[First results of open randomized clinical study of Acridilol in combination therapy of patients with arterial hypertension and obesity or type 2 diabetes (Mellitus-Open Multicenter Clinical Study ACCORD)].
OBJECTIVE
To study efficacy and safety of a preparation of carvedilol Acridilol (Akrikhin, Russia) in patients with mild and moderate arterial hypertension (AH) and obesity and/or compensated type 2 diabetes mellitus (DM).


METHODS
Patients (n=592) suffering from mild to moderate AH in combination with DM and/or obesity participated in a randomized comparative open study with parallel groups. By means of randomization these patients were distributed into 2 groups: patients of group 1 (n=291) after washout period following withdrawal of previously taken b-blockers received acridilol for 24 weeks together with other antihypertensive therapy. In control group 2 (n=301) stable antihypertensive therapy was carried out during 24 weeks. Efficacy of hypotensive therapy was assessed during visits to physicians every 2 weeks throughout the whole study. At the beginning and in the end of the study we conducted assessment of biochemical parameters of carbohydrate and lipid metabolism, registered 12-lead ECG, and assessed status of anxiety and depression.


RESULTS
At the background of the conducted treatment in patients of both groups significant lowering of hemodynamic parameters (systolic and diastolic BP and heart raid) was revealed, differences between groups by the 24-th week were statistically significant. By the end of the study target BP level was achieved in 96.8% of patients in carvedilol group and in 88% of patients of control group (p < 0.001). In both groups positive dynamics of parameters of anxiety-depression status of patients was noted while therapy with carvedilol (acridilol) led to statistically significant (p=0.01) improvement of status of depression compared with control treatment. Also necessity in hospitalization significantly decreased in patients of both groups: number of hospitalizations declined 5 times in acridilol group (p < 0.0001) and 3 times in control group (p < 0.0001). During the study 32 cases of adverse effects were registered: 17 at the background of therapy with acridilol and 15 at the background of control treatment (p=0.58), however most of them were of weak or moderate degree of severity.


CONCLUSIONS
The results obtained demonstrate high efficacy and safety of the preparation of carvedilol acridilol in patients with combination pathology, high metabolic risk, and high risk of cardiovascular complications.
Shal'nova
S A
SA
Martsevich
S Iu
SIu
Deev
A D
AD
Lukina
Iu V
IuV
Oganov
R G
RG
D000317:Adrenergic alpha-Antagonists / Q000627:therapeutic use*; D000328:Adult; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use*; D002227:Carbazoles / Q000627:therapeutic use*; D000077261:Carvedilol; D003131:Combined Modality Therapy; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000453:epidemiology*; D004232:Diuretics / Q000627:therapeutic use*; D005260:Female; D006339:Heart Rate / Q000502:physiology; D006439:Hemodynamics; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000453:epidemiology*; D008297:Male; D009765:Obesity / Q000453:epidemiology* / Q000628:therapy*; D010276:Parasympatholytics / Q000627:therapeutic use*; D011412:Propanolamines / Q000627:therapeutic use*
D000317:Adrenergic alpha-Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors; D002227:Carbazoles; D004232:Diuretics; D010276:Parasympatholytics; D011412:Propanolamines; D000077261:Carvedilol