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Spironolactone Versus Clonidine as a Fourth-Drug Therapy for Resistant Hypertension

2018; Lippincott Williams & Wilkins; Volume: 71; Issue: 4 Linguagem: Inglês

10.1161/hypertensionaha.117.10662

1524-4563

E M Krieger, Luciano F. Drager, D Giorgi, Alexandre C. Pereira, José Augusto Barreto‐Filho, Armando R. Nogueira, José Geraldo Mill, Paulo A. Lotufo, Celso Amodeo, Marcelo C. Batista, Luiz Carlos Bodanese, Antonio C.C Carvalho, Iran Castro, Hilton Chaves, Eduardo A. Costa, Gílson Soares Feitosa, Roberto Jorge da Silva Franco, Flávio Danni Fuchs, Armênio Costa Guimarães, Paulo César Brandão Veiga Jardim, Carlos Alberto Machado, Maria Eliane Campos Magalhães, Décio Mion, Raimundo Marques Nascimento, Fernando Nobre, Antônio Cláudio Lucas da Nóbrega, Antônio Luiz Pinho Ribeiro, Carlos R.M. Rodrigues‐Sobrinho, Antônio Felipe Sanjuliani, Maria do Carmo Borges Teixeira, José Eduardo Krieger, Alessandro Betito, Diogo D.F. Moia, Silvia Beatriz Paulino Cavasin de Souza, Hilton de Castro Chaves Júnior,

Cardiovascular Syncope and Autonomic Disorders

The aim of this study is to compare spironolactone versus clonidine as the fourth drug in patients with resistant hypertension in a multicenter, randomized trial. Medical therapy adherence was checked by pill counting. Patients with resistant hypertension (no office and ambulatory blood pressure [BP] monitoring control, despite treatment with 3 drugs, including a diuretic, for 12 weeks) were randomized to an additional 12-week treatment with spironolactone (12.5–50 mg QD) or clonidine (0.1–0.3 mg BID). The primary end point was BP control during office (<140/90 mm Hg) and 24-h ambulatory (<130/80 mm Hg) BP monitoring. Secondary end points included BP control from each method and absolute BP reduction. From 1597 patients recruited, 11.7% (187 patients) fulfilled the resistant hypertension criteria. Compared with the spironolactone group (n=95), the clonidine group (n=92) presented similar rates of achieving the primary end point (20.5% versus 20.8%, respectively; relative risk, 1.01 [0.55–1.88]; P =1.00). Secondary end point analysis showed similar office BP (33.3% versus 29.3%) and ambulatory BP monitoring (44% versus 46.2%) control for spironolactone and clonidine, respectively. However, spironolactone promoted greater decrease in 24-h systolic and diastolic BP and diastolic daytime ambulatory BP than clonidine. Per-protocol analysis (limited to patients with ≥80% adherence to spironolactone/clonidine treatment) showed similar results regarding the primary end point. In conclusion, clonidine was not superior to spironolactone in true resistant hypertensive patients, but the overall BP control was low (≈21%). Considering easier posology and greater decrease in secondary end points, spironolactone is preferable for the fourth-drug therapy. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01643434.