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Abstract

Objective

The purpose of this study was to investigate the consistency of the proportional effect of fixed-dose combination therapy (the ‘polypill’) on the use of recommended cardiovascular preventative medications among indigenous Māori and non-indigenous adults in New Zealand.

Methods

We randomised Māori and non-Māori primary care patients at high risk of cardiovascular disease (either because of a prior event or with an estimated 5-year risk of a first event of at least 15%) to a polypill (containing aspirin, statin and two antihypertensives) or usual care for a minimum of 12 months. All patients had indications for all polypill components according to their general practitioner, and all medications (including the polypill) were prescribed by the patient’s general practitioner and dispensed at community pharmacies. The main outcome for this study was the use of all recommended medications (antiplatelet, statin and two antihypertensives) at 12 months. Heterogeneity in the effect of polypill-based care compared with usual care on this outcome by ethnicity was assessed by logistic regression.

Results

Baseline use of recommended medications was 36% (93/257) among Māori and 51% (130/156) among non-Māori participants. Polypill-based care was associated with an increase in the use of recommended medications among Māori (relative risk [RR]: 1.87; 95% confidence interval [CI]: 1.50–2.34) and non-Māori (RR: 1.66; 95% CI: 1.37–2.00) when compared with usual care at 12 months, and there was no statistically significant heterogeneity in this outcome by ethnicity (p = 0.92).

Conclusion

Polypill-based care is likely to reduce absolute inequities between Māori and non-Māori in the use of recommended cardiovascular preventative medications given baseline absolute differences and the consistency of the proportional effect of this intervention by ethnicity in this pragmatic trial in primary care.

Keywords

Cardiovascular diseases healthcare disparities ethnic groups secondary prevention polypill

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References

Lozano

Naghavi

Foreman

. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: A systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380: 2095–2128.

World Health Organization. Global Health Estimates 2014 Summary Tables: DALY by Cause, Age and Sex, 2000–2012, Geneva: World Health Organization, 2014.

Mendis

Puska

Norrving

. Global Atlas on Cardiovascular Disease Prevention and Control, Geneva: World Health Organization, 2011.

Yusuf

Islam

Chow

. Use of secondary prevention drugs for cardiovascular disease in the community in high-income, middle-income, and low-income countries (the PURE Study): A prospective epidemiological survey. Lancet 2011; 378: 1231–1243.

World Health Organization. Secondary Prevention of Non-Communicable Disease in Low and Middle Income Countries through Community-Based and Health Service Interventions – Wellcome Trust Meeting Report 1–3 August 2001, Geneva: World Health Organization, 2002.

Yusuf

. Two decades of progress in preventing vascular disease. Lancet 2002; 360: 2–3.

Wald

Law

. A strategy to reduce cardiovascular disease by more than 80%. BMJ 2003; 326: 1419–1424.

Soliman

Mendis

Dissanayake

. A polypill for primary prevention of cardiovascular disease: A feasibility study of the World Health Organization. Trials 2011; 12: 3–3.

Zamorano

Erdine

Pavia

. Proactive multiple cardiovascular risk factor management compared with usual care in patients with hypertension and additional risk factors: The CRUCIAL trial. Curr Med Res Opin 2011; 27: 821–833.

10.

Thom

Poulter

Field

. Effects of a fixed-dose combination strategy on adherence and risk factors in patients with or at high risk of CVD. The UMPIRE randomised clinical trial. JAMA 2013; 310: 918–929.

11.

Patel

Cass

Peiris

. A pragmatic randomized trial of a polypill-based strategy to improve use of indicated preventive treatments in people at high cardiovascular disease risk. Eur J Prev Cardiol 2015; 22: 920–930.

12.

Selak

Elley

Bullen

. Effect of fixed dose combination therapy on adherence and risk factor control among patients at high risk of cardiovascular disease: Randomised controlled trial in primary care. BMJ 2014; 348: g3318–g3318.

13.

Statistics New Zealand. 2013 Census – major ethnic groups in New Zealand. Available from: http://www.stats.govt.nz/Census/2013-census/profile-and-summary-reports/infographic-culture-identity.aspx (2014; accessed 5 December 2014).

14.

Ministry of Health. Mortality and Demographic Data 2010, Wellington: Ministry of Health, 2013.

15.

Chan

Wright

Riddell

. Ethnic and socioeconomic disparities in the prevalence of cardiovascualar disease in New Zealand. N Z Med J 2008; 121: 11–20.

16.

Ministry of Health. Annual Update of Key Results 2013/14: New Zealand Health Survey, Wellington: Ministry of Health, 2014.

17.

Blakely

Tobias

Robson

. Widening ethnic mortality disparities in New Zealand 1981–99. Soc Sci Med 2005; 61: 2233–2251.

18.

MacPherson

. New Zealand Period Life Tables: 2012–14, Wellington: Statistics New Zealand, 2015.

19.

New Zealand Guidelines Group. New Zealand Cardiovascular Guidelines Handbook, Wellington: New Zealand Guidelines Group, 2009.

20.

New Zealand Guidelines Group. New Zealand Primary Care Handbook 2012, Wellington: New Zealand Guidelines Group, 2012.

21.

University of Auckland, Health Quality & Safety Commission. Cardiovascular outcomes. Health Quality & Safety Commission Atlas of Healthcare Variation, 2012. Available at: http://www.hqsc.govt.nz/our-programmes/health-quality-evaluation/projects/atlas-of-healthcare-variation/cardiovascular-disease/ (accessed 3 December 2012).

22.

Bramley

Riddell

Crengle

. A call to action on Maori cardiovascular health. N Z Med J 2004; 117: U957–U957.

23.

Robson B. Mana Whakamarama – Equal Explanatory Power: Maori and non-Maori Sample Size in National Health Surveys. Wellington: Te Ropu Rangahau Hauora a Eru Pomare, Wellington School of Medicine and Health Sciences, University of Otago for Public Health Intelligence, Ministry of Health, New Zealand, 2002.

24.

Selak

Elley

Crengle

. Improving adherence using combination therapy (IMPACT): Design and protocol of a randomised controlled trial in primary care. Contemp Clin Trials 2011; 32: 909–915.

25.

Anderson

Odell

Wilson

PWF

. Cardiovascular disease risk profiles. Am Heart J 1990; 121: 293–298.

26.

New Zealand Guidelines Group. Evidence-Based Best Practice Guideline. The Assessment and Management of Cardiovascular Risk. Wellington: New Zealand Guidelines Group, 2003.

27.

Ni Mhurchu

Blakely

Funaki-Tahifote

. Inclusion of indigenous and ethnic minority populations in intervention trials: Challenges and strategies in a New Zealand supermarket study. J Epidemiol Community Health 2009; 63: 850–855.

28.

Sibthorpe

Bailie

Brady

. The demise of a planned randomised controlled trial in an urban Aboriginal medical service. Med J Aust 2002; 176: 273–276.

29.

Ford

Howerton

Lai

. Barriers to recruiting underrepresented populations to cancer clinical trials: A systematic review. Cancer 2007; 111: 228–242.

30.

Selak

Crengle

Elley

. Recruiting equal numbers of indigenous and non-indigenous participants to a ‘polypill’ randomized trial. Int J Equity Health 2013; 12: 44–44.

31.

International Conference on Harmonisation Expert Working Group. Guideline for Good Clinical Practice E6(R1), Geneva: International Conference on Harmonisation, 1996.

32.

National Ethics Advisory Committee. Ethical Guidelines for Intervention Studies: Revised Edition, Wellington: Ministry of Health, 2012.

33.

Medsafe (New Zealand Medicines and Medical Devices Safety Authority). New Zealand Regulatory Guidelines for Medicines. Volume 3: Interim Good Clinical Research Practice Guideline, Wellington: Ministry of Health, 1998.

34.

Law

Morris

Wald

. Use of blood pressure lowering drugs in the prevention of cardiovascular disease: Meta-analysis of 147 randomised trials in the context of expectations from prospective epidemiological studies. BMJ 2009; 338: b1665–b1665.

35.

Laba

T-L

Hayes

. An economic case for a cardiovascular polypill? A cost analysis of the Kanyini GAP trial. Med J Aust 2014; 11: 671–673.

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Polypill-based therapy likely to reduce ethnic inequities in use of cardiovascular preventive medications: Findings from a pragmatic randomised controlled trial

Abstract

Objective

Methods

Results

Conclusion

Keywords

Get full access to this article

References

Supplementary Material