Evidence map›Paper›PMID 31532959›Full record

Trial reportThe New England journal of medicine2019

Polypill for Cardiovascular Disease Prevention in an Underserved Population.

Daniel Muñoz, Prince Uzoije, Cassandra Reynolds, Roslynn Miller, David Walkley, Susan Pappalardo, Phyllis Tousey, Heather Munro, Holly Gonzales, Wenliang Song and 3 more

3 registry-linked trialsOpen access · bronzeAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02278471. Cited by 80 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
80citing papers in PubMed, 4 pooled it
19.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02278471 phase2completed

The SCCS Polypill Pilot Trial

Ran2015Enrolled303Registered outcomes9Posted comparisons0ConditionsHyperlipidemia, HypertensionArmsPolypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide)
Open the trial in the graph
NCT05514938 phase2completednot on this mapstarted 2022, after this paper: background citation

Polypill Strategy for Evidence-Based Management of Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention in an Underserved Patient Population

TypeinterventionalSponsorUniversity of Texas Southwestern Medical CenterRan2022 to 2025Enrolled140ConditionsAcute Coronary Syndrome, Lipid Disorder, Coronary Artery DiseaseArmsPolypill, Usual Care (individual medications prescribed by primary cardiologist)
NCT06029712 phase2completednot on this mapstarted 2024, after this paper: background citation

Developing a Heart Failure Polypill to Improve Outcomes at a Safety Net Hospital: A Pilot Crossover Randomized Controlled Trial

TypeinterventionalSponsorUniversity of California, San FranciscoRan2024 to 2025Enrolled35ConditionsHeart Failure With Reduced Ejection Fraction, HIV InfectionsArmsHeart failure polypill, Control Rx
3 · Its place in the literature

Who cites it

80 citing papers in PubMed, 4 syntheses or guidelines pooled it, 185 citations in OpenAlex.

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20 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 1 institution in 1 country.

Daniel MuñozFrom the Vanderbilt Translational and Clinical Cardiovascular Research Center (D.M., C.R., T.J.W.), the Division of Cardiovascular Medicine (D.M., C.R., H.G., W.S., T.J.W.), the Division of Epidemiology, Department of Medicine, and Vanderbilt Institute for Clinical and Translational Research (D.W., S.P., P.T., H.M., W.J.B.), Vanderbilt University Medical Center, Vanderbilt University, Nashville; and Franklin Primary Health Center, Mobile, AL (P.U., R.M., C.W.).
Prince UzoijeFrom the Vanderbilt Translational and Clinical Cardiovascular Research Center (D.M., C.R., T.J.W.), the Division of Cardiovascular Medicine (D.M., C.R., H.G., W.S., T.J.W.), the Division of Epidemiology, Department of Medicine, and Vanderbilt Institute for Clinical and Translational Research (D.W., S.P., P.T., H.M., W.J.B.), Vanderbilt University Medical Center, Vanderbilt University, Nashville; and Franklin Primary Health Center, Mobile, AL (P.U., R.M., C.W.).
Cassandra ReynoldsFrom the Vanderbilt Translational and Clinical Cardiovascular Research Center (D.M., C.R., T.J.W.), the Division of Cardiovascular Medicine (D.M., C.R., H.G., W.S., T.J.W.), the Division of Epidemiology, Department of Medicine, and Vanderbilt Institute for Clinical and Translational Research (D.W., S.P., P.T., H.M., W.J.B.), Vanderbilt University Medical Center, Vanderbilt University, Nashville; and Franklin Primary Health Center, Mobile, AL (P.U., R.M., C.W.).
Roslynn MillerFrom the Vanderbilt Translational and Clinical Cardiovascular Research Center (D.M., C.R., T.J.W.), the Division of Cardiovascular Medicine (D.M., C.R., H.G., W.S., T.J.W.), the Division of Epidemiology, Department of Medicine, and Vanderbilt Institute for Clinical and Translational Research (D.W., S.P., P.T., H.M., W.J.B.), Vanderbilt University Medical Center, Vanderbilt University, Nashville; and Franklin Primary Health Center, Mobile, AL (P.U., R.M., C.W.).
David WalkleyFrom the Vanderbilt Translational and Clinical Cardiovascular Research Center (D.M., C.R., T.J.W.), the Division of Cardiovascular Medicine (D.M., C.R., H.G., W.S., T.J.W.), the Division of Epidemiology, Department of Medicine, and Vanderbilt Institute for Clinical and Translational Research (D.W., S.P., P.T., H.M., W.J.B.), Vanderbilt University Medical Center, Vanderbilt University, Nashville; and Franklin Primary Health Center, Mobile, AL (P.U., R.M., C.W.).
Susan PappalardoFrom the Vanderbilt Translational and Clinical Cardiovascular Research Center (D.M., C.R., T.J.W.), the Division of Cardiovascular Medicine (D.M., C.R., H.G., W.S., T.J.W.), the Division of Epidemiology, Department of Medicine, and Vanderbilt Institute for Clinical and Translational Research (D.W., S.P., P.T., H.M., W.J.B.), Vanderbilt University Medical Center, Vanderbilt University, Nashville; and Franklin Primary Health Center, Mobile, AL (P.U., R.M., C.W.).
Phyllis TouseyFrom the Vanderbilt Translational and Clinical Cardiovascular Research Center (D.M., C.R., T.J.W.), the Division of Cardiovascular Medicine (D.M., C.R., H.G., W.S., T.J.W.), the Division of Epidemiology, Department of Medicine, and Vanderbilt Institute for Clinical and Translational Research (D.W., S.P., P.T., H.M., W.J.B.), Vanderbilt University Medical Center, Vanderbilt University, Nashville; and Franklin Primary Health Center, Mobile, AL (P.U., R.M., C.W.).
Heather MunroFrom the Vanderbilt Translational and Clinical Cardiovascular Research Center (D.M., C.R., T.J.W.), the Division of Cardiovascular Medicine (D.M., C.R., H.G., W.S., T.J.W.), the Division of Epidemiology, Department of Medicine, and Vanderbilt Institute for Clinical and Translational Research (D.W., S.P., P.T., H.M., W.J.B.), Vanderbilt University Medical Center, Vanderbilt University, Nashville; and Franklin Primary Health Center, Mobile, AL (P.U., R.M., C.W.).
Holly GonzalesFrom the Vanderbilt Translational and Clinical Cardiovascular Research Center (D.M., C.R., T.J.W.), the Division of Cardiovascular Medicine (D.M., C.R., H.G., W.S., T.J.W.), the Division of Epidemiology, Department of Medicine, and Vanderbilt Institute for Clinical and Translational Research (D.W., S.P., P.T., H.M., W.J.B.), Vanderbilt University Medical Center, Vanderbilt University, Nashville; and Franklin Primary Health Center, Mobile, AL (P.U., R.M., C.W.).
Wenliang SongFrom the Vanderbilt Translational and Clinical Cardiovascular Research Center (D.M., C.R., T.J.W.), the Division of Cardiovascular Medicine (D.M., C.R., H.G., W.S., T.J.W.), the Division of Epidemiology, Department of Medicine, and Vanderbilt Institute for Clinical and Translational Research (D.W., S.P., P.T., H.M., W.J.B.), Vanderbilt University Medical Center, Vanderbilt University, Nashville; and Franklin Primary Health Center, Mobile, AL (P.U., R.M., C.W.).
Charles WhiteFrom the Vanderbilt Translational and Clinical Cardiovascular Research Center (D.M., C.R., T.J.W.), the Division of Cardiovascular Medicine (D.M., C.R., H.G., W.S., T.J.W.), the Division of Epidemiology, Department of Medicine, and Vanderbilt Institute for Clinical and Translational Research (D.W., S.P., P.T., H.M., W.J.B.), Vanderbilt University Medical Center, Vanderbilt University, Nashville; and Franklin Primary Health Center, Mobile, AL (P.U., R.M., C.W.).
William J BlotFrom the Vanderbilt Translational and Clinical Cardiovascular Research Center (D.M., C.R., T.J.W.), the Division of Cardiovascular Medicine (D.M., C.R., H.G., W.S., T.J.W.), the Division of Epidemiology, Department of Medicine, and Vanderbilt Institute for Clinical and Translational Research (D.W., S.P., P.T., H.M., W.J.B.), Vanderbilt University Medical Center, Vanderbilt University, Nashville; and Franklin Primary Health Center, Mobile, AL (P.U., R.M., C.W.).
Thomas J WangFrom the Vanderbilt Translational and Clinical Cardiovascular Research Center (D.M., C.R., T.J.W.), the Division of Cardiovascular Medicine (D.M., C.R., H.G., W.S., T.J.W.), the Division of Epidemiology, Department of Medicine, and Vanderbilt Institute for Clinical and Translational Research (D.W., S.P., P.T., H.M., W.J.B.), Vanderbilt University Medical Center, Vanderbilt University, Nashville; and Franklin Primary Health Center, Mobile, AL (P.U., R.M., C.W.).
Vanderbilt University Medical Center · US

Funding

Southern Community Cohort StudyU01CA202979 · NCI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI BLOT, WILLIAM J., SHRUBSOLE, MARTHA J. · 2016 to 2025
$22.0M
Impact of Dysfunctional HDL on Platelet Function and in vivo ThrombosisK08HL145075 · NHLBI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI SONG, WENLIANG · 2019 to 2022
$635k
American Heart Association Strategically Funded Research Network grant - PrevNCI NIH HHS U01 CA202979NHLBI NIH HHS K08 HL145075NIH HHS U01-CA202979
6 · The paper itself

Abstract

backgroundPersons with low socioeconomic status and nonwhite persons in the United States have high rates of cardiovascular disease. The use of combination pills (also called "polypills") containing low doses of medications with proven benefits for the prevention of cardiovascular disease may be beneficial in such persons. However, few data are available regarding the use of polypill therapy in underserved communities in the United States, in which adherence to guideline-based care is generally low.

methodsWe conducted a randomized, controlled trial involving adults without cardiovascular disease. Participants were assigned to the polypill group or the usual-care group at a federally qualified community health center in Alabama. Components of the polypill were atorvastatin (at a dose of 10 mg), amlodipine (2.5 mg), losartan (25 mg), and hydrochlorothiazide (12.5 mg). The two primary outcomes were the changes from baseline in systolic blood pressure and low-density lipoprotein (LDL) cholesterol level at 12 months.

resultsThe trial enrolled 303 adults, of whom 96% were black. Three quarters of the participants had an annual income below $15,000. The mean estimated 10-year cardiovascular risk was 12.7%, the baseline blood pressure was 140/83 mm Hg, and the baseline LDL cholesterol level was 113 mg per deciliter. The monthly cost of the polypill was $26. At 12 months, adherence to the polypill regimen, as assessed on the basis of pill counts, was 86%. The mean systolic blood pressure decreased by 9 mm Hg in the polypill group, as compared with 2 mm Hg in the usual-care group (difference, -7 mm Hg; 95% confidence interval [CI], -12 to -2; P = 0.003). The mean LDL cholesterol level decreased by 15 mg per deciliter in the polypill group, as compared with 4 mg per deciliter in the usual-care group (difference, -11 mg per deciliter; 95% CI, -18 to -5; P<0.001).

conclusionsA polypill-based strategy led to greater reductions in systolic blood pressure and LDL cholesterol level than were observed with usual care in a socioeconomically vulnerable minority population. (Funded by the American Heart Association Strategically Focused Prevention Research Network and the National Institutes of Health; ClinicalTrials.gov number, NCT02278471.).

Indexed as

Drug CombinationsDrug MonitoringMedically Underserved AreaAdultAlabamaAmlodipineAntihypertensive AgentsAtorvastatinCholesterol, LDLCommunity Health CentersFemaleHumansHydrochlorothiazideHydroxymethylglutaryl-CoA Reductase InhibitorsHypercholesterolemiaHypertensionAmlodipineAntihypertensive AgentsAtorvastatinCholesterol, LDLDrug CombinationsHydrochlorothiazideHydroxymethylglutaryl-CoA Reductase InhibitorsLosartan

Identifiers

PMID31532959
PMCPMC6938029
OpenAlexW2973824785

What Socratic holds

Texttitle and abstract
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.