Fixed-dose combination therapy for the prevention of atherosclerotic cardiovascular diseases.
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ABSTRACT:
SUBMITTER: Bahiru E
PROVIDER: S-EPMC6464321 | biostudies-literature | 2017 Mar
REPOSITORIES: biostudies-literature
Publications
Fixed-dose combination therapy for the prevention of atherosclerotic cardiovascular diseases.
Bahiru Ehete E de Cates Angharad N AN Farr Matthew Rb MR Jarvis Morag C MC Palla Mohan M Rees Karen K Ebrahim Shah S Huffman Mark D MD
The Cochrane database of systematic reviews 20170306
<h4>Background</h4>Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of death and disability worldwide, yet ASCVD 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 ASCVD.<h4>Objectives</h4>To determine the effect of fixed-dose combination therapy on all-cause mortality, fat ...[more]
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| S-EPMC4083498 | 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: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:Background/aimsWe evaluated the contemporary use of lipid-lowering therapy (LLT) in Korean patients with atherosclerotic cardiovascular disease (ASCVD), and identified factors associated with statin non-prescription.MethodsUsing the Korean Health Insurance Review and Assessment data, we identified LLT-naïve subjects newly diagnosed with ASCVD between 2011 and 2012, and followed up until 2015. LLT-naïve status was defined as no LLT prescription for 1 year before ASCVD diagnosis. ASCVD was defined as first hospitalization or emergency room visit for coronary artery disease (CAD), acute cerebrovascular disease (CVD), or peripheral artery disease (PAD). Statin intensity was defined per the 2013 American College of Cardiology/American Heart Association guideline for cholesterol treatment.ResultsThe study enrolled 80,884 subjects newly diagnosed with ASCVD, of whom only 48,725 (60.2%) received LLT during the follow-up period. Statin, combination of statin and non-statin, and non-statin LLT were administered in 50.5%, 9.7%, and 0.1% of all subjects, respectively. Statins were prescribed to 80.4% of CAD patients but only to 50.2% and 46.8% of CVD and PAD patients. Statin-based LLT usually had moderate- (77.2%) or high-intensity (18.5%). Subjects not prescribed statins were younger or older (< 40 or ≥ 70 years), more commonly female, and more likely to have comorbidities. Statins were prescribed at the time of ASCVD diagnosis in 45.5% of all subjects, and in 53.0% within 90 days of diagnosis.ConclusionOnly 60% of LLT-naïve Korean patients newly diagnosed with ASCVD received statins. Statins were often prescribed in subjects with CAD but less commonly in those with CVD or PAD. Moderate-intensity statins were most frequently used.
| S-EPMC7214354 | 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:Background: This study aims to explore the role of low-dose rivaroxaban (≤10 mg daily) for the treatment of atherosclerotic cardiovascular disease (ASCVD). Methods: PubMed, Embase and the Cochrane Library were searched for randomized controlled trials (RCTs) of low-dose rivaroxaban in patients with ASCVD including coronary artery disease (CAD) and peripheral artery disease (PAD). Literature screening, data extraction, and risk of bias assessment were carried out independently by two researchers. Hazard ratio (HR) and 95% confidence interval (CI) were calculated using random-effect models to determine risks of outcomes in ASCVD patients treated with rivaroxaban and comparators, and meta-analysis was conducted via Review Manager 5.3.5 software. Results: 3,768 records were obtained through literature search, and 9 articles representing 6 RCTs ultimately qualified for this study. The meta-analysis indicated that for patients with CAD, the addition of rivaroxaban (5 mg daily) to aspirin could significantly reduce the risk of major adverse cardiovascular events (MACEs) compared with aspirin alone (HR 0.81, 95% CI, 0.72 to 0.91, p = 0.0004, I2 = 60%, 4 studies). For PAD patients receiving rivaroxaban (5 mg daily) plus aspirin, there was no significant reduction in the risk of MACEs (HR 0.84, 95% CI, 0.63 to 1.13, p = 0.25, I2 = 74%, 2 studies); however, there was significant reduction in major adverse limb events (MALEs) (HR 0.54, 95% CI, 0.35 to 0.83, p = 0.005, one studies) and in the composite of MACEs or MALEs (HR 0.78, 95% CI, 0.64 to 0.95, p = 0.02, I2 = 66%, 2 studies) when compared with patients receiving aspirin alone. Meanwhile, rivaroxaban combined with aspirin significantly increased the risk of International Society on Thrombosis and Haemostasis (ISTH) major bleeding compared with aspirin alone in patients with CAD (HR 1.74, 95% CI, 1.43 to 2.13, p < 0.00001, I2 = 0%, 2 studies) and PAD (HR 1.47, 95% CI, 1.19 to 1.83, p = 0.0004, I2 = 0%, 2 studies). Conclusions: Compared with standard antiplatelet therapy, the addition of a 5 mg daily dose of rivaroxaban to standard antiplatelet therapy may improve cardiovascular or limb outcomes of patients with ASCVD, with an increase in major bleeding. Patients who would benefit from the addition of low-dose rivaroxaban to antiplatelet agents and appropriate dual-pathway antithrombotic strategies should be identified in clinical practice to individualize antithrombotic therapy.
| S-EPMC7957832 | 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