Nuffield Department of Population Health

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Nuffield Department of Population Health Richard Doll Building, Old Road Campus, Headington, Oxford OX3 7LF, UK _______________________________________________________________________________________________ Date: 25 February 2015 To: WHO Essential Medications List Expert Committee An application to recommend that fixed-dose combination therapy be added to the WHO model list of essential medicines for secondary prevention of cardiovascular disease (ischemic heart disease and ischemic stroke) We are writing in strong support of the above application. For more than 30 years the Clinical Trial Service Unit of the University of Oxford, of which we are jointly the directors, has conducted large international trials and co- ordinated worldwide meta-analyses of trials, of anti-thrombotic drugs, beta-blockers, converting enzyme inhibitors, blood-pressure lowering drugs and cholesterol- lowering drugs, demonstrating moderate but definite benefits that, in combination, yield substantial benefits, reducing by well over half the likelihood of recurrence and death if taken regularly for several years. If taken for secondary prevention, the absolute annual benefit from appropriate combination of such drugs is substantial. Each of these classes of drug is now available as an affordable generic product, but it is difficult to maintain compliance (both by prescribers and by patients) over many years with multiple medications. Different expert panels, including the WHO and the Combination Pharmacotherapy and Public Health Research Working Group, have recognized the potential value of fixed dose combination therapy for secondary prevention of cardiovascular disease. We agree strongly that affordable availability of low-cost fixed-dose combination therapy is highly desirable, and inclusion of such combinations in the WHO essential drugs list would encourage this. Sir Richard Peto Professor of Medical Statistics and Epidemiology, University of Oxford, UK Colin Baigent Professor of Epidemiology University of Oxford, UK Sir Rory Collins Head, Nuffield Department of Population Health, University of Oxford, UK _______________________________________________________________________________________ Head of Department Professor Sir Rory Collins FMed Sci FRCP .

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Old Road Campus
Old Road Campus 4a, 4b, 4c, U5 n o t Oxford City Centre g OLD ROAD n i d 4a, 4b, 4c, U5 a e H K O L L A D R O W AD E M I L 4,4a,4b,4c, U1X,U5 A41 42 4,4a,4b,4c,U5 Rin D 4 g R oad 6 7 1 13 3 11 C H U R C H I L L 900 D 2 R I 700, 900 V E E O x f o 5 A C rd 12 C i ty 10 C e n t re B 8 CAR PARK C 9 h u r c R F h i O l l O S H E o V s N E p L i T t DRI a VE ENTRANCE ROOSEVELT DRIVE l 900, ST2 Index 1 The Triangle Nursery 9 Old Road Campus Estates Annexe 13 Boundary Brook House Interserve Joint Research Office Kennedy Institute 2 - Research Services, Medical Sciences Division Old Road Campus Research Building 10 - Clinical Trials and Research Governance 3 New Richards Building Department of Oncology - Human Tissue Governance CRUK/MRC Oxford Institute for Radiation Oncology - Medical Sciences Division Business Development 4 NDM Research Building Institute of Biomedical Engineering Nuffield Department of Primary Care Health Sciences Target Discovery Institute Jenner Institute Medical Sciences Divisional Safety Officers Centre for Tropical Medicine and Global Health Bodleian Knowledge Centre (Library Services) Medical Sciences Division IT Services 5 Wellcome Centre for Human Genetics (WHG) Ludwig Institute for Cancer Research Structural Genomics Consortium 6 Henry Wellcome Building for Molecular Physiology Nuffield Department of Surgical Sciences Loading Bays and Delivery Offices of the Nuffield Professor of Medicine ENTRANCE VIA BUILDING 5 11 Big Data Institute A Wellcome Trust Centre for Human Genetics 7 Henry Wellcome Building for Particle Imaging
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A Thesis Submitted for the Degree of PhD at the University of Warwick Permanent WRAP URL: http://wrap.warwick.ac.uk/149337 Copyright and reuse: This thesis is made available online and is protected by original copyright. Please scroll down to view the document itself. Please refer to the repository record for this item for information to help you to cite it. Our policy information is available from the repository home page. For more information, please contact the WRAP Team at: [email protected] warwick.ac.uk/lib-publications A Randomized Trial of Neprilysin Inhibition with Sacubitril/valsartan vs Irbesartan in Chronic Kidney Disease by Dr Parminder Kaur Judge Thesis submitted in fulfilment of the requirements for the degree of Doctor of Philosophy (PhD) in Medicine University of Warwick & Medical Research Council Population Health Research Unit, Nuffield Department of Population Health, University of Oxford Submitted June 2020 1 Contents Section Page List of Tables 7 List of Figures 9 Acknowledgements 10 Declarations 12 Inclusion of Published Work 13 Abstract 14 Chapters 1 List of abbreviations 15 2 Introduction 19 3 Natriuretic peptide system and neprilysin 35 2 4 Angiotensin receptor-neprilysin inhibitor (ARNI) 46 Effects on renal function 50 Effects on albuminuria 53 5 Methods 65 Trial organisation 70 Staff training 70 Data management 70 Trial treatments 70 Consent 72 Biological samples 73 Randomized treatment and blinding 76 Blood and urine samples 76 3 Adverse events and compliance with trial treatment 77 Physical measurements
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1 RECOVERY Central Coordinating Office Nuffield Department Of
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Nuffield Department of Population Health Richard Doll Building, Old Road Campus, Headington, Oxford OX3 7LF Tel: +44 (0)1865 743743, Fax: +44 (0)1865 743985, email: [email protected] _______________________________________________________________________________________________ 14 April 2014 Dr Fiona Godlee Editor, BMJ BMJ Publishing Group Tavistock Square London WC1H 9JR Dear Fiona NOT FOR PUBLICATION Thank you for responding so rapidly to my letter of 31 March, but unfortunately the key points that I raised have not been addressed properly either by the letters from Abramson et al and Malhotra or by your response of 1 April. I can assure you that this issue is not at all personal. As indicated previously, it seems highly likely that the misleading claims that have been reported by the BMJ about side- effect rates with statins will lead to large numbers of unnecessary heart attacks, strokes and premature deaths because patients at elevated risk will be dissuaded from taking statins. My concern is with the BMJ’s failure to correct promptly and prominently such a serious mistake when it has major public health implications. As I explained to you when we met, the evidence cited by Abramson et al and Malhotra does not support their claims that statins cause side-effects in 18-20% of patients. For the sake of clarity, a “statin-related adverse event” (which is what was studied in the paper by Zhang et al that is being cited) is not necessarily caused by, or a side-effect of, a statin. Consequently, it is a serious misrepresentation of the evidence for Abramson et al and Malhotra to state that it is.
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