Implementation of sacubitril/valsartan in Sweden: clinical characteristics, titration patterns, and determinants.

Real-world Registry Sacubitril/valsartan Sweden

Journal

ESC heart failure
ISSN: 2055-5822
Titre abrégé: ESC Heart Fail
Pays: England
ID NLM: 101669191

Informations de publication

Date de publication:
Dec 2020
Historique:
revised: 04 06 2020
received: 17 03 2020
accepted: 17 06 2020
pubmed: 4 9 2020
medline: 4 9 2020
entrez: 4 9 2020
Statut: ppublish

Résumé

The aim of this study is to study the introduction of sacubitril/valsartan (sac/val) in Sweden with regards to regional differences, clinical characteristics, titration patterns, and determinants of use and discontinuation. A national cohort of heart failure was defined from the Swedish Prescribed Drug Register and National Patient Register. A subcohort with additional data from the Swedish Heart Failure Registry (SwedeHF) was also studied. Cohorts were subdivided as per sac/val prescription and registration in SwedeHF. Median sac/val prescription rate was 20 per 100 000 inhabitants. Between April 2016 and December 2017, we identified 2037 patients with ≥1 sac/val prescription, of which 1144 (56%) were registered in SwedeHF. Overall, patients prescribed with sac/val were younger, more frequently male, and had less prior cardiovascular disease than non-sac/val patients. In SwedeHF subcohort, patients prescribed with sac/val had lower ejection fraction. Overall, younger age [hazard ratio 2.81 (95% confidence interval 2.45-3.22)], registration in SwedeHF [1.97 (1.83-2.12)], male gender [1.50 (1.37-1.64)], ischaemic heart disease [1.50 (1.39-1.62)], lower left ventricular ejection fraction [3.06 (2.18-4.31)], and New York Heart Association IV [1.50 (1.22-1.84)] were predictors for sac/val use. As initiation dose in the sac/val cohort, 38% received 24/26 mg, 54% 49/51 mg, and 9% 97/103 mg. Up-titration to the target dose was achieved in 57% of the overall cohort over a median follow-up of 6 months. The estimated treatment persistence for any dose at 360 days was 82%. Implementation of sac/val in Sweden was slow and varied five-fold across different regions; younger age, male, SwedeHF registration, and ischaemic heart disease were among the independent predictors of receiving sac/val. Overall, treatment persistence and tolerability was high.

Identifiants

pubmed: 32881399
doi: 10.1002/ehf2.12883
pmc: PMC7754959
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

3633-3643

Subventions

Organisme : Novartis

Informations de copyright

© 2020 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.

Références

McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR, Investigators P-H, Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med 2014; 371: 993-1004.
Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P, Authors/Task Force M, Document R. 2016 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail 2016; 18: 891-975.
Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Colvin MM, Drazner MH, Filippatos GS, Fonarow GC, Givertz MM, Hollenberg SM, Lindenfeld J, Masoudi FA, McBride PE, Peterson PN, Stevenson LW, Westlake C. 2017 ACC/AHA/HFSA focused update of the 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. J Am Coll Cardiol 2017; 70: 776-803.
Pellicori P, Urbinati A, Shah P, MacNamara A, Kazmi S, Dierckx R, Zhang J, Cleland JGF, Clark AL. What proportion of patients with chronic heart failure are eligible for sacubitril-valsartan? Eur J Heart Fail 2017; 19: 768-778.
Simpson J, Benson L, Jhund PS, Dahlstrom U, McMurray JJV, Lund LH. “Real world” eligibility for sacubitril/valsartan in unselected heart failure patients: data from the Swedish Heart Failure Registry. Cardiovasc Drugs Ther. [journal article] 2019; 33: 315-322.
Kapelios CJ, Lainscak M, Savarese G, Laroche C, Seferovic P, Ruschitzka F, Coats A, Anker SD, Crespo-Leiro MG, Filippatos G, Piepoli MF, Rosano G, Zanolla L, Aguiar C, Murin J, Leszek P, McDonagh T, Maggioni AP, Lund LH, Heart Failure Long-Term Registry Investigators. Sacubitril/valsartan eligibility and outcomes in the ESC-EORP-HFA Heart Failure Long-Term Registry: bridging between European Medicines Agency/Food and Drug Administration label, the PARADIGM-HF trial, ESC guidelines, and real world. Eur J Heart Fail 2019; 21: 1383-1397.
DeVore AD, Hill CL, Thomas L, Sharma PP, Albert NM, Butler J, Patterson JH, Spertus JA, Williams FB, Duffy CI, McCague K, Hernandez AF, Fonarow GC. Patient, provider, and practice characteristics associated with sacubitril/valsartan use in the United States. Circ Heart Fail 2018; 11: e005400.
Albert NM, Swindle JP, Buysman EK, Chang C. Lower hospitalization and healthcare costs with sacubitril/valsartan versus angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker in a retrospective analysis of patients with heart failure. J Am Heart Assoc [Article] 2019; 8: e011089.
Van der Pol S, Postma MJ. CV3-Cost-effectiveness of sacubitril/valsartan in Germany: applying the efficiency threshold. Value Health [Conference Abstract] 2018; 21: S6.
Scardovi AB, Boccanelli A. Valsartan/sacubitril in heart failure and hypotension: how, when and why. Eur Heart J Suppl [Short Survey] 2019; 21: B88-B89.
Savarese G, Sartipy U, Friberg L, Dahlstrom U, Lund LH. Reasons for and consequences of oral anticoagulant underuse in atrial fibrillation with heart failure. Heart (British Cardiac Society) 2018; 104: 1093-1100.
Savarese G, Carrero JJ, Pitt B, Anker SD, Rosano GMC, Dahlstrom U, Lund LH. Factors associated with underuse of mineralocorticoid receptor antagonists in heart failure with reduced ejection fraction: an analysis of 11 215 patients from the Swedish Heart Failure Registry. Eur J Heart Fail 2018; 20: 1326-1334.
Norberg H, Bergdahl E, Lindmark K. Eligibility of sacubitril-valsartan in a real-world heart failure population: a community-based single-centre study. ESC heart failure 2018; 5: 337-343.
Thorvaldsen T, Benson L, Dahlstrom U, Edner M, Lund LH. Use of evidence-based therapy and survival in heart failure in Sweden 2003-2012. Eur J Heart Fail 2016; 18: 503-511.
Maggioni AP, Anker SD, Dahlstrom U, Filippatos G, Ponikowski P, Zannad F, Amir O, Chioncel O, Leiro MC, Drozdz J, Erglis A, Fazlibegovic E, Fonseca C, Fruhwald F, Gatzov P, Goncalvesova E, Hassanein M, Hradec J, Kavoliuniene A, Lainscak M, Logeart D, Merkely B, Metra M, Persson H, Seferovic P, Temizhan A, Tousoulis D, Tavazzi L, Heart Failure Association of the ESC. Are hospitalized or ambulatory patients with heart failure treated in accordance with European Society of Cardiology guidelines? Evidence from 12 440 patients of the ESC Heart Failure Long-Term Registry. Eur J Heart Fail 2013; 15: 1173-1184.
Peri-Okonny PA, Mi X, Khariton Y, Patel KK, Thomas L, Fonarow GC, Sharma PP, Duffy CI, Albert NM, Butler J, Hernandez AF, McCague K, Williams FB, DeVore AD, Patterson JH, Spertus JA. Target doses of heart failure medical therapy and blood pressure: insights from the CHAMP-HF registry. JACC Heart Fail 2019; 7: 350-358.
Greene SJ, Fonarow GC, DeVore AD, Sharma PP, Vaduganathan M, Albert NM, Duffy CI, Hill CL, McCague K, Patterson JH, Spertus JA, Thomas L, Williams FB, Hernandez AF, Butler J. Titration of medical therapy for heart failure with reduced ejection fraction. J Am Coll Cardiol 2019; 73: 2365-2383.
Norberg H, Pranic V, Bergdahl E, Lindmark K. Differences in medical treatment and clinical characteristics between men and women with heart failure-a single-centre multivariable analysis. Eur J Clin Pharmacol 2020; 76: 539-546.
Wachter R, Senni M, Belohlavek J, Straburzynska-Migaj E, Witte KK, Kobalava Z, Fonseca C, Goncalvesova E, Cavusoglu Y, Fernandez A, Chaaban S, Bohmer E, Pouleur AC, Mueller C, Tribouilloy C, Lonn E, Buraiki JAL, Gniot J, Mozheiko M, Lelonek M, Noe A, Schwende H, Bao W, Butylin D, Pascual-Figal D, Investigators T. Initiation of sacubitril/valsartan in haemodynamically stabilised heart failure patients in hospital or early after discharge: primary results of the randomised TRANSITION study. Eur J Heart Fail [Article in Press] 2019; 21: 998-1007.
Bruce Wirta S, Wachter R, Balas B, Klebs S, Fonseca AF, Proenca CC, Dworak M, Schlienger R, Engelhard J, Maier T, Kostev K. Abstracts of the Heart Failure 2018 and the World Congress on Acute Heart Failure, 26-29 May 2018, Vienna, Austria. Eur J Heart Fail 2018; 20: 5-638.
Seferovic PM, Ponikowski P, Anker SD, Bauersachs J, Chioncel O, Cleland JGF, de Boer RA, Drexel H, Ben Gal T, Hill L, Jaarsma T, Jankowska EA, Anker MS, Lainscak M, Lewis BS, McDonagh T, Metra M, Milicic D, Mullens W, Piepoli MF, Rosano G, Ruschitzka F, Volterrani M, Voors AA, Filippatos G, Coats AJS. Clinical practice update on heart failure 2019: pharmacotherapy, procedures, devices and patient management. An expert consensus meeting report of the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail 2019; 21: 1169-1186.

Auteurs

Michael Fu (M)

Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.

Ola Vedin (O)

Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.
Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.

Bodil Svennblad (B)

Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.

Erik Lampa (E)

Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.

Daniel Johansson (D)

Novartis Sweden AB, Stockholm, Sweden.

Ulf Dahlström (U)

Department of Cardiology and Department of Medical and Health Sciences, Linköping University Hospital, Linköping, Sweden.

Krister Lindmark (K)

Heart Centre, Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.

Peter Vasko (P)

Central Hospital, Växjö, Sweden.

Anna Lundberg (A)

Novartis Sweden AB, Stockholm, Sweden.

Madlaina Costa-Scharplatz (M)

Novartis Sweden AB, Stockholm, Sweden.

Lars H Lund (LH)

Department of Medicine, Karolinska Institutet, Stockholm, Sweden.
Heart and Vascular Theme, Karolinska University Hospital, Stockholm, Sweden.

Classifications MeSH