Spironolactone Versus Clonidine as a Fourth-Drug Therapy for Resistant Hypertension: The ReHOT Randomized Study (Resistant Hypertension Optimal Treatment). Issue 4 (April 2018)

• Record Type: Journal Article
• Authors: Krieger, Eduardo M.; Drager, Luciano F.; Giorgi, Dante M.A.; Pereira, Alexandre C.; Barreto-Filho, José Augusto Soares; Nogueira, Armando R.; Mill, José Geraldo; Lotufo, Paulo A.; Amodeo, Celso; Batista, Marcelo C.; Bodanese, Luiz C.; Carvalho, Antônio C.C.; Castro, Iran; Chaves, Hilton; Costa, Eduardo A.S.; Feitosa, Gilson S.; Franco, Roberto J.S.; Fuchs, Flávio D.; Guimarães, Armênio C.; Jardim, Paulo C.; Machado, Carlos A.; Magalhães, Maria E.; Mion, Décio; Nascimento, Raimundo M.; Nobre, Fernando; Nóbrega, Antônio C.; Ribeiro, Antônio L.P.; Rodrigues-Sobrinho, Carlos R.; Sanjuliani, Antônio F.; Teixeira, Maria do Carmo B.; Krieger, Jose E.; Betito, Alessandro; Fagundes Moia, Diogo Duarte; de Souza, Silvia Beatriz Paulino Cavasin; Júnior, Hilton de Castro Chaves;
• Is Part Of: Hypertension. Volume 71:Issue 4(2018:Apr.)
• Publication Date: 2018-04
• Subjects: blood pressure -- clinical trial -- humans -- hypertension -- risk -- therapeutics; Hypertension -- Periodicals; Hypertension -- Treatment -- Periodicals; 616.132005
• DOI: 10.1161/HYPERTENSIONAHA.117.10662
• Languages: English
• ISSNs: 0194-911X

Abstract

Abstract : 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. Abstract : Supplemental Digital Content is available in the text.