What is the clinical evidence from this study?

Study design: RCT. Population: True resistant hypertension (n=24). Intervention: Spironolactone vs. Sympathetic renal denervation (RDN). Primary outcome: Change in 24-h ambulatory systolic blood pressure (SBP) from baseline to 6 months (MD -17.9, 95% CI -30.9 to -4.9, p=0.010).

June 23, 2016Journal of Hypertension81 citationsOpen Access

Spironolactone versus sympathetic renal denervation to treat true resistant hypertension

AOAnna OliverasHospital Del Mar PAPedro ArmarioHospital de Sant Joan Despí Moisès Broggi ACAlbert Benet i ClaràUniversitat Pompeu Fabra

Key Result

Spironolactone reduced 24-h systolic blood pressure significantly more than sympathetic renal denervation (mean difference -17.9 mmHg) at 6 months in patients with true resistant hypertension.

Study Design

Type

RCT (n=24)

Blinding

Open-label

Randomization

1:1 ratio, stratified by centres using randomized blocks of small size and permutation of treatments within each block

Multicenter

Yes

Structured PICO

Does spironolactone reduce 24-h SBP more than renal denervation in patients with resistant hypertension?

Population

24 adults aged 18-80 years with true resistant hypertension on at least three antihypertensive drugs, followed for 6 months.

Intervention

Spironolactone (50 mg) as add-on therapy

Comparator

Renal denervation (RDN) as add-on therapy

Outcome

Change in 24-h SBP at 6 monthssurrogate

Spironolactone 50 mg is more effective than renal denervation at reducing 24-hour ambulatory blood pressure in patients with true resistant hypertension, supporting its use as the preferred fourth-line agent.

Main Result

Mean Difference: -17.9 (95% CI -30.9–-4.9)

Absolute Event Rate: -23.6% vs -5.7%

p-value: p=0.010

Limitations

Relatively small sample size
Open-label design
Exclusion of at-risk patients (low GFR or high baseline serum potassium)
Cannot strictly ensure therapeutic adherence
Results cannot be extrapolated to other clinical settings or generalizable to other RDN catheters or devices

Abstract

OBJECTIVE: Both renal denervation (RDN) and spironolactone have been proposed for the treatment of resistant hypertension. However, they have not been compared in a randomized clinical trial. We aimed to compare the efficacy of spironolactone versus RDN in patients with resistant hypertension. METHODS: A total of 24 patients with office SBP at least 150 mmHg and 24-h SBP at least 140 mmHg despite receiving at least three full-dose antihypertensive drugs, one a diuretic, but without aldosterone antagonists, were randomized to receive RDN or spironolactone (50 mg) as add-on therapy. Primary endpoint was change in 24-h SBP at 6 months. Comparisons between treatment groups were performed using generalized linear models adjusted by age, sex, and baseline values. RESULTS: Spironolactone was more effective than RDN in reducing 24-h SBP and 24-h DBP: mean baseline-adjusted differences between the two groups were -17.9 mmHg (95%CI -30.9 to -4.9); P = 0.010 and -6.6 mmHg (95%CI -12.9 to -0.3); P = 0.041, for 24-h SBP and 24-h DBP, respectively. As regards changes in office blood pressure, mean baseline-adjusted differences between the two groups were -12.1 mmHg (95%CI -29.1 to 5.1); P = 0.158 and of -5.3 mmHg (95%CI -16.3 to 5.8); P = 0.332, for office SBP and office DBP, respectively. Otherwise, the decrease of estimated glomerular filtration rate was greater in the spironolactone group; mean baseline-adjusted difference between the two groups was -10.7 ml/min per 1.73 m (95%CI -20.1 to -1.4); P = 0.027. CONCLUSION: We conclude that spironolactone is more effective than RDN to reduce 24-h SBP and 24-h DBP in patients with resistant hypertension. Therefore, spironolactone should be the fourth antihypertensive drug to prescribe if deemed well tolerated' in all patients with resistant hypertension before considering RDN.

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