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Effectiveness of Chlorthalidone Plus Amiloride for the Prevention of Hypertension: The PREVER‐Prevention Randomized Clinical Trial

2016; Wiley; Volume: 5; Issue: 12 Linguagem: Inglês

10.1161/jaha.116.004248

2047-9980

Sandra Cristina Pereira Costa Fuchs, Carlos Eduardo Poli‐de‐Figueiredo, José Albuquerque de Figueiredo Neto, Luiz César Nazário Scala, Paul K. Whelton, Francisca Mosele, Renato Gorga Bandeira de Mello, José Fernando Vilela-Martin, Leila Beltrami Moreira, Hilton Chaves, Marco Mota Gomes, Marcos Roberto de Sousa, Ricardo Pereira e Silva, Iran Castro, Evandro José Cesarino, Paulo César Brandão Veiga Jardim, João Guilherme Bezerra Alves, André Avelino Steffens, Andréa Araújo Brandão, Fernanda Marciano Consolim‐Colombo, Paulo Ricardo de Alencastro, Abrahão Afiune Neto, Antônio Cláudio Lucas da Nóbrega, Roberto Silva Franco, Dário Celestino Sobral Filho, Alexandro Bordignon, Fernando Nobre, Rosane Paixão Schlatter, Miguel Gus, Felipe Costa Fuchs, Otávio Berwanger, Flávio Danni Fuchs,

Cardiovascular Health and Disease Prevention

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.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).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.URL: http://www.ClinicalTrials.gov, www.ensaiosclinicos.gov. Unique identifiers: NCT00970931, RBR-74rr6s.