Effectiveness of chlorthalidone/amiloride versus losartan in patients with stage I hypertension and diabetes mellitus: results from the PREVER-treatment randomized controlled trial

Detalhes bibliográficos
Autor(a) principal: Fuchs, Flávio D.
Data de Publicação: 2021
Outros Autores: Scala, Luiz C. N., Vilela-Martin, José F., Whelton, Paul K., Poli-de-Figueiredo, Carlos E., Pereira E Silva, Ricardo, Gus, Miguel, Bortolotto, Luiz A., Consolim-Colombo, Fernanda M., Schlatter, Rosane P., Cesarino, José E., Castro, Iran, Figueiredo Neto, José A., Chaves, Hilton, Steffens, André A., Alves, João G., Brandão, Andréa A., de Sousa, Marcos R., Jardim, Paulo C., Moreira, Leila B., Franco, Roberto S. [UNESP], Gomes, Marco M., Afiune Neto, Abrahão, Fuchs, Felipe C., Sobral Filho, Dario C., Nóbrega, Antônio C., Nobre, Fernando, Berwanger, Otávio, Fuchs, Sandra C.
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UNESP
Texto Completo: http://dx.doi.org/10.1007/s00592-020-01611-8
http://hdl.handle.net/11449/221581
Resumo: Aims: To compare the blood pressure (BP)-lowering efficacy of a chlorthalidone/amiloride combination pill with losartan, during initial management of JNC 7 Stage I hypertension in patients with type 2 diabetes mellitus. Methods: In an a priori subgroup analysis of a randomized, double-blind, controlled trial, volunteers aged 30–70 years, with stage I hypertension and diabetes mellitus, were randomized to 12.5/2.5 mg of chlorthalidone/amiloride (N = 47) or 50 mg of losartan (N = 50), and followed for 18 months in 21 clinical centers. If BP remained uncontrolled after three months, study medication dose was doubled, and if uncontrolled after six months, amlodipine (5 and 10 mg) and propranolol (40 and 80 mg BID) were added as open label drugs in a progressive fashion. Results: Systolic BP decreased to a greater extent in participants allocated to diuretics compared to losartan (P < 0.001). After 18 months of follow-up, systolic BP was 128.4 ± 10.3 mmHg in the diuretic group versus 133.5 ± 8.0 in the losartan group (P < 0.01). In the diuretic group, 36 out of 43 participants (83.7%) had a JNC 7 normal BP, compared to 31/47 (66%) in the losartan group (P = 0.089). Serum cholesterol was higher in the diuretic arm at the end of the trial. Other biochemical parameters and reports of adverse events did not differ by treatment. Conclusions: Treatment of hypertension based on a combination of chlorthalidone and amiloride is more effective for BP lowering compared to losartan in patients with diabetes mellitus and hypertension. Trial registration: Clinical trials registration number: NCT00971165
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spelling Effectiveness of chlorthalidone/amiloride versus losartan in patients with stage I hypertension and diabetes mellitus: results from the PREVER-treatment randomized controlled trialAmilorideChlorthalidoneDiabetesDrug treatmentHypertensionLosartanAims: To compare the blood pressure (BP)-lowering efficacy of a chlorthalidone/amiloride combination pill with losartan, during initial management of JNC 7 Stage I hypertension in patients with type 2 diabetes mellitus. Methods: In an a priori subgroup analysis of a randomized, double-blind, controlled trial, volunteers aged 30–70 years, with stage I hypertension and diabetes mellitus, were randomized to 12.5/2.5 mg of chlorthalidone/amiloride (N = 47) or 50 mg of losartan (N = 50), and followed for 18 months in 21 clinical centers. If BP remained uncontrolled after three months, study medication dose was doubled, and if uncontrolled after six months, amlodipine (5 and 10 mg) and propranolol (40 and 80 mg BID) were added as open label drugs in a progressive fashion. Results: Systolic BP decreased to a greater extent in participants allocated to diuretics compared to losartan (P < 0.001). After 18 months of follow-up, systolic BP was 128.4 ± 10.3 mmHg in the diuretic group versus 133.5 ± 8.0 in the losartan group (P < 0.01). In the diuretic group, 36 out of 43 participants (83.7%) had a JNC 7 normal BP, compared to 31/47 (66%) in the losartan group (P = 0.089). Serum cholesterol was higher in the diuretic arm at the end of the trial. Other biochemical parameters and reports of adverse events did not differ by treatment. Conclusions: Treatment of hypertension based on a combination of chlorthalidone and amiloride is more effective for BP lowering compared to losartan in patients with diabetes mellitus and hypertension. Trial registration: Clinical trials registration number: NCT00971165Hospital de Clínicas de Porto AlegreDivision of Cardiology Hospital de Clínicas de Porto Alegre Universidade Federal do Rio Grande Do Sul INCT PREVER, CPC, 5º. and Ramiro Barcelos, 2350Hospital Universitário Júlio Müller Universidade Federal de Mato GrossoFaculdade de Medicina São José Do Rio PretoDepartment of Epidemiology School of Public Health and Tropical Medicine Tulane UniversityFaculdade de Medicina Hospital São Lucas PUCRSHospital Universitário Walter Cantídio Universidade Federal do CearáFaculdade de Medicina Instituto do Coração Universidade de São PauloHospital de Clínicas de Porto Alegre Universidade Federal do Rio Grande Do SulFaculdade de Ciências Farmacêuticas USP Ribeirão PretoInstituto de Cardiologia, Av. Princesa IsabelHospital Universitário Universidade Federal do MaranhãoUniversidade Federal de PernambucoUniversidade Federal de PelotasInstituto de Medicina Integral Prof Fernando FigueiraUniversidade Do Estado do Rio de JaneiroHospital das Clínicas da Universidade Federal de Minas GeraisHospital das Clínicas de Goiânia Universidade Federal de GoiásFaculdade de Medicina de BotucatuHospital do Coração de AlagoasAnis Rassi HospitalHospital Universitário ProcapeHospital Universitário Antônio Pedro UFFFaculdade de Medicina de Ribeirão Preto USP Ribeirão PretoInstituto de Pesquisa Hospital Israelita Albert EinsteinFaculdade de Medicina de BotucatuHospital de Clínicas de Porto Alegre: GPPG: 08-621INCT PREVERUniversidade Federal de Mato GrossoFaculdade de Medicina São José Do Rio PretoTulane UniversityPUCRSUniversidade Federal do CearáUniversidade de São Paulo (USP)Universidade Federal do Rio Grande Do SulInstituto de CardiologiaHospital Universitário Universidade Federal do MaranhãoUniversidade Federal de Pernambuco (UFPE)Universidade Federal de PelotasInstituto de Medicina Integral Prof Fernando FigueiraUniversidade do Estado do Rio de Janeiro (UERJ)Universidade Federal de Minas Gerais (UFMG)Universidade Federal de Goiás (UFG)Universidade Estadual Paulista (UNESP)Hospital do Coração de AlagoasAnis Rassi HospitalHospital Universitário ProcapeUFFHospital Israelita Albert EinsteinFuchs, Flávio D.Scala, Luiz C. N.Vilela-Martin, José F.Whelton, Paul K.Poli-de-Figueiredo, Carlos E.Pereira E Silva, RicardoGus, MiguelBortolotto, Luiz A.Consolim-Colombo, Fernanda M.Schlatter, Rosane P.Cesarino, José E.Castro, IranFigueiredo Neto, José A.Chaves, HiltonSteffens, André A.Alves, João G.Brandão, Andréa A.de Sousa, Marcos R.Jardim, Paulo C.Moreira, Leila B.Franco, Roberto S. [UNESP]Gomes, Marco M.Afiune Neto, AbrahãoFuchs, Felipe C.Sobral Filho, Dario C.Nóbrega, Antônio C.Nobre, FernandoBerwanger, OtávioFuchs, Sandra C.2022-04-28T19:29:26Z2022-04-28T19:29:26Z2021-02-01info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article215-220http://dx.doi.org/10.1007/s00592-020-01611-8Acta Diabetologica, v. 58, n. 2, p. 215-220, 2021.1432-52330940-5429http://hdl.handle.net/11449/22158110.1007/s00592-020-01611-82-s2.0-85092361547Scopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengActa Diabetologicainfo:eu-repo/semantics/openAccess2022-04-28T19:29:26Zoai:repositorio.unesp.br:11449/221581Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-08-05T14:49:45.950012Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false
dc.title.none.fl_str_mv Effectiveness of chlorthalidone/amiloride versus losartan in patients with stage I hypertension and diabetes mellitus: results from the PREVER-treatment randomized controlled trial
title Effectiveness of chlorthalidone/amiloride versus losartan in patients with stage I hypertension and diabetes mellitus: results from the PREVER-treatment randomized controlled trial
spellingShingle Effectiveness of chlorthalidone/amiloride versus losartan in patients with stage I hypertension and diabetes mellitus: results from the PREVER-treatment randomized controlled trial
Fuchs, Flávio D.
Amiloride
Chlorthalidone
Diabetes
Drug treatment
Hypertension
Losartan
title_short Effectiveness of chlorthalidone/amiloride versus losartan in patients with stage I hypertension and diabetes mellitus: results from the PREVER-treatment randomized controlled trial
title_full Effectiveness of chlorthalidone/amiloride versus losartan in patients with stage I hypertension and diabetes mellitus: results from the PREVER-treatment randomized controlled trial
title_fullStr Effectiveness of chlorthalidone/amiloride versus losartan in patients with stage I hypertension and diabetes mellitus: results from the PREVER-treatment randomized controlled trial
title_full_unstemmed Effectiveness of chlorthalidone/amiloride versus losartan in patients with stage I hypertension and diabetes mellitus: results from the PREVER-treatment randomized controlled trial
title_sort Effectiveness of chlorthalidone/amiloride versus losartan in patients with stage I hypertension and diabetes mellitus: results from the PREVER-treatment randomized controlled trial
author Fuchs, Flávio D.
author_facet Fuchs, Flávio D.
Scala, Luiz C. N.
Vilela-Martin, José F.
Whelton, Paul K.
Poli-de-Figueiredo, Carlos E.
Pereira E Silva, Ricardo
Gus, Miguel
Bortolotto, Luiz A.
Consolim-Colombo, Fernanda M.
Schlatter, Rosane P.
Cesarino, José E.
Castro, Iran
Figueiredo Neto, José A.
Chaves, Hilton
Steffens, André A.
Alves, João G.
Brandão, Andréa A.
de Sousa, Marcos R.
Jardim, Paulo C.
Moreira, Leila B.
Franco, Roberto S. [UNESP]
Gomes, Marco M.
Afiune Neto, Abrahão
Fuchs, Felipe C.
Sobral Filho, Dario C.
Nóbrega, Antônio C.
Nobre, Fernando
Berwanger, Otávio
Fuchs, Sandra C.
author_role author
author2 Scala, Luiz C. N.
Vilela-Martin, José F.
Whelton, Paul K.
Poli-de-Figueiredo, Carlos E.
Pereira E Silva, Ricardo
Gus, Miguel
Bortolotto, Luiz A.
Consolim-Colombo, Fernanda M.
Schlatter, Rosane P.
Cesarino, José E.
Castro, Iran
Figueiredo Neto, José A.
Chaves, Hilton
Steffens, André A.
Alves, João G.
Brandão, Andréa A.
de Sousa, Marcos R.
Jardim, Paulo C.
Moreira, Leila B.
Franco, Roberto S. [UNESP]
Gomes, Marco M.
Afiune Neto, Abrahão
Fuchs, Felipe C.
Sobral Filho, Dario C.
Nóbrega, Antônio C.
Nobre, Fernando
Berwanger, Otávio
Fuchs, Sandra C.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv INCT PREVER
Universidade Federal de Mato Grosso
Faculdade de Medicina São José Do Rio Preto
Tulane University
PUCRS
Universidade Federal do Ceará
Universidade de São Paulo (USP)
Universidade Federal do Rio Grande Do Sul
Instituto de Cardiologia
Hospital Universitário Universidade Federal do Maranhão
Universidade Federal de Pernambuco (UFPE)
Universidade Federal de Pelotas
Instituto de Medicina Integral Prof Fernando Figueira
Universidade do Estado do Rio de Janeiro (UERJ)
Universidade Federal de Minas Gerais (UFMG)
Universidade Federal de Goiás (UFG)
Universidade Estadual Paulista (UNESP)
Hospital do Coração de Alagoas
Anis Rassi Hospital
Hospital Universitário Procape
UFF
Hospital Israelita Albert Einstein
dc.contributor.author.fl_str_mv Fuchs, Flávio D.
Scala, Luiz C. N.
Vilela-Martin, José F.
Whelton, Paul K.
Poli-de-Figueiredo, Carlos E.
Pereira E Silva, Ricardo
Gus, Miguel
Bortolotto, Luiz A.
Consolim-Colombo, Fernanda M.
Schlatter, Rosane P.
Cesarino, José E.
Castro, Iran
Figueiredo Neto, José A.
Chaves, Hilton
Steffens, André A.
Alves, João G.
Brandão, Andréa A.
de Sousa, Marcos R.
Jardim, Paulo C.
Moreira, Leila B.
Franco, Roberto S. [UNESP]
Gomes, Marco M.
Afiune Neto, Abrahão
Fuchs, Felipe C.
Sobral Filho, Dario C.
Nóbrega, Antônio C.
Nobre, Fernando
Berwanger, Otávio
Fuchs, Sandra C.
dc.subject.por.fl_str_mv Amiloride
Chlorthalidone
Diabetes
Drug treatment
Hypertension
Losartan
topic Amiloride
Chlorthalidone
Diabetes
Drug treatment
Hypertension
Losartan
description Aims: To compare the blood pressure (BP)-lowering efficacy of a chlorthalidone/amiloride combination pill with losartan, during initial management of JNC 7 Stage I hypertension in patients with type 2 diabetes mellitus. Methods: In an a priori subgroup analysis of a randomized, double-blind, controlled trial, volunteers aged 30–70 years, with stage I hypertension and diabetes mellitus, were randomized to 12.5/2.5 mg of chlorthalidone/amiloride (N = 47) or 50 mg of losartan (N = 50), and followed for 18 months in 21 clinical centers. If BP remained uncontrolled after three months, study medication dose was doubled, and if uncontrolled after six months, amlodipine (5 and 10 mg) and propranolol (40 and 80 mg BID) were added as open label drugs in a progressive fashion. Results: Systolic BP decreased to a greater extent in participants allocated to diuretics compared to losartan (P < 0.001). After 18 months of follow-up, systolic BP was 128.4 ± 10.3 mmHg in the diuretic group versus 133.5 ± 8.0 in the losartan group (P < 0.01). In the diuretic group, 36 out of 43 participants (83.7%) had a JNC 7 normal BP, compared to 31/47 (66%) in the losartan group (P = 0.089). Serum cholesterol was higher in the diuretic arm at the end of the trial. Other biochemical parameters and reports of adverse events did not differ by treatment. Conclusions: Treatment of hypertension based on a combination of chlorthalidone and amiloride is more effective for BP lowering compared to losartan in patients with diabetes mellitus and hypertension. Trial registration: Clinical trials registration number: NCT00971165
publishDate 2021
dc.date.none.fl_str_mv 2021-02-01
2022-04-28T19:29:26Z
2022-04-28T19:29:26Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://dx.doi.org/10.1007/s00592-020-01611-8
Acta Diabetologica, v. 58, n. 2, p. 215-220, 2021.
1432-5233
0940-5429
http://hdl.handle.net/11449/221581
10.1007/s00592-020-01611-8
2-s2.0-85092361547
url http://dx.doi.org/10.1007/s00592-020-01611-8
http://hdl.handle.net/11449/221581
identifier_str_mv Acta Diabetologica, v. 58, n. 2, p. 215-220, 2021.
1432-5233
0940-5429
10.1007/s00592-020-01611-8
2-s2.0-85092361547
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv Acta Diabetologica
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 215-220
dc.source.none.fl_str_mv Scopus
reponame:Repositório Institucional da UNESP
instname:Universidade Estadual Paulista (UNESP)
instacron:UNESP
instname_str Universidade Estadual Paulista (UNESP)
instacron_str UNESP
institution UNESP
reponame_str Repositório Institucional da UNESP
collection Repositório Institucional da UNESP
repository.name.fl_str_mv Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)
repository.mail.fl_str_mv
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