Adherence to antihypertensive treatment and the blood pressure–lowering effects of renal denervation in the renal denervation for hypertension (DENERHTN) trial

M Azizi, H Pereira, I Hamdidouche, P Gosse… - Circulation, 2016 - Am Heart Assoc
M Azizi, H Pereira, I Hamdidouche, P Gosse, M Monge, G Bobrie, P Delsart…
Circulation, 2016Am Heart Assoc
Background: The DENERHTN trial (Renal Denervation for Hypertension) confirmed the
blood pressure–lowering efficacy of renal denervation added to a standardized stepped-
care antihypertensive treatment for resistant hypertension at 6 months. We report the
influence of adherence to antihypertensive treatment on blood pressure control. Methods:
One hundred six patients with hypertension resistant to 4 weeks of treatment with
indapamide 1.5 mg/d, ramipril 10 mg/d (or irbesartan 300 mg/d), and amlodipine 10 mg/d …
Background
The DENERHTN trial (Renal Denervation for Hypertension) confirmed the blood pressure–lowering efficacy of renal denervation added to a standardized stepped-care antihypertensive treatment for resistant hypertension at 6 months. We report the influence of adherence to antihypertensive treatment on blood pressure control.
Methods
One hundred six patients with hypertension resistant to 4 weeks of treatment with indapamide 1.5 mg/d, ramipril 10 mg/d (or irbesartan 300 mg/d), and amlodipine 10 mg/d were randomly assigned to renal denervation plus standardized stepped-care antihypertensive treatment, or the same antihypertensive treatment alone. For standardized stepped-care antihypertensive treatment, spironolactone 25 mg/d, bisoprolol 10 mg/d, prazosin 5 mg/d, and rilmenidine 1 mg/d were sequentially added at monthly visits if home blood pressure was ≥135/85 mm Hg after randomization. We assessed adherence to antihypertensive treatment at 6 months by drug screening in urine/plasma samples from 85 patients.
Results
The numbers of fully adherent (20/40 versus 21/45), partially nonadherent (13/40 versus 20/45), or completely nonadherent patients (7/40 versus 4/45) to antihypertensive treatment were not different in the renal denervation and the control groups, respectively (P=0.3605). The difference in the change in daytime ambulatory systolic blood pressure from baseline to 6 months between the 2 groups was –6.7 mm Hg (P=0.0461) in fully adherent and –7.8 mm Hg (P=0.0996) in nonadherent (partially nonadherent plus completely nonadherent) patients. The between-patient variability of daytime ambulatory systolic blood pressure was greater for nonadherent than for fully adherent patients.
Conclusions
In the DENERHTN trial, the prevalence of nonadherence to antihypertensive drugs at 6 months was high (≈50%) but not different in the renal denervation and control groups. Regardless of adherence to treatment, renal denervation plus standardized stepped-care antihypertensive treatment resulted in a greater decrease in blood pressure than standardized stepped-care antihypertensive treatment alone.
Clinical Trial Registration
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01570777.
Am Heart Assoc
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