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Eur J Prev Cardiol. 2015 Jul;22(7):920-30. doi: 10.1177/2047487314530382. Epub 2014 Mar 27.

A pragmatic randomized trial of a polypill-based strategy to improve use of indicated preventive treatments in people at high cardiovascular disease risk.

Collaborators (271)

Patel A, Cass A, Peiris D, Tchan M, Kengne AP, Liu H, Jan S, Hough S, Gorzeman M, Patel B, Burch C, Flancman M, Walsh R, Bowling D, Segev G, Powell K, Hsu J, Blair D, Page A, Price J, Nangle E, Sheppard L, Anderson R, Ryan S, Ham L, Li Q, Bompoint S, Billot L, Hillis G, Pillai A, Perry E, Farrar N, Perry L, Orosco C, Hibbard J, Webster R, Redfern J, Lawrence C, Laba TL, Bowles M, Nash N, Grosse A, Jackman K, Jackman D, Deshong D, Brady J, Fewquandie B, Cameron S, Brown A, Togni S, Molanus B, Liddle H, Clonan T, Silver N, Rickards B, Tilley E, Wyllie J, Reid C, Shiel L, White K, Steer C, Hooy M, Irwin K, Peiris D, Senior T, Hall G, Bemand A, Tilakaratne A, Vunipola P, Pahos N, Ma J, Carroll V, Burke HP, McInroy K, Gough N, Rowlands H, Deegan J, Roberts-Thompson P, Hall G, Doherty K, Page A, Abbott P, James J, Usherwood T, Taggart A, Reath J, Soliman N, Ruhnau C, Fanous M, Hayman N, Coleman J, Maher C, Spurling G, Erskine E, McLeod J, Jennings W, Iron R, Roberts J, Jaffar P, Kissel R, Bizwas S, Borlado M, Reverente M, Eccles L, Wijewardena N, Preston-Thomas A, Tharumaratnam D, Rafter E, Barry J, Watson A, Savina D, Gregory K, Christoffelz B, Everson B, Fitzpatrick P, Forester S, Le E, Leong M, Patel B, Keily J, Daniels J, Wong W, Pratten C, Frame C, Robertson J, Kain A, Burgess K, Pertsis V, Akinci M, Caterson G, Rugendyke M, Shearing G, Frecklington J, Patel K, Caterson G, Kaipu R, Gudipalli S, Gibson D, McDonnell L, Critchley S, McQueen L, Chaffey G, Karayiannis A, Tran L, Nguyen T, Knight A, Rizkalla K, Quach T, Boswell E, Elliott B, Walter-Hay P, Hung A, Grebert N, Tomlins R, Cheung E, Wong S, Fong A, Reddy A, Bailey C, Chong G, Yeung S, Ngo M, Tefali A, Nand P, Nicholas J, Nguyen T, Ngo LH, Edwards P, Chircop M, Patel N, Safie M, Shah J, Shah S, Fantuzzi R, Jones L, Prakash V, Chatila L, Nguyen Y, Tham YZ, Weyand J, Ticehurst H, Anderson M, Lawler T, Bohm K, Sheehan S, Rutherford K, Masters R, Taylor A, Wright WD, Kirkby RR, Mendis K, Husain N, Wakista S, Masters R, Scott-Marshall L, Brockman D, Saraswati K, Ooi HW, Prewett J, Giacon M, Carter B, McGreevy T, Higgins S, Behan K, Young A, Fitzpatrick P, Jarvis C, Bennett P, Kelly M, Chia I, Pakthagurunathan M, The H, Rosen N, Gordon N, Wong J, Ward S, Christopher M, Demirtzoglou J, Sujecki M, John R, Bateman T, Phelan M, Meaney J, Window J, O'Toole M, Keillar P, Lee J, Romilly S, Macdonald M, Boon B, Miceli A, Chung J, Satyadharma K, Vu L, Nguyen J, Joel S, Di Carlo M, Mahon B, Patel A, Cass A, Rodgers A, Brown A, Burch C, Burke H, Hillis G, Hayman N, Jan S, Molanus B, Neal B, Peiris D, Rafter N, Reid C, Shiel L, Togni S, Tonkin A, Usherwood T, Simes J, Harris M, Walsh W, Chapman N, Gupta A, McGrady M, Chow C, Harikrishnan S, Makinen J, Perry L, Orosco C, Perry E, Rodgers A, Patel A, Webster R.

Author information

1
The George Institute for Global Health, University of Sydney, Australia apatel@georgeinstitute.org.
2
The George Institute for Global Health, University of Sydney, Australia Menzies School of Health Research, Charles Darwin University, Darwin, Australia.
3
The George Institute for Global Health, University of Sydney, Australia.
4
Department of General Practice, Sydney Medical School (Westmead), The University of Sydney, Australia.
5
Baker IDI Centre for Indigenous Vascular and Diabetes Research, Alice Springs, Australia South Australian Health and Medical Research Institute, Adelaide, Australia.
6
National Institute for Health Innovation, School of Population Health, University of Auckland, New Zealand.
7
Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.
8
Maari Ma Aboriginal Corporation, Broken Hill, Australia.
9
Inala Indigenous Health Service, Australia.
10
Baker IDI Centre for Indigenous Vascular and Diabetes Research, Alice Springs, Australia.
11
Monash Centre of Cardiovascular Research and Education in Therapeutics, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.

Abstract

BACKGROUND:

Most individuals at high cardiovascular disease (CVD) risk worldwide do not receive any or optimal preventive drugs. We aimed to determine whether fixed dose combinations of generic drugs ('polypills') would promote use of such medications.

METHODS:

We conducted a randomized, open-label trial involving 623 participants from Australian general practices. Participants had established CVD or an estimated five-year CVD risk of ≥15%, with indications for antiplatelet, statin and ≥2 blood pressure lowering drugs ('combination treatment'). Participants randomized to the 'polypill-based strategy' received a polypill containing aspirin 75 mg, simvastatin 40 mg, lisinopril 10 mg and either atenolol 50 mg or hydrochlorothiazide 12.5 mg. Participants randomized to 'usual care' continued with separate medications and doses as prescribed by their doctor. Primary outcomes were self-reported combination treatment use, systolic blood pressure and total cholesterol.

RESULTS:

After a median of 18 months, the polypill-based strategy was associated with greater use of combination treatment (70% vs. 47%; relative risk 1.49, (95% confidence interval (CI) 1.30 to 1.72) p < 0.0001; number needed to treat = 4.4 (3.3 to 6.6)) without differences in systolic blood pressure (-1.5 mmHg (95% CI -4.0 to 1.0) p = 0.24) or total cholesterol (0.08 mmol/l (95% CI -0.06 to 0.22) p = 0.26). At study end, 17% and 67% of participants in polypill and usual care groups, respectively, were taking atorvastatin or rosuvastatin.

CONCLUSION:

Provision of a polypill improved self-reported use of indicated preventive treatments. The lack of differences in blood pressure and cholesterol may reflect limited study power, although for cholesterol, improved statin use in the polypill group counter-balanced use of more potent statins with usual care.

KEYWORDS:

Cardiovascular disease; adherence; blood pressure; cholesterol; polypill; prevention

PMID:
24676715
DOI:
10.1177/2047487314530382
[Indexed for MEDLINE]

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