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Made available in DSpace on 2022-04-28T19:29:26Z (GMT). No. of bitstreams: 0 Previous issue date: 2021-02-01 Hospital de Clínicas de Porto Alegre 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 Division of Cardiology Hospital de Clínicas de Porto Alegre Universidade Federal do Rio Grande Do Sul INCT PREVER, CPC, 5º. and Ramiro Barcelos, 2350 Hospital Universitário Júlio Müller Universidade Federal de Mato Grosso Faculdade de Medicina São José Do Rio Preto Department of Epidemiology School of Public Health and Tropical Medicine Tulane University Faculdade de Medicina Hospital São Lucas PUCRS Hospital Universitário Walter Cantídio Universidade Federal do Ceará Faculdade de Medicina Instituto do Coração Universidade de São Paulo Hospital de Clínicas de Porto Alegre Universidade Federal do Rio Grande Do Sul Faculdade de Ciências Farmacêuticas USP Ribeirão Preto Instituto de Cardiologia, Av. Princesa Isabel Hospital Universitário Universidade Federal do Maranhão Universidade Federal de Pernambuco Universidade Federal de Pelotas Instituto de Medicina Integral Prof Fernando Figueira Universidade Do Estado do Rio de Janeiro Hospital das Clínicas da Universidade Federal de Minas Gerais Hospital das Clínicas de Goiânia Universidade Federal de Goiás Faculdade de Medicina de Botucatu Hospital do Coração de Alagoas Anis Rassi Hospital Hospital Universitário Procape Hospital Universitário Antônio Pedro UFF Faculdade de Medicina de Ribeirão Preto USP Ribeirão Preto Instituto de Pesquisa Hospital Israelita Albert Einstein Faculdade de Medicina de Botucatu Hospital de Clínicas de Porto Alegre: GPPG: 08-621

Made available in DSpace on 2022-04-28T19:09:40Z (GMT). No. of bitstreams: 0 Previous issue date: 2018-04-01 Ministry of Science and Technology 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 12.5mg and amiloride 2.5mg 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

To compare the blood pressure (BP)-lowering efficacy of a chlorthalidone/amiloride combination pill with losartan, during initial management of stage I hypertension.In a randomized, double-blind, controlled trial, 655 participants were followed for 18 months in 21 Brazilian academic centers. Trial participants were adult volunteers aged 30-70 years with stage I hypertension (BP 140-159 or 90-99 mmHg) following 3 months of a lifestyle intervention. Participants were randomized to 12.5/2.5 mg of chlorthalidone/amiloride (N = 333) or 50 mg of losartan (N = 322). If BP remained uncontrolled after 3 months, study medication dose was doubled, and if uncontrolled after 6 months, amlodipine (5 and 10 mg) and propranolol (40 and 80 mg twice daily) were added as open-label drugs in a progressive fashion. At the end of follow-up, 609 (93%) participants were evaluated.The difference in SBP during 18 months of follow-up was 2.3 (95% confidence interval: 1.2 to 3.3) mmHg favoring chlorthalidone/amiloride. Compared with those randomized to diuretic, more participants allocated to losartan had their initial dose doubled and more of them used add-on antihypertensive medication. Levels of blood glucose, glycosilated hemoglobin, and incidence of diabetes were no different between the two treatment groups. Serum potassium was lower and serum cholesterol was higher in the diuretic arm. Microalbuminuria tended to be higher in patients with diabetes allocated to losartan (28.5 ± 40.4 versus 16.2 ± 26.7 mg, P = 0.09).Treatment with a combination of chlorthalidone and amiloride compared with losartan yielded a greater reduction in BP.NCT00971165.

Background Prehypertension is associated with higher cardiovascular risk, target organ damage, and incidence of hypertension. The Prevention of Hypertension in Patients with PreHypertension (PREVER‐Prevention) trial aimed to evaluate the efficacy and safety of a low‐dose diuretic for the prevention of hypertension and end‐organ damage. Methods and Results This randomized, parallel, double‐blind, placebo‐controlled trial was conducted in 21 Brazilian academic medical centers. Participants with prehypertension who were aged 30 to 70 years and who did not reach optimal blood pressure after 3 months of lifestyle intervention were randomized to a chlorthalidone/amiloride combination pill or placebo and were evaluated every 3 months during 18 months of treatment. The primary outcome was incidence of hypertension. Development or worsening of microalbuminuria, new‐onset diabetes mellitus, and reduction of left ventricular mass were secondary outcomes. Participant characteristics were evenly distributed by trial arms. The incidence of hypertension was significantly lower in 372 study participants allocated to diuretics compared with 358 allocated to placebo (hazard ratio 0.56, 95% CI 0.38–0.82), resulting in a cumulative incidence of 11.7% in the diuretic arm versus 19.5% in the placebo arm (P=0.004). Adverse events; levels of blood glucose, glycosylated hemoglobin, creatinine, and microalbuminuria; and incidence of diabetes mellitus were no different between the 2 arms. Left ventricular mass assessed through Sokolow‐Lyon voltage and voltage‐duration product decreased to a greater extent in participants allocated to diuretic therapy compared with placebo (P=0.02). Conclusions A combination of low‐dose chlorthalidone and amiloride effectively reduces the risk of incident hypertension and beneficially affects left ventricular mass in patients with prehypertension. Fundo A pré-hipertensão está associada a maior risco cardiovascular, lesão de órgãos-alvo e incidência de hipertensão. O estudo Prevention of Hypertension in Patients with PreHypertension (PREVER-Prevention) teve como objetivo avaliar a eficácia e a segurança de um diurético de baixa dosagem para a prevenção da hipertensão e danos aos órgãos-alvo. Métodos e Resultados Este estudo randomizado, paralelo, duplo-cego e controlado por placebo foi conduzido em 21 centros médicos acadêmicos brasileiros. Os participantes com pré-hipertensão com idades entre 30 e 70 anos e que não atingiram a pressão arterial ideal após 3 meses de intervenção no estilo de vida foram randomizados para uma pílula combinada de clortalidona/amilorida ou placebo e foram avaliados a cada 3 meses durante 18 meses de tratamento. O desfecho primário foi a incidência de hipertensão. Desenvolvimento ou agravamento de microalbuminúria, diabetes mellitus de início recente e redução da massa ventricular esquerda foram desfechos secundários. As características dos participantes foram distribuídas uniformemente pelos braços do ensaio. A incidência de hipertensão foi significativamente menor em 372 participantes do estudo alocados para diuréticos em comparação com 358 alocados para placebo (taxa de risco 0,56, IC 95% 0,38–0,82), resultando em uma incidência cumulativa de 11,7% no braço diurético versus 19,5% no braço braço placebo (P = 0,004). Eventos adversos; níveis de glicose no sangue, hemoglobina glicosilada, creatinina e microalbuminúria; e incidência de diabetes mellitus não foram diferentes entre os 2 braços. A massa ventricular esquerda avaliada por meio da voltagem de Sokolow-Lyon e do produto voltagem-duração diminuiu em maior extensão em participantes alocados para terapia diurética em comparação com placebo (P = 0,02). Conclusões Uma combinação de baixa dose de clortalidona e amilorida reduz efetivamente o risco de hipertensão incidente e afeta beneficamente a massa ventricular esquerda em pacientes com pré-hipertensão.

Submitted by Vitor Silverio Rodrigues (vitorsrodrigues@reitoria.unesp.br) on 2014-05-27T11:25:30Z No. of bitstreams: 0Bitstream added on 2014-05-27T14:31:08Z : No. of bitstreams: 1 2-s2.0-79952197520.pdf: 336059 bytes, checksum: 6887bfb6c66c449f86ed80f9d7459718 (MD5) Made available in DSpace on 2014-05-27T11:25:30Z (GMT). No. of bitstreams: 0 Previous issue date: 2011-03-05 Background: Blood pressure (BP) within pre-hypertensive levels confers higher cardiovascular risk and is an intermediate stage for full hypertension, which develops in an annual rate of 7 out of 100 individuals with 40 to 50 years of age. Non-drug interventions to prevent hypertension have had low effectiveness. In individuals with previous cardiovascular disease or diabetes, the use of BP-lowering agents reduces the incidence of major cardiovascular events. In the absence of higher baseline risk, the use of BP agents reduces the incidence of hypertension. The PREVER-prevention trial aims to investigate the efficacy, safety and feasibility of a population-based intervention to prevent the incidence of hypertension and the development of target-organ damage.Methods: This is a randomized, double-blind, placebo-controlled clinical trial, with participants aged 30 to 70 years, with pre-hypertension. The trial arms will be chlorthalidone 12.5 mg plus amiloride 2.5 mg or identical placebo. The primary outcomes will be the incidence of hypertension, 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 sub-clinical atherosclerosis, and sudden death. The study will last 18 months. The sample size was calculated on the basis of an incidence of hypertension of 14% in the control group, a size effect of 40%, power of 85% and P alpha of 5%, resulting in 625 participants per group. The project was approved by the Ethics committee of each participating institution.Discussion: The early use of blood pressure-lowering drugs, particularly diuretics, which act on the main mechanism of blood pressure rising with age, may prevent cardiovascular events and the incidence of hypertension in individuals with hypertension. If this intervention shows to be effective and safe in a population-based perspective, it could be the basis for an innovative public health program to prevent hypertension in Brazil.Trial Registration: Clinical Trials NCT00970931. © 2011 Fuchs et al; licensee BioMed Central Ltd. Hospital de Clínicas de Porto Alegre Universidade Federal do Rio Grande do Sul, Porto Alegre Hospital Universitário Antônio Pedro Universidade Federal Fluminense, Niterói Hospital São Lucas Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre Hospital das Clinicas Universidade de São Paulo, São Paulo Instituto do Coração Universidade de São Paulo, São Paulo Faculdade de Medicina de Ribeirão Preto Universidade de São Paulo, Ribeirão Preto Faculdade de Medicina São José do Rio Preto, São José do Rio Preto Faculdade de Ciências Médicas Universidade de Campinas, Campinas Faculdade de Ciências Farmacêuticas Universidade de São Paulo, Ribeirão Preto Faculdade de Medicina de Botucatu Universidade Estadual de São Paulo, Botucatu Universidade do Estado do Rio de Janeiro, Rio de Janeiro Hospital das Clínicas Universidade Federal de Minas Gerais, Belo Horizonte Hospital das Clínicas de Goiânia Universidade Federal de Goiás, Goiânia Anis Rassi Hospital, Goiânia Hospital Universitário Júlio Muller Universidade Federal de Mato Grosso, Cuiabá Faculdade de Medicina Universidade de Ciências da Saúde Alagoas, Maceió Faculdade de Medicina Universidade Federal de Pernambuco, Recife Instituto de Medicina Integral Prof Fernando Figueira, Recife Hospital Universitário Oswaldo Cruz/PROCAPE Universidade de Pernambuco, Recife Hospital Universitário Valter Cantídio Universidade Federal do Ceará, Fortaleza Hospital Universitário Universidade Federal Maranhão, São Luiz Instituto de Cardiologia Fundação Universitária de Cardiologia, Porto Alegre Faculdade de Medicina Universidade Federal de Pelotas, Pelotas Hospital do Coração, São Paulo Faculdade de Medicina de Botucatu Universidade Estadual de São Paulo, Botucatu

To investigate the influence of race, binge drinking and alcohol addiction on the association between consumption of alcoholic beverages and incidence of hypertension.In a population-based cohort study, 1089 adults were interviewed and had blood pressure and anthropometric measurements carried out at home. Their alcohol consumption was ascertained by an amount-frequency questionnaire. Binge drinking was defined as consumption of five or more drinks on one occasion for men or four drinks for women, and abuse of alcohol as consumption of 30 g/day or more in men or 15 g/day or more in women. Incident cases of hypertension were characterized by blood pressureor = 140/90 mmHg or use of hypertension medication.Among 589 normotensive individuals in the baseline visit, 127 incident cases of hypertension were identified, after a follow-up of 5.6 +/- 1.1 years. Binge drinking and alcohol dependency were not associated with the incidence of hypertension. Adjusted (age, education) risk ratios for the incidence of hypertension (95% confidence interval) were significant only for non-white abusers of ethanol: 11.8 (1.6-86.9). Systolic blood pressure of black abusers increased by 16.1 +/- 3.5 mmHg, in comparison with 4.9 +/- 1.5 mmHg among white abusers (P = 0.004).Individuals with an African ancestry, who consumed larger amounts of ethanol, are at higher risk of developing hypertension. This risk is not explained by a binge drinking pattern or addiction to alcohol.