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Importance: With the high burden of hypertension in sub-Saharan Africa, there is a need for effective, safe and scalable treatment strategies., Objective: To compare, among Black African adults, the effectiveness and safety of a novel low-dose triple-pill protocol compared with a standard-care protocol for blood pressure lowering., Design and Setting: Randomized, parallel-group, open-label, multicenter trial conducted in public hospital-based family medicine clinics in Nigeria., Participants: Black African adults with uncontrolled hypertension (≥140/90 mm Hg) who were untreated or receiving a single blood pressure-lowering drug., Interventions: Participants were randomly allocated to low-dose triple-pill or standard-care protocols. The triple-pill protocol involved a novel combination of telmisartan, amlodipine, and indapamide in triple one-quarter, one-half, and standard doses (ie, 10/1.25/0.625 mg, 20/2.5/1.25 mg, and 40/5/2.5 mg), with accelerated up-titration. The standard-care protocol was the Nigeria hypertension treatment protocol starting with amlodipine (5 mg)., Main Outcomes and Measures: The primary effectiveness outcome was the reduction in home mean systolic blood pressure, and the primary safety outcome was discontinuation of trial treatment due to adverse events, both from randomization to month 6., Results: The first participant was randomized on July 19, 2022, and the last follow-up visit was on July 18, 2024. Among 300 randomized participants (54% female; mean age, 52 years; baseline mean home blood pressure, 151/97 mm Hg; and clinic blood pressure, 156/97 mm Hg), 273 (91%) completed the trial. At month 6, mean home systolic blood pressure was on average 31 mm Hg (95% CI, 28 to 33 mm Hg) lower in the triple-pill protocol group and 26 mm Hg (95% CI, 22 to 28 mm Hg) lower in the standard-care protocol group (adjusted difference, -5.8 mm Hg [95% CI, -8.0 to -3.6]; P < .001]). At month 6, clinic blood pressure control (<140/90 mm Hg) was 82% vs 72% (risk difference, 10% [95% CI, -2% to 20%]) and home blood pressure control (<130/80 mm Hg) was 62% vs 28% (risk difference, 33% [95% CI, 22% to 44%]) in the triple-pill compared with the standard-care protocol group; these were 2 of 21 prespecified secondary effectiveness end points. No participants discontinued trial treatment due to adverse events., Conclusions and Relevance: Among Black African adults with uncontrolled hypertension, a low-dose triple-pill protocol achieved better blood pressure lowering and control with good tolerability compared with the standard-care protocol., Trial Registration: Pan African Clinical Trials Registry Identifier: PACTR202107579572114.

Introduction: A polypill-based implementation strategy has been proposed to increase rates of guideline-directed medical therapy (GDMT) in patients with heart failure with reduced ejection fraction. This has the potential to improve mortality and morbidity in India and undertreated populations globally., Methods: We conducted a convergent parallel mixed methods study integrating quantitative data from stakeholder surveys using modified implementation science outcome measures and qualitative data from key informant in-depth interviews. Our objective was to explore physician, nurse, pharmacist, and patient perspectives on a HFrEF polypill implementation strategy in India from January 2021 to April 2021. Quantitative and qualitative data were integrated to develop an Implementation Research Logic Model., Results: Among 69 respondents to the stakeholder survey, there was moderate acceptability (mean [SD] 3.8 [1.0]), appropriateness (3.6 [1.0]), and feasibility (3.7 [1.0]) of HFrEF polypill implementation strategy. Participants in the key-informant in-depth interviews (n = 20) highlighted numerous relative advantages of the HFrEF polypill innovation including potential to simplify medication regimens and improve patient adherence. Key relative disadvantages elucidated, include concerns about side effects and interruption of multiple GDMT medications due to polypill discontinuation for side effects or hospitalizations. Based on this data, the proposed implementation strategies in the Implementation Research Logic Model include 1) HFrEF polypills, 2) HFrEF polypill initiation, titration, and maintenance protocols, and 3) HFrEF polypill laboratory monitoring protocols for safety which we postulate will lead to desired clinical and implementation outcomes through multiple mechanisms including increased medication adherence to a single pill., Conclusion: This study demonstrates that a HFrEF polypill-based implementation strategy is considered acceptable, feasible, and appropriate among healthcare providers in India. We identified contextually relevant determinants, strategies, mechanism, and outcomes outlined in an Implementation Research Logic Model to inform future research to improve heart failure care in South Asia., Competing Interests: MDH has received travel support from the American Heart Association and World Heart Federation. MDH has an appointment at The George Institute for Global Health, which has a patent, license, and has received investment funding with intent to commercialize fixed-dose combination therapy through its social enterprise business, George Medicines. MDH and AA plan to submit patents for heart failure with reduced ejection fraction polypills., (Copyright: © 2024 The Author(s).)

Background: Prominent product placement is a core promotional tactic in retail food environments. How this practice has been adapted for online supermarkets, and the extent to which it is applied to healthier and less healthy food products in this setting, is largely unknown. We aimed to investigate placement-type promotions of food products in Australian online supermarkets., Methods: We developed a new method to assess placement promotions and applied it to the online stores of the two largest supermarket retailers in Australia. Each online store was audited across six 'locations' (input prior to data collection), including a randomly selected high socio-economic position area and low socio-economic position area from each of the three largest Australian cities. The names, page locations and type of placement strategy of promoted food products were captured, with product healthiness assessed using the Health Star Rating (HSR) nutrient profiling system. Descriptive statistics summarised the page locations of promoted products and the placement strategies used to promote them, and chi-squared tests applied to compare product healthiness by retailer and socio-economic position., Results: We recorded 12,152 food products promoted through placement strategies, 99% of which were eligible for a HSR. Overall, 44% of products promoted through placement strategies were unhealthy. Cross-promotions and recommendations was the most common strategy recorded overall (55.9% of all strategies), and advertisements and site content was the strategy most likely to promote unhealthy products (53.7% of products unhealthy). One retailer was more likely to promote unhealthy products (46% v 43%, p = 0.004) and unhealthy products were more likely to be promoted in more disadvantaged than less disadvantaged locations (45% vs 43%, p = 0.05), though the magnitudes of difference were small., Conclusions: A considerable number of unhealthy products are likely presented to online grocery shoppers in Australia. Public health policies targeting unhealthy food promotions may need to be updated, including with consideration of the different ways that products can be prominently displayed online, to avoid exacerbating risks of diet-related disease and health inequalities. Our novel methodology could be used for ongoing monitoring of online supermarkets in Australia and elsewhere to inform such policies., (© 2024. The Author(s).)

Importance: The high prevalence of hypertension calls for broad, multisector responses that foster prevention and care services, with the goal of leveraging high-quality treatment as a means of reducing hypertension incidence. Health care system improvements require stakeholder input from across the care continuum to identify gaps and inform interventions that improve hypertension care service, delivery, and retention; system dynamics modeling offers a participatory research approach through which stakeholders learn about system complexity and ways to model sustainable system-level improvements., Objective: To assess the association of simulated interventions with hypertension care retention rates in the Nigerian primary health care system using system dynamics modeling., Design, Setting, and Participants: This decision analytical model used a participatory research approach involving stakeholder workshops conducted in July and October 2022 to gather insights and inform the development of a system dynamics model designed to simulate the association of various interventions with retention in hypertension care. The study focused on the primary health care system in Nigeria, engaging stakeholders from various sectors involved in hypertension care, including patients, community health extension workers, nurses, pharmacists, researchers, administrators, policymakers, and physicians., Exposure: Simulated intervention packages., Main Outcomes and Measures: Retention rate in hypertension care at 12, 24, and 36 months, modeled to estimate the effectiveness of the interventions., Results: A total of 16 stakeholders participated in the workshops (mean [SD] age, 46.5 [8.6] years; 9 [56.3%] male). Training of health care workers was estimated to be the most effective single implementation strategy for improving retention in hypertension care in Nigeria, with estimated retention rates of 29.7% (95% CI, 27.8%-31.2%) at 12 months and 27.1% (95% CI, 26.0%-28.3%) at 24 months. Integrated intervention packages were associated with the greatest improvements in hypertension care retention overall, with modeled retention rates of 72.4% (95% CI, 68.4%-76.4%), 68.1% (95% CI, 64.5%-71.7%), and 67.1% (95% CI, 64.5%-71.1%) at 12, 24, and 36 months, respectively., Conclusions and Relevance: This decision analytical model study showed that community-based participatory research could be used to estimate the potential effectiveness of interventions for improving retention in hypertension care. Integrated intervention packages may be the most promising strategies.

Background: Blood pressure (BP) control among treated patients in Africa is very suboptimal, with low levels of combination therapy use and therapeutic inertia being among the major barriers to effective control of hypertension. The VERONICA-Nigeria study aims to evaluate, among Black African adults with hypertension, the effectiveness and safety of a triple pill-based treatment protocol compared to Nigeria hypertension treatment protocol (standard care protocol) for the treatment of hypertension., Methods: This study involves a randomized, parallel-group and open-label trial. Adults with uncontrolled hypertension (n = 300), untreated or receiving monotherapy, with no contraindication to study treatments will be randomly assigned 1:1 to treatment with a triple pill based-treatment protocol or standard care protocol. Follow-up is for 6 months, with interim follow up visits at month 1, 2, and 3. In a noncomparative extension treatment period, participants completing the 6 months randomized period and on ≤3 BP-lowering drugs will receive treatment with the triple pill-based treatment protocol for 12 months. The primary outcome is change in home mean SBP from baseline to month 6, and key secondary efficacy outcome is percentage of participants with clinic BP <140/90 mmHg at month 6. The primary safety outcome is discontinuation of trial treatment due to adverse events from randomization to month 6. Economic evaluation will be conducted to assess the cost-effectiveness of the triple pill-based treatment protocol, and process evaluation will be conducted to understand the context in which the trial was conducted, implementation of the trial and interventions and mechanisms of effect, and potential barriers and facilitators to implementing the intervention in clinical practice., Conclusion: The VERONICA-Nigeria trial will provide evidence of effectiveness and safety of the triple-based treatment protocol for the pharmacological management of hypertension, in Black African adults., Trial Registration: PACTR202107579572114., Competing Interests: Disclosures George Institute Ventures, the social enterprise arm of The George Institute for Global Health, has received investment to develop fixed-dose combination products containing aspirin, statin and blood pressure lowering drugs. George Medicines Pty Ltd (GM), an entity of George Institute Ventures, has submitted patents for low- dose blood pressure combinations, on which Professor Anthony Rodgers is listed as one of the inventors. Professor Rodgers is seconded part-time to GM. All staff employed by The George Institute for Global Health have an institutional interest to declare with respect to George Health Enterprises. None of The George Institute for Global Health staff have a direct financial interest in these investments. In the last 3 years, Professor Alta Schutte has received speaker honoraria from Abbott, Servier, Sanofi, Medtronic, Omron, and Aktiia for work unrelated to this research. Professor Huffman has planned patents for combination therapy for the treatment of heart failure. In the last 5 years, Dr Ojji has received speakers' fees for continuous medical education lectures from Novartis, Pfizer, Servier Pharmaceuticals and Boehringer Ingelheim which are unrelated to this trial., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Hypertension poses a significant health burden globally. In Nigeria, hypertension prevalence is on the rise, with low rates of awareness, treatment, and control. This policy brief explores the critical gaps addressed by the Hypertension Treatment in Nigeria (HTN) Program, highlighting its strengths, initial outcomes, and scalability in primary care settings. The HTN Program employs an integrated, multilevel care model based on the World Health Organization's HEARTS technical package, including patient registration and empanelment, team-based care, training and supervision, a standardized treatment protocol, a health information management system, and a drug revolving fund to improve medication accessibility. By December 2023, hypertension treatment and control rates reached surpassing 90% and 50%, respectively, thus underscoring the program's impact. The HTN Program serves as a model for delivering integrated hypertension care in primary care. Results should be leveraged for political commitment and financing to evaluate and manage non-communicable diseases such as hypertension in primary care through federal and state primary health development agencies. Furthermore, incorporating metrics related to hypertension control and treatment into the Integrated Supportive Management Information System can enhance routine monitoring and evaluation., (© 2024. The Author(s).)

Introduction: Noncommunicable diseases (NCDs) are associated with high and rising burden of morbidity and mortality in sub-Saharan Africa, including Nigeria. Diabetes mellitus (DM) is among the leading causes of NCD-related deaths worldwide and is a foremost public health problem in Nigeria. As part of National policy, Nigeria has committed to implement the World Health Organization (WHO) Package of Essential Non-communicable Disease interventions for primary care. Implementing the intervention requires the availability of essential elements, including guidelines, trained staff, health management information systems (HMIS), equipment, and medications, in primary healthcare centers (PHCs). This study assessed the availability of the DM component of the WHO package, and the readiness of the health workers in these PHCs to implement a DM screening, evaluation, and management program to inform future adoption and implementation., Methods: This cross-sectional formative assessment adapted the WHO Service Availability and Readiness Assessment (SARA) tool to survey 30 PHCs selected by multistage sampling for readiness to deliver DM diagnosis and care in Abuja, Nigeria, between August and October 2021. The SARA tool was adapted to focus on DM services and the availability and readiness indicator scores were calculated based on the proportion of PHCs with available DM care services, minimum staff requirement, diagnostic tests, equipment, medications, and national guidelines/protocols for DM care within the defined SARA domain., Results: All 30 PHCs reported the availability of at least two full-time staff (median [interquartile range] = 5 [4-9]), which were mostly community health extension workers (median [interquartile range]) = 3 [1-4]. At least one staff member was recently trained in DM care in 11 PHCs (36%). The study also reported high availability of paper-based HMIS (100%), and DM screening services using a glucometer (87%), but low availability of DM job aids (27%), treatment (23%), and national guidelines/protocols (0%)., Conclusion: This formative assessment of PHCs' readiness to implement a DM screening, evaluation, and management program in Abuja demonstrated readiness to integrate DM care into PHCs regarding equipment, paper-based HMIS, and nonphysician health workers' availability. However, strategies are needed to promote DM health workforce training, provide DM management guidelines, and supply essential DM medications., (© 2024. The Author(s).)

Background: The recent inclusion of polypills-fixed-dose combinations of antihypertensive medicines and a statin with or without aspirin-in the World Health Organization's Essential Medicines List (EML) reiterates the potential of this approach to improve global treatment coverage for cardiovascular diseases (CVDs). Although there exists extensive evidence on the effectiveness, safety and acceptability of polypills, there has been no research to date assessing the real-world availability and affordability of polypills globally., Methods: We conducted a cross-sectional survey, based on the WHO/Health Action International methodology, in 13 countries around the world. In the surveyed countries, we first ascertained whether any polypill was authorised for marketing and/or included in EMLs and clinical guidelines. In each country, we collected retail and price data for polypills from at least one public-sector facility and three private pharmacies using convenience sampling. Polypills were considered unaffordable if the lowest-paid worker spent more than a day's wage to purchase a monthly supply., Results: Polypills were approved for marketing in four of the 13 surveyed countries: Spain, India, Mauritius and Argentina. None of these countries included polypills in national guidelines, formularies, or EMLs. In the four countries, no surveyed public pharmacies stocked polypills. In the private sector, we identified seven unique polypill combinations, marketed by eight different companies. Private sector availability was 100% in Argentina and Spain. Most combinations (n = 5) identified were in India. Combinations found in India and Spain were affordable in the local context. A lowest-paid government worker would spend between 0.2 (India) and 2.8 (Mauritius) days' wages to pay the price for one month's supply of the polypills. Polypills were likely to be affordable if they were manufactured in the same country., Conclusion: Low availability and affordability of polypills in the public sector suggest that implementation remains poor globally. Context-specific multi-disciplinary health system research is required to understand factors affecting polypill implementation and to design and evaluate appropriate implementation strategies., Competing Interests: MDH has pending patents for heart failure polypills. Other authors have no competing interests to declare., (Copyright: © 2024 The Author(s).)

Background: Quality of chronic care for cardiovascular disease (CVD) remains suboptimal worldwide. The Collaborative Quality ImProvement (C-QIP) trial aims to develop and test the feasibility and clinical effect of a multicomponent strategy among patients with prevalent CVD in India., Methods: The C-QIP is a clinic-based, open randomized trial of a multicomponent intervention vs usual care that was locally developed and adapted for use in Indian settings through rigorous formative research guided by Consolidated Framework for Implementation Research (CFIR). The C-QIP intervention consisted of 5 components: 1) electronic health records and decision support system for clinicians, 2) trained nonphysician health workers (NPHW), 3) text-message based lifestyle reminders, 4) patient education materials, 5) quarterly audit and feedback reports. Patients with CVD (ischemic heart disease, ischemic stroke, or heart failure) attending outpatient CVD clinics were recruited from September 2022 to September 2023 and were randomized to the intervention or usual care arm for at least 12 months follow-up. The co-primary outcomes are implementation feasibility, fidelity (ie, dose delivered and dose received), acceptability, adoption and appropriateness, measured at multiple levels: patient, provider and clinic site-level, The secondary outcomes include prescription of guideline directed medical therapy (GDMT) (provider-level), and adherence to prescribed therapy, change in mean blood pressure (BP) and LDL-cholesterol between the intervention and control groups (patient-level). In addition, a trial-based process and economic evaluations will be performed using standard guidelines., Results: We recruited 410 socio-demographically diverse patients with CVD from 4 hospitals in India. Mean (SD) age was 57.5 (11.7) years, and 73.0% were males. Self-reported history of hypertension (48.5%) and diabetes (41.5%) was common. At baseline, mean (SD) BP was 127.9 (18.2) /76.2 (11.6) mm Hg, mean (SD) LDLc: 80.3 (37.3) mg/dl and mean (SD) HbA1c: 6.8% (1.6%). At baseline, the GDMT varied from 62.4% for patients with ischemic heart disease, 48.6% for ischemic stroke and 36.1% for heart failure., Conclusion: This study will establish the feasibility of delivering contextually relevant, and evidence-based C-QIP strategy and assess whether it is acceptable to the target populations. The study results will inform a larger scale confirmatory trial of a comprehensive CVD care model in low-resource settings., Trial Registration: Clinical Trials Registry India: CTRI/2022/04/041847; Clinicaltrials.gov number: NCT05196659., Competing Interests: Declaration of competimng interest MDH has received travel support from the American Heart Association and World Heart Federation and consulting fees from PwC Switzerland. MDH has an appointment at The George Institute for Global Health, which has a patent, license, and has received investment funding with intent to commercialize fixed-dose combination therapy through its social enterprise business, George Medicines. MDH has pending patents for heart failure polypills., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Globally, cardiovascular disease (CVD) remains the leading cause of mortality and disability, with hypertension being the single most important modifiable risk factor. Hypertension is responsible for about 18% of global deaths from CVD, of which African regions are disproportionately affected, especially sub-Saharan Africa. This study assessed the burden of major CVD subtypes attributable to hypertension in Nigeria., Methods: The population attributable fractions (PAF) for myocardial infarction, all strokes, ischaemic stroke and intracerebral haemorrhagic stroke attributable to hypertension in Nigeria were calculated using published results from the INTERHEART and INTERSTROKE studies and prevalence estimates of hypertension in Nigeria. PAF estimates were obtained for age, sex, and geopolitical zones., Results: Overall, hypertension contributed to 13.2% of all myocardial infarctions and 24.6% of all strokes, including 21.6% of all ischaemic strokes and 33.1% of all intracerebral haemorrhagic strokes. Among men aged ≤55 years, the PAF for myocardial infarction ranged from 11.7% (North-West) to 14.6% (South-East), while in older men, it spanned 9.2% (North-West) to 11.9% (South-East). Among women aged ≤65 years, PAF varied from 18.6% (South-South) to 20.8% (South-East and North-Central), and among women aged >65 years, it ranged from 10.4% (South-South) to 12.7% (South-East)., Conclusion: Hypertension is a key contributor to the burden of CVD in Nigeria. Understanding the burden of hypertension in the Nigerian population overall and key subgroups is crucial to developing and implementing contextualised health policies to reduce the burden of CVD. Public health interventions and policies centred on hypertension will play a critical role in potentially alleviating the burden of cardiovascular diseases (CVD) in Nigeria., Competing Interests: The authors have no competing interests to declare., (Copyright: © 2024 The Author(s).)

New approaches are needed to lower blood pressure (BP) given persistently low control rates. QUARTET USA sought to evaluate the effect of four-drug, quarter-dose BP lowering combination in patients with hypertension. QUARTET USA was a randomized (1:1), double-blinded trial conducted in federally qualified health centers among adults with hypertension. Participants received either a quadpill of candesartan 2 mg, amlodipine 1.25 mg, indapamide 0.625 mg, and bisoprolol 2.5 mg or candesartan 8 mg for 12 weeks. If BP was >130/>80 mm Hg at 6 weeks in either arm, then participants received open label add-on amlodipine 5 mg. The primary outcome was mean change in systolic blood pressure (SBP) at 12 weeks, controlling for baseline BP. Secondary outcomes included mean change in diastolic blood pressure (DBP), and safety included serious adverse events, relevant adverse drug effects, and electrolyte abnormalities. Among 62 participants randomized between August 2019-May 2022 (n = 32 intervention, n = 30 control), mean (SD) age was 52 (11.5) years, 45% were female, 73% identified as Hispanic, and 18% identified as Black. Baseline mean (SD) SBP was 138.1 (11.2) mmHg, and baseline mean (SD) DBP was 84.3 (10.5) mmHg. In a modified intention-to-treat analysis, there was no significant difference in SBP (-4.8 mm Hg [95% CI: -10.8, 1.3, p = 0.123] and a -4.9 mmHg (95% CI: -8.6, -1.3, p = 0.009) greater mean DBP change in the intervention arm compared with the control arm at 12 weeks. Adverse events did not differ significantly between arms. The quadpill had a similar SBP and greater DBP lowering effect compared with candesartan 8 mg. Trial registration number: NCT03640312., (© 2024. The Author(s).)

Background: Cardiovascular disease (CVD) continues to impart a large burden on the global population, especially in lower income countries where affordability limits the use of cardiovascular medicines. A fixed dose combination strategy of at least 2 blood pressure lowering medications and a statin with aspirin in a single pill has been shown to reduce the risk of incident CVD by 38% in primary prevention in a recent meta-analysis. We report the in-trial (median follow-up: 5 years) cost-effectiveness of a fixed dose combination (FDC) pill in different income groups based on data from that meta-analysis., Methods: Countries were categorized using World Bank economic groups: Lower Middle Income Countries (LMIC), Upper Middle Income Countries (UMIC) and High Income Countries (HIC). Country specific costs were obtained for hospitalized events, procedures, and non-study medications (2020 USD). FDC price was based on the cheapest equivalent substitute (CES) for each component., Findings: For the CES-FDC pill versus control the difference in cost was $346 (95% CI: $294-$398) per participant in Lower Middle Income Countries, $838 (95% CI: $781-$895) in Upper Middle Income Countries and $42 (95% CI: -$155 to $239) (cost-neutral) in High Income Countries. During the study period the CES-FDC pill was associated with incremental gain in quality-adjusted life years of 0.06 (95% CI: 0.04-0.08) resulting in an incremental cost-effectiveness ratio (ICER) of $5767 (95% CI: 5735-$5799), $13,937 (95% CI: $13,893-$14,041) and $700 (95% CI: $662-$738) respectively. In subgroups analyses, the highest 10 years CVD risk subgroup had ICERs of $2033, $7322 and -$6000/QALY., Interpretation: A FDC pill produced at CES costs is cost-neutral in HIC. Governments of LMI and UMI countries should assess these results based on the ICER threshold accepted in their own country and own specific health care priorities but should consider prioritizing this strategy for patients with high 10 years CVD risk as a first step., Funding: Population Health Research Institute., Competing Interests: AL, WT, PJ, PG, RM, GR, PL-J, PP, AA, AD and HG have no conflicts to declare. MDH reports Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events outside the submitted work from PwC Switzerland. Support for attending meetings and/or travel outside the submitted work from the World Heart Federation. MDH has an appointment at The George Institute for Global Health, which has a patent, license, and has received investment funding with intent to commercialize fixed-dose combination therapy through its social enterprise business, George Medicines and has patents pending for Heart Failure polypills. DX reports grants from Population Health Research Institute, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Coca-Cola India, the Indian Council of Medical Research, Pfizer, UK Medical Research Council, and Wellcome Trust outside the submitted work. Speaker's fees from Eli Lilly, Sanofi and Intas outside the submitted work. Support for attending meetings and/or travel outside the submitted work from the Indian Council of Medical Research, Eli Lilly, Sanofi, BIRAC and DBC. DX is an honorary VP with SOCHARA and honorary executive committee member of ISCR. SY reports grants from AstraZeneca, and Cadila Pharmaceuticals related to conducting the HOPE-3 or TIPS-3 studies and Honoraria for lectures on the Prevention of Cardiovascular Disease from diverse sources., (© 2024 The Author(s).)

Background: Hypertension control is suboptimal globally. Implementing evidence-based, simple, standardized treatment protocols (STPs) has been instrumental in effectively and efficiently improving treatment and control of hypertension. We aimed to identify, characterize, and critically appraise hypertension STPs., Methods: We defined STP as a series of steps for the pharmacological treatment of primary hypertension, with information on target population, BP threshold for treatment initiation, target BP, specific drugs/classes/doses, and follow-up frequency. STPs for adult patients were identified from the websites of relevant health organizations, Google search, and through expert consultations (until July 2023). STPs for secondary, gestational, or malignant hypertension or those that were templates/samples were excluded. Included STPs were critically appraised using HEARTS in the Americas Checklist for hypertension management in primary care and compared with the 2021 WHO hypertension management guideline recommendations., Results: Fifty STPs were identified. All STPs had a stepwise treatment approach, involved guideline-recommended first-line drugs, and 98% consisted of at least four steps. Majority (54%) recommended monotherapy with calcium channel blockers as first-line treatment. Only 44% STPs recommended treatment initiation with combination therapy, and 16% recommended single-pill combinations. Most (62%) had dose-intensification as the second step. Most (74%) STPs did not provide complete dosing information. Only one STP mentioned a target time for achieving BP control. On average, STPs scored a performance of 68% on the HEARTS Checklist., Conclusion: Several STPs are available globally; however, most of them have enormous scope for improvement through interventions aimed at alignment with the latest evidence-based guidelines and multistakeholder engagement., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Introduction: Blinding participants to randomization is a cornerstone of science. However, participant beliefs about their allocation can influence outcomes. We examined blind integrity, the association between trial arm belief and cessation, and potential mechanisms linking treatment arm and treatment arm belief among people with major depressive disorder (MDD) who smoke receiving varenicline in a placebo-controlled trial., Aims and Methods: 175 participants were asked at the end of treatment (EOT) if they thought they received placebo, varenicline, or were not sure. We assessed the relationship between treatment arm belief and actual treatment allocation, examined the association between treatment arm belief and EOT cessation, and evaluated changes in craving, withdrawal, side effects, depression symptoms, and smoking reward as mediators through which treatment arm was believed., Results: Treatment arm belief was significantly associated with actual arm assignment (χ2(2) = 13.0, p = .002). Participants in the varenicline arm were >3 times as likely to believe they were taking varenicline, versus "not sure" (RR = 3.05 [1.41-6.60], p = .005). Participants in the placebo arm were just as likely to believe they were taking placebo versus "not sure" (χ2[2] = 0.75, p = .69). Controlling for treatment arm, belief that one received varenicline was significantly associated with an increase in cessation rate (OR = 5.91 [2.06-16.92], p = .001). Change in the rewarding experience of smoking may mediate participant ability to discern getting varenicline (B = 0.077 [0.002-0.192], p < .05)., Conclusions: Participants receiving varenicline can discern that they received varenicline and this belief is associated with higher cessation rates. Research is needed to continue to examine how participants correctly identify their allocation to varenicline., Trial Registration: Data come from the trial NCT02378714., Implications: The present study adds to the sparse literature on blind integrity, particularly in the field of tobacco cessation. Randomized clinical trial participants can discern their assignment to varenicline, and believing that one received varenicline was associated with significantly higher cessation rates. Identifying treatment arm allocation may be associated with changes in the rewarding aspects of smoking that have been well documented with varenicline use. Masking allocation to varenicline is challenging. The effects of this medication in clinical trials may represent both pharmacological effects and participants' abilities to recognize that they are receiving the medication., (© The Author(s) 2023. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Introduction: Nigeria is committed to reducing industrial trans- fatty acids (iTFA) from the food supply, but the potential health gains, costs and cost-effectiveness are unknown., Methods: The effect on ischaemic heart disease (IHD) burden, costs and cost-effectiveness of a mandatory iTFA limit (≤2% of all fats) for foods in Nigeria were estimated using Markov cohort models. Data on demographics, IHD epidemiology and trans- fatty acid intake were derived from the 2019 Global Burden of Disease Study. Avoided IHD events and deaths; health-adjusted life years (HALYs) gained; and healthcare, policy implementation and net costs were estimated over 10 years and the population's lifetime. Incremental cost-effectiveness ratios using net costs and HALYs gained (both discounted at 3%) were used to assess cost-effectiveness., Results: Over the first 10 years, a mandatory iTFA limit (assumed to eliminate iTFA intake) was estimated to prevent 9996 (95% uncertainty interval: 8870 to 11 118) IHD deaths and 66 569 (58 862 to 74 083) IHD events, and to save US$90 million (78 to 102) in healthcare costs. The corresponding lifetime estimates were 259 934 (228 736 to 290 191), 479 308 (95% UI 420 472 to 538 177) and 518 (450 to 587). Policy implementation costs were estimated at US$17 million (11 to 23) over the first 10 years, and US$26 million USD (19 to 33) over the population's lifetime. The intervention was estimated to be cost-saving, and findings were robust across several deterministic sensitivity analyses., Conclusion: Our findings support mandating a limit of iTFAs as a cost-saving strategy to reduce the IHD burden in Nigeria., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form and declare the following: MM report grant support from Resolve to Save Lives and the World Health Organization; and travel support from the Nordic Dairy Congress 2022; all outside of the present work. MDH has received travel support from the American Heart Association and World Heart Federation. MDH has an appointment at The George Institute for Global Health, which has a patent, license and has received investment funding with intent to commercialise fixed-dose combination therapy through its social enterprise business, George Medicines. MDH has pending patents for heart failure polypills., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Significance: Little is known about the mechanisms by which medication adherence promotes smoking cessation among adults with MDD. We tested the hypothesis that early adherence promotes abstinence by increasing behavioral treatment (BT) utilization., Methods: Data for this post-hoc analysis were from a randomized trial of 149 adults with current or past MDD treated with BT and either varenicline (n = 81) or placebo (n = 68). Arms were matched on medication regimen. Early medication adherence was measured by the number of days in which medication was taken at the prescribed dose during the first six of 12 weeks of pharmacological treatment (weeks 2-7). BT consisted of eight 45-minute sessions (weeks 1-12). Bioverified abstinence was assessed at end-of-treatment (week 14). A regression-based approach was used to test whether the effect of early medication adherence on abstinence was mediated by BT utilization., Results: Among 141 participants who initiated the medication regimen, BT utilization mediated the effect of early medication adherence on abstinencea) an interquartile increase in early medication days from 20 to 42 predicted a 4.2 times increase in abstinence (Total Risk Ratio (RR) = 4.24, 95% CI = 2.32-13.37; p <.001); b) increases in BT sessions predicted by such an increase in early medication days were associated with a 2.7 times increase in abstinence (Indirect RR = 2.73, 95% CI = 1.54-7.58; p <.001); and c) early medication adherence effects on abstinence were attenuated, controlling for BT (Direct RR = 1.55, 95% CI = 0.83-4.23, p =.17)., Conclusions: The effect of early medication adherence on abstinence in individuals with current or past MDD is mediated by intensive BT utilization., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Brian Hitsman, PhD, has served on scientific advisory boards for Pfizer and received medication and placebo free of charge from Pfizer for the parent study (NCT02378714). Robert A. Schnoll, PhD, has received varenicline and placebo free of charge from Pfizer for National Institutes of Health-funded trials and has served as a consultant for Pfizer, GlaxoSmithKline, and PalliaTech. David C. Mohr, PhD, has accepted honoraria and consulting fees from Otsuka Pharmaceuticals, Optum Behavioral Health, Centerstone Research Institute, and the One Mind Foundation; royalties from Oxford Press, and has an ownership interest in Adaptive Health, Inc. Mark D. Huffman, MD, MPH, has patents for combination therapy for the treatment of heart failure. The George Institute for Global Health has a patent, license, and has received investment funding with the intent to commercialize fixed-dose combination therapy through its social enterprise business, George Medicines. Jacqueline K. Gollan has accepted royalties from the American Psychological Association., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Fixed-dose combination (FDC) therapy, also known as polypill therapy, targets risk factors for atherosclerotic cardiovascular disease (ASCVD) and has been proposed as a strategy to reduce global ASCVD burden. Here we conducted a systematic search for relevant studies from 2016-2022 to assess the effects of FDC therapy for prevention of ASCVD. The studies selected include randomized trials evaluating FDC therapy with at least one blood pressure-lowering drug and one lipid-lowering drug. The study data were independently extracted, the quality of evidence was appraised by multiple reviewers and effect estimates were pooled using a fixed-effect meta-analysis when statistical heterogeneity was low to moderate. The main outcomes of the analysis were all-cause mortality, fatal and nonfatal ASCVD events, adverse events, systolic blood pressure, low-density lipoprotein cholesterol and adherence. Among 26 trials (n = 27,317 participants, 43.2% female and mean age range 52.9-76.0), FDC therapy was associated with lower low-density lipoprotein cholesterol and systolic blood pressure, with higher rates of adherence and adverse events in both primary and mixed secondary prevention populations. For studies with a mostly primary prevention population, FDC therapy was associated with lower risk of all-cause mortality by 11% (5.6% versus 6.3%; relative risk (risk ratio) of 0.89; 95% confidence interval 0.78 to 1.00; I 2  = 0%; four trials and 16,278 participants) and risk of fatal and nonfatal ASCVD events by 29% (6.1% versus 8.4%; relative risk (risk ratio) of 0.71; 95% confidence interval 0.63 to 0.79; I 2  = 0%; five trials and 15,503 participants). One adequately powered trial in an exclusively secondary prevention population showed that FDC therapy reduced the risk of major adverse cardiovascular events by 24%. These findings support adoption and implementation of polypills to lower risk for all-cause mortality and ASCVD., (© 2024. The Author(s), under exclusive licence to Springer Nature America, Inc.)

Background: Regular engagement over time in hypertension care, or retention, is a crucial but understudied step in optimizing patient outcomes. This systematic review leverages a hermeneutic methodology to identify, evaluate, and quantify the effects of interventions and contextual factors for improving retention for patients with hypertension., Methods: We searched for articles that were published between 2000 and 2022 from multiple electronic databases, including MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, clinicaltrials.gov, and WHO International Trials Registry. We followed the latest version of the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guideline to report the findings for this review. We also synthesized the findings using a hermeneutic methodology for systematic reviews, which used an iterative process to review, integrate, analyze, and interpret evidence., Results: From 4686 screened titles and abstracts, 18 unique studies from 9 countries were identified, including 10 (56%) randomized controlled trials (RCTs), 3 (17%) cluster RCTs, and 5 (28%) non-RCT studies. The number of participants ranged from 76 to 1562. The overall mean age range was 41-67 years, and the proportion of female participants ranged from 0% to 100%. Most (n = 17, 94%) studies used non-physician personnel to implement the proposed interventions. Fourteen studies (78%) implemented multilevel combinations of interventions. Education and training, team-based care, consultation, and Short Message Service reminders were the most common interventions tested., Conclusions: This review presents the most comprehensive findings on retention in hypertension care to date and fills the gaps in the literature, including the effectiveness of interventions, their components, and contextual factors. Adaptation of and implementing HIV care models, such differentiated service delivery, may be more effective and merit further study., Registration: CRD42021291368., Protocol Registration: PROSPERO 2021 CRD42021291368. Available at: https://www.crd.york.ac.uk/prospero/display&#95;record.php?RecordID=291368., Competing Interests: Declaration of competing interest MDH has planned patents for combination therapy for the treatment of heart failure. The George Institute for Global Health has a patent, license, and has received investment funding with intent to commercialize fixed-dose combination therapy through its social enterprise business, George Medicines. TLW receives research funding from Gilead Sciences. The other authors do not report any disclosures., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

This commentary describes the potential impact of inclusion of polypills for prevention of cardiovascular disease in the 23rd WHO Model List of Essential Medicines, and provides a roadmap for adoption, implementation, sustainment, and scale-up. The World Health Organization's endorsement of polypills is essential for improving global access, particularly in low- and middle-income countries. The greatest health gains are expected in a primary prevention population which has a significantly higher burden of fatal and non-fatal cardiovascular disease compared with the population of individuals with prevalent cardiovascular disease. A focus on adoption, implementation, sustainment, and scale-up of polypills for prevention of cardiovascular disease is needed including increasing supply of available polypills and incorporating polypills into the World Health Organization HEARTS technical package for integration into primary care systems to realize these benefits for population health. Widespread implementation of polypills for prevention of cardiovascular disease has the potential to equitably reduce the impact of cardiovascular disease globally by simplifying treatment options and expanding accessibility across economic levels, both across and within countries., Competing Interests: MDH has received travel support from the American Heart Association and World Heart Federation and consulting fees from PwC Switzerland. MDH has an appointment at The George Institute for Global Health, which has a patent, license, and has received investment funding with intent to commercialize fixed-dose combination therapy through its social enterprise business, George Medicines. MDH and AA have pending patents for heart failure polypills., (Copyright: © 2024 The Author(s).)

Background: The HEARTS technical package was developed by the World Health Organization to address the implementation gap in cardiovascular disease prevention in low- and middle-income countries. Guatemala is a middle-income country that is currently implementing HEARTS. National authorities in Guatemala are interested in exploring how hypertension and diabetes management can be integrated in HEARTS implementation. The objective of this study is to conduct a feasibility and acceptability pilot trial of integrated hypertension and diabetes management based on HEARTS in the publicly funded primary care system in Guatemala., Methods: A single-arm pilot trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in September 2023. A planned sample of 100 adult patients diagnosed with diabetes (n = 45), hypertension (n = 45), or both (n = 10) will be enrolled. The intervention will consist of HEARTS-aligned components: Training health workers on healthy-lifestyle counseling and evidence-based treatment protocols, strengthening access to medications and diagnostics, training on risk-based cardiovascular disease management, team-based care and task sharing, and systems monitoring and feedback, including implementation of a facility-based electronic monitoring tool at the individual level. Co-primary outcomes of feasibility and acceptability will be assessed using an explanatory sequential mixed-methods design. Secondary outcomes include clinical effectiveness (treatment with medication, glycemic control, and blood pressure control), key implementation outcomes (adoption, fidelity, usability, and sustainability), and patient-reported outcome measures (diabetes distress, disability, and treatment burden). Using an implementation mapping approach, a Technical Advisory Committee will develop implementation strategies for subsequent scale-up planning., Discussion: This trial will produce evidence on implementing HEARTS-aligned hypertension and diabetes care in the MOH primary care system in Guatemala. Results also will inform future HEARTS projects in Guatemala and other low- and middle-income countries., Trial Registration: ClinicalTrials.gov ID NCT06080451. The trial was prospectively registered on October 12, 2023., (© 2024. The Author(s).)

Background: This convergent parallel-design mixed-methods process evaluation of the QUARTET USA (Quadruple Ultra-Low-Dose Treatment for Hypertension USA) clinical trial (NCT03640312) explores patient and health care professional perceptions about the use of low-dose quadruple therapy (LDQT) as a novel strategy for hypertension management., Methods and Results: A survey of all 62 patients enrolled in the QUARTET USA trial was conducted. A subsample of 13 patients and 11 health care professionals, recruited via purposive sampling, took part in semistructured interviews. At enrollment, 68% of participants (mean [SD] age, 51.7 [11.5] years; 56% self-identified as Hispanic: Mexican ethnicity, 16% as Hispanic: other ethnicity, 16% as Black race, 8% as White race, and 1.6% as South Asian race) reported that their current health depended on blood pressure medications, and 48% were concerned about blood pressure medications. At trial completion, 80% were satisfied with LDQT, 96% were certain the benefits of taking LDQT outweighed the disadvantages, and 96% reported that LDQT was convenient to take. Both patients and health care professionals found LDQT acceptable because it reduced patients' perceived pill burden and facilitated medication adherence. Health care professionals stated that a perceived limitation of LDQT was the inability to titrate doses. Steps to facilitate LDQT implementation include introducing stepped-care combinations and treatment protocols, inclusion in clinical practice guidelines, and eliminating patient cost barriers., Conclusions: LDQT was an acceptable strategy for hypertension treatment among patients and health care professionals involved in the QUARTET USA clinical trial. Although LDQT was generally perceived as beneficial for maintaining patients' blood pressure control and facilitating adherence, some clinicians perceived limitations in titration inflexibility, adverse effects, and costs., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03640312.

Background: The Extension for Community Health Outcomes (ECHO) model has been used extensively to link care providers in rural communities with experts with the aim of improving local patient care., Objective: The aim of this qualitative research study was to assess the feasibility, acceptability, perceived needs, and contextual factors to guide implementation of a hypertension focused ECHO program for Community Health Extension Workers (CHEWs) in the Federal Capital Territory, Nigeria., Methods: From September 2020 to December 2020, key informant interviews were performed with seven global organizations (hubs) providing ECHO training focused on cardiovascular disease or nephrology to identify contextual factors and implementation strategies used by each hub. In February 2022, seven focus group discussions were performed with 42 frontline healthcare workers in the Federal Capital Territory to inform local adaptation of a hypertension ECHO program. Directed content analysis identified major themes which were mapped to the Consolidated Framework for Implementation Research. Qualitative analyses were performed using Dedoose, and results were synthesized using the Implementation Research Logic Model., Results: We found both barriers and facilitators across the Consolidated Framework for Implementation Research domains that mapped to a number of constructs in each one. The results of these analyses confirmed that the core components of the ECHO model are a feasible and appropriate intervention for hypertension education of healthcare workers. However, implementing the ECHO program within the Federal Capital Territory may require strategies such as utilizing communications resources effectively, developing incentives to motivate initial participation, and providing rewards or recognition for ongoing engagement., Conclusions: These results provide valuable formative insights to guide implementation of our proposed hypertension ECHO program for CHEWs in the Federal Capital Territory, Nigeria. This information was used for key decisions around: 1) scope and content of training, 2) format and frequency, 3) selection of implementation strategies, and 4) building a community of practice., Competing Interests: MDH has received travel support from the American Heart Association and World Heart Federation. MDH has an appointment at The George Institute for Global Health, which has a patent license and has received investment funding with intent to commercialize fixed-dose combination therapy through its social enterprise business, George Medicines. MDH has pending patents for heart failure polypills., (Copyright: © 2023 The Author(s).)

Competing Interests: MDH has received travel support from the American Heart Association and World Heart Federation and holds an appointment at The George Institute for Global Health, which has a patent, license, and has received investment funding with intent to commercialise, fixed-dose combination therapy through its social enterprise business, George Medicines. MDH has pending patents for heart failure polypills. DBO declares no competing interests.

Background: Food product labelling can support consumer decision-making. Several food product labels (nutrition information panels (NIPs), ingredients lists, allergen declarations and country-of-origin) are mandated for physical product packaging in Australia, with a voluntary front-of-pack nutrition labelling system, Health Star Ratings (HSRs), also available. However, labelling requirements are not explicitly extended to online settings and the extent to which this information is available in these increasingly important food environments has not been assessed., Methods: Data from all individual food product pages was collected from the online stores of the two dominant supermarket retailers in Australia using automated web scraping in April-May 2022 (n = 22,077 products collected). We assessed the proportion of pages displaying NIPs, ingredients, allergens, country-of-origin and HSRs after excluding products ineligible to display the respective label. We also assessed whether HSRs were differentially available for higher- (healthier) and lower-scoring (less healthy) products, with HSR scores drawn from a comprehensive Australian food composition database, FoodSwitch. A manual inspection of randomly selected product pages (n = 100 for each label type per supermarket), drawn from products displaying the relevant label, was conducted to assess whether the labels were immediately visible to users (i.e. without scrolling or clicking). Differences in labelling prevalence and visibility were compared using chi-squared tests., Results: Across both supermarkets, country-of-origin labelling was almost complete (displayed on 93% of food product pages), but NIPs (49%), ingredients (34%) and allergens (53%) were less frequently displayed. HSRs were infrequently displayed (14% across both supermarkets) and more likely to be applied to higher-scoring products (22% on products with ≥ 3.5HSR v 0.4% on products with < 3.5HSR, p < 0.001). One supermarket was far more likely to make NIPs (100% v 2%, p < 0.001), ingredients (100% v 19%, p < 0.001) and allergens (97% v 0%, p < 0.001) information immediately visible, though the other made HSRs more apparent (22% v 75%, p < 0.001). Both supermarkets displayed country-of-origin labels prominently (100% v 86%, p < 0.001)., Conclusions: Food product labelling varies in online supermarkets in Australia overall and between supermarkets, while the design of online stores resulted in differences in labelling visibility. The near-complete display of country-of-origin labels and differential application of HSRs to higher-scoring products may reflect their use as marketing tools. Our findings highlight an urgent need for food labelling regulations to be updated to better account for online retail food environments., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Background: Nigeria has one of the highest burdens of maternal deaths globally, and hypertensive disorders of pregnancy (HDP) are the leading cause of maternal morbidity and mortality in the country. There is a significant implementation gap in utilizing evidence-based practices for the management of HDP in Nigeria. This study evaluated facilitators and barriers to implementing a home blood pressure monitoring program to improve management of HDP., Methods: From August 2022 to September 2022, we conducted 15 semi-structured, key informant interviews and 4 focus group discussions among patients, health care workers, and administrators at University of Abuja Teaching Hospital (UATH), a tertiary care centre in Nigeria. The study used the Consolidated Framework for Implementation Research to assess five domains: individual characteristics, inner and outer settings, intervention characteristics, and process of implementation. Audio files were transcribed, and data were analysed using a combination of inductive and deductive approaches. We also conducted 32 brief surveys on the participants to assess acceptability, appropriateness, and feasibility of a blood pressure monitoring program., Results: The study sample consisted of healthcare workers (n=22) including specialists in cardiology, obstetrics and gynaecology, maternal-foetal medicine, nurses/midwives and resident doctors as well as patients (n=10). Mean (SD) age was 39.5 (10.9), and 78% were female. Participants identified facilitators including the perceived simplicity of home blood pressure monitoring program, high burden of HDP, and availability of a multi-disciplinary team of healthcare professionals with expertise in HDP management. Barriers identified were cost, limited knowledge of HDP amongst patients, limited transportation networks, inconsistent management protocols, and inadequate manpower and facilities. Survey results indicated that between 81% and 88% of participants reported that a blood pressure monitoring program would be acceptable, 56%-72% reported that it would be appropriate, and 47%-69% reported that it would be feasible., Conclusion: This study identified facilitators and barriers while highlighting key implementation strategies to leverage and effectively address these respectively to enable successful implementation of a home blood pressure monitoring program. It also demonstrated that a home blood pressure monitoring program was considered acceptable, appropriate and feasible among respondents interviewed at UATH., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Background and Aims: Treatment of depression-related psychological factors related to smoking behavior may improve rates of cessation among adults with major depressive disorder (MDD). This study measured the efficacy and safety of 12 weeks of behavioral activation for smoking cessation (BASC), varenicline and their combination., Design, Setting, Participants: This study used a randomized, placebo-controlled, 2 × 2 factorial design comparing BASC versus standard behavioral treatment (ST) and varenicline versus placebo, taking place in research clinics at two urban universities in the United States. Participants comprised 300 hundred adult smokers with current or past MDD., Interventions: BASC integrated behavioral activation therapy and ST to increase engagement in rewarding activities by reducing avoidance, withdrawal and inactivity associated with depression. ST was based on the 2008 PHS Clinical Practice Guideline. Both treatments consisted of eight 45-min sessions delivered between weeks 1 and 12. Varenicline and placebo were administered for 12 weeks between weeks 2 and 14., Measurements: Primary outcomes were bioverified intent-to-treat (ITT) 7-day point-prevalence abstinence at 27 weeks and adverse events (AEs)., Findings: No significant interaction was detected between behavioral treatment and pharmacotherapy at 27 weeks (χ 2 (1)  = 0.19, P = 0.67). BASC and ST did not differ (χ 2 (1)  = 0.43, P = 0.51). Significant differences in ITT abstinence rates (χ 2 (1)  = 4.84, P = 0.03) emerged among pharmacotherapy arms (16.2% for varenicline, 7.5% for placebo), with results favoring varenicline over placebo (rate ratio = 2.16, 95% confidence interval = 1.08, 4.30). All significant differences in AE rates after start of medication were higher for placebo than varenicline., Conclusion: A randomized trial in smokers with major depressive disorder found that varenicline improved smoking abstinence versus placebo at 27 weeks without elevating rates of adverse events. Behavioral activation for smoking cessation did not outperform standard behavioral treatment, with or without adjunctive varenicline therapy., (© 2023 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.)

Importance: Aspirin is an effective and low-cost option for reducing atherosclerotic cardiovascular disease (CVD) events and improving mortality rates among individuals with established CVD. To guide efforts to mitigate the global CVD burden, there is a need to understand current levels of aspirin use for secondary prevention of CVD., Objective: To report and evaluate aspirin use for secondary prevention of CVD across low-, middle-, and high-income countries., Design, Setting, and Participants: Cross-sectional analysis using pooled, individual participant data from nationally representative health surveys conducted between 2013 and 2020 in 51 low-, middle-, and high-income countries. Included surveys contained data on self-reported history of CVD and aspirin use. The sample of participants included nonpregnant adults aged 40 to 69 years., Exposures: Countries' per capita income levels and world region; individuals' socioeconomic demographics., Main Outcomes and Measures: Self-reported use of aspirin for secondary prevention of CVD., Results: The overall pooled sample included 124 505 individuals. The median age was 52 (IQR, 45-59) years, and 50.5% (95% CI, 49.9%-51.1%) were women. A total of 10 589 individuals had a self-reported history of CVD (8.1% [95% CI, 7.6%-8.6%]). Among individuals with a history of CVD, aspirin use for secondary prevention in the overall pooled sample was 40.3% (95% CI, 37.6%-43.0%). By income group, estimates were 16.6% (95% CI, 12.4%-21.9%) in low-income countries, 24.5% (95% CI, 20.8%-28.6%) in lower-middle-income countries, 51.1% (95% CI, 48.2%-54.0%) in upper-middle-income countries, and 65.0% (95% CI, 59.1%-70.4%) in high-income countries., Conclusion and Relevance: Worldwide, aspirin is underused in secondary prevention, particularly in low-income countries. National health policies and health systems must develop, implement, and evaluate strategies to promote aspirin therapy.

Introduction: Individuals with major depressive disorder (MDD) exhibit high rates of tobacco use and lower responsiveness to tobacco cessation treatments. Treatment adherence is a strong predictor of treatment outcomes in the general population but has not been evaluated in this under-served community of smokers with MDD., Methods: We used data from a randomized clinical trial on smoking cessation treatment among 300 smokers with MDD to examine the rate of adherence (medication and counseling), the association of adherence with cessation outcomes, and factors associated with adherence, including demographic and smoking characteristics, psychiatric characteristics, smoking cessation processes (e.g., withdrawal, reinforcers), and treatment-related side effects (e.g., nausea)., Results: Overall, 43.7% of participants were adherent with medication and 63.0% were adherent with counseling. Medication adherence was significantly associated with cessation, with 32.1% of adherent vs. 13.0% of non-adherent participants quitting smoking at EOT. Counseling adherence was also significantly associated with cessation, with 32.3% of adherent vs. 2.7% of non-adherent participants quitting smoking. Multivariate regression models showed that medication adherence was associated with higher engagement in complementary reinforcers and higher baseline smoking reward, while counseling adherence was associated with identifying as female, lower alcohol use and nicotine dependence, higher baseline smoking reward, and higher engagement in substitute and complementary reinforcers within the first weeks of medication use., Conclusions: As with the general population of smokers, non-adherence to treatment in smokers experiencing depression is widespread and a significant barrier to cessation. Interventions that target reinforcers may improve rates of treatment adherence., Competing Interests: Declaration of Competing Interest Dr. Schnoll has received varenicline and placebo free from Pfizer and has provided consultation to Pfizer. Dr. Schnoll has provided consultation to GlaxoSmithKline and Palliatech. Dr. Hitsman has received varenicline and placebo free from Pfizer., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Objectives: Team-based care is essential for improving hypertension outcomes in low-resource settings. We assessed perceptions of country representatives and healthcare workers (HCWs) on team-based hypertension care in low/middle-income countries., Design: Two cross-sectional surveys., Setting: The first survey (Country Profile Survey) was conducted in 17 countries and eight in-country regions: Algeria, Bangladesh, Burundi, Chile, China (Beijing, Henan, Shandong), Cuba, Ethiopia, India (Kerala, Madhya Pradesh, Maharashtra, Punjab, Telangana), Nepal, Nigeria, Philippines, Saint Lucia, Sri Lanka, Thailand, Turkey, Uganda and Vietnam. The second survey (HCW Survey) was conducted in four countries: Bangladesh, China, Ethiopia and Nigeria., Participants: Using convenience sampling, participants for the Country Profile Survey were representatives from 17 countries and eight in-country regions, and the HCW Survey was administered to HCWs in Bangladesh, China, Ethiopia and Nigeria., Outcome Measures: Country-level use of team-based hypertension care framework, comprising administrative, basic and advanced clinical tasks. Current practices of different HCW cadres, perspectives on team-based management of hypertension, barriers and facilitators., Results: In the Country Profile Survey, all (23/23, 100%) countries/regions surveyed integrated team-based care for basic clinical hypertension management tasks, less for advanced tasks (7/23, 30%). In the HCW Survey, 854 HCWs participated, 47% of whom worked in rural settings. Most HCWs in the sample acknowledged the value of team-based hypertension care. Although there were slight variations by country in the study sample, overall, barriers to team-based hypertension care were identified as inadequate training (83%); regulatory issues (76%); resistance by patients (56%), physicians (42%) and nurses (40%). Facilitators identified were use of treatment algorithms (94%), telehealth/m-health technology (92%) and adequate compensation for HCWs (80%)., Conclusions: Our findings revealed key lessons for health systems and governments regarding team-based care implementation. Specifically, policies to facilitate additional training, optimise HCWs' roles within care teams, use of hypertension treatment protocols and telehealth/m-health technology will be essential to promote team-based care., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Elevated depressive symptoms and cigarette smoking are independently associated with poorer cardiovascular health (CVH), but it is unknown whether their treatment can synergistically improve CVH. We sought to characterize CVH of adults with comorbid depression and smoking and examine changes in CVH associated with changes in smoking and depression., Methods: Participants (N = 300, 55 % women) were adult smokers (≥ 1 cigarette/day) with lifetime major depressive disorder enrolled in a 12-week intervention trial targeting depression and smoking. Multiple linear regression examined prospective associations between changes in depression (Beck Depression Inventory-II), smoking (past 24-hour cigarettes or smoking abstinence), and modified CVH score (per American Heart Association, excluding smoking: diet, physical activity, body mass index, blood glucose, cholesterol, blood pressure)., Results: Baseline mean CVH score was 5.87/12 points (SD = 2.13). No participants met "ideal" on all CVH components (blood glucose: 48 %, cholesterol: 46 %, physical activity: 38 %, body mass index: 24 %, blood pressure: 22 %, diet: 3 %). CVH scores did not change from baseline to end-of-treatment (M = 0.18 points, SD = 1.36, p = .177), nor did change in depression × smoking predict change in CVH (p = .978). However, greater reductions in depression were significantly associated with greater improvements in CVH (β = -0.04, SE = 0.01, p = .015)., Limitations: This study was limited by a short follow-up period, missing blood glucose and cholesterol data, and treatment-seeking smokers., Conclusions: Adults with comorbid depression and smoking had poor CVH. Although integrated treatment for depression and smoking improved both conditions, only reductions in depression were associated with improvements in CVH. These findings have implications for integrating psychosocial treatment into CVH promotion efforts., Registration: NCT02378714 (clinicaltrials.gov)., Competing Interests: Declaration of competing interest Drs. Schnoll and Hitsman have received varenicline and placebo free from Pfizer. Dr. Schnoll has provided consultation to Pfizer, GlaxoSmithKline, and Palliatech. In the last 3 years, Dr. Huffman has received support from the World Heart Federation through unrestricted education grants from Boehringer Ingelheim, Novartis, and Bupa and from the American Heart Association, Verily, and AstraZeneca for work unrelated to this research. Dr. Huffman has also received salary support from the American Medical Association for his role as an associate editor for JAMA Cardiology. Dr. Huffman has planned patents for combination therapy for the treatment of heart failure. The George Institute for Global Health has a patent, license, and has received investment funding with intent to commercialize fixed-dose combination therapy through its social enterprise business, George Medicines., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Introduction: Asian American subgroups experience heterogeneity in cardiovascular disease, but differences in hypertension-related cardiovascular disease mortality between Asian American subgroups is not known., Methods: Among 1,194,648 deaths in the United States in 2018-2021 with cardiovascular disease as an underlying cause and hypertension-related diseases as contributing cause, sex-specific age-standardized mortality rates, proportional mortality, and proportional mortality ratios for non-Hispanic Asian and Asian subgroups, Hispanic, and non-Hispanic Black individuals were compared with non-Hispanic White individuals. The analysis was conducted in August 2022., Results: There were 37,746; 95,404; 193,899; and 867,599 hypertension-related cardiovascular disease deaths in non-Hispanic Asian; Hispanic; non-Hispanic Black; and non-Hispanic White groups, respectively. Among non-Hispanic Asian females, mortality rates ranged from 41.6 (95% CI 40.0-43.3) per 100,000 population in Japanese to 52.6 (51.0-54.2) per 100,000 in Filipina individuals. Among non-Hispanic Asian males, mortality rates ranged from 45.8 (43.3-48.2) per 100,000 in Korean to 81.0 (78.5-83.5) per 100,000 in Filipino individuals. Proportional mortality was higher for all Asian American subgroups compared to non-Hispanic White individuals. Proportional mortality ratios ranged from 1.11 (in Korean males, proportional mortality was 10.2% [95% CI 9.7-10.8] of all deaths) to 1.38 (in Filipino males, proportional mortality was 12.7% [12.4-13.1] of all deaths; in Chinese females, proportional mortality was 11.9% [11.6-12.3]; and in Filipina females, proportional mortality was 11.9% [12.3-13.0])., Conclusions: There was up to two-fold variation in hypertension-related cardiovascular disease mortality among Asian American subgroups. All subgroups experienced higher proportional mortality for hypertension-related cardiovascular disease compared with non-Hispanic White individuals., (Copyright © 2023 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.)

Background: The rates of guideline-directed medical therapy (GDMT) prescription for heart failure with reduced ejection fraction (HFrEF) in Asia remain sub-optimal. The primary objective of this study was to examine HFrEF polypill eligibility in the context of measured baseline prescription rates of individual components of GDMT among participants with HFrEF in Asia., Methods: A retrospective analysis of 4,868 patients with HFrEF from the multi-national ASIAN-HF registry was performed, and 3,716 patients were included in the final, complete case analysis. Eligibility for a HFrEF polypill, upon which patients were grouped and characterized, was based on the following: left ventricular systolic dysfunction (LVEF < 40% on baseline echocardiography), systolic blood pressure ≥ 100 mm Hg, heart rate ≥ 50 beats/minute, eGFR ≥ 30 mL/min/1.73 m, and serum potassium ≤ 5.0 mEq/L. Regression analyses were performed to evaluate associations of the baseline sociodemographic factors with HFrEF polypill eligibility., Results: Among 3,716 patients with HFrEF in the ASIAN-HF registry, 70.3% were eligible for a HFrEF polypill. HFrEF polypill eligibility was significantly higher than baseline rates of triple therapy prescription of GDMT across sex, all studied geographical regions, and income levels. Patients were more likely to be eligible for a HFrEF polypill if they were younger and male, with higher BMI and systolic blood pressure, and less likely to be eligible if they were from Japan and Thailand., Conclusion: The majority of patients with HFrEF in ASIAN-HF were eligible for a HFrEF polypill and were not receiving conventional triple therapy. HFrEF polypills may be a feasible and scalable implementation strategy to help close the treatment gap among patients with HFrEF in Asia., Competing Interests: AA and MDH have a pending patent for heart failure with reduced ejection fraction polypills. AA is funded by an NIH award (K99HL157687-01A1) to evaluate a HFrEF polypill implementation strategy in South Asia., (Copyright: © 2023 The Author(s).)

Providing quality cardiovascular disease (CVD) care in low resource setting requires understanding of priority and effective interventions. This study aimed to identify and prioritize evidence-based quality improvement strategies for CVD care in India using a modified two-round Delphi process in which, we asked 46 experts (clinicians, researchers, program implementers and policy makers) to rate 25 proven CVD care strategies grouped into: (1) patient support, (2) information communication technology (ICT) for health, (3) group problem solving, (4) training, and (5) multicomponent strategy on a scale of 1 (highest/best)-5 (lowest/worst) on priority, relative advantage, and feasibility. Subsequently, we convened an expert consensus panel of 32 members to deliberate and achieve consensus regarding the prioritized set of strategies for CVD care. The Delphi study found that group problem solving strategies achieved the best score for priority (1.80) but fared poorly on feasibility (2.88). Compared to others, multicomponent strategies were rated favorably across all domains (priority = 1.84, relative advantage = 1.94, and feasibility = 2.40). The ICT for health strategies achieved the worst scores for priority = 2.01, relative advantage = 2.31, and feasibility = 2.85. Training and patient support strategies scored moderately across all domains. The expert panel narrowed the selection of a multicomponent strategy consisting of (1) electronic health records with clinical decision-support system, (2) non-physician health worker facilitated care, (3) patient education materials, (4) text-message based reminders for healthy lifestyle, and (5) audit and feedback report for providers. Future research will evaluate the real-world feasibility and effectiveness of the multicomponent strategy in patients with CVD in a low- and middle-income country setting., Supplementary Information: The online version contains supplementary material available at 10.1007/s43477-023-00087-2., Competing Interests: Conflict of interestIn the last 3 years, MDH has received support from the World Heart Federation through unrestricted education grants from Boehringer Ingelheim, Novartis, and Bupa and from the American Heart Association, Verily, and AstraZeneca for work unrelated to this research. MDH has also received salary support from the American Medical Association for his role as an associate editor for JAMA Cardiology. MDH has planned patents for combination therapy for the treatment of heart failure. The George Institute for Global Health has a patent, license, and has received investment funding with the intent to commercialize fixed-dose combination therapy through its social enterprise business, George Medicines. All other co-authors declare no conflict of interests., (© The Author(s), under exclusive licence to Springer Nature Switzerland AG 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.)

Background: Hypertensive disorders of pregnancy, including hypertension, are a leading cause of maternal mortality in Nigeria. However, there is a paucity of data on pregnant women with hypertension who receive care in primary health care facilities. This study presents the results from a cross-sectional analysis of pregnant women enrolled in the Hypertension Treatment in Nigeria Program which is aimed at integrating and strengthening hypertension care in primary health care centres., Methods: A descriptive analysis of the baseline results from the Hypertension Treatment in Nigeria Program was performed. Baseline blood pressures, treatment and control rates of pregnant women were analysed and compared to other adult women of reproductive age. A complete case analysis was performed, and a two-sided p value < 0.05 was considered statistically significant., Results: Between January 2020 to October 2022, 5972 women of reproductive age were enrolled in the 60 primary healthcare centres participating in the Hypertension Treatment in Nigeria Program and 112 (2%) were pregnant. Overall mean age (SD) was 39.6 years (6.3). Co-morbidities were rare in both groups, and blood pressures were similar amongst pregnant and non-pregnant women (overall mean (SD) first systolic and diastolic blood pressures were 157.4 (20.6)/100.7 (13.6) mm Hg and overall mean (SD) second systolic and diastolic blood pressures were 151.7 (20.1)/98.4 (13.5) mm Hg). However, compared to non-pregnant women, pregnant women had a higher rate of newly diagnosed hypertension (65.2% versus 54.4% p = 0.02) and lower baseline walk-in treatment (32.1% versus 42.1%, p = 0.03). The control rate was numerically lower among pregnant patients (6.3% versus 10.2%, p = 0.17), but was not statistically significant. Some pregnant patients (8.3%) were on medications contraindicated in pregnancy, and none of the pregnant women were on aspirin for primary prevention of preeclampsia., Conclusions: These findings indicate significant gaps in care and important areas for future studies to improve the quality of care and outcomes for pregnant women with hypertension in Nigeria, a country with the highest burden of maternal mortality globally., (© 2023. The Author(s).)

Objective: Consumers in the US make choices within a food supply dominated by processed packaged foods and beverage products. Front-of-package nutrition labels (FOPL) equip consumers to make healthier choices, but further evaluation and regulation regarding FOPL format, scope, and display have been recommended by the World Health Organization. As a leader in consumer FOPL guidance, the American Heart Association's (AHA) Heart Check programme certifies food companies seeking to add an AHA Heart Check logo as a FOPL for qualifying heart healthy products. A cross-sectional assessment of the AHA Heart Check Standard Certification was conducted within the US packaged food and beverage supply to assess the eligibility and prevalence of the programme as a FOPL. Methods: Data were derived from Label Insight's Open Data initiative, which is the largest publicly-available US branded food composition database. The proportions of products that were certified and eligible to be certified for the Standard Certification were reported by nutrient attributes, grocery aisles and food brands. Results: Among 153,453 products examined, fewer than 1% exhibited the Heart Check certification on their label. Among products that were not Heart Check certified,13.8% were eligible for Standard Certification. The most common reason for ineligibility was the saturated fat content (52%), followed by total fat content (47%) and sodium content (47%). Heart Check certification and eligibility differed substantially across grocery aisle categories. Conclusions: The abundance of unhealthy products in the US packaged food and beverage supply and absence of harmonized FOPL policies suggest the need for FOPL like the Heart Check label to promote adherence to healthy diets. There are opportunities for food manufacturers and the AHA to certify more heart healthy foods and beverages. However, more consistent criteria and transparent labelling could enhance Heart Check certification to facilitate consumers' ability to make more informed and healthful purchases.

Background: Hypertension (high blood pressure) is a modifiable risk factor for cardiovascular disease. However, patients may lack confidence in their understanding of what constitutes normal/healthy blood pressure, potentially affecting intentions to seek necessary care. The American Heart Association defines normal/healthy blood pressure as <120/80 mm Hg, with a 130/80 mm Hg threshold for hypertension diagnosis., Methods: Our US sample ( N = 6,592) included 1,342 adults with hypertension alone and 795 with hypertension and relevant comorbidities (heart disease, kidney disease, and diabetes mellitus). We assessed confidence in understanding blood pressure numbers, knowledge of thresholds for normal/healthy blood pressure ("normal or healthy blood pressure is below . . ."; counting 120-130/80 mm Hg as correct), and intentions to seek care for randomly assigned blood pressure readings of 142/91 (stage 2 hypertension), 132/69 (stage 1 hypertension), or 118/78 mm Hg (normal/healthy blood pressure)., Results: Among nonhypertensive participants, 55% expressed confidence in their understanding of blood pressure numbers, but only 36% knew the upper thresholds for normal/healthy blood pressure. Among participants with hypertension alone, 78% were confident while 47% were knowledgeable. Among participants with hypertension and comorbidities, 81% were confident and 40% were knowledgeable. Participants who were confident (v. not) were more likely to express intentions to act on stage 2 hypertension readings but less likely to express intentions to act on stage 1 readings, even after adjustment for knowledge, hypertension diagnosis, and sociodemographics., Limitations: Confidence, knowledge, and intentions were each measured with 1 question., Conclusions: Independent of knowledge, confidence was associated with greater willingness to act on stage 2 hypertension readings but reduced willingness to act on stage 1 hypertension readings. Interventions aiming to improve hypertension care-seeking behavior should improve confidence in accurate knowledge., Highlights: Hypertension or high blood pressure is a major risk factor for heart disease.Most Americans do not know that normal/healthy blood pressure levels are ≤120/80 mm Hg, yet they are confident that they know this information.Inappropriate confidence in understanding of blood pressure numbers undermines intentions to seek care for stage 1 hypertension blood pressure readings.

Home blood pressure management, including self-monitoring and medication self-titration, is an efficient and cost-effective tool. Although its use is increasing globally, little is known about the feasibility of such interventions in low and middle-income countries. Further, the perspectives and experiences of healthcare providers who play a big role in ensuring the success of home blood pressure management interventions have not been documented. This qualitative study was conducted with a total of 35 healthcare providers (60% female, mean [SD] age = 37.3 [6.9 years] years), through 4 in-depth interviews from Peru, and 8 in-depth interviews and 4 focus groups from Cameroon. Study participants (healthcare providers) include physicians (primary care physicians), specialists (cardiologists and geriatricians), and nurses that were purposively recruited from two hospitals in two of the largest cities in both countries. Results were thematically analyzed by two researchers. Themes derived were related to feasibility and acceptability, and largely reflected providers in both countries endorsing home blood pressure management. Providers' concerns were in three main areas; 1) safety of patients when they self-titrate medications, 2) resources such as healthcare financing, local hospital policies that support communications with patients for home blood pressure management, and 3) sustainability through patient adherence, incorporating home blood pressure management within clinical guidelines and hospital policies, and complementing with continued health education and lifestyle modifications. According to providers, home blood pressure management may be feasible and acceptable if tailored multi-faceted protocols were introduced bearing in mind local contexts., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: In the last 3 years, Mark D Huffman has received support from the World Heart Federation through unrestricted education grants from Boehringer Ingelheim, Novartis, and Bupa and from the American Heart Association, Verily, and AstraZeneca for work unrelated to this research. Mark D. Huffman has also received salary support from the American Medical Association for his role as an associate editor for JAMA Cardiology and has planned patents for combination therapy for the treatment of heart failure. The George Institute for Global Health where Mark D. Huffman works has a patent, license, and has received investment funding with the intent to commercialize fixed-dose combination therapy through its social enterprise business, George Medicines., (© 2023 The Author(s).)

Sodium-glucose cotransporter-2 inhibitors (SGLT2is) and glucagon-like peptide-1 receptor agonists (GLP1-RAs) reduce cardiovascular events and mortality in patients with type 2 diabetes mellitus (T2DM). We sought to describe trends in prescribing for SGLT2is and GLP1-RAs in diverse care settings, including (1) the outpatient clinics of a midwestern integrated health system and (2) small- and medium-sized community-based primary care practices and health centers in 3 midwestern states. We included adults with T2DM and ≥1 outpatient clinic visit. The outcomes of interest were annual active prescription rates for SGLT2is and GLP1-RAs (separately). In the integrated health system, 22,672 patients met the case definition of T2DM. From 2013 to 2019, the overall prescription rate for SGLT2is increased from 1% to 15% (absolute difference [AD] 14%, 95% confidence interval [CI] 13% to 15%, p <0.01). The GLP1-RA prescription rate was stable at 10% (AD 0%, 95% CI -1% to 1%, p = 0.9). In community-based primary care practices, 43,340 patients met the case definition of T2DM. From 2013 to 2017, the SGLT2i prescription rate increased from 3% to 7% (AD 4%, 95% CI 3% to 6%, p <0.01), whereas the GLP1-RA prescription rate was stable at 2% to 3% (AD 1%, 95% CI -1 to 1%, p = 0.40). In a fully adjusted regression model, non-Hispanic Black patients had lower odds of SGLT2i or GLP1-RA prescription (odds ratio 0.56, 95% CI 0.34 to 0.89, p = 0.016). In conclusion, the increase in prescription rates was greater for SGLT2is than for GLP1-RAs in patients with T2DM in a large integrated medical center and community primary care practices. Overall, prescription rates for eligible patients were low, and racial disparities were observed., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background To analyze the quantity and impact of cardiovascular research done in Africa or coauthored by researchers based in Africa, their determinants, and the patterns of research collaboration. Methods and Results We retrieved data from Web of Science and additional sources. We analyzed temporal trends from 1971 to 2021 and geographical distribution, research impact using country-level h-index, international research cooperation, and associations of research quantity and quality using linear regression. The annual volume of cardiovascular research from Africa has increased from 4 publications in 1971 to 3867 in 2020 and currently represents ~3% of the global cardiovascular research output. Authors from South Africa (28.1%) and Egypt (24.1%) accounted for more than half of all publications from African countries, and they had the highest h-index (209 and 111, respectively). Important collaborators outside Africa included the United States, United Kingdom, France, Germany, and Australia. The country's publication count was associated with larger population size ( P <0.001), whereas the country's h-index was associated with larger population size ( P =0.001) and higher human development index ( P =0.023). International collaboration was dominated by the United States, South Africa, United Kingdom, Egypt, and Canada. The level of collaboration between African countries was lower than their collaboration with non-African countries. Conclusions Cardiovascular research output from African authors remains low, despite marked progress over the past 5 decades. These findings highlight the urgent need to improve the quantity and quality of cardiovascular research in Africa through increased investments, training of human resources, improved infrastructures, and expansion of collaborative research networks, particularly within Africa.

In most African countries, the prevalence of industrially produced trans -fatty acids (iTFA) in the food supply is unknown. We estimated the number and proportion of products containing specific (any hydrogenated edible oils) and non-specific (vegetable fat, margarine, and vegetable cream) ingredients potentially indicative of iTFAs among pre-packaged foods collected in Kenya and Nigeria. We also summarized the number and proportion of products that reported trans -fatty acids levels and the range of reported trans -fatty acids levels. In total, 99 out of 5668 (1.7%) products in Kenya and 310 out of 6316 (4.9%) products in Nigeria contained specific ingredients indicative of iTFAs. Bread and bakery products and confectioneries in both countries had the most foods that contained iTFAs-indicative ingredients. A total of 656 products (12%) in Kenya and 624 products (10%) in Nigeria contained non-specific ingredients that may indicate the presence of iTFAs. The reporting of levels of trans- fatty acids was low in both Kenya and Nigeria (11% versus 26%, respectively, p < 0.001). With the increasing burden of ischemic heart disease in Kenya and Nigeria, the rapid adoption of WHO best-practice policies and the mandatory declaration of trans- fatty acids are important for eliminating iTFAs.

Fixed-dose combination (FDC) therapy is recommended for hypertension management in Nigeria based on randomized trials at the individual level. This cluster-randomized trial evaluates effectiveness and safety of a treatment protocol that used two-drug FDC therapy as the second and third steps for hypertension control compared with a protocol that used free pill combinations. From January 2021 to June 2021, 60 primary healthcare centers in the Federal Capital Territory of Nigeria were randomized to a protocol using FDC therapy as second and third steps compared with a protocol that used the same medications in free pill combination therapy for these steps. Eligible patients were adults (≥18 years) with hypertension. The primary outcome was the odds of a patient being controlled at their last visit between baseline to 6-month follow-up in the FDC group compared to the free pill group. 4427 patients (mean [SD] age: 49.0 [12.4] years, 70.5% female) were registered with mean (SD) baseline systolic/diastolic blood pressure 155 (20.6)/96 (13.1) mm Hg. Baseline characteristics of groups were similar. After 6-months, hypertension control rate improved in the two treatment protocols, but there were no differences between the groups after adjustment (FDC = 53.9% versus free pill combination = 47.9%, cluster-adjusted p = .29). Adverse events were similarly low (<1%) in both groups. Both protocols improved hypertension control rates at 6-months in comparison to baseline, though no differences were observed between groups. Further work is needed to determine if upfront FDC therapy is more effective and efficient to improve hypertension control rates., (© 2023 The Authors. The Journal of Clinical Hypertension published by Wiley Periodicals LLC.)

Healthcare workers, both globally and in Nigeria, have an increased risk for SARS-CoV-2 infection compared with the general population due to higher risk contacts, including occupational exposures. In addition, primary healthcare workers represent an important group for estimating prior infection to SARS-CoV-2 because they work at the first point-of-contact for most patients yet have not been included in prior COVID-19 seroepidemiology research in Nigeria. We sought to evaluate baseline seroprevalence, rates of seroconversion (IgG- to IgG+) and seroreversion (IgG+ to IgG-), change in IgG concentration at 3- and 6-month follow-up, and factors associated with seropositivity. From June 2020 to December 2020, we conducted a longitudinal seroepidemiology study among frontline health care workers in Nigeria using a validated dried blood spot assay. Among 525 participants, mean (SD) age was 39.1 (9.7) years, 61.0% were female, and 45.1% were community health workers. The six-month follow-up rate was 93.5%. Seropositivity rates increased from 31% (95% CI: 27%, 35%) at baseline to 45% (95% CI: 40%, 49%) at 3-month follow-up, and 70% (95% CI: 66%, 74%) at 6-month follow-up. There was a corresponding increase in IgG levels from baseline (median = 0.18 ug/mL) to 3-month (median = 0.35 ug/mL) and 6-month follow-up (median = 0.59 ug/mL, Ptrend < .0001). A minority of participants reported symptoms from February 2020 until baseline (12.2%) or during 3-month (6.6%) or 6-month (7.5%) follow-up. only 1 participant was hospitalized. This study demonstrated high baseline, 3-month and 6-month follow-up prevalence of IgG antibodies to SARS-CoV-2 during the first two waves of the COVID-19 pandemic in Nigeria among a cohort of unvaccinated frontline healthcare workers, including primary healthcare workers despite low symptomatology. These results may have implications in state- and national-level disease pandemic modeling. Trial registration: NCT04158154., Competing Interests: I have read the journal’s policy and one of the authors, MDH has the following competing interests:” has patents pending for combination therapy for the treatment of heart failure (HFpEF Poly diuretic) with application serial number: 63/261,121. The George Institute for Global Health has a patent, license, and has received investment funding with intent to commercialize fixed-dose combination therapy through its social enterprise business, George Medicines. The other authors do not report any disclosures., (Copyright: © 2023 Ojji et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)