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Ruth Webster - One of the best experts on this subject based on the ideXlab platform.
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Barriers and Facilitators to the Use of Cardiovascular Fixed-Dose Combination Medication (Polypills) in Andhra Pradesh, India: A Mixed-Methods Study.
Global heart, 2019Co-Authors: Abdul Salam, Devarsetty Praveen, Anushka Patel, Abha Tewari, Ruth WebsterAbstract:Abstract Background Polypills, fixed-dose combinations of blood pressure–lowering drug(s), and statin, with or without aspirin, improve the use of these recommended drugs in patients with or at high risk of cardiovascular disease. However, in India, there has been poor uptake of Polypills despite market availability. Objectives This study sought to assess availability and cost of Polypills and explore barriers and facilitators to their use in the state of Andhra Pradesh in India. Methods A mixed-methods study was conducted. Availability and cost of Polypills as well as individual component drugs was assessed through a survey of pharmacies across urban, urban slum, and rural regions in state of Andhra Pradesh in India. In-depth interviews with stakeholders at each level of the health system explored barriers and facilitators to use of Polypills. Results Overall, 30 pharmacies were surveyed (10 in each of urban, urban slum, and rural region). In urban region, 2 pharmacies stocked Polypills (without aspirin) costing 121 Indian rupees (INR) per 10 pills, and 1 other pharmacy stocked a Polypill (with aspirin) costing 24 INR per 10 pills. All pharmacies stocked a wide range of component drugs as separate pills with combined cost of the cheapest angiotensin-converting enzyme inhibitor, statin, and aspirin INR 124 per 10 pills. Patients were willing to use Polypills if prescribed by their doctor, and pharmacies were willing to stock Polypills if there was market demand. For prescribers, key barriers included perceptions that current Polypills contained outdated drugs and inadequate flexibility in prescribing. Conclusions In a market in which Polypill use is licensed, their availability and use is very low. Lack of prescription of Polypills was the predominant barrier to Polypill use; therefore, making Polypills with drugs that are more acceptable and at different available strengths, in conjunction with broader prescriber education and training, may improve their use.
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impact of switching to Polypill based therapy by baseline potency of medication post hoc analysis of the space collaboration dataset
International Journal of Cardiology, 2017Co-Authors: Ruth Webster, Anushka Patel, Chris Bullen, Vanessa Selak, Sandrine Stepien, Simon Thom, Anthony RodgersAbstract:Abstract Background Fixed dose combinations of cardiovascular therapy (‘Polypills') have now been launched in several dozen countries. There is considerable clinical interest in the effects of switching to Polypill-based care from typical current treatment regimens, especially if Polypills contain components at sub-maximal dosage. Methods The SPACE Collaboration includes three trials of Polypill based care vs usual care in patients with established CVD or at high calculated risk. Individual patient data for 3140 trial participants were combined. Patients were categorized according to the potency of the statin and the number of BP lowering medications they were taking at baseline. Effects on adherence to anti-platelet medication, systolic blood pressure (SBP) and LDL cholesterol stratified by baseline potency of medication were determined using fixed effects models. Results Randomisation to the Polypill group was associated with improved SBP at 12months, but this improvement varied according to baseline BP regimen: −3.3, −5.9, −2.5 and +1mmHg for patients taking 0, 1, 2 and 3+ BP lowering medications at baseline. For changes in LDL cholesterol at 12months, significant improvements in LDL cholesterol were seen for those taking no statin (−0.21mmol/L; 95% CI: −0.34 to −0.07), less potent statin (−0.16mmol/L; 95% CI: −0.29 to −0.04) and equipotent statins (−0.14mmol/L; 95% CI −0.26 to −0.02) at baseline. Conclusion The adherence benefits of Polypills tend to offset the loss of potency from use of individual components with lower dose potency, and to facilitate improvements in multiple risk factors.
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Putting Polypills into practice: challenges and lessons learned
Lancet (London England), 2017Co-Authors: Ruth Webster, Jose M. Castellano, Oyere OnumaAbstract:Summary Regulatory approvals for cardiovascular Polypills are increasing rapidly across more than 30 countries. The evidence clearly shows Polypills improve adherence and cardiovascular disease risk factors for patients with indications for use of Polypill components—ie, those with established cardiovascular disease or at high risk. However, the implementation of Polypills into clinical practice has many challenges. The clinical trials literature provides insights into the clinical impact of a Polypill strategy, including cost-effectiveness, safety of use, substantial improvement in adherence, and better risk factor control than usual care. Despite the clear need for such a strategy and the available clinical data backing up the use of the Polypill in different patient populations, challenges to widespread implementation, such as an absence of government reimbursement and poor physician uptake (identified from on the ground experience in countries following commercial rollout), have greatly obstructed real-world implementation. Obtaining the full public health benefit of Polypills will require education, advocacy, endorsement, and implementation by key global agencies such as WHO and national clinical bodies, as well as endorsement from governments.
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impact of switching from different treatment regimens to a fixed dose combination pill Polypill in patients with cardiovascular disease or similarly high risk
European Journal of Preventive Cardiology, 2017Co-Authors: Melvin Lafeber, Ruth Webster, Anushka Patel, Wilko Spiering, Frank L J Visseren, Diederick E Grobbee, Michiel L Bots, Alice Stanton, Dorairaj Prabhakaran, Simon ThomAbstract:Aims Cardiovascular fixed-dose combination pills, or Polypills, may help address the widespread lack of access and adherence to proven medicines. Initiation of Polypill-based care typically entails switching from current separately taken medications. Given the heterogeneity in usual care, there is interest in the impact of Polypill treatment across different patterns of prior medication regimen. Methods A total of 2004 participants with established cardiovascular disease or estimated 5-year cardiovascular risk of over 15% were randomised to Polypill-based treatment (aspirin 75 mg, simvastatin 40 mg, lisinopril 10 mg and either atenolol 50 mg or hydrochlorothiazide 12.5 mg) or usual care. Baseline medications were classified by potency relative to Polypill components. Estimated cardiovascular risk reduction was calculated by combining risk factor changes with results seen in meta-analyses of previous randomised trials. Results For cholesterol reduction conferred by Polypills, there was a dose response across baseline statin groups, with mean low-density lipoprotein (LDL)-cholesterol differences of 0.37, 0.22, 0.14 and 0.07 mmol/L among patients taking no statin, less potent, equipotent and more potent statin at baseline, respectively. Similarly there were differences in mean systolic BP of 5.4, 6.2, 3.3 and 1.8 mmHg among patients taking 0, 1, 2 or 3 BP-lowering agents. Among patients taking more potent statins at baseline, there was no significant difference in LDL-cholesterol but there were benefits for BP and aspirin adherence. Similar results were seen among patients taking 3 BP-lowering agents at baseline. Switching to a Polypill-based strategy resulted in estimated cardiovascular relative risk reductions across a wide range of usual care patterns of antiplatelet, statin and BP-lowering therapy prescribing. Conclusion Adherence benefits from switching to a Polypill resulted in risk factor changes that were at least as good as usual care across a wide variety of treatment patterns, including equally potent or more potent regimens. The benefits of switching to Polypill-based care were greatest among those stepped up from partial treatment or less potent treatment.
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Polypill treatments for cardiovascular diseases
Expert opinion on drug delivery, 2015Co-Authors: Ruth Webster, Anthony RodgersAbstract:Cardiovascular disease (CVD) is the leading cause of mortality globally. Effective CVD preventive medications are available including statin, blood pressure-lowering and antiplatelet medications; however most people do not take these drugs long term. Fixed-dose combination pills (“Polypills”) have been shown, in several clinical trials, to improve adherence to these recommended medications, with corresponding improvements in risk factors such as blood pressure and LDL-cholesterol. In patients not taking all modalities of recommended CVD preventive therapies, Polypill-based strategies could importantly contribute to global CVD control strategies. The largest benefits are seen in those who are under-treated at baseline, rather than those who are already taking the individual components separately: simplified step-up is more important than pill count reduction.Despite the potential benefits for patients and payers, only a few Polypills are available due to market failure in the funding of research and develo...
Anthony Rodgers - One of the best experts on this subject based on the ideXlab platform.
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modeling the cost effectiveness and budgetary impact of Polypills for secondary prevention of cardiovascular disease in the united states
American Heart Journal, 2019Co-Authors: Anthony Rodgers, Thomas A Gaziano, Ankur Pandya, Thiago Veiga Jardim, Jenna M Ogden, Milton C WeinsteinAbstract:Background There is underutilization of appropriate medications for secondary prevention of cardiovascular disease (CVD). Methods Usual care (UC) was compared to Polypill-based care with 3 versions using a validated micro-simulation model in the NHANES population with prior CVD. UC included individual prescription of up to 4 drug classes (antiplatelet agents, beta-blockers, renin-angiotensin-aldosterone inhibitors and statins). The Polypills modeled were aspirin 81 mg, atenolol 50 mg, ramipril 5 mg, and either simvastatin 40 mg (Polypill I), atorvastatin 80 mg (Polypill II), or rosuvastatin 40 mg (Polypill III). Baseline medication use and adherence came from United Healthcare claims data. Results When compared to UC, there were annual reductions of 130,000 to 178,000 myocardial infarctions and 54,000 to 74,000 strokes using Polypill I and II, respectively. From a health sector perspective, in incremental analysis the ICERs for Polypill I and II were $20,073/QALY and $21,818/QALY respectively; Polypill III was dominated but had a similar cost-effectiveness ratio to Polypill II when compared directly to usual care. From a societal perspective, Polypill II was cost-saving and dominated all strategies. Over a 5-year period, those taking Polypill I and II compared to UC saved approximately $12 and $6 per-patient-per-year alive, respectively. Polypill II was the preferred strategy in 98% of runs at a willingness to pay of $50,000 in the probability sensitivity analysis. Conclusions Use of a Polypill has a favorable cost profile for secondary CVD prevention in the United States. Reductions in CVD-related healthcare costs outweighed medication cost increases on a per-patient-per-year basis, suggesting that a Polypill would be economically advantageous to both patients and payers.
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impact of switching to Polypill based therapy by baseline potency of medication post hoc analysis of the space collaboration dataset
International Journal of Cardiology, 2017Co-Authors: Ruth Webster, Anushka Patel, Chris Bullen, Vanessa Selak, Sandrine Stepien, Simon Thom, Anthony RodgersAbstract:Abstract Background Fixed dose combinations of cardiovascular therapy (‘Polypills') have now been launched in several dozen countries. There is considerable clinical interest in the effects of switching to Polypill-based care from typical current treatment regimens, especially if Polypills contain components at sub-maximal dosage. Methods The SPACE Collaboration includes three trials of Polypill based care vs usual care in patients with established CVD or at high calculated risk. Individual patient data for 3140 trial participants were combined. Patients were categorized according to the potency of the statin and the number of BP lowering medications they were taking at baseline. Effects on adherence to anti-platelet medication, systolic blood pressure (SBP) and LDL cholesterol stratified by baseline potency of medication were determined using fixed effects models. Results Randomisation to the Polypill group was associated with improved SBP at 12months, but this improvement varied according to baseline BP regimen: −3.3, −5.9, −2.5 and +1mmHg for patients taking 0, 1, 2 and 3+ BP lowering medications at baseline. For changes in LDL cholesterol at 12months, significant improvements in LDL cholesterol were seen for those taking no statin (−0.21mmol/L; 95% CI: −0.34 to −0.07), less potent statin (−0.16mmol/L; 95% CI: −0.29 to −0.04) and equipotent statins (−0.14mmol/L; 95% CI −0.26 to −0.02) at baseline. Conclusion The adherence benefits of Polypills tend to offset the loss of potency from use of individual components with lower dose potency, and to facilitate improvements in multiple risk factors.
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Polypill treatments for cardiovascular diseases
Expert opinion on drug delivery, 2015Co-Authors: Ruth Webster, Anthony RodgersAbstract:Cardiovascular disease (CVD) is the leading cause of mortality globally. Effective CVD preventive medications are available including statin, blood pressure-lowering and antiplatelet medications; however most people do not take these drugs long term. Fixed-dose combination pills (“Polypills”) have been shown, in several clinical trials, to improve adherence to these recommended medications, with corresponding improvements in risk factors such as blood pressure and LDL-cholesterol. In patients not taking all modalities of recommended CVD preventive therapies, Polypill-based strategies could importantly contribute to global CVD control strategies. The largest benefits are seen in those who are under-treated at baseline, rather than those who are already taking the individual components separately: simplified step-up is more important than pill count reduction.Despite the potential benefits for patients and payers, only a few Polypills are available due to market failure in the funding of research and develo...
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The Effect of a Cardiovascular Polypill Strategy on Pill Burden.
Cardiovascular therapeutics, 2015Co-Authors: Michael Truelove, David Peiris, Alan Cass, Anushka Patel, Severine Bompoint, Alex Brown, Graham S. Hillis, Natasha Rafter, Christopher M. Reid, Anthony RodgersAbstract:Aims Recent trials of cardiovascular Polypills in high-risk populations show improvements in the use of cardiovascular preventive treatments, compared to usual care. We describe patterns of pill burden in Australian practice, define the impact of Polypill therapy on pill burden, and explore how physicians add medication to Polypill therapy. Methods The Kanyini Guidelines Adherence with the Polypill Study was an open-label trial involving 623 participants in Australia which randomized participants to a Polypill strategy (containing a statin, antiplatelet agent, and two blood-pressure-lowering medications) or usual care. Participants either had established cardiovascular disease or were at high calculated risk (≥15% over 5 years). Current medications, daily pill burden, and self-reported use of combination treatment were recorded prior to randomization and at study end. Median pill burden at baseline and study end was compared in both arms. Subgroup analysis of the Polypill strategy on trial primary outcomes was conducted by pill burden at baseline. Results Median total and cardiovascular pill burdens of the Polypill group decreased from 7 to 5 and from 4 to 2, respectively (median change −2; IQR −3, 0), with no change in the usual care group (comparison of change; P Conclusion A cardiovascular Polypill in contemporary Australian practice reduces cardiovascular and total pill burdens, despite frequent prescription of additional medications.
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Polypill progress and challenges to global use update on the trials and policy implementation
Current Cardiology Reports, 2015Co-Authors: Ruth Webster, Anthony RodgersAbstract:Cardiovascular disease (CVD) is the leading cause of mortality globally. Most people with cardiovascular disease do not take long-term cholesterol-lowering, anti-platelet and blood pressure-lowering medications despite proven benefits. Fixed-dose combination pills (‘Polypills’) have been shown to improve adherence to these recommended medications with corresponding improvements in risk factors such as blood pressure and low-density lipoprotein (LDL) cholesterol. Among patients not taking the full complement of recommended CVD preventive therapies, use of a Polypill-based strategy (i.e. initiating treatment with single-pill combination medication then titrating further therapy as needed) has large potential benefits in reducing global morbidity and mortality. Despite this, few Polypills are available on the market due to market failure in the funding of research and development for affordable non-communicable disease medicines. Additionally, defining a path to market has been problematic in that fixed-dose combinations with multiple different drug classes included are quite novel, and regulatory processes to review these types of applications are not well established. Despite these delays, progress is slowly being made.
Larry B Goldstein - One of the best experts on this subject based on the ideXlab platform.
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Polypill Trials for Stroke Prevention-Main Results, Critical Appraisal, and Implications for US Population.
Current neurology and neuroscience reports, 2020Co-Authors: Mam Ibraheem, Larry B GoldsteinAbstract:PURPOSE OF REVIEW The Polypill, referring to a variety of combinations of low-cost cardiovascular and stroke preventive medications combined in a single tablet, has been evaluated as a population-based approach for cardiovascular disease prevention in several trials. This review summarizes the scope of the problem, main trial results, and their potential applicability to the US population. RECENT FINDINGS Initial trials demonstrated the efficacy of the Polypill approach. The most recent, the PolyIran study, showed the effectiveness of one form of a Polypill for cardiovascular disease prevention, high medication adherence, and low adverse event rates. None of published Polypill trials focused on stroke as the primary outcome and most were conducted in developing countries, limiting generalization to the US population. A US-based randomized trial with stroke as the primary outcome is needed to assess the usefulness of this approach for stroke prevention in the USA.
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Polypill Trials for Stroke Prevention—Main Results, Critical Appraisal, and Implications for US Population
Current Neurology and Neuroscience Reports, 2020Co-Authors: Mam Ibraheem, Larry B GoldsteinAbstract:Purpose of Review The Polypill, referring to a variety of combinations of low-cost cardiovascular and stroke preventive medications combined in a single tablet, has been evaluated as a population-based approach for cardiovascular disease prevention in several trials. This review summarizes the scope of the problem, main trial results, and their potential applicability to the US population. Recent Findings Initial trials demonstrated the efficacy of the Polypill approach. The most recent, the PolyIran study, showed the effectiveness of one form of a Polypill for cardiovascular disease prevention, high medication adherence, and low adverse event rates. Summary None of published Polypill trials focused on stroke as the primary outcome and most were conducted in developing countries, limiting generalization to the US population. A US-based randomized trial with stroke as the primary outcome is needed to assess the usefulness of this approach for stroke prevention in the USA.
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what is the future of stroke prevention debate Polypill versus personalized risk factor modification
Stroke, 2010Co-Authors: Walter N Kernan, Lenore J Launer, Larry B GoldsteinAbstract:Background and Purpose—The control of stroke risk factors remains challenging. The “Polypill” concept represents a novel approach for reducing stroke and cardiovascular risk factors in the entire population. The Polypill would include several components and be provided without prescription to all adults of a certain age. Results—A Polypill aimed at lowering blood pressure and cholesterol levels is estimated to potentially reduce the risk of a first ischemic stroke by 53%; this would translate to about 400 000 fewer strokes each year in the United States alone. Recommending a Polypill for the entire older adult population would, however, include many individuals without the multiple risk factors targeted by its components, putting them at risk for drug-related side effects and responsible for the costs of a medication from which they would not derive benefit. Additional arguments for and against the Polypill approach are discussed. Conclusions—Only clinical trials can provide the evidence needed to determi...
Valentin Fuster - One of the best experts on this subject based on the ideXlab platform.
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clinical effectiveness of the cardiovascular Polypill in a real life setting in patients with cardiovascular risk the sors study
Archives of Medical Research, 2019Co-Authors: Jose M. Castellano, Juan Verdejo, Salvador Ocampo, Marco Martinez Rios, Enrique Gomezalvarez, Gabriela Borrayo, Emilio Ruiz, Borja Ibanez, Valentin FusterAbstract:Background The cardiovascular disease pandemic has promoted the cardiovascular Polypill as one of the most scalable public health strategies to improve cardiovascular risk by increasing accessibility and adherence to treatments. Data from randomized clinical trials has shown that the Polypill strategy significantly improves adherence as well as risk factor control (cholesterol and blood pressure), however, to date, no information from phase IV registries has been available. Methods We conducted a multicentre, observational and prospective registry of a Polypill-based treatment strategy. A total of 1193 patients in Mexico were included. Patient demographics, clinical history, blood pressure, analysis of blood lipids and the Framingham risk score were measured at baseline and after 12 months of treatment with the CNIC-Ferrer Polypill. Results At one year with the Polypill, systolic blood pressure (SBP) and diastolic blood pressure (DBP) levels changed from mean 146.9 mmHg to 128 mmHg (p Conclusions To our knowledge, the results of the current study constitute the first real life data on the impact of a Polypill therapy on cardiovascular risk factor control. The results show major improvements on the primary outcome, above and beyond those presented previously in the setting of randomized clinical trials.
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Usefulness of a Cardiovascular Polypill in the Treatment of Secondary Prevention Patients in Spain: A Cost-effectiveness Study.
Revista espanola de cardiologia (English ed.), 2016Co-Authors: Vivencio Barrios, Jose M. Castellano, Valentin Fuster, Lisette Kaskens, Juan Cosín-sales, José Emilio Ruiz, Ilonka Zsolt, Alfredo GraciaAbstract:Abstract Introduction and objectives To estimate the health benefits and cost-effectiveness of a Polypill intervention (aspirin 100 mg, atorvastatin 20 mg, ramipril 10 mg) compared with multiple monotherapy for secondary prevention of cardiovascular events in adults with a history of myocardial infarction from the perspective of the Spanish National Health System. Methods An adapted version of a recently published Markov model developed and validated in Microsoft Excel was used to compare the cost-effectiveness of the Polypill with that of its combined monocomponents over a 10-year time horizon. The population included in the model had a mean age of 64.7 years; most were male and had a history of myocardial infarction. The input parameters were obtained from a systematic literature review examining efficacy, adherence, utilities, and costs. The results of the model are expressed in events avoided, incremental costs, incremental life years, incremental quality-adjusted life years, and the incremental cost-effectiveness ratio. Results Over a 10-year period, use of the cardiovascular Polypill instead of its monocomponents simultaneously would avoid 46 nonfatal and 11 fatal cardiovascular events per 1000 patients treated. The Polypill would also be a more effective and cheaper strategy. Probabilistic analysis of the base case found a 90.9% probability that the Polypill would be a cost-effective strategy compared with multiple monotherapy at a willingness-to-pay of 30 000 euros per quality-adjusted life year. Conclusions The Polypill would be a cost-effective strategy for the Spanish National Health System with potential clinical benefits.
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cost effectiveness and public health benefit of secondary cardiovascular disease prevention from improved adherence using a Polypill in the uk
BMJ Open, 2015Co-Authors: Virginia Becerra, Valentin Fuster, Alfredo Gracia, Kamal Desai, Seye Abogunrin, Sarah Brand, Ruth Chapman, Fernando Garcia Alonso, Ginés SanzAbstract:Objective To evaluate the public health and economic benefits of adherence to a fixed-dose combination Polypill for the secondary prevention of cardiovascular (CV) events in adults with a history of myocardial infarction (MI) in the UK. Design Markov-model-based cost-effectiveness analysis, informed by systematic reviews, which identified efficacy, utilities and adherence data inputs. Setting General practice in the UK. Participants Patients with a mean age of 64.7 years, most of whom are men with a recent or non-recent diagnosis of MI and for whom secondary preventive medication is indicated and well tolerated. Intervention Fixed-dose combination Polypill (100 mg aspirin, 20 mg atorvastatin and 2.5, 5, or 10 mg ramipril) compared with multiple monotherapy. Primary and secondary outcome measures CV events prevented per 1000 patients; cost per life-year gained; and cost per quality-adjusted life-year (QALY) gained. Results The model estimates that for each 10% increase in adherence, an additional 6.7% fatal and non-fatal CV events can be prevented. In the base case, over 10 years, the Polypill would improve adherence by ∼20% and thereby prevent 47 of 323 (15%) fatal and non-fatal CV events per 1000 patients compared with multiple monotherapy, with an incremental cost-effectiveness ratio (ICER) of £8200 per QALY gained. Probabilistic sensitivity analyses for the base-case assumptions showed an 81.5% chance of the Polypill being cost-effective at a willingness-to-pay threshold of £20 000 per QALY gained compared with multiple monotherapy. In scenario analyses that varied structural assumptions, ICERs ranged between cost saving and £21 430 per QALY gained. Conclusions Assuming that some 450 000 adults are at risk of MI, a 10 percentage point uptake of the Polypill could prevent 3260 CV events and 590 CV deaths over a decade.The Polypill appears to be a cost-effective strategy to prevent fatal and non-fatal CV events in the UK.
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The Fuster-CNIC-Ferrer Cardiovascular Polypill: a Polypill for secondary cardiovascular prevention.
International Journal of Cardiology, 2015Co-Authors: Juan Tamargo, Jose M. Castellano, Valentin FusterAbstract:Abstract During the last decade, there has been a tremendous effort to develop different cardiovascular Polypills in response to the upsurge in global cardiovascular disease worldwide. The pharmacological development of such a strategy has proven to be extremely complex from a formulation standpoint. Not all drugs are suitable for use in a Polypill because of potential drug incompatibilities between them. Candidate agents must be safe, well tolerated, effective, guideline recommended and physiochemically compatible with the other components of the pill. The Fuster-CNIC-Ferrer cardiovascular (CV) Polypill has been found to be the first-in-class Polypill to be approved and commercialized in Europe and Latinamerican Countries. In this article, we review the pharmacological properties of its three components, including the clinical evidence supporting their use in patients with established cardiovascular disease, their pharmacokinetic properties, adverse effects, drug interactions and contraindications.
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A Polypill strategy to improve global secondary cardiovascular prevention: from concept to reality.
Journal of the American College of Cardiology, 2014Co-Authors: Jose M. Castellano, Ginés Sanz, Antonio Fernández Ortiz, Ester Garrido, Sameer Bansilal, Valentin FusterAbstract:The prevention of cardiovascular disease (CVD) by using a Polypill has gained increasing momentum as a strategy to contain progression of the disease. Since its initial conception just over a decade ago, only a handful of trials have been completed assessing the efficacy and safety of this innovative concept. The results of these trials have supported the viability of the Polypill in CVD prevention and management, albeit with a few caveats, essentially related to the lack of evidence on the effect of the Polypill to effectively reduce cardiovascular events. The Polypill has the potential to control the global health epidemic of CVD by effectively reaching underdeveloped regions of the world, simplifying healthcare delivery, improving cost-effectiveness, increasing medication adherence, and supporting a comprehensive prescription of evidence-based cardioprotective drugs. Major trials underway will provide definitive evidence on the efficacy of the Polypill in reducing cardiovascular events in a cost-effective manner. The results of these studies will determine whether a Polypill strategy can quell the burgeoning public health challenge of CVD and will potentially provide the evidence to implement an effective, simple, and innovative solution to restrain the global CVD pandemic.
Anushka Patel - One of the best experts on this subject based on the ideXlab platform.
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Barriers and Facilitators to the Use of Cardiovascular Fixed-Dose Combination Medication (Polypills) in Andhra Pradesh, India: A Mixed-Methods Study.
Global heart, 2019Co-Authors: Abdul Salam, Devarsetty Praveen, Anushka Patel, Abha Tewari, Ruth WebsterAbstract:Abstract Background Polypills, fixed-dose combinations of blood pressure–lowering drug(s), and statin, with or without aspirin, improve the use of these recommended drugs in patients with or at high risk of cardiovascular disease. However, in India, there has been poor uptake of Polypills despite market availability. Objectives This study sought to assess availability and cost of Polypills and explore barriers and facilitators to their use in the state of Andhra Pradesh in India. Methods A mixed-methods study was conducted. Availability and cost of Polypills as well as individual component drugs was assessed through a survey of pharmacies across urban, urban slum, and rural regions in state of Andhra Pradesh in India. In-depth interviews with stakeholders at each level of the health system explored barriers and facilitators to use of Polypills. Results Overall, 30 pharmacies were surveyed (10 in each of urban, urban slum, and rural region). In urban region, 2 pharmacies stocked Polypills (without aspirin) costing 121 Indian rupees (INR) per 10 pills, and 1 other pharmacy stocked a Polypill (with aspirin) costing 24 INR per 10 pills. All pharmacies stocked a wide range of component drugs as separate pills with combined cost of the cheapest angiotensin-converting enzyme inhibitor, statin, and aspirin INR 124 per 10 pills. Patients were willing to use Polypills if prescribed by their doctor, and pharmacies were willing to stock Polypills if there was market demand. For prescribers, key barriers included perceptions that current Polypills contained outdated drugs and inadequate flexibility in prescribing. Conclusions In a market in which Polypill use is licensed, their availability and use is very low. Lack of prescription of Polypills was the predominant barrier to Polypill use; therefore, making Polypills with drugs that are more acceptable and at different available strengths, in conjunction with broader prescriber education and training, may improve their use.
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impact of switching to Polypill based therapy by baseline potency of medication post hoc analysis of the space collaboration dataset
International Journal of Cardiology, 2017Co-Authors: Ruth Webster, Anushka Patel, Chris Bullen, Vanessa Selak, Sandrine Stepien, Simon Thom, Anthony RodgersAbstract:Abstract Background Fixed dose combinations of cardiovascular therapy (‘Polypills') have now been launched in several dozen countries. There is considerable clinical interest in the effects of switching to Polypill-based care from typical current treatment regimens, especially if Polypills contain components at sub-maximal dosage. Methods The SPACE Collaboration includes three trials of Polypill based care vs usual care in patients with established CVD or at high calculated risk. Individual patient data for 3140 trial participants were combined. Patients were categorized according to the potency of the statin and the number of BP lowering medications they were taking at baseline. Effects on adherence to anti-platelet medication, systolic blood pressure (SBP) and LDL cholesterol stratified by baseline potency of medication were determined using fixed effects models. Results Randomisation to the Polypill group was associated with improved SBP at 12months, but this improvement varied according to baseline BP regimen: −3.3, −5.9, −2.5 and +1mmHg for patients taking 0, 1, 2 and 3+ BP lowering medications at baseline. For changes in LDL cholesterol at 12months, significant improvements in LDL cholesterol were seen for those taking no statin (−0.21mmol/L; 95% CI: −0.34 to −0.07), less potent statin (−0.16mmol/L; 95% CI: −0.29 to −0.04) and equipotent statins (−0.14mmol/L; 95% CI −0.26 to −0.02) at baseline. Conclusion The adherence benefits of Polypills tend to offset the loss of potency from use of individual components with lower dose potency, and to facilitate improvements in multiple risk factors.
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impact of switching from different treatment regimens to a fixed dose combination pill Polypill in patients with cardiovascular disease or similarly high risk
European Journal of Preventive Cardiology, 2017Co-Authors: Melvin Lafeber, Ruth Webster, Anushka Patel, Wilko Spiering, Frank L J Visseren, Diederick E Grobbee, Michiel L Bots, Alice Stanton, Dorairaj Prabhakaran, Simon ThomAbstract:Aims Cardiovascular fixed-dose combination pills, or Polypills, may help address the widespread lack of access and adherence to proven medicines. Initiation of Polypill-based care typically entails switching from current separately taken medications. Given the heterogeneity in usual care, there is interest in the impact of Polypill treatment across different patterns of prior medication regimen. Methods A total of 2004 participants with established cardiovascular disease or estimated 5-year cardiovascular risk of over 15% were randomised to Polypill-based treatment (aspirin 75 mg, simvastatin 40 mg, lisinopril 10 mg and either atenolol 50 mg or hydrochlorothiazide 12.5 mg) or usual care. Baseline medications were classified by potency relative to Polypill components. Estimated cardiovascular risk reduction was calculated by combining risk factor changes with results seen in meta-analyses of previous randomised trials. Results For cholesterol reduction conferred by Polypills, there was a dose response across baseline statin groups, with mean low-density lipoprotein (LDL)-cholesterol differences of 0.37, 0.22, 0.14 and 0.07 mmol/L among patients taking no statin, less potent, equipotent and more potent statin at baseline, respectively. Similarly there were differences in mean systolic BP of 5.4, 6.2, 3.3 and 1.8 mmHg among patients taking 0, 1, 2 or 3 BP-lowering agents. Among patients taking more potent statins at baseline, there was no significant difference in LDL-cholesterol but there were benefits for BP and aspirin adherence. Similar results were seen among patients taking 3 BP-lowering agents at baseline. Switching to a Polypill-based strategy resulted in estimated cardiovascular relative risk reductions across a wide range of usual care patterns of antiplatelet, statin and BP-lowering therapy prescribing. Conclusion Adherence benefits from switching to a Polypill resulted in risk factor changes that were at least as good as usual care across a wide variety of treatment patterns, including equally potent or more potent regimens. The benefits of switching to Polypill-based care were greatest among those stepped up from partial treatment or less potent treatment.
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The Effect of a Cardiovascular Polypill Strategy on Pill Burden.
Cardiovascular therapeutics, 2015Co-Authors: Michael Truelove, David Peiris, Alan Cass, Anushka Patel, Severine Bompoint, Alex Brown, Graham S. Hillis, Natasha Rafter, Christopher M. Reid, Anthony RodgersAbstract:Aims Recent trials of cardiovascular Polypills in high-risk populations show improvements in the use of cardiovascular preventive treatments, compared to usual care. We describe patterns of pill burden in Australian practice, define the impact of Polypill therapy on pill burden, and explore how physicians add medication to Polypill therapy. Methods The Kanyini Guidelines Adherence with the Polypill Study was an open-label trial involving 623 participants in Australia which randomized participants to a Polypill strategy (containing a statin, antiplatelet agent, and two blood-pressure-lowering medications) or usual care. Participants either had established cardiovascular disease or were at high calculated risk (≥15% over 5 years). Current medications, daily pill burden, and self-reported use of combination treatment were recorded prior to randomization and at study end. Median pill burden at baseline and study end was compared in both arms. Subgroup analysis of the Polypill strategy on trial primary outcomes was conducted by pill burden at baseline. Results Median total and cardiovascular pill burdens of the Polypill group decreased from 7 to 5 and from 4 to 2, respectively (median change −2; IQR −3, 0), with no change in the usual care group (comparison of change; P Conclusion A cardiovascular Polypill in contemporary Australian practice reduces cardiovascular and total pill burdens, despite frequent prescription of additional medications.
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patients and providers perspectives of a Polypill strategy to improve cardiovascular prevention in australian primary health care a qualitative study set within a pragmatic randomized controlled trial
Circulation-cardiovascular Quality and Outcomes, 2015Co-Authors: Hueiming Liu, Tim Usherwood, David Peiris, Julie Redfern, Tracey Laba, Alan Cass, Anushka Patel, Luciana Massi, Annemarie Eades, Noel HaymanAbstract:Background—This study explores health provider and patient attitudes toward the use of a cardiovascular Polypill as a health service strategy to improve cardiovascular prevention. Methods and Results—In-depth, semistructured interviews (n=94) were conducted with health providers and patients from Australian general practice, Aboriginal community-controlled and government-run Indigenous Health Services participating in a pragmatic randomized controlled trial evaluating a Polypill-based strategy for high-risk primary and secondary cardiovascular disease prevention. Interview topics included Polypill strategy acceptability, factors affecting adherence, and trial implementation. Transcribed interview data were analyzed thematically and interpretively. Polypill patients commented frequently on cost-savings, ease, and convenience of a daily-dosing pill. Most providers considered a Polypill strategy to facilitate improved patient medication use. Indigenous Health Services providers and indigenous patients though...