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Addition of Spironolactone in Patients With Resistant Arterial Hypertension (ASPIRANT): A Randomized, Double-Blind, Placebo-Controlled Trial.
MedLine Citation:
PMID:  21536989     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
There is currently limited data on which drug should be used to improve blood pressure (BP) control in patients with resistant hypertension. This study was designed to assess the effect of the addition of 25 mg of spironolactone on BP in patients with resistant arterial hypertension. Patients with office systolic BP >140 mm Hg or diastolic BP >90 mm Hg despite treatment with at least 3 antihypertensive drugs, including a diuretic, were enrolled in this double-blind, placebo-controlled, multicenter trial. One hundred seventeen patients were randomly assigned to receive spironolactone (n=59) or a placebo (n=58) as an add-on to their antihypertensive medication, by the method of simple randomization. Analyses were done with 111 patients (55 in the spironolactone and 56 in the placebo groups). At 8 weeks, the primary end points, a difference in mean fall of BP on daytime ambulatory BP monitoring (ABPM), between the groups was -5.4 mm Hg (95% CI -10.0; -0.8) for systolic BP (P=0.024) and -1.0 mm Hg (95% CI -4.0; 2.0) for diastolic BP (P=0.358). The APBM nighttime systolic, 24-hour ABPM systolic, and office systolic BP values were significantly decreased by spironolactone (difference of -8.6, -9.8, and -6.5 mm Hg; P=0.011, 0.004, and 0.011), whereas the fall of the respective diastolic BP values was not significant (-3.0, -1.0, and -2.5 mm Hg; P=0.079, 0.405, and 0.079). The adverse events in both groups were comparable. In conclusion, spironolactone is an effective drug for lowering systolic BP in patients with resistant arterial hypertension.
Authors:
Jan Václavík; Richard Sedlák; Martin Plachy; Karel Navrátil; Jirí Plásek; Jirí Jarkovsky; Tomás Václavík; Roman Husár; Eva Kociánová; Milos Táborsky
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-5-2
Journal Detail:
Title:  Hypertension     Volume:  -     ISSN:  1524-4563     ISO Abbreviation:  -     Publication Date:  2011 May 
Date Detail:
Created Date:  2011-5-3     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7906255     Medline TA:  Hypertension     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Department of Internal Medicine I, University Hospital Olomouc and Palacký University School of Medicine, Olomouc, Czech Republic; Department of Internal Medicine, Prostějov Hospital, Prostějov, Czech Republic; Internal Medicine Department II, St. Anne's University Hospital, Brno, Czech Republic; Department of Internal Medicine, Military Hospital, Olomouc, Czech Republic; Department of Internal Medicine, University Hospital Ostrava, Ostrava, Czech Republic; Institute of Biostatistics and Analyses at the Faculty of Medicine and the Faculty of Science of the Masaryk University, Brno, Czech Republic; Statistics and Probability Department, Faculty of Informatics and Statistics, University of Economics in Prague, Prague, Czech Republic; Department of Internal Medicine, Hranice Hospital, Hranice na Moravě, Czech Republic.
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