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Vaclavik J.,Palacky University | Vaclavik J.,University Hospital Olomouc | Sedlak R.,Prostejov Hospital | Plachy M.,St Annes University Hospital | And 7 more authors.
Hypertension | Year: 2011

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. © 2011 American Heart Association, Inc. Source


Vaclavik J.,Palacky University | Sedlak R.,Prostejov Hospital | Plachy M.,St Annes University Hospital | Navratil K.,Military Hospital | And 4 more authors.
Biomedical Papers | Year: 2011

Background. There is currently limited data on which drug should be used to improve blood pressure control in patients with resistant hypertension. Recent observational trials reported spironolactone as having good effects. This study is designed to assess the effect of the addition of 25 mg of spironolactone on blood pressure (BP) in patients with resistant arterial hypertension. Methods. Patients with office systolic BP >140 mmHg or diastolic BP >90 mmHg despite treatment with at least 3 antihypertensive drugs including a diuretic, are enrolled in this double-blind, placebo-controlled, multicentre trial. Patients are randomly assigned to receive spironolactone or a placebo at a ratio of 1:1 by the method of simple randomisation. Our primary endpoints are to show a statistically significant difference in the fall of mean day-time systolic and diastolic BP by ambulatory blood pressure monitoring (ABPM), between the spironolactone and placebo groups, after 8 weeks of treatment. Secondary outcomes are changes of serum potassium, natrium, creatinine, body weight, casual blood pressure in office, difference in the fall of mean night-time and 24-hour ABPM BP and treatment response depending on different baseline levels of aldosterone and aldosterone/PRA ratio. This study is registered with ClinicalTrials.gov, No. NCT00524615. Discussion. If spironolactone proves effective, it might become the standard of treatment in patients with resistant arterial hypertension. ©J. Vaclavik, R. Sedlak, M. Plachy, K. Navratil, J. Plasek, R. Husar, E. Kocianova, M. Taborsky. Source


Vaclavik J.,Palacky University | Sedlak R.,Prostejov Hospital | Jarkovsky J.,Masaryk University | Kocianova E.,Palacky University | Taborsky M.,Palacky University
Biomedical Papers | Year: 2014

Methods. Patients with an office systolic blood pressure (BP) >140 mmHg or diastolic BP >90 mmHg, despite treatment with at least 3 antihypertensive drugs including a diuretic, were randomly assigned to receive spironolactone or a placebo for 8 weeks in a double-blind, placebo-controlled, multicentre trial (ASPIRANT).Background. There are currently limited data on whether the effect of spironolactone in patients with resistant arterial hypertension depends on age and sex.Results. Analyses were done on 55 patients treated with spironolactone and 56 patients treated with placebo. Significant reductions of office systolic BP (-8.9 ± 6.7 mmHg, P=0.012), 24-h ABPM systolic BP (-7.9 ± 7.2 mmHg, P=0.032) and ABPM day-time systolic BP (-7.5 ± 7.1 mmHg) after 8 weeks of spironolactone treatment, compared to placebo, were only observed in patients with a median age >62 years. The office and ABPM systolic BP reductions in patients aged ≤62 years and diastolic BP reductions by spironolactone in both age groups were not significant compared to placebo. Women tended to have a nonsignificantly higher reduction in systolic BP with spironolactone treatment, and there was no difference in diastolic BP reduction between women and men.Conclusions. Spironolactone only leads to a reduction of systolic BP in older patients with resistant arterial hypertension aged >62 years, and is effective to a similar extent in men and women. © 2014, PALACKY UNIV. All rights reserved. Source


Vaclavik J.,University Hospital Olomouc | Vaclavik J.,Palacky University | Sedlak R.,Prostejov Hospital | Jarkovsky J.,Masaryk University | And 4 more authors.
Biomedical Papers | Year: 2013

Aims. There are currently limited data about whether the effect of spironolactone in patients with resistant arterial hypertension depends on baseline blood pressure and the presence of a secondary cause of hypertension. Methods. Patients with office systolic blood pressure (BP) >140 mmHg or diastolic BP >90 mmHg, despite treatment with at least 3 antihypertensive drugs including a diuretic, were randomly assigned to receive spironolactone or a placebo for 8 weeks in a double-blind, placebo-controlled, multicentre trial (ASPIRANT). Results. Analyses were done with 55 patients treated with spironolactone. The degree of BP reduction after 8 weeks of spironolactone treatment did not differ significantly between the three tertiles of baseline systolic BP and patients with and without a secondary cause of hypertension. The reduction of office systolic, office diastolic BP and office pulse pressure was significantly lower in the highest tertile with baseline diastolic BP > 97 mmHg. Conclusions. Spironolactone treatment is effective to a similar extent both in patients with and without a secondary cause of hypertension and regardless of the baseline value of systolic BP. Less effect of spironolactone was found in patients with the highest baseline diastolic BP. Source


Vaclavik J.,Palacky University | Sedlak R.,Prostejov Hospital | JarkovskY J.,Masaryk University | Kocianova E.,Palacky University | TaborskY M.,Palacky University
Medicine (United States) | Year: 2014

This study was designed to assess the effect of the addition of low-dose spironolactone on blood pressure (BP) in patients with resistant arterial hypertension. Patients with office systolic blood pressure (SBP) >140mm Hg or diastolic blood pressure (DBP)>90mmHg despite treatment with at least 3 antihypertensive drugs, including a diuretic, were enrolled in this double-blind, placebo-controlled, multicentre trial. One hundred sixtyone patients in outpatient internal medicine departments of 6 hospitals in the Czech Republic were randomly assigned to receive 25mg of spironolactone (N=81) or a placebo (N=80) once daily as an add-on to their antihypertensivemedication, using simple randomization. This study was registered with ClinicalTrials.gov, number NCT00524615. Analyses were done with 150 patients who finished the follow-up (74 in the spironolactone and 76 in the placebo group). At 8 weeks, BP values were decreased more by spironolactone, with differences in mean fall of SBP of-9.8, -13.0, -10.5, and -9.9mm Hg (P<0.001 for all) in daytime, nighttime, and 24-hour ambulatory BP monitoring and in the office. The respective DBP differences were -3.2, -6.4,-3.5, and -3.0mm Hg (P=0.013, P<0.001, P=0.005, and P=0.003). Adverse events in both groups were comparable. The office SBP goal <140mm Hg at 8 weeks was reached in 73% of patients using spironolactone and 41% using placebo (P=0.001). Spironolactone in patients with resistant arterial hypertension leads to a significant decrease of both SBP and DBP and markedly improves BP control. Copyright © 2014 Wolters Kluwer Health / Lippincott Williams & Wilkins. Source

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