Explore the vast range of titles available.

In 2023 there are still even 75% of patients over the LDL-C target, and hypercholesterolemia is the most common and the worst monitored CVD risk factor. How it is possible, considering the knowledge we have on the role of cholesterol in the process of atherosclerosis, ASCVD and its complications, on the methods of lipid disorders diagnosis, prevention, and treatment. Nowadays, almost 4 million deaths per year are attributed to LDL-C, and even 2/3 of all CVD deaths to ASCVD, therefore hypothetically we should easily prevent few to several million of deaths with early diagnosis, and early and intensive non-pharmacological and pharmacological therapies. Moreover, lipidology is the area with the highest number of new and ongoing trials with new medications that have already appeared and will soon be available. Therefore, we have no doubt that year 2023 should be called the year of new and prospective LLTs.

Purpose Additive manufacturing (AM), also known as three-dimensional (3D) printing technology, has been used in the health-care industry for over two decades. It is in high demand in the health-care industry due to its strength to manufacture custom-designed and personalized 3D constructs. Recently, AM technologies are being explored to develop personalized drug delivery systems, such as personalized oral dosages, implants and others due to their potential to design and develop systems with complex geometry and programmed controlled release profile. Furthermore, in 2015, the US Food and Drug Administration approved the first AM medication, Spritam® (Apprecia Pharmaceuticals) which has led to tremendous interest in exploring this technology as a bespoke solution for patient-specific drug delivery systems. The purpose of this study is to provide a comprehensive overview of AM technologies applied to the development of personalized drug delivery systems, including an analysis of the commercial status of AM based drugs and delivery devices. Design/methodology/approach This review paper provides a detailed understanding of how AM technologies are used to develop personalized drug delivery systems. Different AM technologies and how these technologies can be chosen for a specific drug delivery system are discussed. Different types of materials used to manufacture personalized drug delivery systems are also discussed here. Furthermore, recent preclinical and clinical trials are discussed. The challenges and future perceptions of personalized medicine and the clinical use of these systems are also discussed. Findings Substantial works are ongoing to develop personalized medicine using AM technologies. Understanding the regulatory requirements is needed to establish this area as a point-of-care solution for patients. Furthermore, scientists, engineers and regulatory agencies need to work closely to successfully translate the research efforts to clinics. Originality/value This review paper highlights the recent efforts of AM-based technologies in the field of personalized drug delivery systems with an insight into the possible future direction.

Purpose of Review It is clear from epidemiological studies that patients at high and very-high risk of atherosclerotic cardiovascular diseases (ASCVD) risk do not reach lipid guideline–recommended targets. Thus, fixed-dose combinations of statins/ezetimibe, bempedoic acid/ezetimibe and statins/fibrates may represent a further armamentarium in the field of lipid-lowering approaches in these individuals. Recent Findings The combination therapy of moderate-intensity statin with ezetimibe is not inferior to high-intensity statin monotherapy in reducing cardiovascular outcomes. Drug discontinuation or dose reduction is inferior with fixed-dose combination. The fixed-dose combination of bempedoic acid with ezetimibe is superior to bempedoic acid in monotherapy in lowering LDL-C and in reducing high-sensitivity C-reactive protein concentrations. The combination fenofibrate with atorvastatin is superior to monotherapies in lowering triglycerides. Summary Lipid-lowering fixed-dose combinations may guarantee a higher therapy adherence, representing a better approach to control plasma lipids and thus ameliorate ASCVD burden. Additional studies will define the advantages on cardiovascular outcomes in high and very high-risk patients.

Many patients, especially those with a high pill burden and multiple chronic illnesses, are less adherent to medication. In medication treatments utilizing polypills, this problem might be diminished since multiple drugs are fused into one formulation and, therefore, the therapy regimen is simplified. This systematic review summarized evidence to assess the effect of polypills on medication adherence. The following databases were searched for articles published between 1 January 2000, and 14 May 2019: PubMed, Web of Science, Cochrane Library, and Scopus. Medication adherence was the only outcome assessed, regardless of the method of measuring it. Sixty-seven original peer-reviewed articles were selected. Adherence to polypill regimens was significantly higher in 56 articles (84%) compared to multiple pill regimens. This finding was also supported by the results of 13 out of 17 selected previously published systematic reviews and meta-analyses dealing with this topic. Adherence can be improved through the formulation of polypills, which is probably why the interest in researching them is growing. There are many polypills on the market, but the adherence studies so far focused mainly on a small range of medical conditions.

This article details a correction to: Satheesh, G., Gyawali, B., Sun, M.F.C., Huffman, M.D., Banerjee, A., Perel, P. and Murphy, A. (2024) ‘A Survey of Availability and Affordability of Polypills for Cardiovascular Disease in Selected Countries’. Global Heart. 19(1):p. 56. Available at: https://doi.org/10.5334/gh.1335.

Secondary prevention lifestyle and pharmacological treatment of atherosclerotic cardiovascular disease (ASCVD) reduce a high proportion of recurrent events and mortality. However, significant gaps exist between guideline recommendations and usual clinical practice. Describe the state of the art, the roadblocks, and successful strategies to overcome them in ASCVD secondary prevention management. A writing group reviewed guidelines and research papers and received inputs from an international committee composed of cardiovascular prevention and health systems experts about the article's structure, content, and draft. Finally, an external expert group reviewed the paper. Smoking cessation, physical activity, diet and weight management, antiplatelets, statins, beta-blockers, renin-angiotensin-aldosterone system inhibitors, and cardiac rehabilitation reduce events and mortality. Potential roadblocks may occur at the individual, healthcare provider, and health system levels and include lack of access to healthcare and medicines, clinical inertia, lack of primary care infrastructure or built environments that support preventive cardiovascular health behaviours. Possible solutions include improving health literacy, self-management strategies, national policies to improve lifestyle and access to secondary prevention medication (including fix-dose combination therapy), implementing rehabilitation programs, and incorporating digital health interventions. Digital tools are being examined in a range of settings from enhancing self-management, risk factor control, and cardiac rehab. Effective strategies for secondary prevention management exist, but there are barriers to their implementation. WHF roadmaps can facilitate the development of a strategic plan to identify and implement local and national level approaches for improving secondary prevention.

Therapy for Parkinson’s disease is quite challenging. Numerous drugs are available for symptomatic treatment, and levodopa (LD), in combination with a dopa decarboxylase inhibitor (e.g., benserazide (BZ)), has been the drug of choice for years. As the disease progresses, therapy must be supplemented with a dopamine agonist (e.g., pramipexole (PDM)). Side effects increase, as do the required dose and dosing intervals. For these specific requirements of drug therapy, the 3D printing method fused deposition modelling (FDM) was applied in this study for personalized therapy. Hot melt extrusion was utilized to produce two different compositions into filaments: PDM and polyvinyl alcohol for rapid drug release and a fixed combination of LD/BZ (4:1) in an ethylene-vinyl acetate copolymer matrix for prolonged drug release. Since LD is absorbed in the upper gastrointestinal tract, a formulation that floats in gastric fluid was desired to prolong API absorption. Using the FDM 3D printing process, different polypill geometries were printed from both filaments, with variable dosages. Dosage forms with 15–180 mg LD could be printed, showing similar release rates (f2 > 50). In addition, a mini drug delivery dosage form was printed that released 75% LD/BZ within 750 min and could be used as a gastric retentive drug delivery system due to the floating properties of the composition. The floating mini-polypill was designed to accommodate patients’ swallowing difficulties and to allow for individualized dosing with an API release over a longer period of time.

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.

Background: Treatment inertia, non-adherence and non-persistence to medical treatment contribute to poor blood pressure (BP) control worldwide. Fixed dose combination (FDC) antihypertensive medicines simplify prescribing patterns and improve adherence. The aim of this study was to identify factors associated with prescribing FDC antihypertensive medicines and to understand if these factors differ among doctors worldwide. Methods: A cross-sectional survey was conducted online from June 2023 to January 2024 to recruit doctors. We collaborated with an international network of researchers and clinicians identified through institutional connections. A passive snowballing recruitment strategy was employed, where network members forwarded the survey link to their clinical colleagues. The survey instrument, developed through a literature review, interviews with academic and clinical researchers, and pilot testing, assessed participants perspectives on prescribing FDC antihypertensive medicines for hypertension. Participants rated their level of agreement (5-point Likert scale) with statements representing six barriers and four facilitators to FDC use. Findings: Data from 191 surveys were available for analysis. 25% (n = 47) of participants worked in high-income countries, 38% (n = 73) in upper-middle income, 25% (n = 48) in lower-middle income, 6% (n = 10) in low-income countries. Forty percent (n = 70) of participants were between 36–45 years of age; two thirds were male. Cost was reported as a barrier to prescribing FDC antihypertensive medicines [51% (n = 87) agreeing or strongly agreeing], followed by doctors’ confidence in BP measured in clinic [40%, (n = 70)], access [37%, (n = 67)], appointment duration [35%, (n = 61)], concerns about side-effects [(21%, n = 37)], and non-adherence [12%, (n = 21)]. Facilitators to FDC antihypertensive polypills prescribing were clinician facing, such as access to educational supports [79%, (n = 143)], more BP measurement data [67%, (n = 120)], a clinical nudge in health records [61%, (n = 109)] and patient-facing including improved patient health literacy [49%, (n = 88)]. The levels of agreement and strong agreement across all barriers and facilitators were similar for participants working in higher or lower income countries. Across all countries, participants rated FDC antihypertensive medications highly valuable for managing patients with non-adherence, (82% reported high or very high value), for patients with high pill burden (80%). Interpretation: Cost and access were the most common barriers to prescribing FDCs across high- and low-income countries. While greater educational support for clinicians was perceived as the leading potential facilitator of FDC use, this seems unlikely to be effective without addressing access.