was to assess changes in QOL after the addition of ivabradine to the standard treatment of patients with systolic HF, under conditions of daily practice.


  Patients and Methods Top


Selection of investigators

Primary care physicians known to the authors, and interested in the management of HF, were identified. Those who agreed to maintain surveillance on patients with HF under their care were invited to participate as investigators.

Selection of patients

Patients with a diagnosis of systolic HF under the care of the investigators, and who were prospectively prescribed ivabradine 5–7.5 mg twice a day for 60 days were selected for surveillance.

Surveillance

Primary data on demography, clinical characteristics, and QOL during a 60-day follow-up, were extracted for analysis from the case records of selected patients kept by the investigators. QOL was assessed using a visual analog scale of 0%–100%. Patients were asked to locate their subjective feeling of well-being on the scale (a higher score indicating a better QOL), at baseline, 15, 30, and 60 days after receiving treatment with ivabradine.

Statistical analysis

The primary outcomes were the number of patients reporting improvement in QOL on an intention to treat basis and the mean change in QOL score from baseline, after receiving treatment with ivabradine. Categorical data were expressed as percentages with their 95% confidence intervals (CIs). Change in QOL score was expressed as the difference in means between baseline and day 60 and 95% CI.


  Results Top


Forty investigators maintained epidemiologic surveillance on QOL for 60 days in 594 patients [Figure 1] with systolic HF who received ivabradine in addition to standard treatment. At baseline, most patients were aged between 55 and 75 years, of whom 198 (33.3%) were females. As shown in [Table 1], 56.4% had Type 2 diabetes and 64.8% had hypertension. HF severity was of New York Heart Association Class I in 1.3%, Class II in 32.5%, Class III in 23.2%, and Class IV in 7.2%. Its cause was coronary artery disease in 64.6%. Resting heart rate (HR) was 96.0 ± 13.0 bpm. The distribution of existing HF treatments received by patients was diuretic 69.7%, BB 60.3%, ACEI 56.6%, ARB 31.0%, and aldosterone antagonists 43.8%. At day 60 of treatment, on an intention to treat basis [Figure 2], 465 (78.3%, 95% CI: 74.7–81.4) had improvement in QOL. The mean (95% CI) QOL score increased by 37.0% (35.1–39.1) from baseline.
Figure 1: Patient flow.

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Figure 2: Quality of life scores (%) in patients with systolic heart failure receiving ivabradine.

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Table 1: Baseline characteristics of patients with systolic heart failure

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Comment

The patients with systolic HF selected for surveillance on QOL, before ivabradine was added to their treatment, were mostly middle-aged males with Type 2 diabetes, hypertension, and coronary artery disease. Although the majority of patients were receiving standard medication for HF, HR was high and QOL was perceived to be a third that of normal.

The addition of ivabradine for 60 days to standard treatment for systolic HF, resulted in substantial and clinically useful improvement in patient's perception of QOL.

At present, evidence-based treatment of systolic HF includes ACEI or ARB and BB for all patients.[2] Despite this, the majority have shortness of breath, nearly half have orthopnea, and about one-third suffer from paroxysmal nocturnal dyspnea,[4] leading to poor QOL. This may be partly due to the adverse effects of BB such as bronchospasm, hypotension, and rebound tachycardia which often limit their use at recommended doses in a large proportion of patients.

One of the principal actions of BB is to reduce HR. The evidence that these agents reduce morbidity and mortality in HF,[7] exert a favorable effect on left ventricular remodeling,[8] and reduce the risk of sudden death,[9] have raised the possibility that HR reduction could be related to these benefits,[10] suggesting the need for other HR reducing drugs that are relatively free of side effects.

In this regard, ivabradine is a novel drug that reduces HR by modulating the intrinsic pacemaker activity of the sinoatrial node. It inhibits entry of the If current into the cell and retards diastolic depolarization. This action reduces sinoatrial node firing rate and HR.[11] In contrast to BB, the HR reduction by ivabradine is devoid of any limitation on myocardial contractility or conduction or other side effects associated with BB.[12]

In patients with symptomatic chronic HF and systolic dysfunction, stabilized on standard background treatment that included ACEI or ARB and BB, the addition of ivabradine resulted in a significant reduction in the primary end point of cardiovascular death or hospital admission for worsening HF and brought about a significant improvement in QOL.[5]

This surveillance on QOL has limitations. The assessment of QOL was based on patient's subjective perception and not on a validated objective measure. However, patients received treatment and reported its effect on QOL under conditions reflective of usual clinical practice.

These results confirm the observations of previous randomized trials that in day-to-day clinical practice, over the short term, patients with systolic HF benefit from an improvement in QOL when ivabradine is added to their standard treatment.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Hellermann JP, Goraya TY, Jacobsen SJ, Weston SA, Reeder GS, Gersh BJ, et al. Incidence of heart failure after myocardial infarction: Is it changing over time? Am J Epidemiol 2003;157:1101-7.  Back to cited text no. 1
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2.
Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr., Drazner MH, et al. 2013 ACCF/AHA guideline for the management of heart failure: A report of the American College of Cardiology Foundation/American Heart Association task Force on Practice Guidelines. J Am Coll Cardiol 2013;62:e147-239.  Back to cited text no. 2
    
3.
Hellermann JP, Jacobsen SJ, Gersh BJ, Rodeheffer RJ, Reeder GS, Roger VL, et al. Heart failure after myocardial infarction: A review. Am J Med 2002;113:324-30.  Back to cited text no. 3
    
4.
Bhatia RS, Tu JV, Lee DS, Austin PC, Fang J, Haouzi A, et al. Outcome of heart failure with preserved ejection fraction in a population-based study. N Engl J Med 2006;355:260-9.  Back to cited text no. 4
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5.
Swedberg K, Komajda M, Böhm M, Borer JS, Ford I, Dubost-Brama A, et al. Ivabradine and outcomes in chronic heart failure (SHIFT): A randomised placebo-controlled study. Lancet 2010;376:875-85.  Back to cited text no. 5
    
6.
Volterrani M, Cice G, Caminiti G, Vitale C, D'Isa S, Perrone Filardi P, et al. Effect of Carvedilol, Ivabradine or their combination on exercise capacity in patients with Heart Failure (the CARVIVA HF trial). Int J Cardiol 2011;151:218-24.  Back to cited text no. 6
    
7.
Gheorghiade M, Colucci WS, Swedberg K. Beta-blockers in chronic heart failure. Circulation 2003;107:1570-5.  Back to cited text no. 7
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8.
Udelson JE. Ventricular remodeling in heart failure and the effect of beta-blockade. Am J Cardiol 2004;93:43B-8B.  Back to cited text no. 8
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9.
MERIT-HF Study Group. Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). Lancet 1999;353:2001-07.  Back to cited text no. 9
    
10.
McAlister FA, Wiebe N, Ezekowitz JA, Leung AA, Armstrong PW. Meta-analysis: Beta-blocker dose, heart rate reduction, and death in patients with heart failure. Ann Intern Med 2009;150:784-94.  Back to cited text no. 10
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11.
Sulfi S, Timmis AD. Ivabradine - The first selective sinus node I (f) channel inhibitor in the treatment of stable angina. Int J Clin Pract 2006;60:222-8.  Back to cited text no. 11
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12.
Simon L, Ghaleh B, Puybasset L, Giudicelli JF, Berdeaux A. Coronary and hemodynamic effects of S 16257, a new bradycardic agent, in resting and exercising conscious dogs. J Pharmacol Exp Ther 1995;275:659-66.  Back to cited text no. 12
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