The use of drug based on technologically processed antibodies to endocannabinoid receptor type 1 in the treatment of obesity in adults: results of a multicenter double blind placebo controlled randomized clinical trial

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Abstract

Aim. To evaluate the clinical efficacy and safety of Dietressa at a dose of 6 tablets per day for 24 weeks in the treatment of patients with Class 1 obesity. To compare the clinical efficacy of two treatment regimens (1 tablet 6 times per day and 2 tablets 3 times per day) for 24 weeks in the treatment of patients with Class 1 obesity.

Materials and methods. A clinical trial included 493 patients with Class 1 obesity from 18 to 65 years. The proportion of patients who lose greater than or equal to 5 percent of baseline body weight, an average decrease of body weight, a change in waist circumference, dynamics of the quality of life, and the safety of the therapy were assessed.

Results. A weight decrease was established among patients without regard to the studied regimens of Dietressa (in a daily dose of 6 tablets with a six- or three-time intake). The goals were achieved by 49% [53%] of patients in the first treatment regimen (statistically significant compared to placebo therapy: p=0.04) [р=0.018]), 48% (51%) in the second (p=0.004 [р=0.0004]) and 48% [52%] of patients in the combined Dietressa group (p=0.0007 [р<0.0001]). The average absolute weight loss was -4.4±4.2 [-4.8±4.2] kg in the Dietressa-1 group (p=0.0001 [р<0.0001]) and -4.4±4.4 [-4.7±4.4] kg in the Dietressa-2 group (p<0.0001) [р<0.0001]). Against the background of the conducted therapy mental component was improved on week 4 (p<0.0001) and 24 (p=0.006) as well as parameter of physical health on week 4 (p=0,003) and 12 (p=0,006). Waist circumference significantly decreased every 4 weeks in patients receiving Dietressa (p<0.0001 for three comparisons between weeks). A 6-month course of Dietressa therapy demonstrated a favorable safety profile. The frequency of adverse events had no significant differences between Dietressa and Placebo groups.

Conclusion. The monotherapy with Dietressa is safe, and it leads to at least 5 percent reduction in body weight during 24 weeks of therapy in patients with Class 1 obesity.

About the authors

Tatiana Y. Demidova

Pirogov Russian National Research Medical University

Author for correspondence.
Email: t.y.demidova@gmail.com

доктор медицинских наук, профессор, заведующий кафедрой эндокринологии

Russian Federation, Moscow

Elena I. Krasil’nikova

Pavlov First Saint Petersburg State Medical University,

Email: t.y.demidova@gmail.com

доктор медицинских наук, профессор каф. факультетской терапии

Russian Federation, Saint Petersburg

Sergey V. Vorob’ev

Rostov State Medical University

Email: t.y.demidova@gmail.com
ORCID iD: 0000-0001-7884-2433

доктор медицинских наук, профессор, заведующий кафедрой эндокринологии с курсом детской эндокринологии факультета пост­дипломного образования

Russian Federation, Rostov-on-Don

Tatiana V. Morugova

Bashkir State Medical University

Email: t.y.demidova@gmail.com
ORCID iD: 0000-0001-7405-486X

доктор медицинских наук, профессор, заведующий кафедрой эндокринологии

Russian Federation, Ufa

Tatiana V. Adasheva

5Yevdokimov Moscow State University of Medicine and Dentistry

Email: t.y.demidova@gmail.com
ORCID iD: 0000-0002-3763-8994

доктор медицинских наук, профессор кафедры поликлинической терапии

Russian Federation, Moscow

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Supplementary files

Supplementary Files
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2. Fig. 1. Edmonton Obesity staging system [8].

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3. Fig. 2. Patient flow.

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4. Fig. 3. Relative weight loss over 24 weeks for a Per Protocol sample for 2 regimens.

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5. Fig. 4. Proportion of patients with a weight loss of 5% or more during 24 weeks of treatment for the PP sample.

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6. Fig. 5. Dynamics of the mental (a) and physical (b) health components according to the SF-36 questionnaire during treatment with Dietressa for the PP sample.

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7. Fig. 6. Dynamics of the severity of anxiety in accordance with the HADS scale during treatment.

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8. Fig. 7. Dynamics of depression severity in accordance with the HADS scale during treatment.

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