Adherence to Antihypertensive Treatment and the Blood Pressure–Lowering Effects of Renal Denervation in the Renal Denervation for Hypertension (DENERHTN) Trial
Authors: Azizi Michel , Pereira Helena , Hamdidouche Idir , Gosse Philippe , Monge Matthieu , Bobrie Guillaume , Delsart Pascal , Mounier-Véhier Claire , Courand Pierre-Yves , Lantelme Pierre , Denolle Thierry , Dourmap-Collas Caroline , Girerd Xavier , Michel Halimi Jean , Zannad Faiez , Ormezzano Olivier , Vaïsse Bernard , Herpin Daniel , Ribstein Jean , Chamontin Bernard , Mourad Jean-Jacques , Ferrari Emile , Plouin Pierre-François , Jullien Vincent , Sapoval Marc , Chatellier Gilles , Amar L. , Lorthioir A. , Pagny J.-Y. , Claisse G. , Midulla M. , Dauphin R. , Fauvel J.P. , Rouvière O. , Cremer A. , Grenier N. , Lebras Y. , Trillaud H. , Heautot J.F. , Larralde A. , Paillard F. , Cluzel P. , Rosenbaum D. , Alison D. , Claudon M. , Popovic B. , Rossignol P. , Baguet J.P. , Thony F. , Bartoli J.M. , Drouineau J. , Sosner P. , Tasu J.P. , Velasco S. , Vernhet-Kovacsik H. , Bouhanick B. , Rousseau H. , Le Jeune S. , Lopez-Sublet M. , Bellmann L. , Esnault V. , Baguet J.P. , Vernhet-Kovacsik H. , Durand-Zaleski I. , Beregi (chair) J.P. , Lièvre M. , Persu A. 
Published: August 2016

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.