title: Quality of Life With Ivabradine in Patients With Angina Pectoris: The Study Assessing the Morbidity-Mortality Benefits of the If Inhibitor Ivabradine in Patients With Coronary Artery Disease Quality of Life Substudy.
abstract: BACKGROUND
  To explore the effect of ivabradine on angina-related quality of life (QoL) in patients participating in the Study Assessing the Morbidity-Mortality Benefits of the If Inhibitor Ivabradine in Patients with Coronary Artery Disease (SIGNIFY) QoL substudy.
  
  
  RESULTS
  QoL was evaluated in a prespecified subgroup of SIGNIFY patients with angina (Canadian Cardiovascular Society class score, ≥ 2 at baseline) using the Seattle Angina Questionnaire and a generic visual analogue scale on health status. Data were available for 4187 patients (2084 ivabradine and 2103 placebo). There were improvements in QoL in both treatment groups. The primary outcome of change in physical limitation score at 12 months was 4.56 points for ivabradine versus 3.40 points for placebo (E, 0.96; 95% confidence interval, -0.14 to 2.05; P=0.085). The ivabradine-placebo difference in physical limitation score was significant at 6 months (P=0.048). At 12 months, the visual analogue scale and the other Seattle Angina Questionnaire dimensions were higher among ivabradine-treated patients, notably angina frequency (P<0.001) and disease perception (P=0.006). Patients with the worst QoL at baseline (ie, those in the lowest tertile of score) had the best improvement in QoL for 12 months, with improvements in physical limitation and a significant reduction in angina frequency (P=0.034). The effect on QoL was maintained over the study duration, and ivabradine patients had better scores on angina frequency at every visit to 36 months.
  
  
  CONCLUSIONS
  Treatment with ivabradine did not affect the primary outcome of change in physical limitation score at 12 months. It did produce consistent improvements in other self-reported QoL parameters related to angina pectoris, notably in terms of angina frequency and disease perception.
  
  
  BACKGROUND
  URL: http://www.isrctn.com. Unique identifier: ISRCTN61576291.
authors.affiliation: From the 3rd Department of Cardiology, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland (M.T.); Université Paris-Diderot, Sorbonne-Paris Cité, LEA 7334 (REMES) Patient-Centered Outcomes Research, Paris, France (O.C.); AP-HP, Unité de Recherche Clinique en économie de la Santé, Hôpital Hôtel-Dieu, Paris, France (O.C.); Department of Cardiology and LTTA Centre, University Hospital of Ferrara and Maria Cecilia Hospital, GVM Care and Research, Ettore Sansavini: Health Science Foundation, Cotignola, Italy (R.F.); Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom (I.F.); Département Hospitalo-Universitaire FIRE, Hôpital Bichat, Assistance Publique, Hôpitaux de Paris, Paris, France (P.G.S.); INSERM U-1148, Paris, France (P.G.S.); Université Paris-Diderot, Paris, France (P.G.S.); Sorbonne-Paris Cité, Paris, France (P.G.S.); Montreal Heart Institute Coordinating Center (MHICC), Université de Montréal, Montreal, Quebec, Canada (J.-C.T.); and NHLI Imperial College, ICMS Royal Brompton Hospital, London, United Kingdom (P.G.S., K.F.). michal.tendera@sum.edu.pl.
authors.forename: Michal
authors.initials: M
authors.lastname: Tendera
authors.affiliation: From the 3rd Department of Cardiology, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland (M.T.); Université Paris-Diderot, Sorbonne-Paris Cité, LEA 7334 (REMES) Patient-Centered Outcomes Research, Paris, France (O.C.); AP-HP, Unité de Recherche Clinique en économie de la Santé, Hôpital Hôtel-Dieu, Paris, France (O.C.); Department of Cardiology and LTTA Centre, University Hospital of Ferrara and Maria Cecilia Hospital, GVM Care and Research, Ettore Sansavini: Health Science Foundation, Cotignola, Italy (R.F.); Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom (I.F.); Département Hospitalo-Universitaire FIRE, Hôpital Bichat, Assistance Publique, Hôpitaux de Paris, Paris, France (P.G.S.); INSERM U-1148, Paris, France (P.G.S.); Université Paris-Diderot, Paris, France (P.G.S.); Sorbonne-Paris Cité, Paris, France (P.G.S.); Montreal Heart Institute Coordinating Center (MHICC), Université de Montréal, Montreal, Quebec, Canada (J.-C.T.); and NHLI Imperial College, ICMS Royal Brompton Hospital, London, United Kingdom (P.G.S., K.F.).
authors.forename: Olivier
authors.initials: O
authors.lastname: Chassany
authors.affiliation: From the 3rd Department of Cardiology, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland (M.T.); Université Paris-Diderot, Sorbonne-Paris Cité, LEA 7334 (REMES) Patient-Centered Outcomes Research, Paris, France (O.C.); AP-HP, Unité de Recherche Clinique en économie de la Santé, Hôpital Hôtel-Dieu, Paris, France (O.C.); Department of Cardiology and LTTA Centre, University Hospital of Ferrara and Maria Cecilia Hospital, GVM Care and Research, Ettore Sansavini: Health Science Foundation, Cotignola, Italy (R.F.); Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom (I.F.); Département Hospitalo-Universitaire FIRE, Hôpital Bichat, Assistance Publique, Hôpitaux de Paris, Paris, France (P.G.S.); INSERM U-1148, Paris, France (P.G.S.); Université Paris-Diderot, Paris, France (P.G.S.); Sorbonne-Paris Cité, Paris, France (P.G.S.); Montreal Heart Institute Coordinating Center (MHICC), Université de Montréal, Montreal, Quebec, Canada (J.-C.T.); and NHLI Imperial College, ICMS Royal Brompton Hospital, London, United Kingdom (P.G.S., K.F.).
authors.forename: Roberto
authors.initials: R
authors.lastname: Ferrari
authors.affiliation: From the 3rd Department of Cardiology, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland (M.T.); Université Paris-Diderot, Sorbonne-Paris Cité, LEA 7334 (REMES) Patient-Centered Outcomes Research, Paris, France (O.C.); AP-HP, Unité de Recherche Clinique en économie de la Santé, Hôpital Hôtel-Dieu, Paris, France (O.C.); Department of Cardiology and LTTA Centre, University Hospital of Ferrara and Maria Cecilia Hospital, GVM Care and Research, Ettore Sansavini: Health Science Foundation, Cotignola, Italy (R.F.); Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom (I.F.); Département Hospitalo-Universitaire FIRE, Hôpital Bichat, Assistance Publique, Hôpitaux de Paris, Paris, France (P.G.S.); INSERM U-1148, Paris, France (P.G.S.); Université Paris-Diderot, Paris, France (P.G.S.); Sorbonne-Paris Cité, Paris, France (P.G.S.); Montreal Heart Institute Coordinating Center (MHICC), Université de Montréal, Montreal, Quebec, Canada (J.-C.T.); and NHLI Imperial College, ICMS Royal Brompton Hospital, London, United Kingdom (P.G.S., K.F.).
authors.forename: Ian
authors.initials: I
authors.lastname: Ford
authors.affiliation: From the 3rd Department of Cardiology, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland (M.T.); Université Paris-Diderot, Sorbonne-Paris Cité, LEA 7334 (REMES) Patient-Centered Outcomes Research, Paris, France (O.C.); AP-HP, Unité de Recherche Clinique en économie de la Santé, Hôpital Hôtel-Dieu, Paris, France (O.C.); Department of Cardiology and LTTA Centre, University Hospital of Ferrara and Maria Cecilia Hospital, GVM Care and Research, Ettore Sansavini: Health Science Foundation, Cotignola, Italy (R.F.); Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom (I.F.); Département Hospitalo-Universitaire FIRE, Hôpital Bichat, Assistance Publique, Hôpitaux de Paris, Paris, France (P.G.S.); INSERM U-1148, Paris, France (P.G.S.); Université Paris-Diderot, Paris, France (P.G.S.); Sorbonne-Paris Cité, Paris, France (P.G.S.); Montreal Heart Institute Coordinating Center (MHICC), Université de Montréal, Montreal, Quebec, Canada (J.-C.T.); and NHLI Imperial College, ICMS Royal Brompton Hospital, London, United Kingdom (P.G.S., K.F.).
authors.forename: Philippe Gabriel
authors.initials: PG
authors.lastname: Steg
authors.affiliation: From the 3rd Department of Cardiology, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland (M.T.); Université Paris-Diderot, Sorbonne-Paris Cité, LEA 7334 (REMES) Patient-Centered Outcomes Research, Paris, France (O.C.); AP-HP, Unité de Recherche Clinique en économie de la Santé, Hôpital Hôtel-Dieu, Paris, France (O.C.); Department of Cardiology and LTTA Centre, University Hospital of Ferrara and Maria Cecilia Hospital, GVM Care and Research, Ettore Sansavini: Health Science Foundation, Cotignola, Italy (R.F.); Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom (I.F.); Département Hospitalo-Universitaire FIRE, Hôpital Bichat, Assistance Publique, Hôpitaux de Paris, Paris, France (P.G.S.); INSERM U-1148, Paris, France (P.G.S.); Université Paris-Diderot, Paris, France (P.G.S.); Sorbonne-Paris Cité, Paris, France (P.G.S.); Montreal Heart Institute Coordinating Center (MHICC), Université de Montréal, Montreal, Quebec, Canada (J.-C.T.); and NHLI Imperial College, ICMS Royal Brompton Hospital, London, United Kingdom (P.G.S., K.F.).
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Tardif
authors.affiliation: From the 3rd Department of Cardiology, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland (M.T.); Université Paris-Diderot, Sorbonne-Paris Cité, LEA 7334 (REMES) Patient-Centered Outcomes Research, Paris, France (O.C.); AP-HP, Unité de Recherche Clinique en économie de la Santé, Hôpital Hôtel-Dieu, Paris, France (O.C.); Department of Cardiology and LTTA Centre, University Hospital of Ferrara and Maria Cecilia Hospital, GVM Care and Research, Ettore Sansavini: Health Science Foundation, Cotignola, Italy (R.F.); Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom (I.F.); Département Hospitalo-Universitaire FIRE, Hôpital Bichat, Assistance Publique, Hôpitaux de Paris, Paris, France (P.G.S.); INSERM U-1148, Paris, France (P.G.S.); Université Paris-Diderot, Paris, France (P.G.S.); Sorbonne-Paris Cité, Paris, France (P.G.S.); Montreal Heart Institute Coordinating Center (MHICC), Université de Montréal, Montreal, Quebec, Canada (J.-C.T.); and NHLI Imperial College, ICMS Royal Brompton Hospital, London, United Kingdom (P.G.S., K.F.).
authors.forename: Kim
authors.initials: K
authors.lastname: Fox
mesh_terms: D000787:Angina Pectoris / Q000188:drug therapy*; D001552:Benzazepines / Q000627:therapeutic use*; D002317:Cardiovascular Agents / Q000627:therapeutic use*; D003324:Coronary Artery Disease / Q000188:drug therapy*; D005260:Female; D006801:Humans; D000077550:Ivabradine; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011795:Surveys and Questionnaires; D064232:Visual Analog Scale
chemical_list: D001552:Benzazepines; D002317:Cardiovascular Agents; D000077550:Ivabradine
keywords: angina pectoris; coronary artery disease; ivabradine; quality of life; therapeutics