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Background: No routinely recommended cardiovascular disease (CVD) risk prediction equations have adjusted for CVD preventive medications initiated during follow-up (treatment drop-in) in their derivation cohorts. This will lead to underestimation of risk when equations are applied in clinical practice if treatment drop-in is common. We aimed to quantify the treatment drop-in in a large contemporary national cohort to determine whether equations are likely to require adjustment., Methods: Eight de-identified individual-level national health administrative datasets in Aotearoa New Zealand were linked to establish a cohort of almost all New Zealanders without CVD and aged 30-74 years in 2006. Individuals dispensing blood-pressure-lowering and/or lipid-lowering medications between 1 July 2006 and 31 December 2006 (baseline dispensing), and in each 6-month period during 12 years' follow-up to 31 December 2018 (follow-up dispensing), were identified. Person-years of treatment drop-in were determined., Results: A total of 1 399 348 (80%) out of the 1 746 695 individuals in the cohort were not dispensed CVD medications at baseline. Blood-pressure-lowering and/or lipid-lowering treatment drop-in accounted for 14% of follow-up time in the group untreated at baseline and increased significantly with increasing predicted baseline 5-year CVD risk (12%, 31%, 34% and 37% in <5%, 5-9%, 10-14% and ≥15% risk groups, respectively) and with increasing age (8% in 30-44 year-olds to 30% in 60-74 year-olds)., Conclusions: CVD preventive treatment drop-in accounted for approximately one-third of follow-up time among participants typically eligible for preventive treatment (≥5% 5-year predicted risk). Equations derived from cohorts with long-term follow-up that do not adjust for treatment drop-in effect will underestimate CVD risk in higher risk individuals and lead to undertreatment. Future CVD risk prediction studies need to address this potential flaw., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: This study aimed to understand the reasons behind evidence-practice gaps and inequities in cardiovascular care for Māori and Pacific people, as evidenced by the experiences and perspectives of patients and their families., Methods: The research was guided by Māori and Pacific worldviews, incorporating Kaupapa Māori Theory and Pacific conceptual frameworks and research methodologies. Template analysis was used to analyse interview data from 61 Māori and Pacific people who had experienced a cardiovascular disease (CVD) risk assessment, acute coronary syndrome, and/or heart failure., Results: The range of experiences relating to participants' heart health journeys are presented in five main themes: Context, Mana (maintaining control and dignity), Condition, People and Journey., Conclusions: Māori and Pacific people want to take charge of their heart health but face challenges. Participants described important obligations to family, community and tikanga (the culturally correct way of doing things). Participants described times when health care undermined existing responsibilities, their dignity and/or their mana, and they felt excluded from treatment as a result., Implications for Public Health: Good reciprocal communication, stemming from a high-quality relationship is essential for successful outcomes. A workforce that is representative of the population it serves and is culturally safe lays the foundation for excellence in care., Competing Interests: Conflicts of interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Matire Harwood and Corina Grey reports financial support was provided by Heart Foundation of New Zealand. Matire Harwood and Corina Grey reports financial support was provided by Healthier Live National Science Challenge. Funding: This research was jointly funded by The Heart Foundation of New Zealand and Healthier Lives National Science Challenge, grant number 1819. The funders had no role in this research. Financial interests: Authors KB, VS and CG receive funding from the Health Research Council of New Zealand. KB and SH receive funding from Pūtahi Manawa. SH receives funding from the Heart Foundation of New Zealand. KB received travel support from the Cardiac Society of Australia and New Zealand. VS receives funding from the Auckland Medical Research Foundation. Non-financial interests: SH is a member of the Whānau, Consumer and Clinician Digital Council – Te Whatu Ora Health New Zealand and an advisory board member for the Healthier Lives Implementation Network. VS is a member of the Data Safety Monitoring Board for the Cess@Tion clinical trial and a board member and deputy chair of the medical assessment committee for the Auckland Medical Research Foundation. KB is co-director of Pūtahi Manawa. All other authors declare no relevant financial or non-financial interests., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Introduction: M&#257;ori (the Indigenous Peoples of Aotearoa New Zealand) are disproportionately represented in cardiovascular disease (CVD) prevalence, morbidity and mortality rates, and are less likely to receive evidence-based CVD health care. Rural M&#257;ori experience additional barriers to treatment access, poorer health outcomes and a greater burden of CVD risk factors compared to Non-M&#257;ori and M&#257;ori living in urban areas. Importantly, these inequities are similarly experienced by Indigenous Peoples in other nations impacted by colonisation. Given the scarcity of available literature, a systematic scoping review was conducted on literature exploring barriers and facilitators in accessing CVD health care for rural M&#257;ori and other Indigenous Peoples in nations impacted by colonisation., Methods: The review was underpinned by Kaupapa M&#257;ori Research methodology and was conducted utilising Arksey and O'Malley's (2005) methodological framework. A database search of MEDLINE (OVID), PubMed, Embase, SCOPUS, CINAHL Plus, Australia/New Zealand Reference Centre and NZResearch.org was used to explore empirical research literature. A grey literature search was also conducted. Literature based in any healthcare setting providing care to adults for CVD was included. Rural or remote Indigenous Peoples from New Zealand, Australia, Canada, and the US were included. Literature was included if it addressed cardiovascular conditions and reported barriers and facilitators to healthcare access in any care setting., Results: A total of 363 articles were identified from the database search. An additional 19 reports were identified in the grey literature search. Following screening, 16 articles were included from the database search and 5 articles from the grey literature search. The literature was summarised using the Te Tiriti o Waitangi (Treaty of Waitangi) Framework principles: tino rangatiratanga (self-determination), partnership, active protection, equity and options. Themes elucidated from the literature were described as key drivers of CVD healthcare access for rural Indigenous Peoples. Key driver themes included input from rural Indigenous Peoples on healthcare service design and delivery, adequate resourcing and support of indigenous and rural healthcare services, addressing systemic racism and historical trauma, providing culturally appropriate health care, rural Indigenous Peoples' access to family and wellbeing support, rural Indigenous Peoples' differential access to the wider social determinants of health, effective interservice linkages and communication, and equity-driven and congruent data systems., Conclusion: The findings are consistent with other literature exploring access to health care for rural Indigenous Peoples. This review offers a novel approach to summarising literature by situating the themes within the context of equity and rights for Indigenous Peoples. This review also highlighted the need for further research in this area to be conducted in the context of Aotearoa New Zealand.

Aims: Multiple health administrative databases can be individually linked in Aotearoa New Zealand, using encrypted identifiers. These databases were used to develop cardiovascular risk prediction equations for patients with known cardiovascular disease (CVD)., Methods and Results: Administrative health databases were linked to identify all people aged 18-84 years with known CVD, living in Auckland and Northland, Aotearoa New Zealand, on 1 January 2014. The cohort was followed until study outcome, death, or 5 years. The study outcome was death or hospitalization due to ischaemic heart disease, stroke, heart failure, or peripheral vascular disease. Sex-specific 5-year CVD risk prediction equations were developed using multivariable Fine and Gray models. A total of 43 862 men {median age: 67 years [interquartile range (IQR): 59-75]} and 32 724 women [median age: 70 years (IQR: 60-77)] had 14 252 and 9551 cardiovascular events, respectively. Equations were well calibrated with good discrimination. Increasing age and deprivation, recent cardiovascular hospitalization, Mori ethnicity, smoking history, heart failure, diabetes, chronic renal disease, atrial fibrillation, use of blood pressure lowering and anti-thrombotic drugs, haemoglobin A1c, total cholesterol/HDL cholesterol, and creatinine were statistically significant independent predictors of the study outcome. Fourteen per cent of men and 23% of women had predicted 5-year cardiovascular risk <15%, while 28 and 24% had ≥40% risk., Conclusion: Robust cardiovascular risk prediction equations were developed from linked routine health databases, a currently underutilized resource worldwide. The marked heterogeneity demonstrated in predicted risk suggests that preventive therapy in people with known CVD would be better informed by risk stratification beyond a one-size-fits-all high-risk categorization., Competing Interests: Conflict of interest: S.C. reports board meeting fees from Te Aka Whai Ora and WellSouth Primary Heath Network. M.L. reports speaker fees from Bayer, BMS, and Astra Zeneca. All other authors report no disclosures., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Aim: This systematic review aimed to determine to what extent and why the care pathways for acute cardiac events in the community might differ for minoritised ethnic populations compared to non-minoritised populations. It also sought to identify the barriers and enablers that could influence variations in access to care for minoritised populations., Methods: A multi-database search was conducted for articles published between 1 January 2000 and 1 January 2023. A combination of MeSH terms and keywords was used. Inclusion criteria for papers were published in English, adult population, the primary health condition was an acute cardiac event, and the primary outcomes were disaggregated by ethnicity or race. A narrative review of extracted data was performed, and findings were reported according to the PRISMA 2020 guidelines., Results: Of the 3552 articles identified using the search strategy, 40 were deemed eligible for the review. Studies identified a range of variables in the care pathway that differed by ethnicity or race. These could be grouped as time to care, transportation, event related-variables, EMS interactions and symptoms. A meta-analysis was not performed due to heterogeneity across the studies., Conclusion: The extent and reasons for differences in cardiac care pathways are considerable. There are several remediable barriers and enablers that require attention to achieve equitable access to care for minoritised populations., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: People with cancer have an increased risk of cardiovascular disease. Risk prediction equations developed in New Zealand accurately predict 5-year cardiovascular disease risk in a general primary care population in the country. We assessed the performance of these equations for survivors of cancer in New Zealand., Methods: For this validation study, patients aged 30-74 years from the PREDICT open cohort study, which was used to develop the New Zealand cardiovascular disease risk prediction equations, were included in the analysis if they had a primary diagnosis of invasive cancer at least 2 years before the date of the first cardiovascular disease risk assessment. The risk prediction equations are sex-specific and include the following predictors: age, ethnicity, socioeconomic deprivation index, family history of cardiovascular disease, smoking status, history of atrial fibrillation and diabetes, systolic blood pressure, total cholesterol to HDL cholesterol ratio, and preventive pharmacotherapy (blood-pressure-lowering, lipid-lowering, and antithrombotic drugs). Calibration was assessed by comparing the mean predicted 5-year cardiovascular disease risk, estimated using the risk prediction equations, with the observed risk across deciles of risk, for men and women, and according to the three clinical 5-year cardiovascular disease risk groups in New Zealand guidelines (<5%, 5% to <15%, and ≥15%). Discrimination was assessed by Harrell's C statistic., Findings: 14 263 patients were included in the study. The mean age was 61 years (SD 9) for men and 60 years (SD 8) for women, with a median follow-up of 5·8 years for men and 5·7 years for women. The observed cardiovascular disease risk was underpredicted by a maximum of 2·5% in male and 3·2% in female decile groups. When patients were grouped according to clinical risk groups, observed cardiovascular disease risk was underpredicted by less than 2% in the lower risk groups and overpredicted by 2·2% for men and 3·3% for women in the highest risk group. Harrell's C statistics were 0·67 (SE 0·01) for men and 0·73 (0·01) for women., Interpretation: The New Zealand cardiovascular disease risk prediction equations reasonably predicted the observed 5-year cardiovascular disease risk in survivors of cancer in the country, in whom risk prediction was considered clinically appropriate. Prediction could be improved by adding cancer-specific variables and considering competing risks. Our findings suggest that the equations are reasonable clinical tools for use in survivors of cancer in New Zealand., Funding: Auckland Medical Research Foundation, Health Research Council of New Zealand., Competing Interests: Declaration of interests ET's salary was supported by the Auckland Medical Research Foundation (AMRF) grant, project number 3722609, grant reference 1120015. VS's research was supported by grants from the AMRF, the Health Research Council of New Zealand (HRC), the National Heart Foundation of New Zealand (NHF), and the National Science Challenge (Healthier Lives) (NSCHL). VS is an unpaid member of data safety monitoring boards for investigator-led trials. RP's research was supported by the HRC. STT's research was supported by grants from the HRC, the AMRF, and the Breast Cancer Foundation of New Zealand. JME's research was supported by the AMRF. MM's research was supported by the HRC. CG's research was supported by the NHF and the NSCHL. MH's research was supported by grants from the HRC, the NHF, and the NSCHL. SW's research was supported by the HRC, the NHF, and the Stevenson Foundation., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Introduction: Māori (the Indigenous peoples of New Zealand) are disproportionately represented in cardiovascular disease (CVD) prevalence, morbidity and mortality rates, and are less likely to receive evidence-based CVD healthcare. Rural Māori experience additional barriers to treatment access, poorer health outcomes and a more significant burden of CVD risk factors compared with non-Māori and Māori living in urban areas. Importantly, these inequities are similarly experienced by Indigenous peoples in other nations impacted by colonisation. Given the scarcity of available literature, we are conducting a scoping review of literature exploring barriers and facilitators in accessing quality CVD healthcare for rural Māori and other Indigenous peoples in nations impacted by colonisation., Methods and Analysis: A scoping review will be conducted to identify and map the extent of research available and identify any gaps in the literature. This review will be underpinned by Kaupapa Māori Research methodology and will be conducted using Arksey and O'Malley's (2005) methodological framework. A database search of MEDLINE (OVID), PubMed, Embase, SCOPUS, CINAHL Plus, Australia/New Zealand Reference Centre and NZResearch.org will be used to explore empirical research literature. A grey literature search will also be conducted. Two authors will independently review and screen search results in an iterative manner. The New Zealand Ministry of Health Te Tiriti o Waitangi (Treaty of Waitangi) Framework principles will be used as a framework to summarise and construct a narrative of existing literature. Existing literature will also be appraised using the CONSolIDated critERia for strengthening the reporting of health research involving Indigenous Peoples (CONSIDER) statement., Ethics and Dissemination: Ethical approval has not been sought for this review as we are using publicly available data. We will publish this protocol and the findings of our review in an open-access peer-reviewed journal. This protocol has been registered on Open Science Framework (DOI:10.17605/osf.io/xruhy)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: In New Zealand, significant inequities exist between Māori and Pacific peoples compared with non-Māori, non-Pacific peoples in cardiovascular disease (CVD) risk factors, hospitalisations and management rates. This review will quantify and qualify already-reported gaps in CVD risk assessment and management in primary care for Māori and Pacific peoples compared with non-Māori/non-Pacific peoples in New Zealand., Methods and Analysis: We will conduct a systematic search of the following electronic databases and websites from 1 January 2000 to 31 December 2021: MEDLINE (OVID), EMBASE, Scopus, CINAHL Plus, NZresearch.org, National Library Catalogue (Te Puna), Index New Zealand (INNZ), Australia/New Zealand Reference Centre. In addition, we will search relevant websites such as the Ministry of Health and research organisations. Data sources will include published peer reviewed articles, reports and theses employing qualitative, quantitative and mixed methods.Two reviewers will independently screen the titles and abstracts of the citations and grade each as eligible, not eligible or might be eligible. Two reviewers will read each full report, with one medically qualified reviewer reading all reports and two other reviewers reading half each. The final list of included citations will be compiled from the results of the full report reading and agreed on by three reviewers. Data abstracted will include authors, title, year, study characteristics and participant characteristics. Data analysis and interpretation will involve critical inquiry and a strength-based approach that is inclusive of Māori and Pacific values. This means that critical appraisal includes an assessment of quality from an Indigenous perspective., Ethics and Dissemination: Ethical approval is not required. The findings will be published in a peer-reviewed journal and shared with stakeholders. This review contributes to a larger project which creates a Quality-Improvement Equity Roadmap to reduce barriers to Māori and Pacific peoples accessing evidence-based CVD care., Competing Interests: Competing interests: JP receives funding from GlaxoSmithKline for research on vaccine safety and effectiveness. MH is employed as a general practitioner at a marae-based clinic and holds board memberships including the Medical Research institute of New Zealand (MRINZ). CG holds board memberships including Vaka Tautua- a New Zealand-wide Pacific health, disability and social services provider. KMB, JW-S, SH, VS and SA report no conflicts., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To describe the dispensing of cardiovascular disease (CVD) preventive medications among older New Zealanders with and without prior CVD or diabetes., Methods: New Zealanders aged ≥65 years in 2013 were identified using anonymised linkage of national administrative health databases. Dispensing of blood pressure lowering (BPL), lipid lowering (LL) or antithrombotic (AT) medications, was documented, stratified by age and by history of CVD, diabetes, or neither., Results: Of the 593,549 people identified, 32% had prior CVD, 14% had diabetes (of whom half also had prior CVD) and 61% had neither diagnosis. For those with prior CVD, between 79-87% were dispensed BPL and 73-79% were dispensed AT medications, across all age groups. In contrast, LL dispensing was lower than either BPL or AT in every age group, falling from 75% at age 65-69 years to 43% at 85+ years. For people with diabetes, BPL and LL dispensing was similar to those with prior CVD, but AT dispensing was approximately 20% lower. Among people without prior CVD or diabetes, both BPL and AT dispensing increased with age (from 39% and 17% at age 65-69 years to 56% and 35% at 85+ years respectively), whereas LL dispensing was 26-31% across the 65-84 year age groups, falling to 17% at 85+ years., Conclusion: The much higher dispensing of BPL and AT compared to LL medications with increasing age suggests a preventive treatment paradox for older people, with the medications most likely to cause adverse effects being dispensed most often., (© The Author(s) 2021. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Pacific people experience a disproportionate burden of cardiovascular disease (CVD), whether they remain in their country of origin or migrate to higher-income countries, such as Australia, Aotearoa New Zealand or the United States of America. We sought to determine whether the CVD health needs of Pacific people vary according to their ethnicity or place of birth., Methods: We conducted a systematic review of medical research databases and grey literature to identify relevant data published up to 2020. Texts were included if they contained original data stratified by Pacific-specific ethnicity or place of birth on the burden or management of CVD, and were assessed as having good quality using a National Heart, Lung, and Blood Institute quality assessment tool. The protocol for this review was registered with the Open Science Forum ( https://doi.org/10.17605/OSF.IO/X7NR6 )., Results: Of 3679 texts identified, 310 full texts were reviewed and the quality of 23 of these assessed, using the pre-defined search strategy. Six items (four reports, one article, one webpage) of good quality met the review eligibility criteria. All included texts provided data on epidemiology but only one reported on the management of CVD. Four texts were of Pacific populations in Pacific Island countries and two were of Pacific diaspora in other countries. Data from the Global Burden of Disease study, which provided estimates for the greatest number of Pacific countries, showed substantial differences in mortality rates between Pacific countries for every CVD type. For example, the mortality rate per 100,000 for ischemic heart disease (IHD) ranged from 103.41 in the Cook Islands to 430.35 in the Solomon Islands. A New Zealand-based report showed differences in CVD rates by Pacific ethnicity (e.g. the age-standardised prevalence of IHD per 1,000 population in Auckland ranged from 107.8 (Niuean) to 138 among Cook Islands Māori (p < 0.001))., Conclusions: This review of published studies reveals that the epidemiology of CVD among Pacific people varies by specific ethnic groups, place of birth, and country of residence. There is a critical need for high-quality contemporary ethnic-specific Pacific data to respond to the diverse CVD health needs in these underrepresented groups., (© 2021. The Author(s).)

Background: Until recently, most patients with diabetes worldwide have been diagnosed when symptomatic and have high cardiovascular risk, meaning most should be prescribed cardiovascular preventive medications. However, in New Zealand, a world-first national programme led to approximately 90% of eligible adults being screened for diabetes by 2016, up from 50% in 2012, identifying many asymptomatic patients with recent-onset diabetes. We hypothesised that cardiovascular risk prediction equations derived before widespread screening would now significantly overestimate risk in screen-detected patients., Methods: New Zealanders aged 30-74 years with type 2 diabetes and without known cardiovascular disease, heart failure, or substantial renal impairment were identified from the 400 000-person PREDICT primary care cohort study between Oct 27, 2004, and Dec 30, 2016, covering the period before and after widespread screening. Sex-specific equations estimating 5-year risk of cardiovascular disease were developed using Cox regression models, with 18 prespecified predictors, including diabetes-related and renal function measures. Equation performance was compared with an equivalent equation derived in the New Zealand Diabetes Cohort Study (NZDCS), which recruited between 2000 and 2006, before widespread screening., Findings: 46 652 participants were included in the PREDICT-1° Diabetes subcohort, of whom 4114 experienced first cardiovascular events during follow-up (median 5·2 years, IQR 3·3-7·4). 14 829 (31·8%) were not taking oral hypoglycaemic medications or insulin at baseline. Median 5-year cardiovascular risk estimated by the new equations was 4·0% (IQR 2·3-6·8) in women and 7·1% (4·5-11·2) in men. The older NZDCS equation overestimated median cardiovascular risk by three times in women (median 14·2% [9·7-20·0]) and two times in men (17·1% [4·5-20·0]). Model and discrimination performance measures for PREDICT-1° Diabetse equations were also significantly better than for the NZDCS equation (eg, for women: R 2 =32% [95% CI 29-34], Harrell's C=0·73 [0·72-0·74], Royston's D=1·410 [1·330-1·490] vs R 2 =24% [21-26], C=0·69 [0·67-0·70], and D=1·147 [1·107-1·187])., Interpretation: International treatment guidelines still consider most people with diabetes to be at high cardiovascular risk; however, we show that recent widespread diabetes screening has radically changed the cardiovascular risk profile of people with diabetes in New Zealand. Many of these patients have normal renal function, are not dispensed glucose-lowering medications, and have low cardiovascular risk. These findings have clear international implications as increased diabetes screening is inevitable due to increasing obesity, simpler screening tests, and the introduction of new-generation glucose-lowering medications that prevent cardiovascular events. Cardiovascular risk prediction equations derived from contemporary diabetes populations, with multiple diabetes-related and renal function predictors, will be required to better differentiate between low-risk and high-risk patients in this increasingly heterogeneous population and to inform appropriate non-pharmacological management and cost-effective targeting of expensive new medications., Funding: Health Research Council of New Zealand, Heart Foundation of New Zealand, and Healthier Lives National Science Challenge., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Background: Antithrombotic medications (antiplatelets and anticoagulants) reduce the risk of cardiovascular disease (CVD), but with the disadvantage of increasing bleeding risk. Ethnicity and socioeconomic deprivation are independent predictors of major bleeds among patients without CVD, but it is unclear whether they are also predictors of major bleeds among patients with CVD or atrial fibrillation (AF) after adjustment for clinical variables., Methods: Prospective cohort study of 488,107 people in New Zealand Primary Care (including 64,420 Māori, the indigenous people of New Zealand) aged 30-79 years who had their CVD risk assessed between 2007 and 2016. Participants were divided into three mutually exclusive subgroups: (1) AF with or without CVD (n = 15,212), (2) CVD and no AF (n = 43,790), (3) no CVD or AF (n = 429,105). Adjusted hazards ratios (adjHRs) were estimated from Cox proportional hazards models predicting major bleeding risk for each of the three subgroups to determine whether ethnicity and socioeconomic deprivation are independent predictors of major bleeds in different cardiovascular risk groups., Results: In all three subgroups (AF, CVD, no CVD/AF), Māori (adjHR 1.63 [1.39-1.91], 1.24 [1.09-1.42], 1.57 [95% CI 1.45-1.70], respectively), Pacific people (adjHR 1.90 [1.58-2.28], 1.30 [1.12-1.51], 1.62 [95% CI 1.49-1.75], respectively) and Chinese people (adjHR 1.53 [1.08-2.16], 1.15 [0.90-1.47], 1.13 [95% CI 1.01-1.26], respectively) were at increased risk of a major bleed compared to Europeans, although for Chinese people the effect did not reach statistical significance in the CVD subgroup. Compared to Europeans, Māori and Pacific peoples were generally at increased risk of all bleed types (gastrointestinal, intracranial and other bleeds). An increased risk of intracranial bleeds was observed among Chinese and Other Asian people and, in the CVD and no CVD/AF subgroups, among Indian people. Increasing socioeconomic deprivation was also associated with increased risk of a major bleed in all three subgroups (adjHR 1.07 [1.02-1.12], 1.07 [1.03-1.10], 1.10 [95% CI 1.08-1.12], respectively, for each increase in socioeconomic deprivation quintile)., Conclusion: Ethnicity and socioeconomic status should be considered in bleeding risk assessments to guide the use of antithrombotic medication for the management of AF and CVD.

Aim: In Aotearoa, New Zealand, cardiovascular disease (CVD) burden is greatest among Indigenous Māori, Pacific and Indian people. The aim of this study was to describe CVD risk profiles by ethnicity., Methods: We conducted a cross-sectional analysis of a cohort of people aged 35-74 years who had a CVD risk assessment in primary care between 2004 and 2016. Primary care data were supplemented with linked data from regional/national databases. Comparisons between ethnic groups were made using age-adjusted summaries of continuous or categorical data., Results: 475,241 people (43% women) were included. Fourteen percent were Māori, 13% Pacific, 8% Indian, 10% Other Asian and 55% European. Māori and Pacific people had a much higher prevalence of smoking, obesity, heart failure, atrial fibrillation and prior CVD compared with other ethnic groups. Pacific and Indian peoples, and to a lesser extent Māori and Other Asian people, had markedly elevated diabetes prevalence compared with Europeans. Indian men had the highest prevalence of prior coronary heart disease., Conclusions: Māori and Pacific people experience the most significant inequities in exposure to CVD risk factors compared with other ethnic groups. Indians have a high prevalence of diabetes and coronary heart disease. Strong political commitment and cross-sectoral action to implement effective interventions are urgently needed., Competing Interests: The authors report grants from the Health Research Council of New Zealand, Heart Foundation New Zealand, Stevenson Foundation, to conduct this study.

Background: Whether the benefits of aspirin for the primary prevention of cardiovascular disease (CVD) outweigh its bleeding harms in some patients is unclear., Objective: To identify persons without CVD for whom aspirin would probably result in a net benefit., Design: Individualized benefit-harm analysis based on sex-specific risk scores and estimates of the proportional effect of aspirin on CVD and major bleeding from a 2019 meta-analysis., Setting: New Zealand primary care., Participants: 245 028 persons (43.6% women) aged 30 to 79 years without established CVD who had their CVD risk assessed between 2012 and 2016., Measurements: The net effect of aspirin was calculated for each participant by subtracting the number of CVD events likely to be prevented (CVD risk score × proportional effect of aspirin on CVD risk) from the number of major bleeds likely to be caused (major bleed risk score × proportional effect of aspirin on major bleeding risk) over 5 years., Results: 2.5% of women and 12.1% of men were likely to have a net benefit from aspirin treatment for 5 years if 1 CVD event was assumed to be equivalent in severity to 1 major bleed, increasing to 21.4% of women and 40.7% of men if 1 CVD event was assumed to be equivalent to 2 major bleeds. Net benefit subgroups had higher baseline CVD risk, higher levels of most established CVD risk factors, and lower levels of bleeding-specific risk factors than net harm subgroups., Limitations: Risk scores and effect estimates were uncertain. Effects of aspirin on cancer outcomes were not considered. Applicability to non-New Zealand populations was not assessed., Conclusion: For some persons without CVD, aspirin is likely to result in net benefit., Primary Funding Source: Health Research Council of New Zealand.

Wald and Law, who popularised the term 'polypill' in 2003, proposed giving everyone above a certain age a polypill to reduce the burden of cardiovascular disease (CVD). A more compelling potential application, proposed in 2001 by the World Health Organization, is to use a polypill containing antiplatelet, statin and blood pressure-lowering therapy among people with established CVD, in whom the components are already indicated but in whom guideline implementation and adherence are suboptimal. This article outlines relevant international and New Zealand evidence on the likely benefits and harms of a polypill for the secondary prevention of CVD. The evidence indicates that the benefits are likely to outweigh the harms, particularly given the persistence of substantial treatment gaps and inequities in the management of and outcomes in CVD. The time is long overdue for the polypill to be funded for the secondary prevention of CVD., Competing Interests: Nil.

There is a strong body of evidence that supports identifying and managing people according to their risk of a future cardiovascular (CVD) event. Since 2012 the New Zealand public health sector has achieved 90% CVD risk assessment (CVDRA) for each eligible person across New Zealand using a modified version of an overseas risk equation, through incentivising Primary Health Organisation (PHO) performance. In 2018 the New Zealand Ministry of Health endorsed the use of a suite of four new CVDRA equations which were developed using the large NZ Predict cohort (500,000 people). These equations more accurately reflect an individual's CVD risk and incorporate both traditional CVD risk factors, such as smoking and diabetes, but also sociodemographic factors including ethnicity and a deprivation score. The new CVDRA equations are an important tool to address the major inequities in CVD incidence, prevalence and mortality in Aotearoa-New Zealand. However, while the new equations provide more accurate assessment of risk, they are more complicated and therefore more prone to error if not properly validated and systematically implemented. To take advantage of this important opportunity to address equity in heart health we need strategic vision and national leadership. In this paper we make the case that to most safely and cost effectively implement the new equations, the Ministry of Health (MOH) should support a unified national CVD risk generator. A single, electronic, national CVD risk generator would: a) ensure national consistency and quality control-a single set of validated and current equations would be available to both clinicians and patients; b) avoid substantial replication of effort and cost in both developing and validating multiple calculators; c) enable central collection of the encrypted dataset required to develop more accurate risk assessment equations in population subgroups, both now and in the future, as CVD risk evolves; d) provide a platform to facilitate systematic and consistent national CVD risk communication and management; and e) facilitate ease of updating the tool and practice in the future as changes to the algorithm are agreed., Competing Interests: Dr Jackson and Dr Kerr report grants from HRC during the conduct of the study. Dr Wells reports grants from HRC and The Stevenson Foundation during the conduct of the study. Dr Harwood reports grants from HRC and National Science Challenge—Healthier Lives during the conduct of the study.

Background: Many prognostic models for cardiovascular risk can be used to estimate aspirin's absolute benefits, but few bleeding risk models are available to estimate its likely harms., Objective: To develop prognostic bleeding risk models among persons in whom aspirin might be considered for the primary prevention of cardiovascular disease (CVD)., Design: Prospective cohort study., Setting: New Zealand primary care., Participants: The study cohort comprised 385 191 persons aged 30 to 79 years whose CVD risk was assessed between 2007 and 2016. Those with indications for or contraindications to aspirin and those who were already receiving antiplatelet or anticoagulant therapy were excluded., Measurements: For each sex, Cox proportional hazards models were developed to predict major bleeding risk; participants were censored at the earliest of the date on which they first met an exclusion criterion, date of death, or study end date (30 June 2017). The main models included the following predictors: demographic characteristics (age, ethnicity, and socioeconomic deprivation), clinical measurements (systolic blood pressure and ratio of total-high-density lipoprotein cholesterol), family history of premature CVD, medical history (smoking, diabetes, bleeding, peptic ulcer disease, cancer, chronic liver disease, chronic pancreatitis, or alcohol-related conditions), and medication use (nonsteroidal anti-inflammatory agents, corticosteroids, and selective serotonin reuptake inhibitors)., Results: During 1 619 846 person-years of follow-up, 4442 persons had major bleeding events (of which 313 [7%] were fatal). The main models predicted a median 5-year bleeding risk of 1.0% (interquartile range, 0.8% to 1.5%) in women and 1.1% (interquartile range, 0.7% to 1.6%) in men. Plots of predicted-against-observed event rates showed good calibration throughout the risk range., Limitation: Hemoglobin level, platelet count, and body mass index were excluded from the main models because of high numbers of missing values, and the models were not externally validated in non-New Zealand populations., Conclusion: Prognostic bleeding risk models were developed that can be used to estimate the absolute bleeding harms of aspirin among persons in whom aspirin is being considered for the primary prevention of CVD., Primary Funding Source: The Health Research Council of New Zealand.

Aim: To investigate eGFR as an independent risk factor for CVD in a New Zealand primary care cohort, stratified by disease status (prior CVD, diabetes or no CVD or diabetes)., Method: The PREDICT-CVD open cohort study is a large, ethnically diverse, New Zealand primary care cohort, generated by using a web-based CVD risk assessment tool. Using encrypted identifiers, participant profiles were linked anonymously to a regional laboratory database (to determine renal function) and to national hospitalisation and mortality datasets. Analyses using a single baseline eGFR measurement were undertaken in three clinical sub-cohorts of participants: those with prior CVD (n=29,742), with diabetes (n=44,416) and with neither CVD nor diabetes (n=192,696). The association between baseline eGFR (by category ≥90, 60-89.9, 30-59.9, and <30ml/min/1.73m2) and incident CVD was analysed with Kaplan Meier plots and Cox regression models., Results: After adjustment for traditional CVD risk factors, there was an inverse relationship between CVD risk and eGFR, up to an eGFR of 60ml/min/1.73m2 in all three clinical sub-cohorts, and up to an eGFR of 90ml/min/1.73m2 in the sub-cohort with CVD or diabetes. Compared to eGFR ≥90ml/min/1.73m2, the adjusted hazard ratios of a new CVD event for eGFR <30ml/min/1.73m2 in the CVD, diabetes and no CVD/no diabetes sub-cohorts were 2.29 (95% CI 2.00-2.61), 4.71 (3.92-5.67) and 2.78 (2.05-3.77), respectively. Compared to European/Other ethnic groups, Māori participants remained at greater adjusted risk of a new CVD event in all clinical sub-cohorts and Pacific people only in the no CVD/no diabetes sub-cohort, whereas Indian participants had a similar adjusted risk to European/Other, and Other Asian patients were consistently at lower adjusted risk. Sensitivity analyses for individuals with consecutive eGFR results (>90 days apart) yielded similar results., Conclusion: This study has confirmed that, in a large ethnically diverse primary care cohort, eGFR is a significant independent predictor of CVD risk, and the risk varies by ethnic group., Competing Interests: SW had a Stevenson Fellowship in Health Innovation and Quality Improvement during the conduct of the study. KP holds the Heart Foundation Hynds Senior Fellowship. MM is a full-time employee of Baxter Healthcare (Asia) Pte Ltd. CG holds a fellowship from the National Heart Foundation. SM, VS, CG and KP report grants from Health Research Council of New Zealand during the conduct of the study. EC reports grants from NZ College of Public Medicine during the conduct of the study.

Objective: The aim of this study was to determine the effect of polypill-based care on the achievement of 2016 European Society of Cardiology (ESC) guideline targets for blood pressure (BP), low-density lipoprotein (LDL) cholesterol and antiplatelet therapy., Methods: We conducted an individual participant data meta-analysis of three randomised clinical trials that compared a strategy using a polypill containing aspirin, statin and antihypertensive therapy with usual care in patients with a prior cardiovascular disease (CVD) event or who were at high risk of their first event. Overall, the trials included 3140 patients from Australia, England, India, Ireland, the Netherlands and New Zealand (75% male, mean age 62 years and 76% with a prior CVD event). The primary outcome for this study was the proportion of people achieving ESC guideline targets for BP, LDL and antiplatelet therapy., Results: Those randomised to polypill-based care were more likely than those receiving usual care to achieve recommended targets for BP (62% vs 58%, risk ratio (RR) 1.08, 95% CI 1.02 to 1.15), LDL (39% vs 34%, RR 1.13, 95% CI 1.02 to 1.25) and all three targets for BP, LDL and adherence to antiplatelet therapy (the latter only applicable to those with a prior CVD event) simultaneously (24% vs 19%, RR 1.27, 95% CI 1.10 to 1.47) at 12 months. There was no difference between groups in antiplatelet adherence (96% vs 96%, RR 1.00, 95% CI 0.98 to 1.01). There was heterogeneity by baseline treatment intensity such that treatment effects increased with the fewer the number of treatments being taken at baseline: for patients taking 3, 2 and 0-1 treatment modalities the RRs for reaching all three guideline goals simultaneously were 1.10 (95% CI 0.94 to 1.30, 22% vs 20%), 1.62 (95% CI 1.09 to 2.42, 27% vs 17%) and 3.07 (95% CI 1.77 to 5.33, 35% vs 11%), respectively., Conclusions: Polypill-based therapy significantly improved the achievement of all three ESC targets for BP, LDL and antiplatelet therapy compared with usual care, particularly among those undertreated at baseline., Competing Interests: Competing interests: Support for the submitted work: RW is funded by an NHMRC early career fellowship. The authors have received grants from several research charities and national funding agencies for research on cardiovascular polypills, and from Dr Reddy’s Laboratories for coordination of the SPACE programme (www.spacecollaboration.org). The polypills used in the SPACE trials were manufactured and supplied by Dr Reddy’s Laboratories free of charge. Some authors received funding from Dr Reddy’s Laboratories to attend investigator meetings related to the polypill (VS, RW, AP, ST, NR, AW and AR). George Health Enterprises, the social enterprise arm of The George Institute for Global Health (employer of some coauthors) has received investment for the development of fixed dose combination therapy containing statin, aspirin and blood pressure lowering medications., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2019. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Importance: A decision to initiate aspirin therapy for primary prevention of cardiovascular disease (CVD) requires consideration of both treatment benefits and harms. The most significant harm associated with aspirin is major bleeding, yet there is a paucity of data on bleeding risk in suitable community populations., Objective: To determine the risk of major bleeding among people without CVD who are not receiving antiplatelet therapy., Design, Setting, and Participants: Prospective cohort study of 359 166 individuals aged 30 to 79 years receiving primary care in New Zealand who had CVD risk assessment between 2002 and 2015. Participants were censored at the earliest date on which they had a first major bleeding event, died, or met any baseline cohort exclusion criteria or the study end date of December 31, 2015. Analyses were repeated after excluding people with medical conditions associated with increased bleeding risk (non-high-risk cohort; n=305 057) and after further excluding people receiving other medications associated with increased bleeding risk (nonmedication cohort; n=240 254)., Exposures: Sex and age group in 10-year bands from 30 to 79 years., Main Outcomes and Measures: Risk of a major bleeding event (hospitalization or death associated with bleeding); nonfatal gastrointestinal tract bleeding; and gastrointestinal tract bleeding-related case fatality., Results: Mean participant age was 54 years (SD, 10 years), 44% were women, and 57% were European. Among the 359 166 individuals in the baseline cohort, 3976 had a major bleeding event during 1 281 896 person-years of follow-up. Most had gastrointestinal (GI) bleeding (n=2910 [73%]). There were 274 fatal bleeding events (7%), of which 153 were intracerebral. The risk of a nonfatal GI bleeding event per 1000 person-years was 2.19 (95% CI, 2.11-2.27), 1.77 (95% CI, 1.69-1.85) and 1.61 (95% CI, 1.52-1.69), in the baseline, non-high-risk, and nonmedication cohorts, respectively. Case fatality associated with GI bleeding was 3.4% (95% CI, 2.2%-4.1%), 4.0% (95% CI, 3.2%-5.1%), and 4.6% (95% CI, 3.6%-6.0%) in the baseline, non-high-risk, and nonmedication cohorts, respectively., Conclusions and Relevance: In a population not receiving antiplatelet therapy, the annual risk of major bleeding events and nonfatal major bleeding was estimated. These findings could inform population-level guidelines for primary prevention of CVD.

Background: Most cardiovascular disease risk prediction equations in use today were derived from cohorts established last century and with participants at higher risk but less socioeconomically and ethnically diverse than patients they are now applied to. We recruited a nationally representative cohort in New Zealand to develop equations relevant to patients in contemporary primary care and compared the performance of these new equations to equations that are recommended in the USA., Methods: The PREDICT study automatically recruits participants in routine primary care when general practitioners in New Zealand use PREDICT software to assess their patients' risk profiles for cardiovascular disease, which are prospectively linked to national ICD-coded hospitalisation and mortality databases. The study population included male and female patients in primary care who had no prior cardiovascular disease, renal disease, or congestive heart failure. New equations predicting total cardiovascular disease risk were developed using Cox regression models, which included clinical predictors plus an area-based deprivation index and self-identified ethnicity. Calibration and discrimination performance of the equations were assessed and compared with 2013 American College of Cardiology/American Heart Association Pooled Cohort Equations (PCEs). The additional predictors included in new PREDICT equations were also appended to the PCEs to determine whether they were independent predictors in the equations from the USA., Findings: Outcome events were derived for 401 752 people aged 30-74 years at the time of their first PREDICT risk assessment between Aug 27, 2002, and Oct 12, 2015, representing about 90% of the eligible population. The mean follow-up was 4·2 years, and a third of participants were followed for 5 years or more. 15 386 (4%) people had cardiovascular disease events (1507 [10%] were fatal, and 8549 [56%] met the PCEs definition of hard atherosclerotic cardiovascular disease) during 1 685 521 person-years follow-up. The median 5-year risk of total cardiovascular disease events predicted by the new equations was 2·3% in women and 3·2% in men. Multivariable adjusted risk increased by about 10% per quintile of socioeconomic deprivation. Māori, Pacific, and Indian patients were at 13-48% higher risk of cardiovascular disease than Europeans, and Chinese or other Asians were at 25-33% lower risk of cardiovascular disease than Europeans. The PCEs overestimated of hard atherosclerotic cardiovascular disease by about 40% in men and by 60% in women, and the additional predictors in the new equations were also independent predictors in the PCEs. The new equations were significantly better than PCEs on all performance metrics., Interpretation: We constructed a large prospective cohort study representing typical patients in primary care in New Zealand who were recommended for cardiovascular disease risk assessment. Most patients are now at low risk of cardiovascular disease, which explains why the PCEs based mainly on old cohorts substantially overestimate risk. Although the PCEs and many other equations will need to be recalibrated to mitigate overtreatment of the healthy majority, they also need new predictors that include measures of socioeconomic deprivation and multiple ethnicities to identify vulnerable high-risk subpopulations that might otherwise be undertreated., Funding: Health Research Council of New Zealand, Heart Foundation of New Zealand, and Healthier Lives National Science Challenge., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

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., (© The European Society of Cardiology 2016.)

Background: The burden of cardiovascular disease (CVD) among New Zealand (NZ) indigenous people (Māori) is well recognized. A major challenge to CVD risk management is to improve adherence to long-term medications., Objectives: To elicit patients' and providers' perspectives on how to support Māori with high CVD risk and low medication adherence to achieve better adherence., Methods: Analysis of electronic health records (EHR) of four NZ general practices identified medication adherence status of Māori patients with high CVD risk (≥15%, 5-year). A random sample of these patients participated in focus group discussions on barriers to long-term medication adherence. Their primary care providers also participated in separate focus groups on the same topic., Results: A range of factors are identified influencing adherence behaviour, including patient's medication knowledge, patient-doctor communication effectiveness and cost., Conclusion: Analysis of barriers to medication adherence in primary care suggests opportunities for health information technology to improve adherence, including patient education, decision support, clinician training and self-service facilities.

Introduction: Māori are overrepresented in cardiovascular disease (CVD) mortality and morbidity statistics in New Zealand (NZ)., Aim: To examine cardiovascular risk (CVR) assessment and management for Māori, utilising Caring Does Matter (CDM) initiative data., Methods: Using 16 general practices' electronic medical records—which include ethnicity data—the rate of CVR screening, CVD medication treatment and adherence levels, and physiological measures for Māori patients at high CVR (≥15% five-year risk of a cardiovascular event) were compared to findings for Pacific and non-Māori/non-Pacific patients., Results: Records for 72,351 adults (10,358 Māori; 14%) showed that Māori patients have a poorer CVR assessment rate (46% at guideline-indicated age) than Pacific and non-Māori/non-Pacific groups; when assessed, a greater proportion of Māori patients (38%) were at high CVR. The proportion of high-CVR Māori patients being treated with oral antidiabetic medication (42%) was lower than for Pacific patients but higher than for non-Māori/non-Pacific patients. Lower rates of antihypertensive adherence were found for high-CVR Māori patients than for non-Māori/non-Pacific patients (although higher than for Pacific patients). The high-CVR Māori patients who adhered to CVD medications had lower blood pressure, total-to-HDL cholesterol ratio and HbA1c than non-adherers., Discussion: The association between higher medication adherence and better control of risk factors suggests that adherence should be further promoted by clinicians. More active CVR assessment, treatment and support of medication adherence in Māori attending general practices is justified, given their high mortality rate from CVD in comparison to the overall NZ population.

Background: Cardiovascular diseases (CVD) are leading causes of mortality and morbidity among Indigenous people in New Zealand, Australia and Canada and are a major driver of the inequities in life expectancy between Indigenous and non-Indigenous people in these countries. Evidence-based pharmaceutical management of CVD can significantly reduce mortality and morbidity for persons diagnosed with CVD or for those at intermediate or high risk of CVD. Health literacy has been identified as a major barrier in the communication and implementation of appropriate pharmaceutical management plans for CVD. Addressing health literacy is particularly relevant in Indigenous populations where there are unique health and adult literacy challenges., Methods/design: This study will examine the effect of a customized, structured CVD medication programme, delivered by health professionals, on the health literacy of Indigenous people with, or at risk, of CVD. Primary outcomes are patient's knowledge about CVD medications; secondary outcomes examine changes in health literacy skills and practices. The study will employ a multi-site pre-post design with multiple measurement points to assess intervention efficacy. Participants will be recruited from four Indigenous primary care services in Australia, Canada and New Zealand. Three educational sessions will be delivered over four weeks. A tablet application will support the education sessions and produce a customized pill card for each participant. Participants will be provided with written information about CVD medications. Medication knowledge scores, and specific health literacy skills and practices will be assessed before and after the three sessions. Statistical analyses will identify significant changes in outcomes over each session, and from the pre-session one to post-session three time points., Discussion: This study will make an important contribution to understanding the effect of a structured primary care-based intervention on CVD health literacy in Indigenous populations. The study also illustrates the incorporation of Indigenous health research principles and processes in clinical trials and provides insights that may be useful in other contexts., Trial Registration: Australian and New Zealand Clinical Trials Register (ACTRN12612001309875; date of registration 18/12/2012).

Objective: To evaluate whether provision of fixed dose combination treatment improves adherence and risk factor control compared with usual care of patients at high risk of cardiovascular disease in primary care., Design: Open label randomised control trial: IMPACT (IMProving Adherence using Combination Therapy)., Setting: 54 general practices in the Auckland and Waikato regions of New Zealand, July 2010 to August 2013., Participants: 513 adults (including 257 indigenous Māori) at high risk of cardiovascular disease (established cardiovascular disease or five year risk ≥ 15%) who were recommended for treatment with antiplatelet, statin, and two or more blood pressure lowering drugs. 497 (97%) completed 12 months' follow-up., Interventions: Participants were randomised to continued usual care or to fixed dose combination treatment (with two versions available: aspirin 75 mg, simvastatin 40 mg, and lisinopril 10 mg with either atenolol 50 mg or hydrochlorothiazide 12.5 mg). All drugs in both treatment arms were prescribed by their usual general practitioners and dispensed by local community pharmacists., Main Outcome Measures: Primary outcomes were self reported adherence to recommended drugs (antiplatelet, statin, and two or more blood pressure lowering agents) and mean change in blood pressure and low density lipoprotein cholesterol at 12 months., Results: Adherence to all four recommended drugs was greater among fixed dose combination than usual care participants at 12 months (81% v 46%; relative risk 1.75, 95% confidence interval 1.52 to 2.03, P<0.001; number needed to treat 2.9, 95% confidence interval 2.3 to 3.7). Adherence for each drug type at 12 months was high in both groups but especially in the fixed dose combination group: for antiplatelet treatment it was 93% fixed dose combination v 83% usual care (P<0.001), for statin 94% v 89% (P=0.06), for combination blood pressure lowering 89% v 59% (P<0.001), and for any blood pressure lowering 96% v 91% (P=0.02). Self reported adherence was highly concordant with dispensing data (dispensing of all four recommended drugs 79% fixed dose combination v 47% usual care, relative risk 1.67, 95% confidence interval 1.44 to 1.93, P<0.001). There was no statistically significant improvement in risk factor control between the fixed dose combination and usual care groups over 12 months: the difference in systolic blood pressure was -2.2 mm Hg (-4.5 v -2.3, 95% confidence interval -5.6 to 1.2, P=0.21), in diastolic blood pressure -1.2 mm Hg (-2.1 v -0.9, -3.2 to 0.8, P=0.22) and in low density lipoprotein cholesterol -0.05 mmol/L (-0.20 v -0.15, -0.17 to 0.08, P=0.46). The number of participants with cardiovascular events or serious adverse events was similar in both treatment groups (fixed dose combination 16 v usual care 18 (P=0.73), 99 v 93 (P=0.56), respectively). Fixed dose combination treatment was discontinued in 94 participants (37%). The most commonly reported reason for discontinuation was a side effect (54/75, 72%). Overall, 89% (227/256) of fixed dose combination participants' general practitioners completed a post-trial survey, and the fixed dose combination strategy was rated as satisfactory or very satisfactory for starting treatment (206/227, 91%), blood pressure control (180/220, 82%), cholesterol control (170/218, 78%), tolerability (181/223, 81%), and prescribing according to local guidelines (185/219, 84%). When participants were asked at 12 months how easy they found taking their prescribed drugs, most responded very easy or easy (224/246, 91% fixed dose combination v 212/246, 86% usual care, P=0.09). At 12 months the change in other lipid fractions, difference in EuroQol-5D, and difference in barriers to adherence did not differ significantly between the treatment groups., Conclusions: Among this well treated primary care population, fixed dose combination treatment improved adherence to the combination of all recommended drugs but improvements in clinical risk factors were small and did not reach statistical significance. Acceptability was high for both general practitioners and patients, although the discontinuation rate was high., Trial Registration: Australian New Zealand Clinical Trial Registry ACTRN12606000067572., (© Selak et al 2014.)

Introduction: Māori are disproportionately affected by cardiovascular disease (CVD), which is the main reason for the eight year difference in life expectancy between Māori and non-Māori. The primary care-based IMPACT (IMProving Adherence using Combination Therapy) trial evaluates whether fixed dose combination therapy (a "polypill") improves adherence to guideline-based therapy compared with current care among people at high risk of CVD. Interventions shown in trials to be effective do not necessarily reduce ethnic disparities, and may in fact widen them. Indigenous populations with poorer health outcomes are often under-represented in trials so the effect of interventions cannot be assessed for them, specifically. Therefore, the IMPACT trial aimed to recruit as many Māori as non-Māori to assess the consistency of the effect of the polypill. This paper describes the methods and results of the recruitment strategy used to achieve this., Methods: Experienced Māori researchers were involved in trial governance throughout trial development and conduct. The trial Steering Committee included leading Māori researchers and was committed to equal recruitment of Māori and non-Māori. Additional funding and Māori research nurses were sought to allow home-based assessment, establishment of the relationship between research nurse and participant, more family involvement prior to enrollment, continuity of the research nurse-participant relationship, and acknowledgement of other Māori culturally important procedures, interactions, language and manners. Primary care practices with high enrollment of Māori were targeted, with over-sampling of potentially eligible Māori patients, lower thresholds for screening of Māori and 6 months continued Māori recruitment after non-Māori recruitment had finished., Results: A total of 257 Māori and 256 non-Māori participants were randomized. Four Māori and eight non-Māori participants were randomized per research nurse per month. Potentially eligible Māori were more likely than non-Māori to proceed to subsequent stages of recruitment. Differences between randomized Māori and non-Māori were evident (e.g. Maori were less likely to have established coronary artery disease)., Conclusions: Recruitment of equal numbers of indigenous and non-indigenous participants is possible if it is prioritised, adequately resourced and self-determination is supported., Trial Registration: The trial is registered with the Australian New Zealand Clinical Trial Registry ACTRN12606000067572.

Background: Cardiovascular disease (CVD) is the leading cause of death, and principal reason for the large difference in life expectancy between indigenous Māori and the non-indigenous population in New Zealand. CVD guidelines recommend that people who are at high risk or who have had previous CVD should be offered aspirin, blood pressure lowering and lipid lowering therapies. However, prescribing and adherence rates are low and CVD events remain high., Aim: To assess whether a medication strategy using a fixed dose combination pill ('polypill') could improve prescribing and adherence to recommended medications, lower blood pressure and improve lipids compared with current care over 12 months., Methods: IMProving Adherence using Combination Therapy (IMPACT) is an open-label randomised controlled trial comparing a once-daily polypill containing four preventive medications with usual care. Six hundred participants who have had previous CVD events or are at high risk of CVD will be enrolled, including 300 Māori. Participants are identified, enrolled and prescribed either the polypill or current medications at their usual primary health care practice, with medications (including the polypill) dispensed through local community pharmacies. The polypill contains 75 mg aspirin, 40 mg simvastatin, 10mg lisinopril and either 12.5mg hydrochlorothiazide or 50mg atenolol. Primary outcomes are adherence to guidelines-recommended medications and changes in systolic blood pressure and low density lipoprotein at 12 months. Secondary outcomes include other lipids, medication dispensing, barriers to adherence, CVD and other serious adverse events, quality of life and prescriber acceptability. The trial is registered with the Australian New Zealand Clinical Trial Registry (ACTRN12606000067572)., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Background: The burden of cardiovascular disease (CVD) among New Zealand (NZ) indigenous people (Mori) is well recognized. A major challenge to CVD risk management is to improve adherence to long-term medications. Objectives: To elicit patients' and providers' perspectives on how to support Mori with high CVD risk and low medication adherence to achieve better adherence. Methods: Analysis of electronic health records (EHR) of four NZ general practices identified medication adherence status of Maori patients with high CVD risk (15%, 5-year). A random sample of these patients participated in focus group discussions on barriers to long-term medication adherence. Their primary care providers also participated in separate focus groups on the same topic. Results: A range of factors are identified influencing adherence behaviour, including patient's medication knowledge, patient-doctor communication effectiveness and cost. Conclusion: Analysis of barriers to medication adherence in primary care suggests opportunities for health information technology to improve adherence, including patient education, decision support, clinician training and self-service facilities. [ABSTRACT FROM AUTHOR]

INTRODUCTION: Māori are overrepresented in cardiovascular disease (CVD) mortality and morbidity statistics in New Zealand (NZ). AIM: To examine cardiovascular risk (CVR) assessment and management for Māori, utilising Caring Does Matter (CDM) initiative data. METHODS: Using 16 general practices' electronic medical records--which include ethnicity data--the rate o f CVR screening, CVD medication treatment and adherence levels, and physiological measures for Māori patients at high CVR (≥15% five-year risk o f a cardiovascular event) were compared to findings for Pacific and non-Māori/non-Pacific patients. RESULTS: Records for 72 351 adults (10 358 Māori; 14%) showed that Māori patients have a poorer CVR assessment rate (46% at guideline-indicated age) than Pacific and non-Māori/non-Pacific groups; when assessed, a greater proportion o f Māori patients (38%) were at high CVR. The proportion o f high-CVR Māori patients being treated with oral antidiabetic medication (42%) was lower than for Pacific patients but higher than for non-Māori/non-Pacific patients. Lower rates o f antihypertensive adherence were found for high-CVR Māori patients than for non-Māori/non-Pacific patients (although higher than for Pacific patients). The high-CVR Māori patients who adhered to CVD medications had lower blood pressure, total- to-HDL cholesterol ratio and HbA1c than non-adherers. DISCUSSION: The association between higher medication adherence and better control o f risk factors suggests that adherence should be further promoted by clinicians. More active CVR assessment, treatment and support o f medication adherence in Māori attending general practices is justified, given their high mortality rate from CVD in comparison to the overall NZ population. [ABSTRACT FROM AUTHOR]