Polypill for Cardiovascular Disease Prevention in an Underserved Population.

Adult Alabama Amlodipine / administration & dosage Antihypertensive Agents / administration & dosage Atorvastatin / administration & dosage Cholesterol, LDL / blood Community Health Centers Drug Combinations Female Humans Hydrochlorothiazide / administration & dosage Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage Hypercholesterolemia / blood Hypertension / complications Losartan / administration & dosage Male Medically Underserved Area Medication Adherence / statistics & numerical data Middle Aged

Journal

The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562

Informations de publication

Date de publication:
19 09 2019
Historique:
entrez: 19 9 2019
pubmed: 19 9 2019
medline: 27 9 2019
Statut: ppublish

Résumé

Persons 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. We 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. The 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). A 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.).

Sections du résumé

BACKGROUND
Persons 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.
METHODS
We 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.
RESULTS
The 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).
CONCLUSIONS
A 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.).

Identifiants

DOI: 10.1056/NEJMoa1815359 PMID: 31532959 PMC: PMC6938029
pubmed: 31532959
doi: 10.1056/NEJMoa1815359
pmc: PMC6938029
mid: NIHMS1064213
doi:

Substances chimiques

Antihypertensive Agents 0
Cholesterol, LDL 0
Drug Combinations 0
Hydroxymethylglutaryl-CoA Reductase Inhibitors 0
Hydrochlorothiazide 0J48LPH2TH
Amlodipine 1J444QC288
Atorvastatin A0JWA85V8F
Losartan JMS50MPO89

Banques de données

ClinicalTrials.gov
['NCT02278471']

Types de publication

Comparative Study Journal Article Randomized Controlled Trial Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1114-1123

Subventions

Organisme : NHLBI NIH HHS
ID : K08 HL145075
Pays : United States
Organisme : NCI NIH HHS
ID : U01 CA202979
Pays : United States
Organisme : NIH HHS
ID : U01-CA202979
Pays : United States
Organisme : American Heart Association
ID : Strategically Funded Research Network grant - Prev
Pays : International

Commentaires et corrections

Type : CommentIn
Type : CommentIn
Type : CommentIn

Informations de copyright

Copyright © 2019 Massachusetts Medical Society.

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Auteurs

Daniel Muñoz (D)

From 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 Uzoije (P)

From 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 Reynolds (C)

From 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 Miller (R)

From 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 Walkley (D)

From 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 Pappalardo (S)

From 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 Tousey (P)

From 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 Munro (H)

From 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 Gonzales (H)

From 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 Song (W)

From 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 White (C)

From 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 Blot (WJ)

From 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 Wang (TJ)

From 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.).

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Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Polypill for Cardiovascular Disease Prevention...
questionsmedicales.fr › Régions géographiques › Amériques › Amérique du Nord › États-Unis › États du Sud-Est des États-Unis › Alabama › Polypill for Cardiovascular Disease Prevention...
questionsmedicales.fr › Composés hétérocycliques › Composés hétéromonocycliques › Pyridines › Dihydropyridines › Amlodipine › Polypill for Cardiovascular Disease Prevention...
questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Utilisations thérapeutiques › Agents cardiovasculaires › Antihypertenseurs › Polypill for Cardiovascular Disease Prevention...
questionsmedicales.fr › Lipides › Acides gras › Acides heptanoïques › Atorvastatine › Polypill for Cardiovascular Disease Prevention...
questionsmedicales.fr › Acides aminés, peptides et protéines › Protéines › Lipoprotéines › Lipoprotéines LDL › Cholestérol LDL › Polypill for Cardiovascular Disease Prevention...
questionsmedicales.fr › Établissements, main d'oeuvre et services de soins de santé › Établissements de santé › Établissements de soins ambulatoires › Centres de santé communautaires › Polypill for Cardiovascular Disease Prevention...
questionsmedicales.fr › Préparations pharmaceutiques › Association médicamenteuse › Polypill for Cardiovascular Disease Prevention...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Polypill for Cardiovascular Disease Prevention...
questionsmedicales.fr › Composés hétérocycliques › Composés hétérocycliques à cycles fusionnés › Composés hétérobicycliques › Benzothiadiazines › Chlorothiazide › Hydrochlorothiazide › Polypill for Cardiovascular Disease Prevention...
questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Utilisations thérapeutiques › Agents régulateurs du métabolisme des lipides › Hypolipémiants › Anticholestérolémiants › Inhibiteurs de l'hydroxyméthylglutaryl-CoA réductase › Polypill for Cardiovascular Disease Prevention...
questionsmedicales.fr › Maladies métaboliques et nutritionnelles › Maladies métaboliques › Troubles du métabolisme lipidique › Dyslipidémies › Hyperlipidémies › Hypercholestérolémie › Polypill for Cardiovascular Disease Prevention...
questionsmedicales.fr › Maladies cardiovasculaires › Maladies vasculaires › Hypertension artérielle › Polypill for Cardiovascular Disease Prevention...
questionsmedicales.fr › Composés hétérocycliques › Composés hétéromonocycliques › Azoles › Tétrazoles › Losartan › Polypill for Cardiovascular Disease Prevention...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Prestations des soins de santé › Besoins et demandes de services de santé › Zone médicalement sous-équipée › Polypill for Cardiovascular Disease Prevention...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Prestations des soins de santé › Attitude envers la santé › Adhésion et observance thérapeutiques › Acceptation des soins par les patients › Observance par le patient › Adhésion au traitement médicamenteux › Polypill for Cardiovascular Disease Prevention...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Adulte d'âge moyen › Polypill for Cardiovascular Disease Prevention...