A SPECIFIC 3 MONTHS-PROGRAM TO IMPROVE NON-ADHERENCE IN UNCONTROLLED HYPERTENSION IMPROVES BLOOD PRESSURE CONTROL AND ASSOCIATED ORGAN DAMAGE (ATHAN CLINICAL TRIAL)

Abstract

Objective: To evaluate whether a specific 3-month(m) action plan to improve therapeutic adherence in patients with uncontrolled hypertension on ◊ 2 drugs results in a decrease in BP and whether this is maintained at 12m. Secondly, to assess if this correlates with an improvement in subclinical organ damage. Design and Method: Prospective, randomized clinical trial where patients attended consecutively in a Hypertension Unit with ambulatory 24h-BP ◊130/80 mmHg despite receiving at least 2 antihypertensive drugs and with therapeutic non-compliance confirmed by the determination of antihypertensive drugs in the urine, were randomized (1:1) to receive a specific 3-month program to improve adherence (INT = intervention) or routine follow-up (C = control). Antihypertensive treatment was not modified, but beyond 3m all patients received usual care. Before randomization, and at 3m and 12m, urinary screening for antihypertensive drugs and albuminuria, and 24h-ambulatory BP monitoring were determined. Results: Forty-six patients were randomized. At 3m, mean (95%CI) baseline-adjusted BP differences (INT vs. C) were -14.7 mmHg (-5.4 to -24.1), p = 0.001 and -10.0 mmHg (-3.9 to -16.2), p<0.001 for 24h-SBP and 24h-DBP, respectively. The INT group maintained the BP decrease at 12m. vs. baseline: mean(95%CI) variation of 24h-SBP = -16.1 mmHg (-22.8 to -9.4), p<0.001 and variation of 24h-DBP = -7.8 (-12.8 to -2.7), p = 0.002. In the INT group, the percentage of non-detected antihypertensive drugs decreased compared to baseline: median [IQR]: 40% [20-85.7], 0% [0-25], and 18.3 % [0-40] at baseline, 3m and 12m respectively; Z = -3.295 (p<0.001) and Z = -3.055 (p = 0.002) for changes at 3m and 12m, respectively. Albuminuria (median [IQR]) decreased in the INT group: 27.1 mg/g [11.2-116.2] and 22.4 mg/g [6.4-91.9] at baseline and 12m, respectively (Z = -2.207, p = 0.027). At 12m, variation of albuminuria correlated with variation of 24h-BP but not with variation of percentage of non-detected antihypertensive drugs. Conclusions: a 3-month specific nursing intervention to improve therapeutic adherence results in improved BP control in patients with inadequate therapeutic compliance. This improvement continues beyond the completion of this program. Decreased BP correlates with a regression of albuminuria.