- Simon Stewart, head, Preventative Health Group1,
- Melinda J Carrington, postdoctoral research fellow1,
- Carla H Swemmer, head of medical operations2,
- Craig Anderson, senior director3,
- Nicol P Kurstjens, chief scientific officer and medical director2,
- John Amerena, director4,
- Alex Brown, director5,
- Louise M Burrell, head6,
- Ferdinandus J de Looze, senior lecturer7,
- Mark Harris, executive director8,
- Joseph Hung, professor of cardiology9,
- Henry Krum, director10,
- Mark Nelson, professor and chair, discipline of general practice11,
- Markus Schlaich, head, hypertension and kidney disease laboratory1,
- Nigel P Stocks, head12,
- Garry L Jennings, director1
- on behalf of the VIPER-BP study investigators
- 1Baker IDI Heart and Diabetes Institute, PO Box 6492, St Kilda Road Central, Melbourne, Vic 8008, Australia
- 2Novartis Pharmaceuticals Australia, Sydney, NSW, Australia
- 3Neurological and Mental Health Division, The George Institute, University of Sydney, Australia
- 4Geelong Cardiology Research Department, Deakin University, Geelong, Vic, Australia
- 5Baker IDI Heart and Diabetes Institute, Alice Springs, NT, Australia
- 6Departments of Medicine and Cardiology, Austin Health, University of Melbourne, Australia
- 7School of Medicine, University of Queensland, Brisbane, Qld, Australia
- 8Centre for Primary Health Care and Equity, University of New South Wales, Sydney, Australia
- 9School of Medicine and Pharmacology, Sir Charles Gairdner Hospital Unit, University of Western Australia, Perth, WA, Australia
- 10Monash Centre of Cardiovascular Research and Education in Therapeutics, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia
- 11Menzies Research Institute Tasmania, University of Tasmania, Hobart, Tas, Australia
- 12Discipline of General Practice, University of Adelaide, Adelaide, SA, Australia
- Correspondence to: S Stewart
- Accepted 12 October 2012
Objective To determine the effectiveness of intensive structured care to optimise blood pressure control based on individual absolute risk targets in primary care.
Design Pragmatic multicentre randomised controlled trial.
Setting General practices throughout Australia, except Northern Territory, 2009-11.
Participants Of 2185 patients from 119 general practices who were eligible for drug treatment for hypertension according to national guidelines 416 (19.0%) achieved their individual blood pressure target during a 28 day run-in period of monotherapy. After exclusions, 1562 participants not at target blood pressure (systolic 150 (SD 17) mm Hg, diastolic 88 (SD 11) mm Hg) were randomised (1:2 ratio) to usual care (n=524) or the intervention (n=1038).
Intervention Computer assisted clinical profiling and risk target setting (all participants) with intensified follow-up and stepwise drug titration (initial angiotensin receptor blocker monotherapy or two forms of combination therapy using angiotensin receptor blockers) for those randomised to the intervention. The control group received usual care.
Main outcome measures The primary outcome was individual blood pressure target achieved at 26 weeks. Secondary outcomes were change in mean sitting systolic and diastolic blood pressure, absolute risk for cardiovascular disease within five years based on the Framingham risk score, and proportion and rate of adverse events.
Results On an intention to treat basis, there was an 8.8% absolute difference in individual blood pressure target achieved at 26 weeks in favour of the intervention group compared with usual care group (358/988 (36.2%) v 138/504 (27.4%)): adjusted relative risk 1.28 (95% confidence interval 1.10 to 1.49, P=0.0013). There was also a 9.5% absolute difference in favour of the intervention group for achieving the classic blood pressure target of ≤140/90 mm Hg (627/988 (63.5%) v 272/504 (54.0%)): adjusted relative risk 1.18 (1.07 to 1.29, P<0.001). The intervention group achieved a mean adjusted reduction in systolic blood pressure of 13.2 mm Hg (95% confidence interval −12.3 to −14.2 mm Hg) and diastolic blood pressure of 7.7 mm Hg (−7.1 to −8.3 mm Hg) v 10.1 mm Hg (−8.8 to 11.3 mm Hg) and 5.5 mm Hg (−4.7 to −6.2 mm Hg) in the usual care group (P<0.001). Among 1141 participants in whom five year absolute cardiovascular risk scores were calculated from baseline to the 26 week follow-up, the reduction in risk scores was greater in the intervention group than usual care group (14.7% (SD 9.3%) to 10.9% (SD 8.0%); difference −3.7% (SD 4.5%) and 15.0% (SD 10.1%) to 12.4% (SD 9.4%); −2.6% (SD 4.5%): adjusted mean difference −1.13% (95% confidence interval −0.69% to −1.63%; P<0.001). Owing to adverse events 82 (7.9%) participants in the intervention group and 10 (1.9%) in the usual care group had their drug treatment modified.
Conclusions In a primary care setting intensive structured care resulted in higher levels of blood pressure control, with clinically lower blood pressure and absolute risk of future cardiovascular events overall and with more people achieving their target blood pressure. An important gap in treatment remains though and applying intensive management and achieving currently advocated risk based blood pressure targets is challenging.
We thank the study nurse coordinators for helping the general practitioner to participate in the study and the clinical trial research staff and data management staff at Baker IDI Heart and Diabetes Institute.
The following general practitioners were involved in the study: Fadi Abouzeid, Geoffrey Adsett, Ata Ahmadi, Robert Allan, Olataga Alofivae-Doorbinnia, Paul Anderson (Queensland), Paul Anderson (Victoria), Jacob Artinian, Luke Ashford, David Austin, Enrique Avedillo, Alex Avergun, Claudio Baldi, Das Balgi, Rekha Balgi, Chistopher Balkwill, Usha Bansal, Dominic Barbaro, Antwan Barich, Sanaa Barich, Annette Barratt, Neyamul Bashir, Patricia Batchelor, Indranie Benedict, Atul Bhatnager, Leocadio Blanco-Isquierdo, Mark Bloch, Neil Bodsworth, Olof Boshoff, Roly Bott, Sandra Bransgrove, Paddy Brazier, Keith Brennan, David Brockman, Sergey Bromberg, Sarah Burbury, Donna Burgess, Rob Burns, John Byrne, Gillian Cameron, Ken Cameron, Ian Cameron, Fiona Campbell, Robert Cargill, Michael Neil Cavanagh, Aaron Chambers, Joe Chamizo, Jose Chamizo, Maria Cheng, Robert Chester, Ka Cho Cheung, Herbert Keung Cheung, Saroj Chhajed, John Chin, Michael Chin, Susan Chupungco, Kim Chye, Ray Cibulskis, Trevor Claridge, Peter Clarke, George Clegg, Edward Collinson, Ewe Conroy, Stephen Cook, David Copeland, Norman Cornish, Ian Robert Cram, Peter Cummins, Andrew Cunnane, Alexander Daniel, Suzanne Davey, Peter Day, Chaminda De Silva, Annette Deada, Arnold Dela Cruz, May Dennis, Ivor Desouza, Neil Donovan, Philip Downing, Nichola Dunn, Philippa Eccles, Mark Faigen, Fred Faigenbaum, Mario Fantasia, Ramsis Farag, Graham Farquhar, John Feros, Joseph Fieber, Michael Fine, Robert Finlayson, Robert Flynn, Gerard Peter Foley, Jacob Foo, Seyed Afshin Forghani, Gregory Frean, Brad Gallagher, Hong Gan, Jason Garrood, Peter Gavrilov, Peter Gibson, Chris Gillis, Peter Goodwin, Andrew Gowers, Francis Graham, Peter Grant, Philip Greenfield, Richard Grove, Birute Gunsberg, Michael James Hand, Peter Hay, Daniel Hendry, Michael Hickey, Alfred Hoh, Alexander Holliday, Rachid Homsi, Robert Houston, Chris Hughes, Jonathan Hughes, Robin Hughes, Jonathan Isles, Bindiganaral Jayashree, James Jeong, Christopher Jones, Thavamany Kanapathipillai, Sarit Kanungo, Lakshimi Kathigesu, Harjinder Kaur, Cath Keaney, Peter Kemp, Thomas Kerr, Richard Keys, Alireza Khossousi, Owen King, Christopher Knight,Lilian Lao, Quang Le, William Leadston, Warren Lee, James Liew, Juliette Little, Hsin-Hua Liu, Ying Liu, Dianne Loeffler, Shyuan Jium Loh, Edward Lurie, Russell Macdougall, Ewa Maczuba-Pilch, Sitalakshmi Mahadevan, Drew Mattsson, Lloyd Mayson, Stephen McKelvie, Felix McKnight, Keki Mehta, Ralph Mendelsohn, Robert Micallef, Evette Mikhail, Tiasha Mills, Gordon Milne, Vahid Mohabbati, Chandra Mohan, Stephen Moulding, Mina Mounir Moussa, David Muirhead, Patrick Mulhern, Philip Myers, Victor Nakhla, Raulito Naval, Ratna Neville, Lawrence Noonan, Ashley Noud, Mohammed Obeidullah, Charles Obinwanor, James Ogundipe, Judith Omalley-Ford, Andre Oracki, John O’Sullivan, John Pak, Raymol Pallath, George Panaretos, Ing T Pang, Chandra Panicker, Earl Pantillano, Naresh Parajuli, Mala Pasupuleti, Praful Patel, Veena Patel, Rodney Pearce, Jinxin Peng, Benedict Ponti, Anthony John Portelli, Jane Potter, Tonse Prasad, Cameron Profitt, Jane Purdie, Dick Quan, Mohammad Rafiq, Mohammed Rahman, Neil Rajanayagam, Surjit Rana, Jey Randhawa, Yuri Raymon, Roberto Regozo, Kiro Ristevski, Christopher Roach, Gary Roberts, David Rockman, Bede Rogers, Caroline Rogers, Fiona Ronsberg, Erica Rowley, Paul Russell, Debbie Saw, Blacelina Sayo, Tim Schindler, Amirtharajan Selvakumar, Ann Darian Sharp, Jan Sheringham, Matthew Shields, Suranahalli Shivaprakash, Vince Signoriello, Kanwal Singh, Promica Singh-Panwar, Thakur Singh-Panwar, Malathy Sivapalan, Michelle Skellern, Vasa Skorupanovic, Susan Smythe, Michael Sorani, Andrew Springfield, Judith Spurling, Nagappan Srigandan, Mahalingam Srinivasan, Philip Stowell, Darko Sulava, PHilip Sutherland, Mohammad Taghisadeh, Ven Tan, Janine Teasdale, Alex Terris, Esther Tham, Terrence Than, Dunstan Thompson, Liping Tian, Albert Tran, Jacobus Van Staden, Sarita Vasram, Eva Velickovski, Gemma Victorino, Girolano Vinci, Stefan Visagie, Emanuel Vlahakis, David Voon, Steven Wade, Arief Wahab, Joseph Waks, David Alan Wallace, Lynette Wallace, Michelle Walsh, Malathi Waran, Caroline Warne, Bahgat Wassif, Robert Welsh, Gerald Westhoff, Rodney Willett, Jennifer Williams, Sheena Wilmot, Susan Wong, Guy Wright, Joseph Yam, Suellen Young, Leonard Yudeiken, George Zankov, Robert Zubeshaw, and Michele Zwi.
Contributors: The VIPER-BP study was designed by Baker IDI Heart and Diabetes Institute (SS, MJC, and GLJ) in consultation with a scientific advisory board (CA, JA, AB, LMB, FJdeL, MH, JH, HK, MN, MS, and NPS) who received remuneration (MH excepted) from Novartis Pharmaceuticals Australia as study consultants. SS prepared the first draft of the manuscript, with edits and revisions provided by all authors. All authors had full access to all the data and read and approved the final version of the manuscript. All authors had final responsibility for the decision to submit the manuscript for publication. SS, MJC, and GLJ act as guarantors for the study.
Funding: The VIPER-BP study was sponsored by Novartis Pharmaceuticals Australia. The sponsors participated in discussions on the design and conduct of the study and provided logistical support during the trial. The study statistician (Adrian Esterman, University of South Australia) independently generated analyses on behalf of the other members of the clinical safety and efficacy committee (Colin Johnston, MN, Richard Gerraty) who received remuneration from Novartis Pharmaceuticals Australia as study consultants. The study investigators and sponsor jointly assessed study data. All the investigators received remuneration from Baker IDI for the research component of clinical study activities.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare that all authors had a form of support (as described above) and specific relationships (as described above) with Novartis Pharmaceuticals Australia for the submitted work. SS, GLJ, and MJC are supported by the National Health and Medical Research Council of Australia. VIPER-BP study was supported by the Victoria government’s operational infrastructure support program.
Ethical approval: This study was approved by the Alfred Human Research Ethics Committee (Melbourne Australia; Project No 358/08) and the Royal Australian College of General Practitioners (Melbourne Australia; Project No NREEC 09/006).
Data sharing: From January 2014, study data will be available from the corresponding author ().
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