Fixed-dose combination therapy for the prevention of cardiovascular disease.
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ABSTRACT:
SUBMITTER: de Cates AN
PROVIDER: S-EPMC4083498 | biostudies-literature | 2014 Apr
REPOSITORIES: biostudies-literature
Publications
Fixed-dose combination therapy for the prevention of cardiovascular disease.
de Cates Angharad N AN Farr Matthew R B MR Wright Nicola N Jarvis Morag C MC Rees Karen K Ebrahim Shah S Huffman Mark D MD
The Cochrane database of systematic reviews 20140416 4
<h4>Background</h4>Cardiovascular disease (CVD) is the leading cause of death and disability worldwide, yet CVD risk factor control and secondary prevention rates remain low. A fixed-dose combination of blood pressure and cholesterol lowering and antiplatelet treatments into a single pill, or polypill, has been proposed as one strategy to reduce the global burden of CVD by up to 80% given its potential for better adherence and lower costs.<h4>Objectives</h4>To determine the effectiveness of fixe ...[more]
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| S-EPMC6464321 | biostudies-literature
Project description:IntroductionDespite the consistent evidence of the benefits of physical activity on preventing atherosclerotic cardiovascular diseases (ASCVD) and some cardiovascular risk factors, such as hypertension and dyslipidaemia, the prescription of drugs remains the most widely used approach to prevent ASCVD in clinical settings. The purpose of this study protocol is to provide a meta-synthesis methodology for comparing the effect of fixed-dose combination therapy and physical exercise on controlling cardiovascular risk factors and preventing ASCVD.Methods and analysisThis protocol follows the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols and the recommendations of the Cochrane Collaboration Handbook. We plan to conduct a computerised search in Medline, Web of Science, Embase, Cochrane Database of Systematic Reviews and SPORTDiscus from inception to May 2020 for studies testing the effectiveness of physical exercise or fixed-dose combination drug therapy in preventing ASCVD, all-cause and cardiovascular mortality and controlling some cardiovascular risk factors (hypertension and dyslipidaemia). Since performing network meta-analyses (NMA) is a statistical approach that allows direct and indirect comparisons of interventions, where sufficient studies are included, we plan to perform the following NMA comparing the effect of fixed-dose combination therapy and physical exercise interventions on (1) improving lipid profile, (2) reducing blood pressure, (3) preventing cardiovascular events and all-cause and cardiovascular mortality and (4) improving compliance with the therapeutic strategy and reducing adverse events.Ethics and disseminationEthical approval will not be needed because data included in the NMA will be extracted from published trials that meet accepted ethical standards. The results will be published in academic peer-reviewed journals, and the evidence gathered by this project could be included in the preventive cardiovascular disease guidelines.Prospero registration numberCRD42019122794.
| S-EPMC7348467 | biostudies-literature
Project description:BackgroundWe report findings of a qualitative evaluation of fixed-dose combination therapy for patients with established atherosclerotic cardiovascular disease (ASCVD) attending Médecins Sans Frontières (MSF) clinics in Lebanon. Cardiovascular disease is a leading cause of death and disability worldwide, and humanitarian actors are increasingly faced with the challenge of providing care for chronic diseases such as ASCVD in settings where health systems are disrupted. Secondary prevention strategies, involving 3-5 medications, are known to be effective for patients at risk of heart attack or stroke, but supply and adherence are challenging in humanitarian settings. Fixed dose combination therapy, combining two or more medications in one tablet, may be a strategy to address this.MethodsThe evaluation was nested within a prospective mixed-methods study in which eligible ASCVD patients were followed for 1 year during (i) 6 months of usual care then (ii) 6 months of fixed dose combination (FDC) therapy. After 1 year, we conducted in-depth interviews with a purposive sample of patients, MSF staff and external stakeholders. Interviews focused on acceptability and sustainability of the fixed dose therapy intervention. Interview data were analysed thematically, informed by thea Theoretical Framework of Acceptability. Additional attention was paid to non-typical cases in order to test and strengthen analysis.ResultsPatients and health care providers were positive about the FDC intervention. For patients, acceptability was related to ease of treatment and trust in MSF staff, while, for staff, it was related to perceived improvements in adherence, having a good understanding of the medication and its use, and fitting well with their priorities for patient's wellbeing. External stakeholders were less familiar with FDC therapy. While external clinicals expressed concerns about treatment inflexibility, non-clinician stakeholder interviews suggested that cost-effectiveness would have a major influence on FDC therapy acceptability. Sustainability was tied to the future role of MSF care provision and coherence with the local health system.ConclusionsFor patients and clinic staff, FDC was an acceptable treatment approach for secondary prevention of ASCVD disease in two MSF clinics in Lebanon. Sustainability is more complex and calls for better alignment of care with public systems.
| S-EPMC9167520 | biostudies-literature
Project description:Highlights: - Despite clinical evidence of its effectiveness in secondary prevention of cardiovascular disease, uptake of fixed dose combination therapy (FDCs) for CVD has been poor.- A symposium was held bringing together stakeholders on this issue, including from academia, government and NGOs.- The conclusion made was that what is now needed to improve implementation of FDCs is country-specific health systems analyses to design appropriate implementation strategies.- Implementation strategies must look beyond listing on the WHO Essential Medicines List to consider approaches to improving FDC availability, accessibility, affordability, and adherence.- Strategies might include incorporation of FDCs into the WHO HEARTS technical package, simplified treatment and monitoring algorithms, decentralisation of medicine dispensing and task-sharing for treatment management.
| S-EPMC7442173 | biostudies-literature
Project description:BackgroundA significant proportion of cardiovascular disease (CVD) morbidity and mortality could be prevented via the population-based and cost-effective interventions. A fixed-dose combination treatment is known as the polypill for the primary and secondary prevention of CVD has come up in recent years.PurposeIn order to provide recommendations for future economic evaluations, this systematic review aimed to review and assess the quality of published evidence on the cost-effectiveness of polypill in primary and secondary prevention of CVD, to identify the key drivers that impact the cost-effectiveness.MethodsA systematic review of literature, following the PRISMA guidelines, was undertaken in the electronic databases. Two researchers identified the relevant studies according to inclusion and exclusion criteria. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist was used to quality assessment of included studies. ICERs value adjusted to 2020 United States Dollar using consumer price index (CPI) and purchasing power parity (PPP). Finally, data were summarized via a narrative synthesis.ResultsIn total, 24 articles were identified based on the determined inclusion criteria. All studies met more than 50% of the CHEERS criteria. Adjusted incremental cost-effectiveness ratios varied from 24$ to 31000$(2020 US dollar) among the studies. The polypill resulted in the improved adherence and quality of life, at a price equal to or lower than multiple monotherapies. This price is typically below the commonly accepted thresholds or cost saving in both, primary and secondary prevention of CVD. The main identified cost-effectiveness drivers were the polypill price, adherence, age, CVD risk, and drug combination.ConclusionsThis systematic review found that the polypill seemed to be a cost-effective intervention in primary and secondary prevention of CVD. However, it is necessary to conduct more economic evaluation studies based on the long-term clinical trials with large populations. Also, studies should consider how the polypill interacts with other primary and secondary preventive strategies as a complementary health strategy.
| S-EPMC9333258 | biostudies-literature
Project description:Cardiovascular disease (CVD) has become a major concern in low- and middle-income countries, which bear about 80% of the cardiovascular mortality worldwide. Curbing the burden of CVD implies the management and control of many cardiovascular risk factors that act synergistically to increase cardiovascular mortality. Such actions may require expensive polymedications in a context of limited resources. Therefore, alternative solutions for CVD prevention in low- and middle-income countries are urgently needed. In this context, the concept of a fixed-dose combination therapy, a polypill composed of drugs known to effectively treat or prevent CVD, has been proposed as a scalable strategy to overcome nonadherence to polymedications and reduce costs. While this has recently been approved in more than 30 countries across America and Europe, there is a crucial need to analyze the potential benefits and challenges related to cardiovascular polypills implementation and vulgarization in low- and middle-income countries, the epicenter of CVD.
| S-EPMC8031286 | biostudies-literature
Project description:ObjectivesThis pre-post implementation study evaluated the introduction of fixed dose combination (FDC) medications for atherosclerotic cardiovascular disease (ASCVD) secondary prevention into routine care in a humanitarian setting.SettingTwo Médecins sans Frontières (MSF) primary care clinics serving Syrian refugee and host populations in north Lebanon.ParticipantsConsenting patients ≥18 years with existing ASCVD requiring secondary prevention medication were eligible for study enrolment. Those with FDC contraindication(s) or planning to move were excluded. Of 521 enrolled patients, 460 (88.3%) were retained at 6 months, and 418 (80.2%) switched to FDC. Of these, 84% remained on FDC (n=351), 8.1% (n=34) discontinued and 7.9% (n=33) were lost to follow-up by month 12.InterventionsEligible patients, enrolled February-May 2019, were switched to Trinomia FDC (atorvastatin 20 mg, aspirin 100 mg, ramipril 2.5/5/10 mg) after 6 months' usual care. During the study, the COVID-19 pandemic, an economic crisis and clinic closures occurred.Outcome measuresDescriptive and regression analyses compared key outcomes at 6 and 12 months: medication adherence, non-high density lipoprotein cholesterol (non-HDL-C) and systolic blood pressure (SBP) control. We performed per-protocol, intention-to-treat and secondary analyses of non-switchers.ResultsAmong 385 switchers remaining at 12 months, total adherence improved 23%, from 63% (95% CI 58 to 68) at month 6, to 86% (95% CI 82 to 90) at month 12; mean non-HDL-C levels dropped 0.28 mmol/L (95% CI -0.38 to -0.18; p<0.0001), from 2.39 (95% CI 2.26 to 2.51) to 2.11 mmol/L (95% CI 2.00 to 2.22); mean SBP dropped 2.89 mm Hg (95% CI -4.49 to -1.28; p=0.0005) from 132.7 (95% CI 130.8 to 134.6) to 129.7 mm Hg (95% CI 127.9 to 131.5). Non-switchers had smaller improvements in adherence and clinical outcomes.ConclusionImplementing an ASCVD secondary prevention FDC improved adherence and CVD risk factors in MSF clinics in Lebanon, with potential for wider implementation by humanitarian actors and host health systems.
| S-EPMC9884866 | biostudies-literature
Project description:ObjectiveWe examined the effects of fixe-dose combinations (FDCs) versus loose-dose combinations (LDCs) on costs from the payer and patient perspective and investigated potential channels contributing to differences in costs between the two modes of treatment.MethodsWe investigated administrative data from 2017 to 2020 on diabetes patients in Germany. After using prospensity-score matching to remove dissimilarities between FDC and LDC patients, we compared changes in costs with a difference-in-differences approach. We analyzed pharmaceutical costs, inpatient and outpatient costs, other costs and total healthcare costs from the payer perspective, and co-payments from the patient perspective.ResultsThe sample comprised 1117 FDC and 1272 LDC patients. Regression analysis revealed that FDC therapy significantly increased antidiabetic pharmaceutical spending in the first year by 5.5% (p < 0.01), but decreased co-payments by 33% (p < 0.01) in the first and 44% (p < 0.01) in the second year. We also observed a trend towards higher outpatient spending in the first year. No significant differences were found with respect to inpatient or other costs. The increase in antidiabetic pharmaceutical spending did not contribute to a significant increase in total healthcare expenditure. We identified a shift of co-payments to the payer and higher adherence as possible mechanisms behind the increase in antidiabetic pharmaceutical spending.ConclusionAlthough FDC therapy increased disease-specific pharmaceutical spending in the short term, this increase did not lead to differences in total healthcare costs from the payer perspective. From the patient perspective, FDC therapy may be the preferred treatment approach, because of significant saving in co-payments, which is likely attributable to the elimination of one co-payment and therefore a shift in costs to the payer.
| S-EPMC9834204 | biostudies-literature
Project description:PurposeTo compare the safety and efficacy of fixed-dose tafluprost/timolol combination (Taf/T-FDC) with those of fixed-dose latanoprost/timolol combination (Lat/T-FDC) by measuring the intraocular pressure (IOP)-lowering effect, ocular pharmacokinetics, and ocular surface toxicity.MethodsThe IOP-lowering effect of Taf/T-FDC and Lat/T-FDC in ocular normotensive monkeys was evaluated at 4 and 8 h after instillation in study A, at 12, 14, 16, and 18 h after instillation in study B, and at 24, 26, 28, and 30 h after instillation in study C. Drug penetration into the eye was evaluated by measuring the concentrations of timolol, tafluprost acid (active metabolic form of tafluprost), and latanoprost acid (active metabolic form of latanoprost) using liquid chromatography coupled with tandem mass spectrometry after single instillation of Taf/T-FDC or Lat/T-FDC to Sprague Dawley rats. Cytotoxicity following 1-30 min exposure of SV40-transformed human corneal epithelial cells to Taf/T-FDC or Lat/T-FDC was analyzed using 3-(4,5-dimethylthiazol-2-yl)-5-(3-carboxymethoxyphenyl)-2-(4-sulfophenyl)-2H-tetrazolium assays. Undiluted and 10-fold diluted solutions of each FDC were evaluated.ResultsThe IOP-lowering effect of Taf/T-FDC was almost equivalent to that of Lat/T-FDC at 4-8 h after instillation. The peak IOP reduction of Taf/T-FDC and Lat/T-FDC was observed at 8 h after instillation, and there is no difference between the two. The difference between them was observed at 24-30 h after instillation, and Taf/T-FDC demonstrated a significantly greater IOP-lowering effect than Lat/T-FDC at 24-30 h after instillation. The IOP-lowering effect of Taf/T-FDC was sustained up to 30 h after instillation, while that of Lat/T-FDC had almost disappeared at 28 h after instillation. Timolol concentrations in aqueous humor after Taf/T-FDC instillation were higher than those after Lat/T-FDC instillation (Cmax, 3870 ng/mL vs 1330 ng/mL; AUCinf, 3970 ng·h/mL vs 1250 ng·h/mL). The concentrations of tafluprost acid and latanoprost acid in aqueous humor after instillation of Taf/T-FDC and Lat/T-FDC, respectively, were similar to those after instillation of mono-preparations of tafluprost and latanoprost, respectively. The cytotoxic effect of Taf/T-FDC to the human corneal epithelial cells was significantly lower than that of Lat/T-FDC at all evaluated time points in both undiluted and 10-fold diluted FDCs.ConclusionTaf/T-FDC provides increased IOP-lowering effect duration and lower potential ocular surface toxicity than Lat/T-FDC.
| S-EPMC4934872 | biostudies-literature
Project description:BackgroundSuboptimal patient adherence to pharmacological therapy of type 2 diabetes may be due in part to pill burden. One way to reduce pill burden in patients who need multiple medications is to use fixed-dose combinations. Our study aimed to compare the effects of fixed-dose combination versus loose-dose combination therapy on medication adherence and persistence, health care utilization, therapeutic safety, morbidities, and treatment modification in patients with type 2 diabetes over three years.MethodsUsing administrative data, we conducted a retrospective controlled cohort study comparing type 2 diabetes patients who switched from monotherapy to either a fixed-dose combination or a loose-dose combination. Adherence was assessed as the primary endpoint and calculated as the proportion of days covered with medication. After using entropy balancing to eliminate differences in observable baseline characteristics between the two groups, we applied difference-in-difference estimators for each outcome to account for time-invariant unobservable heterogeneity.ResultsOf the 990 type 2 diabetes patients included in our analysis, 756 were taking a fixed-dose combination and 234 were taking a loose-dose combination. We observed a statistically significantly higher change in adherence (year one: 0.22, p<0.001, year two: 0.25, p<0.001, and year three: 0.29, p<0.001) as well as higher persistence and a smaller change in the number of drug prescriptions in each of the three years in the fixed-dose combination group compared to the loose-dose combination group. The differences were most pronounced in patients who were poorly adherent, had a high pill burden, or did not have a severe concomitant disease.ConclusionOur results indicate that taking a fixed-dose combination can lead to a significant improvement in adherence to pharmacological therapy of type 2 diabetes compared to a loose-dose combination. In particular, these findings suggest that reducing pill burden may improve disease management among patients with more complex medication demand and patients who have demonstrated poor medication adherence.
| S-EPMC8096115 | biostudies-literature