The Concept of the Polypill in the Prevention of Cardiovascular
                        Disease

Wiley, Brandon M.; Fuster, Valentín

doi:10.1016/j.aogh.2013.12.008

Cited by 26 publications

(23 citation statements)

References 38 publications

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“…There is high-quality evidence to support use of aspirin, ACEIs/ARBs, β blockers and statins in secondary prevention of CVD. 9 42 However, a recent analysis of Cochrane reviews and RCTs in non-communicable diseases (including CVD) showed that almost 90% of trials and over 80% of participants were from high-income countries, 43 and our analysis further highlights the sparse data for policymakers to make evidence-based changes to improve adherence to secondary prevention medications for CVD, particularly in low-income settings. The overall quality of evidence is low by objective criteria, 44 due to lack of directness of evidence, heterogeneity across studies and only 12 (48%) of the 25 included studies being RCTs.…”

Section: Discussionmentioning

confidence: 80%

Health system barriers and facilitators to medication adherence for the secondary prevention of cardiovascular disease: a systematic review

et al. 2016

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BackgroundSecondary prevention is cost-effective for cardiovascular disease (CVD), but uptake is suboptimal. Understanding barriers and facilitators to adherence to secondary prevention for CVD at multiple health system levels may inform policy.ObjectivesTo conduct a systematic review of barriers and facilitators to adherence/persistence to secondary CVD prevention medications at health system level.MethodsIncluded studies reported effects of health system level factors on adherence/persistence to secondary prevention medications for CVD (coronary artery or cerebrovascular disease). Studies considered at least one of β blockers, statins, angiotensin–renin system blockers and aspirin. Relevant databases were searched from 1 January 1966 until 1 October 2015. Full texts were screened for inclusion by 2 independent reviewers.ResultsOf 2246 screened articles, 25 studies were included (12 trials, 11 cohort studies, 1 cross-sectional study and 1 case–control study) with 132 140 individuals overall (smallest n=30, largest n=63 301). 3 studies included upper middle-income countries, 1 included a low middle-income country and 21 (84%) included high-income countries (9 in the USA). Studies concerned established CVD (n=4), cerebrovascular disease (n=7) and coronary heart disease (n=14). Three studies considered persistence and adherence. Quantity and quality of evidence was limited for adherence, persistence and across drug classes. Studies were concerned with governance and delivery (n=19, including 4 trials of fixed-dose combination therapy, FDC), intellectual resources (n=1), human resources (n=1) and health system financing (n=4). Full prescription coverage, reduced copayments, FDC and counselling were facilitators associated with higher adherence.ConclusionsHigh-quality evidence on health system barriers and facilitators to adherence to secondary prevention medications for CVD is lacking, especially for low-income settings. Full prescription coverage, reduced copayments, FDC and counselling may be effective in improving adherence and are priorities for further research.

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Section: Discussionmentioning

confidence: 80%

Health system barriers and facilitators to medication adherence for the secondary prevention of cardiovascular disease: a systematic review

et al. 2016

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“…The simplification of treatment through the combination of different drugs into a singlepill markedly raises medication persistence in patients with chronic conditions [43]. This may be particularly important, but not solely limited, to those countries lacking adequate healthcare infrastructure [44]. Combining acetylsalicylic acid, BP lowering drugs and statins may provide substantial risk factor reductions, and improve medication adherence in the prevention of cardiovascular disease, without any increase of safety concerns [45].…”

Section: • Importance Of Medication Adherencementioning

confidence: 99%

Improving Cardiovascular Protection: Focus On a Cardiovascular Polypill

Barrios

Escobar

2015

Future Cardiol.

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Lack of adherence may explain, at least in part, the poor cardiovascular risk factors control observed in patients with ischemic heart disease, increasing the risk of developing new events. Polypill improves medication adherence, which may actually reduce blood pressure and LDL cholesterol compared with the drugs given separately. The fixed combination of acetylsalicylic acid 100 mg + ramipril 2.5, 5, or 10 mg + either simvastatin 40 mg or atorvastatin 20 mg is the unique cardiovascular polypill that has been registered in 22 countries worldwide. The polypill-containing simvastatin has been specifically tested in a clinical trial including only patients with ischemic heart disease. The FOCUS study showed that patients treated with the polypill showed a higher adherence compared with those receiving separate medications.

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“…Fixed-dose combination pills, also known as “polypills,” containing generic drugs: aspirin, a statin and blood pressure (BP)-lowering medication(s) may be a viable low-cost avenue to broadly improve medication adherence and consequently reduce further disability or death on a large scale among stroke survivors in SSA [ 39 – 54 ]. The principal objectives for the polypill strategy are improving drug adherence by reducing pill burden and thereby improving risk factor control and potentially reducing vascular event risk as a cost-effective intervention [ 44 ].…”

Section: Introductionmentioning

confidence: 99%

Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART): study protocol for a randomized controlled trial

Sarfo

Sarfo‐Kantanka

Adamu

et al. 2018

Trials

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BackgroundThere is an unprecedented rise in the prevalence of stroke in sub-Saharan Africa (SSA). Secondary prevention guidelines recommend that antihypertensive, statin and antiplatelet therapy be initiated promptly after ischemic stroke and adhered to in a persistent fashion to achieve optimal vascular-risk reduction. However, these goals are seldom realized in routine clinical care settings in SSA due to logistical challenges.We seek to assess whether a polypill containing fixed doses of three antihypertensive agents, a statin and antiplatelet therapy taken once daily per os for 12 months among recent stroke survivors would result in carotid intimal thickness regression compared with usual care (UC).MethodsThe Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART) trial is a phase 2, open-label, evaluator-blinded trial involving 120 Ghanaian recent-ischemic-stroke survivors. Using a computer-generated sequence, patients will be randomly allocated 1:1 into either the intervention arm or UC. Patients in the intervention arm will receive Polycap DS® (containing aspirin, 100 mg; atenolol, 50 mg; ramipril, 5 mg; thiazide, 12.5 mg; simvastatin, 20 mg) taken as two capsules once daily. Patients in the UC will receive separate, individual secondary preventive medications prescribed at the physician’s discretion. Both groups will be followed for 12 months to assess changes in carotid intimal thickness regression – a surrogate marker of atherosclerosis – as primary outcome measure. Secondary outcome measures include adherence to therapy, safety and tolerability, health-related quality of life, patient satisfaction, functional status, depression and cognitive dysfunction.DiscussionAn efficacy-suggesting SMAART trial could inform the future design of a multi-center, double-blinded, placebo-controlled, parallel-group, randomized controlled trial comparing the clinical efficacy of the polypill strategy for vascular risk moderation among stroke survivors in SSA.Trial registrationClinicalTrials.gov, ID: NCT03329599. Registered on 11 February 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2564-0) contains supplementary material, which is available to authorized users.

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The Concept of the Polypill in the Prevention of Cardiovascular Disease

Cited by 26 publications

References 38 publications

Health system barriers and facilitators to medication adherence for the secondary prevention of cardiovascular disease: a systematic review

Health system barriers and facilitators to medication adherence for the secondary prevention of cardiovascular disease: a systematic review

Improving Cardiovascular Protection: Focus On a Cardiovascular Polypill

Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART): study protocol for a randomized controlled trial

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