BLOOD PRESSURE LOWERING DEVICE IN PATIENTS WITH DRUG-REFRACTORY HYPERTENSION

Svintsova G. Improvement of blood pressure control with non-invasive blood pressure lowering device in patients with drug-refractory arterial hypertension / G. Svintsova, N. Bagmanova, M. Umnikova, Y. Kotovskaya, Z. Kobalava // 19th European Meeting on hypertension: abstracts -Milan. 2009. р. 423

IMPROVEMENT OF BLOOD PRESSURE CONTROL WITH NONINVASIVE BLOOD PRESSURE LOWERING DEVICE IN PATIENTS WITH DRUG-REFRACTORY ARTERIAL HYPERTENSION

G. Svintsova, N. Bagmanova, Y. Kotovskaya, Z. Kobalava.
Russian Peoples’ Friendship University, Moscow, Russia,

M. Umnikova
Denas MS Corporation Medical Center, Ekaterinburg, Russia

Objective: To evaluate efficacy of non-invasive blood pressure (BP) lowering device DiaDENS-Cardio on home BP in patients with drug-refractory arterial hypertension (AH) in a placebo controlled study.

Methods: DiaDENS-Cardio device works as a bracelet impulsive stimulator of anterior wrist zone including the active point MS6 Nay-Guan. Sixty non-diabetic patients (32 female, mean age 53.7±9.7 years, clinic BP 155.4±8.9/83.3±5,9mmHg) with uncontrolled AH despite adherence to an appropriate 3-drug regimen including a diuretic participate in the single blind placebo controlled study. The patients were randomly assigned to start treatment from active or placebo device followed by changing type of the device in two weeks without wash-out period. Duration each treatment period was 2 weeks. The device was applied on the wrist OD in the morning for 6-8 minutes. HBPM was performed with UA767PC (AND, Japan) device every day in the morning and in the evening during the whole study. ABPM was performed with BP-Lab («Petr Telegin», Nizhniy Novgorog, Russia) before start of the device treatment and after each 2 week period. Antihypertensive medication treatment remained unchanged during the study. The data are presented as M±SD, p<0.05 was considered significant.

Results: After 2 weeks of treatment with active device target BP (<140/90 mmHg) was observed in all patients, the BP normalization rate during placebo was 20%. Baseline ABPM and HBPM confirmed drug resistant AH: 24-hours BP was 144.2±6.0/81.9±4.8, daytime 145.6±7.6/84.2±5.8, nighttime 127,2±5.8/79.1±6.2mmHg, HBP 149.2±8,4/89.1 ±6.9mmHg. HBPM revealed no placebo effect: on the 1st day of placebo device treatment BP was 149.2±8.4/89.1±6.9, on the 14th 146±7.9/90.8±8.1 mmHg. During active device treatment HBPM was significantly lower comparing to placebo: respectively, 133.4±7.4/82.6±6.1 vs 144.9±7.4/87.9±7.5mmHg, p05. Morning HBP values were 134.4±6.2/82,1±6J vs 147.9±8.4/ 88.9±7.2mmHg, p<0.05, evening 131.4±6.0/83.1±5.1 vs 142.9±6.2/ 85.9±6.2 mmHg, p<0.05. After active device treatment ABPM values were significantly lower than after placebo: 24-hours 129.2±6.0/79.2±4.7 vs 143.9±5.9/81.3±5.0, daytime 132.2±6.2/82.0±4.2 vs 145.1±8.6/83.5±6.4 and nighttime 121.1±7.0/73.4±4.2 vs 128.0±5.4/77.3±5.0mmHg). No increase in BP variability was found. One patient with baseline clinic BP 144/93 mmHg reported dizziness due to lowering BP to 112/70 mmHg with active device.

Conclusion: DiaDENS-Cardio device is an effective tool to treat drug-resistant arterial hypertension.