Adherence to Antihypertensive Treatment and the Blood Pressure Lowering Effects of Renal Denervation in the Renal Denervation for Hypertension (DENERHTN) Trial
Background—The DENERHTN trial 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—106 patients with resistant hypertension to 4-week treatment with indapamide 1.5 mg/day, ramipril 10 mg/day (or irbesartan 300 mg/day), and amlodipine 10 mg/day 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/day, bisoprolol 10 mg/day, prazosin 5 mg/day, and rilmenidine 1 mg/day were sequentially added at monthly visits if home blood pressure was ≥135/85 mmHg 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 vs. 21/45), partially non-adherent (13/40 vs. 20/45) or completely non-adherent patients (7/40 vs. 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 two groups was -6.7 mmHg (p= 0.0461) in fully adherent and -7.8 mmHg (p= 0.0996) in non-adherent (partially non-adherent plus completely non-adherent) patients. The between-patient variability of daytime ambulatory systolic blood pressure was greater for non-adherent than for fully adherent patients.
Conclusions—In the DENERHTN trial, the prevalence of non-adherence 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.
- Received April 13, 2016.
- Revision received July 19, 2016.
- Accepted July 29, 2016.