Flávio D Fuchs1, Sandra C Fuchs1, Carlos E Poli-de-Figueiredo2, José A Figueiredo Neto3, Luiz César N Scala4, José F Vilela-Martin5, Leila B Moreira1, Hilton Chaves6, Marco Mota Gomes7, Marcos R de Sousa8, Ricardo Pereira E Silva9, Iran Castro10, Evandro José Cesarino11, Ana Luiza Lima Sousa12, João Guilherme Alves13, André Avelino Steffens14, Andréa Araujo Brandão15, Luiz Aparecido Bortolotto16, Abrahão Afiune Neto17, Antônio C Nóbrega18, Roberto Silva Franco19, Dario C Sobral Filho20, Fernando Nobre21, Rosane Schlatter1, Miguel Gus1, Caroline Nespolo De David1, Leticia Rafaelli1, Guilhermo Prates Sesin1, Otávio Berwanger22, Paul K Whelton23. 1. Division of Cardiology, Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul. 2. Faculdade de Medicina, Hospital São Lucas, PUCRS, Porto Alegre. 3. Hospital Universitário, Universidade Federal do Maranhão, São Luis. 4. Hospital Universitário Júlio Müller, Universidade Federal de Mato Grosso, Cuiabá. 5. Faculdade de Medicina de São José do Rio Preto e Hospital de Base, São José do Rio Preto. 6. Universidade Federal de Pernambuco, Recife. 7. Hospital do Coração, Maceio. 8. Hospital das Clínicas da Universidade Federal de Minas Gerais, Belo Horizonte. 9. Hospital Universitário Walter Cantídio, Universidade Federal do Ceará, Fortaleza. 10. Instituto de Cardiologia, Porto Alegre, Porto Alegre. 11. Faculdade de Ciências Farmacêuticas, USP Ribeirão Preto, Ribeirão Preto. 12. Hospital das Clínicas da Universidade Federal de Goiás, Goiania. 13. Instituto de Medicina Integral Prof. Fernando Figueira, Recife. 14. Universidade Federal de Pelotas, Pelotas. 15. Universidade do Estado do Rio de Janeiro, Rio de Janeiro. 16. Instituto do Coração, Faculdade de Medicina, Universidade de São Paulo, São Paulo. 17. Hospital do Coração Anis Rassi, Goiania. 18. Hospital Universitário Antônio Pedro, Universidade Federal Fluminense, Niteroi. 19. Faculdade de Medicina de Botucatu, Botucatu. 20. Hospital Universitário PROCAPE, Recife. 21. Faculdade de Medicina de Ribeirão Preto, USP Ribeirão Preto, Ribeirão Preto. 22. Research Institute HCor Hospital do Coração, São Paulo, Brazil. 23. Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana, USA.
Abstract
BACKGROUND: To determine the effectiveness of low-dose diuretic therapy to achieve an optimal level of blood pressure (BP) in adults with prehypertension. METHODS: The PREVER-prevention trial was a randomized, parallel, double-blinded, placebo-controlled trial, with 18 months of follow-up, conducted at 21 academic medical centers in Brazil. Of 1772 individuals evaluated for eligibility, 730 volunteers with prehypertension who were aged 30-70 years, and who did not reach optimal blood pressure after 3 months of lifestyle intervention, were randomized to a fixed association of chlorthalidone 12.5 mg and amiloride 2.5 mg or placebo once a day. The main outcomes were the percentage of participants who achieved an optimal level of BP. RESULTS: A total of 372 participants were randomly allocated to diuretics and 358 to placebo. After 18 months of treatment, optimal BP was noted in 25.6% of the diuretic group and 19.3% in the placebo group (P < 0.05). The mean net reduction in SBP and DBP for the diuretic group compared with placebo was 2.8 mmHg (95% CI 1.1 to 4.5) and 1.1 mmHg (95% CI -0.09 to 2.4), respectively. Most participants in the active treatment group (74.5%) and in the placebo group (80.7%) continued to have BP in the prehypertension range or progressed to hypertension. CONCLUSION:Low-dose diuretic therapy increased the probability of individuals with prehypertension to achieve optimal BP but most of those treated continued to have a BP in the prehypertension range or progressed to having overt hypertension.
RCT Entities:
BACKGROUND: To determine the effectiveness of low-dose diuretic therapy to achieve an optimal level of blood pressure (BP) in adults with prehypertension. METHODS: The PREVER-prevention trial was a randomized, parallel, double-blinded, placebo-controlled trial, with 18 months of follow-up, conducted at 21 academic medical centers in Brazil. Of 1772 individuals evaluated for eligibility, 730 volunteers with prehypertension who were aged 30-70 years, and who did not reach optimal blood pressure after 3 months of lifestyle intervention, were randomized to a fixed association of chlorthalidone 12.5 mg and amiloride 2.5 mg or placebo once a day. The main outcomes were the percentage of participants who achieved an optimal level of BP. RESULTS: A total of 372 participants were randomly allocated to diuretics and 358 to placebo. After 18 months of treatment, optimal BP was noted in 25.6% of the diuretic group and 19.3% in the placebo group (P < 0.05). The mean net reduction in SBP and DBP for the diuretic group compared with placebo was 2.8 mmHg (95% CI 1.1 to 4.5) and 1.1 mmHg (95% CI -0.09 to 2.4), respectively. Most participants in the active treatment group (74.5%) and in the placebo group (80.7%) continued to have BP in the prehypertension range or progressed to hypertension. CONCLUSION: Low-dose diuretic therapy increased the probability of individuals with prehypertension to achieve optimal BP but most of those treated continued to have a BP in the prehypertension range or progressed to having overt hypertension.