Impact of Post Manufacturing Handling of Protein-Based Biologic Drugs on Product Quality and User Centricity

Authors: Cappelletto, Elia, Kwok, Stanley C., Sorret, Léa, Fuentes, Nathalie, Medina, Annette M., Burleigh, Stephen, Fast, Jonas, Mackenzie, Isla S., Fureby, Anna Millqvist, Paulsson, Mattias, Wahlgren, Marie, Elofsson, Ulla, Flynn, Angela, Miolo, Giorgia, Nyström, Lina, De Laureto, Patrizia Polverino, De Paoli, Giorgia

Source: In Journal of Pharmaceutical Sciences August 2024 113(8):2055-2064

Effect of timed dosing of usual antihypertensives according to patient chronotype on cardiovascular outcomes: the Chronotype sub-study cohort of the Treatment in Morning versus Evening (TIME) study

Authors: Pigazzani, Filippo, Dyar, Kenneth A., Morant, Steve V., Vetter, Céline, Rogers, Amy, Flynn, Robert W.V., Rorie, David A., Mackenzie, Isla S., Cappuccio, Francesco P., Manfredini, Roberto, MacDonald, Thomas M.

Source: In eClinicalMedicine June 2024 72

Getting our ducks in a row: The need for data utility comparisons of healthcare systems data for clinical trials

Authors: Sydes, Matthew R., Murray, Macey L., Ahmed, Saiam, Apostolidou, Sophia, Bliss, Judith M., Bloomfield, Claire, Cannings-John, Rebecca, Carpenter, James, Clayton, Tim, Clout, Madeleine, Cosgriff, Rebecca, Farrin, Amanda J., Gentry-Maharaj, Aleksandra, Gilbert, Duncan C., Harper, Charlie, James, Nicholas D., Langley, Ruth E., Lessels, Sarah, Lugg-Widger, Fiona, Mackenzie, Isla S., Mafham, Marion, Menon, Usha, Mintz, Harriet, Pinches, Heather, Robling, Michael, Wright-Hughes, Alexandra, Yorke-Edwards, Victoria, Love, Sharon B.

Source: In Contemporary Clinical Trials June 2024 141

Impact of beta-blockers on mortality and cardiovascular disease outcomes in patients with obstructive sleep apnoea: a population-based cohort study in target trial emulation framework

Authors: Chen, Anthony, Ju, Chengsheng, Mackenzie, Isla S., MacDonald, Thomas M., Struthers, Allan D., Wei, Li, Man, Kenneth K.C.

Source: In The Lancet Regional Health - Europe October 2023 33

Cardiovascular outcomes in adults with hypertension with evening versus morning dosing of usual antihypertensives in the UK (TIME study): a prospective, randomised, open-label, blinded-endpoint clinical trial

Authors: Mackenzie, Isla S, Rogers, Amy, Poulter, Neil R, Williams, Bryan, Brown, Morris J, Webb, David J, Ford, Ian, Rorie, David A, Guthrie, Greg, Grieve, J W Kerr, Pigazzani, Filippo, Rothwell, Peter M, Young, Robin, McConnachie, Alex, Struthers, Allan D, Lang, Chim C, MacDonald, Thomas M ^*

Source: In The Lancet 22-28 October 2022 400(10361):1417-1425

Allopurinol versus usual care in UK patients with ischaemic heart disease (ALL-HEART): a multicentre, prospective, randomised, open-label, blinded-endpoint trial

Authors: Ahmed, Husnat, Arthur, Peter, Aziz, Jane, Barnes, Lawrence, Boyle, Sarah, Brighton, Tom, Brown, Morris, Caulfield, Mark, Dawson, Jesse, Denvir, Martin, Doney, Alexander SF, Doshi, Sagar, Dryburgh, Moira, Eddleston, Michael, Finlayson, Jim, Fuat, Ahmet, Furnace, Jacqueline, Grieve, JW Kerr, Guthrie, Greg, Ham, Sharon, Isaard, Emma, Jennings, Claudine, Johnson, Richard, Kerr, Claire, Khan, Sohail, Krishnan, Kailash, Long, Susan, Mackintosh, Anne, Macleod, Mary Joan, McCormack, Terry, McEleny, Paul, Morar, Monique, Nadir, Adnan, Newby, David, Petrie, Colin, Preiss, David, Ralston, Stuart, Randall, Marc, Routledge, Helen, Shakir, Saad, Sharma, Raj, Shepherd, Bridget, Sims, Don, Snedden, Gordon, Trevelyan, Jasper, Weir, Christopher, Weir, Robin, Wetherall, Kirsty, Wilson, Robbie, Wilson, Adam, Zutis, Kris, Mackenzie, Isla S ^*, Hawkey, Christopher J, Ford, Ian, Greenlaw, Nicola, Pigazzani, Filippo, Rogers, Amy, Struthers, Allan D, Begg, Alan G, Wei, Li, Avery, Anthony J, Taggar, Jaspal S, Walker, Andrew, Duce, Suzanne L, Barr, Rebecca J, Dumbleton, Jennifer S, Rooke, Evelien D, Townend, Jonathan N, Ritchie, Lewis D, MacDonald, Thomas M

Source: In The Lancet 8-14 October 2022 400(10359):1195-1205

When innovation outpaces regulations: The legal challenges for direct‐to‐patient supply of investigational medicinal products

Authors: Malone, Maeve, Ferguson, Pamela, Rogers, Amy, Mackenzie, Isla S., Rorie, David A., MacDonald, Thomas M.

Source: British journal of clinical pharmacology. 88(3):1115-1142

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100141116142.0x000001&indx=1&recIds=ETOCvdc_100141116142.0x000001

Learning from remote decentralised clinical trial experiences: A qualitative analysis of interviews with trial personnel, patient representatives and other stakeholders

Authors: Coyle, Joanne, Rogers, Amy, Copland, Rachel, De Paoli, Giorgia, MacDonald, Thomas M., Mackenzie, Isla S.

Source: British journal of clinical pharmacology. 88(3):1031-1042

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100141116000.0x000001&indx=1&recIds=ETOCvdc_100141116000.0x000001

Allopurinol versus usual care in UK patients with ischaemic heart disease (ALL-HEART): a multicentre, prospective, randomised, open-label, blinded-endpoint trial

Authors: Mackenzie, Isla S, Hawkey, Christopher J, Ford, Ian, Greenlaw, Nicola, Pigazzani, Filippo, Rogers, Amy, Struthers, Allan D, Begg, Alan G, Wei, Li, Avery, Anthony J, Taggar, Jaspal S, Walker, Andrew, Duce, Suzanne L, Barr, Rebecca J, Dumbleton, Jennifer S, Rooke, Evelien D, Townend, Jonathan N, Ritchie, Lewis D, MacDonald, Thomas M

Source: Lancet. 400(10359):1195-1205

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100180511844.0x000001&indx=1&recIds=ETOCvdc_100180511844.0x000001

A systematic review of methods used to conduct decentralised clinical trials

Authors: Rogers, Amy, De Paoli, Giorgia, Subbarayan, Selvarani, Copland, Rachel, Harwood, Kate, Coyle, Joanne, Mitchell, Lyn, MacDonald, Thomas M., Mackenzie, Isla S.

Source: British journal of clinical pharmacology. 88(6):2843-2862

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100153620658.0x000001&indx=1&recIds=ETOCvdc_100153620658.0x000001

Impact of EU regulatory label changes for diclofenac in people with cardiovascular disease in four countries: Interrupted time series regression analysis

Authors: Morales, Daniel R., Morant, Steven V., MacDonald, Thomas M., Hallas, Jesper, Ernst, Martin Thomsen, Pottegard, Anton, Herings, Ron M.C., Smits, Elisabeth, Overbeek, Jetty A., Mackenzie, Isla S., Doney, Alexander S.F., Mitchell, Lyn, Bennie, Marion, Robertson, Chris, Wei, Li, Nicholson, Lizzie, Morris, Carole, Flynn, Robert W.V.

Source: British journal of clinical pharmacology. 87(3):1129-1140

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100115841138.0x000001&indx=1&recIds=ETOCvdc_100115841138.0x000001

Initial cardiovascular treatment patterns during the first 90 days following an incident cardiovascular event

Authors: Ma, Tian‐Tian, Wong, Ian C.K., Whittlesea, Cate, Mackenzie, Isla S., Man, Kenneth K.C., Lau, Wallis, Brauer, Ruth, Wei, Li

Source: British journal of clinical pharmacology. 87(3):1043-1055

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100115841000.0x000001&indx=1&recIds=ETOCvdc_100115841000.0x000001

Use of heart failure medical therapy before and after a cancer diagnosis: A longitudinal study.

Authors: Ju, Chengsheng, Lau, Wallis C.Y., Manisty, Charlotte, Chambers, Pinkie, Brauer, Ruth, Forster, Martin D., Mackenzie, Isla S., Wei, Li

Source: ESC Heart Failure; Dec2024, Vol. 11 Issue 6, p3911-3923, 13p

Subject Terms: MINERALOCORTICOID receptors, PATIENT compliance, CANCER diagnosis, HEART failure, MEDICAL research

Vascular and inflammatory biomarkers of cardiovascular events in non-steroidal anti-inflammatory drug users.

Authors: Vaja, Ricky, Ferreira, Plinio, Portas, Laura, Ahmetaj-Shala, Blerina, Cypaite, Neringa, Gashaw, Hime, Quint, Jennifer, Khamis, Ramzi, Hartley, Adam, MacDonald, Thomas M, Mackenzie, Isla S, Kirkby, Nicholas S, Mitchell, Jane A

Source: European Heart Journal Open; Nov2024, Vol. 4 Issue 6, p1-11, 11p

Subject Terms: GROWTH differentiation factors, CARDIOTOXICITY, ASYMMETRIC dimethylarginine, ANTI-inflammatory agents, NONSTEROIDAL anti-inflammatory agents

UMOD Genotype-Blinded Trial of Ambulatory Blood Pressure Response to Torasemide.

Authors: McCallum, Linsay, Lip, Stefanie, McConnachie, Alex, Brooksbank, Katriona, MacIntyre, Iain M., Doney, Alexander, Llano, Andrea, Aman, Alisha, Caparrotta, Thomas M., Ingram, Gareth, Mackenzie, Isla S., Dominiczak, Anna F., MacDonald, Thomas M., Webb, David J., Padmanabhan, Sandosh

Source: Hypertension (0194911X); Oct2024, Vol. 81 Issue 10, p2049-2059, 11p

Long-term cardiovascular safety of febuxostat compared with allopurinol in patients with gout (FAST): a multicentre, prospective, randomised, open-label, non-inferiority trial

Authors: Aziz, J., Dobson, G., Doney, A.S.F., Flynn, R.W.V., Furnace, J., Grieve, J.W.K., Guthrie, G., Jamieson, D., Jennings, C.G., Kean, S., Lund, L.C., McConnachie, A., Pigazzani, F., Riches, P.L., Rix Hanson, M., Rogers, A, Rooke, E.D.M., Thomson, J., Warren, M., Wetherall, K., Wilson, R., Hall, C.P., Maseri, A., Bird, H.A., Murray, G., Dear, J.W., Petrie, M., MacDonald, M., Jhund, P.S., Connolly, E., Murphy, D.J., Paul, N., Olsson, A., Koskinen, P.T., Fuat, A., Foster, A., Saywood, W., Barr, R.J., McConnachie, L., Wilson, L.F., Larsen Rasmussen, L., McGinnis, A.R., Birrell, H., Keiller, M., Bremner, I.S., Forbes, G.J., Dumbleton, J.S., Rhodes, J., Waller, T., Mackenzie, Isla S, Ford, Ian, Nuki, George, Hallas, Jesper, Hawkey, Christopher J, Webster, John, Ralston, Stuart H, Walters, Matthew, Robertson, Michele, De Caterina, Raffaele, Findlay, Evelyn, Perez-Ruiz, Fernando, McMurray, John J V, MacDonald, Thomas M ^*

Source: In The Lancet 28 November-4 December 2020 396(10264):1745-1757

Serum uric acid lowering with empagliflozin in heart failure with reduced ejection fraction: a sweet added benefit?

Authors: Mackenzie, Isla S, MacDonald, Thomas M

Source: European heart journal. 43(36):3447-3449

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100165687859.0x000001&indx=1&recIds=ETOCvdc_100165687859.0x000001

Long-term cardiovascular safety of febuxostat compared with allopurinol in patients with gout (FAST): a multicentre, prospective, randomised, open-label, non-inferiority trial

Authors: Mackenzie, Isla S, Ford, Ian, Nuki, George, Hallas, Jesper, Hawkey, Christopher J, Webster, John, Ralston, Stuart H, Walters, Matthew, Robertson, Michele, De Caterina, Raffaele, Findlay, Evelyn, Perez-Ruiz, Fernando, McMurray, John J V, MacDonald, Thomas M

Source: Lancet. 396(10264):1745-1757

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100112437467.0x000001&indx=1&recIds=ETOCvdc_100112437467.0x000001

Impact of EMA regulatory label changes on systemic diclofenac initiation, discontinuation, and switching to other pain medicines in Scotland, England, Denmark, and The Netherlands

Authors: Morales, Daniel R., Morant, Steve V., MacDonald, Thomas M., Mackenzie, Isla S., Doney, Alexander S. F., Mitchell, Lyn, Bennie, Marion, Robertson, Chris, Hallas, Jesper, Pottegard, Anton, Ernst, Martin Thomsen, Wei, Li, Nicholson, Lizzie, Morris, Carole, Herings, Ron M. C., Overbeek, Jetty A., Smits, Elisabeth, Flynn, Robert W. V.

Source: Pharmacoepidemiology and drug safety. 29(3):296-305

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100103237098.0x000001&indx=1&recIds=ETOCvdc_100103237098.0x000001

Endocrine and haemodynamic changes in resistant hypertension, and blood pressure responses to spironolactone or amiloride: the PATHWAY-2 mechanisms substudies

Authors: Balakrishnan, K, Burton, T, Cannon, J, Collier, D, Coughlan, C, D'Souza, R, Enobakhare, E, Findlay, E, Gardiner-Hill, C, Gupta, P, Helmy, J, Helmy, C, Hobbs, L, Hobbs, R, Hood, S, Iles, R, Kean, S, Kwok, S, Lacy, P, MacIntyre, I, Mackay, J, Markandu, N, Martin, U, McCallum, L, McCann, G, McGinnis, A, Melville, V, Muir, S, Myint, KS, Nazir, S, Palmer, J, Papworth, R, Rutkowski, K, Saxena, M, Schumann, A, Soran, H, Stanley, A, Thom, S, Webb, A, White, C, Wilson, R, Zak, A, Williams, Bryan, MacDonald, Thomas M, Morant, Steve V, Webb, David J, Sever, Peter, McInnes, Gordon T, Ford, Ian, Cruickshank, J Kennedy, Caulfield, Mark J, Padmanabhan, Sandosh, Mackenzie, Isla S, Salsbury, Jackie, Brown, Morris J

Source: In The Lancet Diabetes & Endocrinology June 2018 6(6):464-475