Spironolactone Versus Clonidine as a Fourth-Drug Therapy for Resistant Hypertension: The ReHOT Randomized Study (Resistant Hypertension Optimal Treatment) - PubMed (original) (raw)

Randomized Controlled Trial

. 2018 Apr;71(4):681-690.

doi: 10.1161/HYPERTENSIONAHA.117.10662. Epub 2018 Feb 20.

Luciano F Drager 2, Dante M A Giorgi 2, Alexandre C Pereira 2, José Augusto Soares Barreto-Filho 2, Armando R Nogueira 2, José Geraldo Mill 2, Paulo A Lotufo 2, Celso Amodeo 2, Marcelo C Batista 2, Luiz C Bodanese 2, Antônio C C Carvalho 2, Iran Castro 2, Hilton Chaves 2, Eduardo A S Costa 2, Gilson S Feitosa 2, Roberto J S Franco 2, Flávio D Fuchs 2, Armênio C Guimarães 2, Paulo C Jardim 2, Carlos A Machado 2, Maria E Magalhães 2, Décio Mion Jr 2, Raimundo M Nascimento 2, Fernando Nobre 2, Antônio C Nóbrega 2, Antônio L P Ribeiro 2, Carlos R Rodrigues-Sobrinho 2, Antônio F Sanjuliani 2, Maria do Carmo B Teixeira 2, Jose E Krieger 2; ReHOT Investigators

Collaborators, Affiliations

Randomized Controlled Trial

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

Eduardo M Krieger et al. Hypertension. 2018 Apr.

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.

Keywords: blood pressure; clinical trial; humans; hypertension; risk; therapeutics.

© 2018 American Heart Association, Inc.

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