Importance Most patients with cardiovascular disease (CVD) do not take recommended medications long-term. The use of fixed-dose combinations (FDCs) improves adherence in several clinical areas. Previous trials of cardiovascular FDCs have assessed short-term effects compared with placebo or no treatment. Objective To assess whether FDC delivery of aspirin, statin, and 2 blood pressure–lowering agents vs usual care improves long-term adherence to indicated therapy and 2 major CVD risk factors, systolic blood pressure (SBP) and low-density lipoprotein cholesterol (LDL-C). Design, Setting, and Participants The UMPIRE trial, a randomized, open-label, blinded-end-point trial among 2004 participants with established CVD or at risk of CVD enrolled July 2010–July 2011 in India and Europe. The trial follow-up concluded in July 2012. Interventions Participants were randomly assigned (1:1) to an FDC-based strategy (n=1002) containing either (1) 75 mg aspirin, 40 mg simvastatin, 10 mg lisinopril, and 50 mg atenolol or (2) 75 mg aspirin, 40 mg simvastatin, 10 mg lisinopril, and 12.5 mg hydrochlorothiazide or to usual care (n=1002). Main Outcomes and Measures Adherence to medication (defined as self-reported use of antiplatelet, statin, and ≥2 BP-lowering medications) and changes in SBP and LDL-C from baseline. Results At baseline, mean BP was 137/78 mm Hg, LDL-C was 91.5 mg/dL, and 1233 (61.5%) of 2004 participants reported use of antiplatelet, statin, and 2 or more BP-lowering medications. Median follow-up was 15 months (interquartile range, 12-18 months). The FDC group had improved adherence vs usual care (86% vs 65%; relative risk [RR] of being adherent, 1.33; 95% CI, 1.26-1.41; P P P P P  = .01 for interaction), and LDL-C was reduced by 6.7 mg/dL (95% CI, 10.5-2.8 mg/dL; P  = .11 for interaction). There were no significant differences in serious adverse events or cardiovascular events (50 [5%] in the FDC group and 35 [3.5%] in the usual care group; RR, 1.45; 95% CI, 0.94-2.24; P =.09) between the groups. Conclusions and Relevance Among patients with or at high risk of CVD, use of an FDC strategy for blood pressure, cholesterol, and platelet control vs usual care resulted in significantly improved medication adherence at 15 months and statistically significant but small improvements in SBP and LDL-C. Trial Registration clinicaltrials.gov Identifier:NCT01057537

https://jamanetwork.com/journals/jama/articlepdf/1734704/joi130052.pdf

Effects of a Fixed-Dose Combination Strategy on Adherence and Risk Factors in Patients With or at High Risk of CVD: The UMPIRE Randomized Clinical Trial

The national Closing the Gap framework commits to reducing persisting disadvantage in the health of Aboriginal and Torres Strait Islander people in Australia, with cross-government-sector initiatives and investment. Central to efforts to build healthier communities is the Aboriginal community controlled health service (ACCHS) sector; its focus on prevention, early intervention and comprehensive care has reduced barriers to access and unintentional racism, progressively improving individual health outcomes for Aboriginal people. There is now a broad range of primary health care data that provides a sound evidence base for comparing the health outcomes for Indigenous people in ACCHSs with the outcomes achieved through mainstream services, and these data show: models of comprehensive primary health care consistent with the patient-centred medical home model; coverage of the Aboriginal population higher than 60% outside major metropolitan centres; consistently improving performance in key performance on best-practice care indicators; and superior performance to mainstream general practice. ACCHSs play a significant role in training the medical workforce and employing Aboriginal people. ACCHSs have risen to the challenge of delivering best-practice care and there is a case for expanding ACCHSs into new areas. To achieve the best returns, the current mainstream Closing the Gap investment should be shifted to the community controlled health sector.

/pdf/aboriginal-community-controlled-health-services-leading-the-3pk2j0vf06.pdf

Aboriginal community controlled health services: leading the way in primary care

BackgroundMost 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...

http://journals.sagepub.com/doi/pdf/10.1177/2047487314530382

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

https://spiral.imperial.ac.uk/bitstream/10044/1/30542/2/SPACE_mainresults_IJC_revised.pdf

Effectiveness of fixed dose combination medication ('polypills') compared with usual care in patients with cardiovascular disease or at high risk: A prospective, individual patient data meta-analysis of 3140 patients in six countries☆ , ☆☆

Noncommunicable disease (NCD), comprising cardiovascular disease, stroke, diabetes, and chronic obstructive pulmonary disease, are increasing in incidence rapidly in low- and middle-income countries (LMICs). Some patients have access to the same treatments available in high-income countries, but most do not, and different strategies are needed. Most research on noncommunicable diseases has been conducted in high-income countries, but the need for research in LMICs has been recognized. LMICs can learn from high-income countries, but they need to devise their own systems that emphasize primary care, the use of community health workers, and sometimes the use of mobile technology. The World Health Organization has identified “best buys” it advocates as interventions in LMICs. Non-laboratory-based risk scores can be used to identify those at high risk. Targeting interventions to those at high risk for developing diabetes has been shown to work in LMICs. Indoor cooking with biomass fuels is an important cause of chronic obstructive pulmonary disease in LMICs, and improved cookstoves with chimneys may be effective in the prevention of chronic diseases.

https://globalheartjournal.com/articles/10.1016/j.gheart.2014.11.003/galley/258/download/

Management of NCD in low- and middle-income countries.

Background
The Kanyini Guidelines Adherence with the Polypill (Kanyini-GAP) Study aims to examine whether a polypill-based strategy (using a single capsule containing aspirin, a statin and two blood pressure-lowering agents) amongst Indigenous and non-Indigenous people at high risk of experiencing a cardiovascular event will improve adherence to guideline-indicated therapies, and lower blood pressure and cholesterol levels.

/pdf/rationale-and-design-of-the-kanyini-guidelines-adherence-1z83c6zft8.pdf

Rationale and design of the Kanyini guidelines adherence with the polypill (Kanyini-GAP) study: a randomised controlled trial of a polypill-based strategy amongst Indigenous and non Indigenous people at high cardiovascular risk

Victoria Wade

Papers

Rationale and design of the Kanyini guidelines adherence with the polypill (Kanyini-GAP) study: a randomised controlled trial of a polypill-based strategy amongst Indigenous and non Indigenous people at high cardiovascular risk