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A comparison between diuretics and angiotensinreceptor blocker agents in patients with stage I hypertension (PREVER-treatment trial) : study protocol for a randomized double-blind controlled trial

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A comparison between diuretics and angiotensinreceptor blocker agents in patients with stage I hypertension (PREVER-treatment trial) : study protocol for a randomized double-blind controlled trial

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Título A comparison between diuretics and angiotensinreceptor blocker agents in patients with stage I hypertension (PREVER-treatment trial) : study protocol for a randomized double-blind controlled trial
Autor Fuchs, Flávio Danni
Fuchs, Sandra Cristina Pereira Costa
Moreira, Leila Beltrami
Gus, Miguel
Nobrega, Antonio Claudio Lucas da
Figueiredo, Carlos Eduardo Poli de
Mion Junior, Décio
Bortolotto, Luiz Aparecido
Colombo, Fernanda Marciano Consolim
Nobre, Fernando
Coelho, Eduardo Barbosa
Martin, Jose Fernando Vilela
Moreno Junior, Heitor
Cesarino, Evandro José
Franco, Roberto Jorge da Silva
Brandão, Andréa Araujo
Sousa, Marcos Roberto de
Ribeiro, Antônio Luiz Pinho
Jardim, Paulo Cesar B. Veiga
Afiune Neto, Abrahão
Scala, Luiz César Nazário
Gomes, Marco Antônio Mota
Chaves, Hilton
Alves, João Guilherme Bezerra
Sobral Filho, Dário Celestino
Silva, Ricardo Pereira e
Figueiredo Neto, José Albuquerque de
Irigoyen, Maria Claudia Costa
Castro, Iran
Steffens, André Avelino
Schlatter, Rosane Paixão
Mello, Renato Bandeira de
Mosele, Francisca
Ghizzoni, Flávia
Berwanger, Otávio
Abstract Background: Cardiovascular disease is the leading cause of death in Brazil, and hypertension is its major risk factor. The benefit of its drug treatment to prevent major cardiovascular events was consistently demonstrated. Angiotensin-receptor blockers (ARB) have been the preferential drugs in the management of hypertension worldwide, despite the absence of any consistent evidence of advantage over older agents, and the concern that they may be associated with lower renal protection and risk for cancer. Diuretics are as efficacious as other agents, are well tolerated, have longer duration of action and low cost, but have been scarcely compared with ARBs. A study comparing diuretic and ARB is therefore warranted. Methods/design: This is a randomized, double-blind, clinical trial, comparing the association of chlorthalidone and amiloride with losartan as first drug option in patients aged 30 to 70 years, with stage I hypertension. The primary outcomes will be variation of blood pressure by time, adverse events and development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. The secondary outcomes will be fatal or non-fatal cardiovascular events: myocardial infarction, stroke, heart failure, evidence of new subclinical atherosclerosis and sudden death. The study will last 18 months. The sample size will be of 1200 participants for group in order to confer enough power to test for all primary outcomes. The project was approved by the Ethics committee of each participating institution. Discussion: The putative pleiotropic effects of ARB agents, particularly renal protection, have been disputed, and they have been scarcely compared with diuretics in large clinical trials, despite that they have been at least as efficacious as newer agents in managing hypertension. Even if the null hypothesis is not rejected, the information will be useful for health care policy to treat hypertension in Brazil.
Contido em Trials (Online). London. Vol. 12 (2011), 5 p.
Assunto Adulto
Amilorida
Anti-hipertensivos
Bloqueadores do receptor tipo I de angiotensina II
Brasil
Clortalidona
Diuréticos
Efeitos adversos
Efeitos de drogas
Fatores de tempo
Feminino
Fisiopatologia
Hipertensão
Humanos
Idoso
Índice de gravidade de doença
Losartan
Masculino
Meia-idade
Método duplo-cego
Pressão arterial
Projetos de pesquisa
Quimioterapia
Quimioterapia combinada
Resultado de tratamento
Uso terapêutico
Origem Estrangeiro
Tipo Artigo de periódico
URI http://hdl.handle.net/10183/30373
Arquivos Descrição Formato
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